cefoxitin
cisplatin

There is a risk of very uncommon or previously unknown side effects occurring. Treatment may result in allergic reactions, the decreased ability of the body to fight infection, and abnormalities in growth or structure of the fetus. Very rarely, one or a combination of these side effects may cause death. These drugs may interact with other drugs to produce unexpected side-effects.  
| Cisplatin                                                                                                                                                                          | Common                                                                                                 | Occasional         |                   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------|-------------------|
| Happens to 21-100 children out of 100                                                                                                                                              | Happens to 5-20                                                                                        |                    |                   |
| children out of every  100                                                                                                                                                         | Rare                                                                                                   |                    |                   |
| Happens to <5                                                                                                                                                                      |                                                                                                        |                    |                   |
| children out of every  100                                                                                                                                                         |                                                                                                        |                    |                   |
| Immediate: Within 1-2 days of  receiving drug                                                                                                                                      | Nausea (L), vomiting (L)                                                                               | Metallic Taste (L) | Allergic reaction |
| Prompt:                                                                                                                                                                            | Loss of appetite (L), low level of                                                                     |                    |                   |
| Within 2-3 weeks,                                                                                                                                                                  | magnesium salts in the blood (L),                                                                      |                    |                   |
| prior to the next course hearing loss (high sounds [L]), damage to  kidney tissue (L), Decrease in the  number of red and white blood cells and  platelets made in the bone marrow | Numbness, tingling,  clumsiness (L),  ringing in the ears  (L), seizure (L),  damage to the liver  (L) |                    |                   |
| Delayed: Any time later during  therapy, excluding the  above conditions                                                                                                           | Abnormal levels of  certain salts in the body  like sodium and  potassium (L) Hearing Loss             |                    |                   |
| Late: Any time after  completion of  treatment                                                                                                                                     | Cancer caused by  treatment for a previous  cancer or leukemia                                         |                    |                   |
| (L) Toxicity may also occur later.                                                                                                                                                 |                                                                                                        |                    |                   |
cefoxitin
citalopram adverse effects serious

- **Cardiovascular:** Myocardial infarction (0.1% to 1%), Prolonged QT interval (0.5% to 1.9%), Torsades de pointes, Tachycardia (0.5-1%)
- **Neurologic:** Cerebrovascular accident (0.1% to 1%) - **Psychiatric:** Depression, worsening (rare), Suicidal thoughts, Suicide
- **Other:** Serotonin syndrome  
- **Dermatologic:** Diaphoresis (5% to 18%)
- **Gastrointestinal:** Constipation (13%), Diarrhea (8%), Nausea (20% to 21%), Vomiting
(4% to 20%), Xerostomia (17% to 20%)
- **Musculoskeletal:** Arthralgia (2%), Myalgia (2%)
- **Neurologic:** Dizziness (up to 14%), Headache (up to 18%), Insomnia (15%), Sedated
(15%), Somnolence (18%), Tremor (8% to 16%)
- **Psychiatric:** Agitation (3% to 10%) - **Reproductive:** Disorder of ejaculation (6.1%)
Respiratory: Rhinitis (5%), Sinusitis (3%), Upper Respiratory Tract Infection (5%)**Other:** Fatigue
(5%);
cefoxitin
clemastine adverse effects

Serious:
- **None indicated**
Common:
- **Gastrointestinal:** Xerostomia
- **Neurologic:** Sedated, Somnolence
- **Renal:** Urinary retention
cefoxitin
clindamycin adverse effects serious

- **Dermatologic:** Erythema multiforme - **Gastrointestinal:** Pseudomembranous enterocolitis - **Hematologic:** Agranulocytosis - **Hepatic:** Increased liver function test, Jaundice
- **Dermatologic:** Dry skin, Rash
- **Gastrointestinal:** Abdominal pain, Diarrhea, Nausea
- **Reproductive:** Candida vaginitis (14% vaginal cream ; 1.5% vaginal suppository),
Vaginal pain (up to 2% vaginal suppository)  
| Risks and side effects related to the clofarabine include: Likely Less Likely   | Rare but serious                                                                                                                                                                                                                                                                                       |              |    |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| -                                                                               | A fast heartbeat which may  cause pain in the chest                                                                                                                                                                                                                                                    |              |    |
| -                                                                               | A feeling of extreme tiredness  not relieved by sleep                                                                                                                                                                                                                                                  |              |    |
| -                                                                               | A decrease in blood pressure                                                                                                                                                                                                                                                                           |              |    |
| -                                                                               | Pain in the abdomen (belly)                                                                                                                                                                                                                                                                            |              |    |
| -                                                                               | Diarrhea                                                                                                                                                                                                                                                                                               |              |    |
| -                                                                               | Nausea and/or vomiting                                                                                                                                                                                                                                                                                 |              |    |
| -                                                                               | Headache                                                                                                                                                                                                                                                                                               |              |    |
| -                                                                               | Fever                                                                                                                                                                                                                                                                                                  |              |    |
| -                                                                               | Chills                                                                                                                                                                                                                                                                                                 |              |    |
| -                                                                               | Anxiety                                                                                                                                                                                                                                                                                                |              |    |
| -                                                                               | Fever with a low white blood  cell count which could mean  that you have an infection and  might require hospitalization  and treatment with antibiotics                                                                                                                                               |              |    |
| -                                                                               | Loss of appetite                                                                                                                                                                                                                                                                                       |              |    |
| -                                                                               | Elevation in the blood of  certain enzymes found in the  liver and bilirubin (a substance  that comes from the liver  breaking down waste products)  which may mean the liver is  not working as well as normal                                                                                        |              |    |
| -                                                                               | Skin rash                                                                                                                                                                                                                                                                                              |              |    |
| -                                                                               | Skin rash with inflammation                                                                                                                                                                                                                                                                            |              |    |
| -                                                                               | Itching                                                                                                                                                                                                                                                                                                |              |    |
| -                                                                               | Red spots on the skin from low  platelets                                                                                                                                                                                                                                                              |              |    |
| -                                                                               | Bloody nose                                                                                                                                                                                                                                                                                            |              |    |
| -                                                                               | Fewer white blood cells, red  blood cells and platelets in the  blood (may be prolonged) o a low number of white  blood cells can make it  easier to get infections o a low number of red blood  cells can make you feel                                                                               | -            | The rapid death of large  numbers of tumor cells which  can cause the potassium and  phosphate salts and the uric  acid in the blood to rise quickly  and this could lead to a lifethreatening irregular heart beat  or damage to the kidneys.    |
| -                                                                               | Fluid build-up in the tissues                                                                                                                                                                                                                                                                          |              |    |
| -                                                                               | Sleepiness and weakness                                                                                                                                                                                                                                                                                |              |    |
| -                                                                               | Changes to your emotions such  that you feel depressed,  anxious, agitated, irritable or  confused                                                                                                                                                                                                     |              |    |
| -                                                                               | Difficulty sleeping or falling  asleep                                                                                                                                                                                                                                                                 |              |    |
| -                                                                               | High blood pressure                                                                                                                                                                                                                                                                                    |              |    |
| -                                                                               | Cough or shortness of breath                                                                                                                                                                                                                                                                           |              |    |
| -                                                                               | Reddening of the face with  feelings of warmth when the  drug is infusing                                                                                                                                                                                                                              |              |    |
| -                                                                               | A fast rate of respiration that  may cause pain in the chest                                                                                                                                                                                                                                           |              |    |
| -                                                                               | A change in alertness,  concentration, and memory                                                                                                                                                                                                                                                      |              |    |
| -                                                                               | Allergic reaction                                                                                                                                                                                                                                                                                      |              |    |
| -                                                                               | Constipation                                                                                                                                                                                                                                                                                           |              |    |
| -                                                                               | Dizziness                                                                                                                                                                                                                                                                                              |              |    |
| -                                                                               | Tremor (shakiness usually of  the hands)                                                                                                                                                                                                                                                               |              |    |
| -                                                                               | Shaking chills                                                                                                                                                                                                                                                                                         |              |    |
| -                                                                               | Fainting                                                                                                                                                                                                                                                                                               |              |    |
| -                                                                               | Low levels of oxygen in the  blood which may make you feel  short of breath                                                                                                                                                                                                                            |              |    |
| -                                                                               | Inflammation and/or sores in  the mouth that may make  swallowing difficult and are  painful (painful mouth sores)                                                                                                                                                                                     | -            | Severe loss of water from the  body (dehydration) which if  untreated may cause low  blood pressure and severe  loss of salts such as sodium  and potassium from the body  and could lead to the kidneys  failing which could be lifethreatening    |
| -                                                                               | Capillary leak syndrome: a  condition in which fluid and  proteins leak out of tiny blood  vessels and flow into  surrounding tissues, resulting  in dangerously low blood  pressure. Capillary leak  syndrome may lead to  multiple organ failure such as  kidney, heart or liver failure  and shock. |              |    |
| -                                                                               | Inflammation of the pancreas  (an organ in the abdomen  which produces insulin and  certain digestive chemicals)  which may affect the function  of the pancreas and which  may cause pain in the  abdomen (belly) which can be  severe and may increase the  blood sugar                              |              |    |
| -                                                                               | Severe inflammation and  damage to the large intestine  wall which can be life  threatening                                                                                                                                                                                                            |              |    |
| -                                                                               | Inflammation or damage to  the liver which can be severe  and life-threatening and  which may lead to an  enlarged liver and spleen,  bleeding from the veins in the                                                                                                                                   |              |    |
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cefoxitin
clofarabine

| tired and weak      |                                                                                                                                                                                                                     |                                                                                                                                                                         |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| o                   | a low number of platelets  causes you to bruise and  bleed more easily                                                                                                                                              |                                                                                                                                                                         |
| -                   | Abnormal levels of potassium  or magnesium in the body  which may require that you  take extra potassium by mouth  or vein                                                                                          |                                                                                                                                                                         |
| -                   | An increase in an enzyme  (called lipase) that helps break  down fats in the body                                                                                                                                   | esophagus (the passage that  leads from the throat to the  stomach), a yellow  appearance to the skin and  fluid collection in the  abdomen which makes it look  larger |
| -                   | Abnormal clotting of the  blood that can lead to formation of blood clots  and/or bleeding with  abnormal findings on  neurologic exam                                                                              |                                                                                                                                                                         |
| -                   | Severe kidney damage (which  may be permanent)                                                                                                                                                                      |                                                                                                                                                                         |
| -                   | Severe rashes which can  result in loss of skin and  damage to mucous  membranes and which may  be life-threatening (occurred  in combination of other drugs  known to cause this effect)                           |                                                                                                                                                                         |
| -                   | Failure of the bone marrow to  produce blood cells and  platelets which can be life  threatening.                                                                                                                   |                                                                                                                                                                         |
| -                   | A change to the heart such  that it does not pump the  blood as well which may  make you tired, weak, feel  short of breath, and retain  fluid                                                                      |                                                                                                                                                                         |
| -                   | Pain including back, bone, arm,  or leg pain                                                                                                                                                                        |                                                                                                                                                                         |
| -                   | The skin and the whites of the  eyes appears yellow as a result  of too much bilirubin (a  substance that comes from the  liver breaking down waste  products) in the blood                                         |                                                                                                                                                                         |
| -                   | Weight loss                                                                                                                                                                                                         |                                                                                                                                                                         |
| -                   | Aches and pains in the muscles  and joints                                                                                                                                                                          |                                                                                                                                                                         |
| -                   | Bleeding from the bladder, gut,  mouth, or gums                                                                                                                                                                     |                                                                                                                                                                         |
| -                   | Vomiting or coughing blood                                                                                                                                                                                          |                                                                                                                                                                         |
| -                   | Fluid build-up in the lungs that  can make you feel short of  breath                                                                                                                                                |                                                                                                                                                                         |
| -                   | A life threatening condition in  which the level of oxygen in the  blood becomes too low or the  level of carbon dioxide in the  blood becomes too high                                                             |                                                                                                                                                                         |
| -                   | Damage to the sac around the  heart which can lead a build-up  of fluid around the heart which  may be painful and affect the  ability of the heart to work  normally but in most cases is  only mild and temporary |                                                                                                                                                                         |
| -                   | Severe rash with redness and  pain on the palms of the hand  and soles of the feet                                                                                                                                  |                                                                                                                                                                         |
| -                   | Bruising of the skin from low  platelets                                                                                                                                                                            |                                                                                                                                                                         |
| -                   | Rash with redness or red bumpy  rash                                                                                                                                                                                |                                                                                                                                                                         |
| -                   | Increased levels of a chemical  (creatinine) in the blood which  could mean kidney damage                                                                                                                           |                                                                                                                                                                         |
| -                   | Occasional sudden sharp pain  in the rectal area                                                                                                                                                                    |                                                                                                                                                                         |
| -                   | Infections including those  caused by bacteria, virus, and  fungus and can be found in the  lung, the blood, the skin and  other places in the body                                                                 |                                                                                                                                                                         |
| -                   | A life-threatening form of  severe blood infection that  usually results from the  presence of bacteria and their  toxins in the bloodstream and is                                                                 |                                                                                                                                                                         |
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| Issued 12 June 2013 |                                                                                                                                                                                                                     |                                                                                                                                                                         |  
| characterized especially by  persistent hypotension with  reduced blood flow to organs  and tissues and often organ  dysfunction   |                                                                                                                                                                                                     |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -                                                                                                                                  | Abnormal high level of  potassium in the blood which  may cause irregular heart beat  and require drug treatment to  lower the level                                                                |
| -                                                                                                                                  | An increase in an enzyme  (called amylase) that helps  break down starch and sugars in  the body                                                                                                    |
| -                                                                                                                                  | Numbness and tingling in the  fingers and toes                                                                                                                                                      |
| -                                                                                                                                  | A problem in nerve function  that may cause pain, numbness,  tingling, and muscle weakness  in various parts of the body and  may affect the ability to  perform tasks that require fine  movements |  
| Common                                                                                                                                                                                                                                                                                  | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |              |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Abdominal pain Constipation  Diarrhea Nausea Headache Rash dry skin dry hair urticaria alopecia weight gain constipation (2%) epigastric pain (frequent) nausea (10%) vomiting (10%) diarrhea (10%) flatulence (10%) Fatigue  Weakness Drowsiness dizziness  headache Light intolerance | Cardiac arrhythmias Cardiomyopathy (very rare) Peripheral vascular disease (rare) pulmonary embolism (rarae) thrombophlebitis (rare) angina pectoris (rare) cardiac arrhythmias (rare) cardiomyopathy  cardiomegaly intermittent claudication  Thrombophlebitis Pruritus erythema multiforme toxic epidermal necrolysis Stevens-Johnson Syndrome Fevers gallstones  Pancreatitis (rare) Leukopenia (rare) Anemia (rare) Eosinophilia (rare) Agranulocytosis (rare) increase in liver transaminases |              |
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cefoxitin
clofibrate

| Lethargy Somnolence  tiredness   | Systemic lupus erythematosus Drug-induced myopathy flu-like symptoms (rare) myositis (rare) arthralgia (rare) rhadomyolysis (rare) mood disorders cognitive disorders sleep disorders perception disorders  Impotence  decreased libido dysuria  hematuria proteinuria  renal failure   |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
cefoxitin
clomipramine adverse effects serious

- **Cardiovascular:** Cardiac arrest, Orthostatic hypotension (4% to 6%), Prolonged QT
interval, Syncope (2%)
- **Endocrine metabolic:** Hyperglycemia, Increased body temperature
- **Hematologic:** Agranulocytosis, Leukopenia, Pancytopenia, Thrombocytopenia
- **Hepatic:** Hepatotoxicity (1% to 3%) - **Neurologic:** Seizure (0.7%), Serotonin syndrome, Neuromuscular blockade
- **Psychiatric:** Suicidal thoughts, Suicide  
- **Dermatologic:** Diaphoresis (9% to 29%)
- **Endocrine metabolic:** Weight increased (18%) - **Gastrointestinal:** Constipation (22% to 47%), Diarrhea (13%), Indigestion (13% to 22%),
Loss of appetite (12% to 22%), Nausea (33%), Xerostomia (63%% to 84%)
- **Musculoskeletal:** Myalgia (13%) - **Neurologic:** Dizziness (41% to 54%), Feeling nervous (2% to 18%), Headache (28% to 52%), Insomnia (11% to 25%), Myoclonus (13%), Somnolence (46% to 54%), Tremor
(33% to 54%)
- **Ophthalmic:** Abnormal vision (7% to 18%) - **Renal:** Disorder of the urinary system (14%) - **Reproductive:** Disorder of ejaculation (6% to 42%), Impotence (20%),
Respiratory: Pharyngitis (14%)
- **Other:** Fatigue (35% to 39%)
cefoxitin
clonidine adverse effects serious

- **Cardiovascular:** Atrioventricular block, Bradyarrythmia, Rebound Hypertension ,  
- **Dermatologic:** Contact dermatitis (5% to 47%), Erythema (26%), Pruritus, Hyperpigmentation of skin (5%)
- **Gastrointestinal:** Xerostomia (25%) - **Neurologic:** Dizziness (2%), Headache (5%), Sedated (3%), Somnolence (12%) - **Other:** Fatigue (6%)  
| Common                                                                                                                                                                                                                                     | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chest pain Hypertension (4.3%) Pruritus (3.3%) Purpuric disorder (5.3%) Rash (4.2%) Hypercholesterolemia Abdominal pain  Constipation  Diarrhea Gastritis Indigestion  Epistaxia (2.9%) Purpura (5.3%) Arthralgia Backache Headache (7.6%) | Acute myocardial infarction, rebound effect Atrial fibrillation (1% to 2.5%) Congestive heart failure (1% to 2.5%) coronary artery stent thrombosis  erythema multiforme Stevens-Johnson syndrome Gastrointestinal hemorrhage (2%, 2.7% with aspirin) Gastrointestinal ulcer Agranulocytosis (<1%)pancytopenia (severe) Thrombotic thrombocytopenic purpura (rare) Drug-induced liver disorder Hepatitis (rare) Hepatotoxicity Abnormal liver function test (rare) Anaphylaxis (rare) Abnormal renal function (< 1%) Acute renal failure (< 1%) Non-cardiogenic pulmonary edema |
|                                                                                                                                                                                                                                           | This drug may cause chest pain, edema, purpuric disorder, abdominal pain, constipation,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |  
| Common                                                                                                                                                                               | Rare                                                                                                               |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Diarrhea (frequent) Nausea (frequent) Vomiting (frequent) Pruritus Skin irritation (topical application) Abnormal liver enzymes Depression  Drowsiness Disorientation Vision changes | Erythema Stinging  Burning  Urticaria Edema  Loss of appetite Urinary frequency Lower abdominal cramps Dyspareunia |  
- Oral form may cause nausea or vomiting.  
- Advise patients using the intravaginal formulation to not use tampons during treatment.  
- Instruct patients using the topical formulation to not use occlusive dressings over the treated area.  
- Patient should avoid douches or other intravaginal products during drug therapy.  
| Common                                                                                                                                                                                                                                                                                                                                                                                                                                          | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |              |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Hypotension Tachyarrhythmia (25%) Rash (2%) Sweating symptom (6%) Excessive salivation (31%) Nausea (5%) Xerostomia (6%) Motor function behavior changes (4%) Muscle rigidity (3%) Akathisia (3%) Confusion (3%) Dizziness (19%) Headache (7%) Insomnia (2%) Somnolence (39%) Tremor (6%) Vertigo (19%) Visual disturbance (5%) Agitation (4%) Dyssomnia  Nightmares (4%) Restlessness (4%) Urinary tract disorder (2%) Fatigue (2%) Fever (2%) | Cardiac arrest (rare) Myocarditis  Orthostatic hypotension Pericardial effusion (rare) Sudden cardiac death  Syncope (5%) Hyperglycemia (rare) Bowel obstruction  Colitis Necrotizing Fecal impaction Gastrointestinal hypomotility  Ischemic bowel disease Pancreatitis Paralytic ileus Perforation of intestine Agranulocytosis (1.3%) Drug-induced eosinophilia (1%) leucopenia  neutropenia (3%) thrombocytopenia (rare) decreased white blood cells hepatitis (rare) neuroleptic malignant syndrome seizure (5%) tardive dyskinesia (rare) pulmonary embolism (rare) respiratory arrest (rare) |              |
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cefoxitin
clozapine

- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause anticholinergic symptoms, hypotension, sweating, abdominal discomfort, excessive salivation, nausea, headache, tremor, vertigo, dyssomnia, fever, orthostatic hypotension, syncope, or seizure.  
- May cause hypotension, especially with first dose and with dose adjustments.  
- Drug may also cause neuroleptic malignant syndrome (sweating, fever, stupor, unstable blood pressure, muscular rigidity, autonomic dysfunction).  
- Instruct patient to report signs/symptoms of hyperglycemia. - Advise patient to report signs/symptoms of infection, as drug can cause leukopenia. - Instruct patient to report signs/symptoms of heart failure, myocarditis, or cardiomyopathy.  
- Patient should report signs/symptoms of extrapyramidal effects or tardive dyskinesia
(jerky muscle movements, tongue thrusting, facial grimacing/ticks, random movements of extremities), especially when taking high doses or with prolonged treatment.  
- Advise patient against sudden discontinuation of drug. - Encourage patient to maintain adequate hydration during drug therapy. - If dose has been missed for more than two days, advise patient to consult healthcare professional for instructions as dose may not be the same.
cefoxitin
colchicine adverse effects serious

- **Hematologic:** Myelosuppression  
- **Gastrointestinal:** Diarrhea (high dose, 77%; low-dose, 23%), Nausea (high dose, 17%;
low-dose, 4%), Vomiting (17%)
cefoxitin
cortisone adverse effects serious

- **Endocrine metabolic:** Hyperglycemia, Primary adrenocortical insufficiency
- **Musculoskeletal:** Osteoporosis - **Ophthalmic:** Cataract, Glaucoma  
- **Cardiovascular:** Hypertension
- **Dermatologic:** Atrophic condition of skin, Finding of skin healing, Impaired
- **Endocrine metabolic:** Cushing's syndrome, Decreased body growth
- **Gastrointestinal:** Disorder of gastrointestinal tract - **Immunologic:** At risk for infection - **Psychiatric:** Depression, Euphoria
cefoxitin
crizotinib

Common >10%:
- **Cardiovascular**: Edema (28%)
- **Central nervous system**: Fatigue (20%), dizziness (16%)
- **Gastrointestinal**: Nausea (53%), diarrhea (43%), vomiting (40%), constipation (27%),
appetite decreased (19%), taste alteration (12%), esophageal disorder (11%; includes dyspepsia, dysphagia, epigastric burning/discomfort/pain, esophageal obstruction/pain/spasm/ulcer, esophagitis, gastroesophageal reflux, odynophagia, reflux esophagitis)
- **Hematologic**: Lymphopenia (grades 3/4: 11%) - **Hepatic**: ALT increased (13%; grades 3/4: 5%) - **Neuromuscular & skeletal:** Neuropathy (13%; grades 3/4: <1%)
- **Ocular**: Vision disorder (62%; onset: <2 weeks; includes blurred vision, diplopia, photophobia, photopsia, visual acuity decreased, visual brightness, visual field defect, visual impairment, vitreous floaters)
Rare/Occasional 1% to 10%:
- **Cardiovascular**: Bradycardia (5%), chest pain (1%)
- **Central nervous system**: Headache (4%), insomnia (3%) - **Dermatologic**: Rash (10%)
- **Gastrointestinal**: Abdominal pain (8%), stomatitis (6%)
- **Hematologic**: Neutropenia (grades 3/4: 5%) - **Hepatic**: AST increased (9%; grades 3/4: 2%) - **Neuromuscular & skeletal:** Arthralgia (2%) - **Renal**: Renal cysts (1%) - **Respiratory**: Cough (4%), dyspnea (2%), pneumonitis (2%), upper respiratory infection
(2%)  
| Cyanocobalamin                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                             |                                                                                                                                            |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Occasional                                                                                                  | Rare                                                                                                                                       |
| Immediate:  Within 1-2  days of  receiving drug                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Injection site pain                                                                                         | Skin rash, pruritis, urticaria,  diarrhea, anaphylaxis, hypokalemia  (secondary to erythrocyte production  in severe megaloblastic anemia) |
| Prompt:  Within 2-3  weeks,  prior to  next course                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Optic atrophy in Leber's disease                                                                            |                                                                                                                                            |
| Delayed:  Any time  later during  therapy,  excluding the  above  conditions                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Pulmonary edema, congestive heart  failure, peripheral vascular  thrombosis, unmasking of  polycytemia vera |                                                                                                                                            |
| Unknown                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Fetal and teratogenic toxicities: Vitamin B-12 crosses the placenta. Vitamin B12 is an essential            |                                                                                                                                            |
| Frequency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | vitamin and requirements are increased during pregnancy. Amounts of Vitamin B12 that are                    |                                                                                                                                            |
| and Timing:  recommended by the Food and Nutrition Board, National Academy of Science-National  Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.  Vitamin B12 is distributed into breast milk. The American Academy of Pediatrics considers its use to be usually  compatible with breast feeding.  1The product may contain aluminum which can accumulate in patients with renal dysfunction and  premature infants. The product may contain benzyl alcohol dependent upon the manufacturer and  should be avoided in premature infants. |                                                                                                             |                                                                                                                                            |
cefoxitin
cyclophosphamide

| Common                                                                          | Occasional                                                                                                                                                                                                                 | Rare                                                  |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Immediate:                                                                      | Loss of appetite (L), nausea (L),                                                                                                                                                                                          | Metallic taste (L), abnormal                          |
| vomiting (L)                                                                    | hormone function affecting  levels of salt in the blood and  urine, causing too much or too  little urine1 Temporary blurred vision1 , heart  damage with abnormal heart  rhythms1 , decay of muscle tissue  in the heart2 |                                                       |
| Within 2-3                                                                      | Decrease in the number of red and                                                                                                                                                                                          |                                                       |
| wks:                                                                            | white blood cells and platelets  made in the bone marrow, hair  loss                                                                                                                                                       | Bleeding and inflammation of  the urinary bladder (L) |
| Delayed:                                                                        | decreased ability of the body to  fight infection or disease, absence  of sperm or stopped monthly  periods, inability to have  children(L)                                                                                | Damage/scarring of lung tissue 3  (L)                 |
| Late:                                                                           | Cancer caused by treatment for a  previous cancer or leukemia,  damage/scarring of bladder tissue                                                                                                                          |                                                       |
| Unknown Timing and Frequency: Abnormalities in unborn and breast-fed children - |                                                                                                                                                                                                                            |                                                       |  
Late: Cancer caused by treatment for a  
previous cancer or leukemia, damage/scarring of bladder tissue  
Unknown Timing and Frequency: Abnormalities in unborn and breast-fed children  
•  
- 1 *Less common with lower doses.* - 2*Only with very high doses.*  
- 3 Risk increased in someone who has had chest radiation.
cycloserine brand name(s) seromycin adverse
cyclophosphamide

- **Neurologic:** Confusion, Dizziness, Headache, Somnolence  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause confusion, dizziness, headache, somnolence, or seizure.  
- Instruct patient to report depression, suicidal ideation, or unusual changes in behavior. - Advise patients receiving daily doses greater than 500 mg to monitor for and report signs/symptoms of CNS toxicity.  
- Patient should not drink alcohol while taking this drug.  
- hypersensitivity to cycloserine
- epilepsy (current or history of) - depression, anxiety, psychosis (current or history of) - severe renal insufficiency (creatinine clearance less than 50 mL/min) - alcohol abuse
cyclosporin brand name(s) gengraf neoral
adverse effects serious

- **Endocrine metabolic:** Hyperkalemia, Hypomagnesemia
- **Hepatic:** Hepatotoxicity (7% or less)
- **Immunologic:** Infectious disease - **Neurologic:** Coma, Encephalopathy, Leukoencephalopathy, Seizure (1% to 5%) - **Renal:** Hemolytic uremic syndrome, Nephrotoxicity (25% to 38%)  
- **Cardiovascular:** Hypertension (13% to 53%)
- **Dermatologic:** Hirsutism (21% to 45%)
- **Gastrointestinal:** Drug-induced gingival hyperplasia (4% to 16%) - **Neurologic:** Headache (2% to 15%), Tremor (12% to 55%)
- **Ophthalmic:** Burning sensation in eye (17%)  
- Patient should not use ophthalmic preparation in an infected eye .  
- Advise patient to avoid vaccines during therapy unless approved by a healthcare professional .  
- To decrease the risk of skin malignancies, advise patient to avoid excessive exposure to ultraviolet light .  
- Drug may cause hypertension, renal dysfunction, hirsutism, diarrhea, nausea, vomiting, headache, tremor, or gingival enlargement .  
- The ophthalmic preparation may cause a foreign body or burning sensation in the eye .  
- Instruct patient to report signs/symptoms of transplant rejection or infection .  
- Advise patient to report signs/symptoms of hepatotoxicity or encephalopathy, especially patients receiving high-dose therapy .  
- Instruct patients to report signs/symptoms of nephrotoxicity, especially when on concomitant nephrotoxic drugs .  
- Patients using the ophthalmic preparation should report visual disturbances, conjunctival hyperemia, eye pain, or discharge from eye .  
- Patient should allow at least 5 minutes between instillation of this drug and other ophthalmic products .  
- Warn patient that rinsing the oral solution syringe with water either before or after use will cause a variation in dose and should be avoided .  
- Tell patient to remove contact lenses prior to instilling ophthalmic formulation. Lenses may be reinserted 15 minutes following instillation .  
- Patient should not eat grapefruit or drink grapefruit juice while taking this drug .  
- Patient should avoid concomitant potassium-sparing drugs, potassium supplements, and foods/salt substitutes that are high in potassium .  
- Tell patient that there are multiple significant drug-drug interactions for this drug. Consult healthcare professional prior to new drug use (including over-the-counter and herbal drugs) .  
- hypersensitivity to cyclosporine or any of ingredient in the formulation of the product including polyoxyethylated castor oil (Cremophor(R) EL) in Sandimmune(R) injection
- ocular infections, active (ophthalmic emulsion)
Precautions
- multiple immunosuppressant treatment regimens; increased risk for lymphomas, malignancies, some fatal, and/or infections
- bioequivalence, Sandimmune(R) and Neoral(R) are NOT bioequivalent; monitoring during conversion recommended
- concomitant use with nephrotoxic drugs; increased risk of renal dysfunction
- concomitant use with potassium sparing diuretics should be avoided
- concomitant use with PUVA, UVB or other radiation therapy should be avoided - encephalopathy, (eg, impaired consciousness, convulsions, visual disturbances, motor function loss, movement disorders, psychiatric disturbances); has been reported; most cases reversible upon dose reduction or discontinuation
- high dose cyclosporine; increased risk of hepatotoxicity and nephrotoxicity - hyperkalemia, significant, sometimes associated with hyperchloremic metabolic acidosis; has been reported
- hyperuricemia, significant; has been reported
- hypertension; common effect that may require antihypertensive therapy and/or dose reduction
- malabsorption conditions; risk of inadequate therapeutic levels with cyclosporine capsules or oral suspension
- nephrotoxicity, mild, severe, chronic progressive cyclosporine-associated; has been reported
- opportunistic infections (eg, activation of latent viral infections); increased risk associated with immunosuppression; BK-virus associated nephropathy may lead to renal allograft loss; monitoring and dose adjustment recommended
- optic disc edema, including papilloedema, with possible visual impairment secondary to intracranial hypertension; has been reported
- radiation therapy; excessive immunosuppression possible and subsequent risk of malignancies
- seizure, particularly with concomitant high-dose methylprednisolone; has been reported
- serious infections; increased risk of; fatalities have been reported
- vaccination; may be less effective; avoid use of live attenuated vaccines during cyclosporine therapy
cyproheptadine hydrochloride brand name(s) periactin
adverse effects serious

- **Endocrine metabolic:** Increased appetite, Weight gain - **Gastrointestinal:** Abdominal discomfort, Diarrhea, Nausea, Vomiting, Xerostomia - **Neurologic:** Central nervous system depression, Somnolence - **Respiratory:** Thick sputum, Bronchial  
- Patient should avoid activities requiring mental alertness until drug effects are realized, as drug may cause somnolence.  
- This drug may cause increased appetite, weight gain, abdominal discomfort, nausea, xerostomia, diarrhea, vomiting, or thickened bronchial sputum.  
- Advise patient to take with food to minimize gastric irritation. - Patient should avoid concomitant use of alcohol or other CNS depressants during therapy.  
- Tell patient to not take concurrent MAO inhibitors, as this may intensify anticholinergic effects.  
- angle-closure glaucoma
- elderly, debilitated patients - hypersensitivity to cyproheptadine products - MAOI therapy - newborn or premature infants
- nursing mothers
- stenosing peptic ulcer, pyloroduodenal obstruction
- symptomatic prostatic hypertrophy, bladder neck obstruction Precautions
- avoid use during activities which require mental alertness - avoid use with alcohol and other central nervous system depressants
- cardiovascular disease
- elderly are more susceptible
- history of bronchial asthma - hypertension - hyperthyroidism - increased intraocular pressure may cause drowsiness in adults and excitation in children  
| Risks and side effects related to cytarabine include those which are: Likely Less Likely   | Rare but serious                                                                                                                                                                                                                                                                                                                                                |    |                                                                                                                            |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------|
| -                                                                                          | Nausea and  vomiting                                                                                                                                                                                                                                                                                                                                            |    |                                                                                                                            |
| -                                                                                          | Hair loss                                                                                                                                                                                                                                                                                                                                                       |    |                                                                                                                            |
| -                                                                                          | Mouth sores                                                                                                                                                                                                                                                                                                                                                     |    |                                                                                                                            |
| -                                                                                          | Loss of desire to eat                                                                                                                                                                                                                                                                                                                                           |    |                                                                                                                            |
| -                                                                                          | Fewer red and white  blood cells and  platelets in the  blood  o a low number of  red blood cells  can make you  feel tired and  weak o a low number of  white blood  cells can make it  easier to get  infections o a low number of  platelets causes  you to bruise  and bleed more  easily o Redness, pain  and  inflammation of  the eye with  higher doses | -  | Rash                                                                                                                       |
| -                                                                                          | Severe rash with redness  and pain on the palms of  the hand and soles of the  feet                                                                                                                                                                                                                                                                             |    |                                                                                                                            |
| -                                                                                          | Flu type symptoms with  fever, tiredness, aches  and pains                                                                                                                                                                                                                                                                                                      |    |                                                                                                                            |
| -                                                                                          | Diarrhea                                                                                                                                                                                                                                                                                                                                                        |    |                                                                                                                            |
| -                                                                                          | Low levels of certain salts  in the body like  potassium and calcium                                                                                                                                                                                                                                                                                            |    |                                                                                                                            |
| -                                                                                          | Difficulty emptying the  bladder                                                                                                                                                                                                                                                                                                                                |    |                                                                                                                            |
| -                                                                                          | High levels of uric acid in  the blood which could  damage the kidneys                                                                                                                                                                                                                                                                                          |    |                                                                                                                            |
| -                                                                                          | With higher doses of  cytarabine fluid may  accumulate in the lungs  making it difficult to  breathe                                                                                                                                                                                                                                                            | -  | Allergic reactions (can be severe  and life-threatening causing  difficulty in breathing and or a drop  in blood pressure) |
| -                                                                                          | A syndrome called Ara-C syndrome  where there is fever, aches, pains,  sometimes chest pain, a rash and  inflammation of the eye                                                                                                                                                                                                                                |    |                                                                                                                            |
| -                                                                                          | With higher doses of cytarabine  there can be effects on the brain  which can lead to headaches,  incoordination of the muscles when  walking, rapid jerky eye movements,  difficulty with speech, sleepiness,  personality changes, coma                                                                                                                       |    |                                                                                                                            |
| -                                                                                          | With higher does of cytarabine there  can be effects on the heart which  can lead to chest pain and damage  to the heart muscle                                                                                                                                                                                                                                 |    |                                                                                                                            |
| -                                                                                          | Inflammation or damage to the liver  which can be severe and lifethreatening and which may lead to  an enlarged liver and spleen,  bleeding from the veins in the  esophagus (the passage that leads  from the throat to the stomach), a  yellow appearing skin, and fluid  collection in the abdomen which  makes it look larger.                                                                                                                                                                                                                                                                                                                                                                 |    |                                                                                                                            |
| -                                                                                          | Kidney Damage                                                                                                                                                                                                                                                                                                                                                   |    |                                                                                                                            |
| -                                                                                          | Muscle breakdown which can lead to  injury to the kidneys and other  organs                                                                                                                                                                                                                                                                                     |    |                                                                                                                            |  
| Common                                                                                                                                        | Serious                                                                                                                                                                                                               |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lightheadedness Constipation  Diarrhea Asthenia  Dizziness Headache Somnolence  Diplopia  Visual disturbance Fatigue  Malaise Sun-sensitivity | Abnormal blood pressure Heart failure (infrequent) Phlebitis Tachyarrhythmia  Aplastic anemia Leukopenia  Malignant lymphoma (small lymphocytic) Thrombocytopenia (infrequent) Disease of liver (fatal and non-fatal) |  
- Drug causes sun-sensitivity. Advise patient to use sunscreen and avoid tanning beds.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause light-headedness, dizziness, or somnolence.  
- This drug may cause constipation, diarrhea, asthenia, headache, diplopia, visual disturbance, fatigue, or malaise.  
- Instruct patient to report any difficulties with swallowing.
cyproheptadine hydrochloride brand name(s) periactin
dasatinib

Likely:
- Low platelet count which may lead to bleeding or bruising
- Diarrhea Less Likely:
- *Low Blood Counts:* low red blood cell count may make you feel tired; low white blood cell count increases the risk of infection, fever or pneumonia.  
- *Skin-related:* reddening of the face with feelings of warmth; itching; rash with peeling of the skin.  
- *Stomach/Intestine-related:* loss of appetite; excessive gas in the intestines; nausea; vomiting; bloating; loss of water from the body; stomach pain
- *General:* infection; headache; tingling, burning, or prickling sensation; fatigue; fever
- *Laboratory test-related:* abnormal liver function; temporary increase in the blood of creatinine which may indicate kidney damage  
- *Risk of Bleeding:* there is a risk of bleeding which may be life-threatening.  
Specifically, damage to the intestine may result in bleeding.
- *Fluid Retention:* fluid buildup in the lungs that can make you feel short of breath
cyproheptadine hydrochloride brand name(s) periactin
rare but serious

- Damage to the sac around the heart which can lead to a build-up of fluid around the heart which may be painful and affect the ability of the heart to work normally.  
- *Tumor Lysis Syndrome:* very rapid death of cancer cells releases chemicals which may lead to reduced kidney function. Accumulation of these chemicals may harm muscle or nerve function.
Side effects reported by patients, but it is not certain yet if they are related to taking the drug
cyproheptadine hydrochloride brand name(s) periactin
dasatinib

- *Low Blood Counts:* decrease in the number of immune system cells; low numbers of white blood cells called lymphocytes that may last a long time and make it easier to get infections which may be life threatening.  
- *Heart-related:* a rapid heart rate of over 100 beats per minute; chest pain that may mean heart damage; irregular heartbeat; problems with the electrical system of the heart; high blood pressure
- *General:* inability to sleep; rigors/chills; changes in your weight
- *Skin-related:* an allergic reaction in the blood vessels of the skin which turn the skin red, inflamed and bumpy and which may lead to skin breakdown; acne; changes in your nails; open sores on the skin; hives; puffiness or swelling around the eyes  
- *Stomach/Intestine-related:* constipation; dry mouth; inflammation of the small intestine; difficulty or discomfort in swallowing; ulcer in the small intestine; heartburn; painful mouth sores
- *Fluid Retention:* excess buildup of fluids in body tissues; usually the tissues of the head, neck, buttocks, and genital areas
- *Laboratory test-related:* high levels of enzymes in the blood which could affect liver, kidney, and heart functions; decrease in the level of magnesium in the blood.  
- *Muscle/Joint-related:* stiffness of the neck, pain in the muscles and bones; pain throughout the body; back pain; pain in the arms and legs.  
- *Nervous system-related:* anxiety; depression; dizziness; seizure; damage to a nerve of the brain which may affect hearing and balance; a feeling of sleepiness, an inability to stay awake or aware or be aroused by someone else.  
- *Breathing-related:* shortness of breath; buildup of fluid in the lungs which can also make you feel short of breath.  
- *Kidney-related:* damage to the kidney that may be serious and life-threatening; increased need to urinate
- *Vein-related:* inflammation of a vein; problems with blood clotting which may be life-threatening.  
| Risks and side effects related to the daunorubicin include: Common Happens to 21-100  children out of every  100 Occasional Happens to 5-20  children out of every  100   | Rare Happens to < 5 children out of  every 100                                                                                                   |                                                                                               |    |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----|
| Immediate: Within 1-2 days of  receiving drug                                                                                                                             | Hyperuricemia, sclerosis                                                                                                                         | Diarrhea, anorexia, abdominal                                                                 |    |
| of the vein                                                                                                                                                               | pain, extravasation (rare) but if occurs = local ulceration, anaphylaxis, fever, chills, rash,  urticaria, acute arrhythmias                     |                                                                                               |    |
| Prompt: Within 2-3 weeks,  prior to the next course                                                                                                                       | Nausea, vomiting, pink  or  red color to urine,  sweat, tears, and saliva                                                                        | Radiation recall reactions, myocarditis-pericarditis syndrome, conjunctivitis and lacrimation |    |
| Delayed: Any time later during  therapy                                                                                                                                   | Myelosuppression (leukopenia,  thrombocytopenia,  anemia), alopecia                                                                              | Mucositis (stomatitis  and esophagitis),hepatotoxici ty                                       | Cardiomyopathy1 (uncommon  at cumulative doses ≤ 550  mg/m², 400 mg/m² with  mediastinal radiation, 300  mg/m² in children, or 10  mg/kg in children < 2 yrs or  0.5 m²) (L), hyperpigmentation of nail beds    |
| Late: Any time after  completion of  treatment                                                                                                                            | Subclinical cardiac                                                                                                                              | CHF (on long term follow up                                                                   |    |
| dysfunction                                                                                                                                                               | in pediatric patients), secondary  malignancy (in combination  regimens)                                                                         |                                                                                               |    |
| Unknown Frequency and  Timing:                                                                                                                                            | Fetal toxicities and teratogenic effects of daunorubicin have been noted in animals. It  is unknown whether the drug is excreted in breast milk. |                                                                                               |    |
cyproheptadine hydrochloride brand name(s) periactin
daunorubicin decitabine

While on the study, you are at risk for side effects (see table below). You should discuss these with your child's doctor. If you experience any side effects you may be given other medications to make them less serious or uncomfortable. We believe that most side effects will go away shortly after treatment with decitabine is stopped, but in some cases side effects may be serious, long lasting or permanent. There may also be other side effects that we cannot predict. There is also a small, but real possibility that life-threatening complications, death, or a second cancer may occur.  
| Known risks and side effects related to the decitabine include: Common Occasional                                                                                                                                                                                  | Rare                                                                                                                                                                                                                                                 |                        |                        |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|
| (21-100% Frequency)                                                                                                                                                                                                                                                | (5-20% Frequency)                                                                                                                                                                                                                                    | (< 5% Frequency)       |                        |
| Immediate: Within 1-2                                                                                                                                                                                                                                              | Fever with a low white                                                                                                                                                                                                                               |                        |                        |
| days of receiving drug                                                                                                                                                                                                                                             | blood                                                                                                                                                                                                                                                | cell                   | count                  |
| making                                                                                                                                                                                                                                                             | you                                                                                                                                                                                                                                                  | more                   |                        |
| susceptible to infection  (potentially lifethreatening), nausea,  and vomiting.                                                                                                                                                                                                                                                                    | Allergic reactions, which  appear as a rash and bumps.  Tiredness, peritonitis  (inflammation in the lining  of your abdomen, poor  appetite, difficulty staying  awake, increased chance of  liver damage, stomach pain  or cramping, and diarrhea. |                        |                        |
| Prompt: Within 2-3  weeks, prior to next  course.                                                                                                                                                                                                                  | Anemia* (making  you weak and tired),  low white blood cell  count which increases  your risk for infection  and low platelet  count* which may  cause bruising or  bleeding                                                                         | Soreness, and sores in | Kidney or liver damage |
| mouth or throat.                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                      |                        |                        |
| Delayed: Anytime after                                                                                                                                                                                                                                             | Anemia* (making                                                                                                                                                                                                                                      |                        |                        |
| above.                                                                                                                                                                                                                                                             | you weak and tired),  low white blood cell  count which increases  your risk for infection  and low platelet  count* which may  cause bruising or  bleeding                                                                                          | Hair loss.             |                        |
| Late: Anytime after  completion of treatment Unknown Timing and  Frequency *Patients who develop anemia or low platelet counts may require red blood cell or platelet  transfusions and as a result transfusion of blood and/or blood components may be necessary. |                                                                                                                                                                                                                                                      |                        |                        |  
Late: Anytime after completion of treatment  
Unknown Timing and  
Frequency *Patients who develop anemia or low platelet counts may require red blood cell or platelet transfusions and as a result transfusion of blood and/or blood components may be necessary.  
Transfusions may be accompanied or followed by fever and/or reactions that can cause kidney  
failure, heart failure, anemia, hepatitis, A.I.D.S. (acquired immune deficiency syndrome) and other infections.  
Other toxicities that may or may not be related to decitabine have been reported in adult patients. These include: allergy, irregular heart beats, blood clots, swelling of veins, decreased blood flow to heart, face swelling, low blood pressure, heart attacks, veno-occlusive disease (blood vessels that carry blood through the liver become swollen or clogged), build up of fluid in the stomach, heart failure, fever, chills, weight loss, skin rash, itching, inability to taste, constipation, inflammation of the gallbladder, blood in the urine, liver failure, increased alkaline phosphatase, reactivation of an infection caused by the herpes virus, low levels of salts in the blood, weakness or pain due to nerve injury, depression, dizziness, headache, lightheadedness, restlessness, sleep disorder, seizures, paralysis of arm/leg on the same side of the body, muscle pain, bone pain, shortness of breath, hiccups, fluid in the lungs, difficulty in breathing caused by a collapse of a lung, cough, painful urination, kidney failure, and decreased blood flow to brain, or flow of blood to the lungs. If a person gets pregnant while receiving decitabine, it could be dangerous for the baby. You should not become pregnant or father a baby while on this study. You should not nurse (breast feed) a baby while on this study. Ask about counseling and more information about preventing pregnancy.
cyproheptadine hydrochloride brand name(s) periactin
deferoxamine mesylate brand name(s) desferal

- **Cardiovascular:** Cardiac complication, Hypotension, Shock, Tachyarrhythmia
- **Immunologic:** Immune hypersensitivity reaction (frequent)
- **Neurologic:** Ototoxicity (frequent)
- **Ophthalmic:** Eye / vision finding (frequent) - **Other:** Mucormycosis (rare)
Common:
- **Dermatologic:** Injection site pain  
- anuria
- hypersensitivity to deferoxamine mesylate - renal disease, severe
cyproheptadine hydrochloride brand name(s) periactin
precautions

- aluminum overload, comorbid; may result in decreased serum calcium and aggravation of hyperparathyroidism  
- Warn patient that drug may cause a reddish discoloration of the urine.  
- If dizziness or vision or hearing impairment are experienced, advise patient to avoid driving or performing other hazardous tasks.  
- Instruct patient to report signs/symptoms of hypotension or tachyarrhythmia.  
- Patient should not use vitamin C concurrently, unless approved by healthcare professional.  
- dialysis and comorbid aluminum-related encephalopathy; may cause neurological dysfunction (seizures) or dialysis dementia
- ferritin levels, low; ocular disturbances (blurry vision; cataracts in chronic iron overload; decreased visual acuity; impaired peripheral, color, and night vision; optic neuritis, cataracts, corneal opacities, and retinal pigmentary abnormalities) and auditory disturbances (tinnitus and hearing loss including high frequency sensorineural hearing loss), reversible in most cases, have been reported; monitoring recommended
- geriatric patients; may have an increased risk of ocular and auditory disturbances, including deafness and hearing loss; dose adjustment recommended
- high-dose therapy; ocular (blurry vision; cataracts in chronic iron overload; decreased visual acuity; impaired peripheral, color, and night vision; optic neuritis, cataracts, corneal opacities, and retinal pigmentary abnormalities) and auditory disturbances (tinnitus and hearing loss including high frequency sensorineural hearing loss), reversible in most cases, have been reported; monitoring recommended
- increased susceptibility to Yersinia enterocolitica, Yersinia pseudotuberculosis; drug discontinuation recommended
- IV administration; excessively high doses has resulted in respiratory distress syndrome; rapid injection has resulted in urticaria, hypotension, and shock; use proper administration
- mucormycosis, including fatalities have been reported; if suspected discontinue therapy and institute medical management
- pediatric patients; high doses and concomitant low ferritin levels have been associated with growth retardation; monitoring recommended
- prolonged use; ocular (blurry vision; cataracts in chronic iron overload; decreased visual acuity; impaired peripheral, color, and night vision; optic neuritis, cataracts, corneal opacities, and retinal pigmentary abnormalities) and auditory disturbances (tinnitus and hearing loss including high frequency sensorineural hearing loss), reversible in most cases, have been reported; monitoring recommended
- renal toxicity, including increases in serum creatinine (possibly dose-related), acute renal failure, and renal tubular disorders, has been reported; monitoring recommended
- scintigraphy with gallium-67; imaging may be distorted; discontinue deferoxamine 48 hours prior to procedure is recommended  
| Common                                                     | Serious                                                                                                                                                                                                                                                         |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Injection site pain Abdominal discomfort Vomiting diarrhea | Cardiac complication Hypotension  Shock  Tachyarrhythmia  Immune hypersensitivity reaction (frequent) Ototoxicity (frequent) Eye/vision changes (frequent) Mucormycosis (rare) Rash (rare) Seizure (rare Renal failure (rare) Acute respiratory distress (rare) |
cyproheptadine hydrochloride brand name(s) periactin
deferoxamine

- Warn patient that drug may cause a reddish discoloration of the urine.  
- If dizziness or vision or hearing impairment are experienced, advise patient to avoid driving or performing other hazardous tasks.  
- Instruct patient to report signs/symptoms of hypotension or tachyarrhythmia.  
- Patient should not use vitamin C concurrently, unless approved by healthcare professional.  
| Common                                                                                                                                                                                                                                                                   | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application site reaction (gel: all reactions, 7%;  dermatitis, 4% to 11%) Blood coagulation disorder (1% to 10%) Burning sensation in eye (15%) Keratitis (up to 28%) Lacrimation and lacrimal drainage - finding ( up  to 30%) Raised intraocular pressure (up to 15%) | Congestive heart failure Hypertension  Myocardial infarction (rare) Thrombotic tendency observations  Erythema multiforme (rare) Generalized exfoliative dermatitis (rare) Stevens-Johnson syndrome (rare) Toxic epidermal necrolysis (rare) Gastrointestinal hemorrhage Gastrointestinal perforation Gastrointestinal ulcer (1% to 10%) Inflammatory disorder of digestive tract Melena pancreatitis (rare) Agranulocytosis (rare) Aplastic anemia (rare) Hemolytic anemia (rare) Hepatic necrosis Liver failure (rare) Anaphylactoid reaction (rare) Cerebrovascular accident Meningitis (rare) Seizure (rare) Acute renal failure Papillary necrosis Angioedema (rare) |  
- Advise patient to avoid use in late pregnancy as drug may cause premature closure of ductus arteriosus.  
- The topical formulation of this drug can cause sun-sensitivity. Advise patient to avoid exposure to sunlight and tanning beds.  
- This drug may cause edema, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea, dizziness, headache, bronchospasm, or tinnitus. The ophthalmic formulation may also cause a burning sensation, conjunctivitis, corneal deposit/opacity/edema, or discharge from eye. The topical formulation may also cause application site skin reactions.  
- Advise patient to report signs/symptoms of serious cardiovascular thrombotic events such as myocardial infarction or stroke.  
- Instruct patient to report signs/symptoms of serious gastrointestinal adverse events such as bleeding, ulceration, and perforation of stomach or intestines.  
- Instruct patient to report signs/symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms).  
- Patient should promptly report skin rash, blistering, or any symptoms of a serious skin reaction.  
- Patient should take tablet with a full glass of water, food, or milk to minimize gastric irritation.  
- Instruct patient on proper instillation technique of ophthalmic formulation. - Tell patient using ophthalmic form to avoid wearing soft contact lenses during drug therapy.  
- Instruct patient using topical form to avoid applying this drug to open wounds, infections, or inflamed areas and to avoid contact of this drug with eyes and mucous membranes
- Patient should avoid showering, bathing or washing any area where drug is applied, including treated hands, for at least one hour after topical application of this drug.  
- Patient should not use occlusive dressing or external heat over areas treated with the topical formulation.  
- Patient should not drink alcohol while taking oral form of this drug.  
- Tell patient to avoid use of additional NSAIDs during therapy, unless approved by healthcare professional.  
- Patient using ophthalmic form should not use other ophthalmic medications, unless approved by healthcare professional.  
- Advise patient to avoid concomitant use of the topical form of this drug with other topical products, including sunscreens, cosmetics, lotions, moisturizers and insect repellants.
cyproheptadine hydrochloride brand name(s) periactin
dextromethorphan hydrobromide brand name(s) delsym

- **Neurologic:** Dizziness (mild), Somnolence (mild)
- **Other:** Fatigue (mild)  
- Instruct patient to report use of a MAO inhibitor within the last 14 days prior to initiating therapy.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause dizziness, somnolence, or fatigue.  
- hypersensitivity to dextromethorphan or levorphanol
- Coadministration with monoamine oxidase inhibitors Precautions
- Not to be used for chronic, persistent cough accompanying a disease state or for cough associated with excessive secretions
- Cough accompanied by other symptoms (fever, rash, headache, nausea, vomiting) to be treated with DEXTROMETHORPHAN only under medical supervision
brand name(s) hyperstat proglycem
adverse effects serious

- **Cardiovascular:** Cardiac arrest, Congestive heart failure
- **Endocrine metabolic:** Diabetic ketoacidosis
- **Gastrointestinal:** Bowel obstruction, Pancreatitis - **Hematologic:** Thrombocytopenia - **Ophthalmic:** Optic nerve infarction  
- **Cardiovascular:** Hypotension (7%)
- **Endocrine metabolic:** Hyperglycemia
- **Gastrointestinal:** Nausea and vomiting (4%) - **Neurologic:** Asthenia, Dizziness (2%)  
- functional hypoglycemia - hypersensitivity to diazoxide or to other thiazides Precautions
- cardiac reserve, compromised; risk of congestive heart failure
- concomitant use of coumarin (or its derivatives), diphenylhydantoin, or thiazides (or other diuretics); use with caution
- gout, history
- hyperuricemia - ketoacidosis and nonketotic hyperosmolar coma have been reported - newborns with increased bilirubinemia; diazoxide may displace bilirubin from albumin
- prolonged treatment; regular monitoring of urine for sugar and ketones is required - renal function, impaired; risk of drug toxicity  
- Instruct patient to rise slowly from a sitting/supine position, especially if patient is taking concurrent diuretics.  
- This drug may cause angina, palpitations, tachyarrhythmia, hirsutism, abdominal pain, constipation, diarrhea, loss of appetite, loss of taste, nausea, vomiting, and dizziness.  
- Drug may also cause serious adverse effects such as congestive heart failure, bowel obstruction, or extrapyramidal disease.  
- Tell patient to report signs/symptoms of hyperglycemia, infection, unusual bleeding/bruising, or fluid retention.  
- Advise diabetic patients to regularly monitor urine for sugar and ketones and to immediately report abnormal findings.  
- If injectable formulation is used, advise patient to report signs/symptoms of extravasation immediately.  
- Patient should remain supine for at least 1 h after IV injection, as drug may cause hypotension.
brand name(s) hyperstat proglycem
dexamethasone

| Risks and side effects related to dexamethasone include those which are: Likely Less Likely   | Rare But Serious                                                                                                                                                                          |    |                                                                                                                      |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------|
| -                                                                                             | Overeating                                                                                                                                                                                |    |                                                                                                                      |
| -                                                                                             | Difficulty sleeping or  falling asleep                                                                                                                                                    |    |                                                                                                                      |
| -                                                                                             | Decreased ability of  the body to fight  infection                                                                                                                                        |    |                                                                                                                      |
| -                                                                                             | Personality changes  with mood swings                                                                                                                                                     |    |                                                                                                                      |
| -                                                                                             | Changes in hormone  production that cause  weight gain  especially around the  abdomen and  shoulders, puffy  cheeks, muscle  weakness and make  your body less able  to deal with stress |    |                                                                                                                      |
| -                                                                                             | Pimples                                                                                                                                                                                   | -  | Damage to the joints which can result in  pain and loss of motion usually involving  the joints of the hip and knee* |
| -                                                                                             | Red face                                                                                                                                                                                  |    |                                                                                                                      |
| -                                                                                             | Fluid retention                                                                                                                                                                           |    |                                                                                                                      |
| -                                                                                             | Wounds don't heal as well                                                                                                                                                                 |    |                                                                                                                      |
| -                                                                                             | Slowed growth                                                                                                                                                                             |    |                                                                                                                      |
| -                                                                                             | Upset and irritated stomach with heartburn                                                                                                                                                |    |                                                                                                                      |
| -                                                                                             | Stomach ulcers                                                                                                                                                                            |    |                                                                                                                      |
| -                                                                                             | High blood sugar which may require  treatment                                                                                                                                             |    |                                                                                                                      |
| -                                                                                             | Stretch marks and easy bruising of the skin                                                                                                                                               |    |                                                                                                                      |
| -                                                                                             | Abnormal amounts of uric acid in the blood                                                                                                                                                |    |                                                                                                                      |
| -                                                                                             | Increased pressure in the eyes                                                                                                                                                            |    |                                                                                                                      |
| -                                                                                             | High blood pressure                                                                                                                                                                       |    |                                                                                                                      |
| -                                                                                             | Lessening of calcium in the bones making  them more susceptible to fracture                                                                                                               |    |                                                                                                                      |
| -                                                                                             | Cataracts which are usually more reversible  in children                                                                                                                                  |    |                                                                                                                      |
| -                                                                                             | Headache                                                                                                                                                                                  |    |                                                                                                                      |
| -                                                                                             | Dizziness                                                                                                                                                                                 |    |                                                                                                                      |
| -                                                                                             | Kidney stones that may cause back,  stomach or pelvic pain and /or may lead to  the appearance of blood in the urine                                                                      | -  | Inflammation of the  pancreas                                                                                        |
| -                                                                                             | Stomach and intestinal  tract bleeding from  ulcers                                                                                                                                       |    |                                                                                                                      |
| -                                                                                             | Infections                                                                                                                                                                                |    |                                                                                                                      |
| -                                                                                             | Increased pressure in  the brain which can  lead to difficulty  seeing, pressure in the  eyes and headache                                                                                |    |                                                                                                                      |
| -                                                                                             | Bone fractures                                                                                                                                                                            |    |                                                                                                                      |
| -                                                                                             | Serious changes in  mood, personality  and/or severe  depression                                                                                                                          |    |                                                                                                                      |
| * This effect happens less often in patients less than 10 years of age.                       |                                                                                                                                                                                           |    |                                                                                                                      |  
Steroid drugs, such as dexamethasone (and less frequently prednisone), are known causes of a disease called "osteonecrosis" (ON). Osteonecrosis results from the temporary or permanent loss of the blood supply to the bones. Without blood, the bone tissue dies and causes the bone to breakdown. ON is most commonly seen in the hip joint. If the bones near a joint breakdown it can cause the joint to collapse. ON can cause pain and if severe, the patient may need to have surgery. The exact reason why corticosteroids cause ON is not known.
brand name(s) hyperstat proglycem
dicloxacillin sodium brand name(s) dycill

- **Gastrointestinal:** Hemorrhagic colitis - **Hepatic:** Hepatotoxicity - **Immunologic:** Anaphylaxis (0.015% to 0.04%)
- **Renal:** Nephrotoxicity
brand name(s) hyperstat proglycem
common patient information

- Drug may cause nausea, vomiting, diarrhea, stomatitis, or black tongue. - Patient should take drug 1 h before or 2 h after meals.  
- hypersensitivity to penicillins
brand name(s) hyperstat proglycem
diltiazem hydrochloride brand name(s) cardizem

- **Cardiovascular:** Congestive heart failure (less than 2%), Heart block, Myocardial infarction
- **Hepatic:** Hepatotoxicity  
- acute MI with pulmonary congestion on x-ray (Oral only)
- administration of IV beta-blockers within a few hours of IV diltiazem  
- **Cardiovascular:** Bradyarrhythmia (1.7% to 3.6%), Peripheral edema (4.6% to 8%)
- **Neurologic:** Dizziness (3.5% to 6.4%), Headache (4.6%)
- **Respiratory:** Cough (2%)
- **Other:** Fatigue (4.8%)  
- Patient should avoid activities requiring coordination until drug effects are realized, as drug may cause dizziness.  
- This drug may cause gingival hyperplasia, headache, or dermatologic reactions such as exfoliative dermatitis (reddened skin, skin peeling/flaking) or erythema multiforme (flu-like symptoms, spreading red rash, may progress to more severe form with blistering).  
- Instruct patient to report symptomatic hypotension, bradyarrhythmia, peripheral edema, or syncope.  
- Advise patient against sudden discontinuation of drug. - This drug is available in multiple brand names with varying properties by brand. Instruct patient to follow administration instructions specific to the prescribed brand with regards to meals and timing.  
- Patient should avoid concomitant use of beta-blockers or digitalis during drug therapy, unless otherwise directed by healthcare professional.  
- Patient should not drink alcohol while taking this drug.  
- atrial fibrillation or flutter associated with an accessory bypass tract (Wolff-ParkinsonWhite or short PR syndromes); risk of potentially fatal heart rate fluctuations (IV only)
- cardiogenic shock (IV only)
- heart block, second or third-degree atrioventricular without a functioning ventricular pacemaker
- hypersensitivity to diltiazem
- hypotension, symptomatic (90 mmHg or less systolic) - newborns; some injections contain benzyl alcohol (IV only)
- sick sinus syndrome without a functioning ventricular pacemaker - ventricular tachycardia; may lead to hemodynamic deterioration and ventricular fibrillation
(IV only)
brand name(s) hyperstat proglycem
precautions

- coadministration with other drugs known to decrease peripheral resistance, intravascular volume, or myocardial contractility or conduction (IV only)
- concomitant use of beta blockers or digitalis; additive effect on heart rate (Oral only)
- dermatologic reactions leading to erythema multiforme and/or exfoliative dermatitis have been reported
- hepatic impairment; increased risk of toxicity
- hypotension
- renal impairment; increased risk of toxicity - supraventricular arrhythmias with hemodynamic compromise (IV only) - ventricular function, impaired; worsening congestive heart failure has been reported
brand name(s) hyperstat proglycem
diphenhydramine hydrochloride brand name(s) antitussive

- **Gastrointestinal:** Xerostomia - **Neurologic:** Dizziness, Dyskinesia, Sedated - **Psychiatric:** Somnolence - **Respiratory:** Nasal mucosa dry, Pharyngeal dryness, Thick sputum, Bronchial  
- Young children may experience a paradoxical excitation effect.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause drowsiness.  
- This drug may cause anticholinergic effects. Elderly patients may be more susceptible to these effects.  
- Patient should not use topical form on eyes or eyelid.  
- Instruct patient to avoid applying occlusive dressings, cosmetics, or other skin products over areas treated with topical formulation.  
- Patient should avoid concomitant use of MAO inhibitors or CNS depressants.  
- hypersensitivity to diphenhydramine - newborns or premature infants
- nursing mothers
brand name(s) hyperstat proglycem
precautions

- bladder neck obstruction
- concurrent MAOI therapy - concurrent use of central nervous system depressants - decreases mental alertness and psychomotor performance
- do not use topical form on eyes or eye lids - elderly are more susceptible to the side effects of diphenhydramine
- history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension
- may cause excitation in young children
- narrow angle glaucoma
- pyloroduodenal obstruction - stenosing peptic ulcer
- symptomatic prostatic hypertrophy
- use of the topical form on patients with chicken pox, measles, blisters, or large areas of skin unless directed by a physician
brand name(s) hyperstat proglycem
dipyridamole brand name(s) persantine adverse

- **Cardiovascular:** Angina, Exacerbation with IV (19.7%), Myocardial infarction (rare),
Ventricular arrhythmia (rare)
- **Respiratory:** Bronchospasm (rare)  
- **Cardiovascular:** Electrocardiogram abnormal (15.9%), Hypotension, IV (4.6%) - **Gastrointestinal:** Abdominal discomfort, Oral (6.1%), Nausea, IV (4.6%) - **Neurologic:** Dizziness (12%), Headache, IV (12.2%), Headache, Oral (2.3%)  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause abdominal discomfort or dizziness. The IV formulation may also cause headache or an exacerbation of angina.  
- Advise patient to take oral formulation on an empty stomach 1 h before or 2 h after meals. If gastric irritation occurs, tell patient to take drug with food or milk.  
- Patient should avoid caffeine prior to cardiac stress testing.  
- hypersensitivity to dipyridamole or any other product component Precautions
- anaphylactoid reactions have been reported (IV) - asthma, history; may be at increased risk for bronchospasm; IV aminophylline may be administered (IV)
- cardiac impulse abnormalities; may be at increased risk for asystole, sinus node arrest, sinus node depression, and conduction block (IV)
- asystole, sinus node arrest, sinus node depression, and conduction block have been reported; risk may be increased with cardiac impulse formation/conduction abnormalities or severe coronary artery disease (IV)
- bronchospasm has been reported (IV)
- cardiovascular events, serious and some fatal (including cardiac death, myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia), have been reported (IV)
- chest pain, severe; monitoring recommended; IV aminophylline and SL nitroglycerin may be needed (IV)
- coronary artery disease (unstable angina or recently sustained myocardial infarction),
severe; chest pain may be aggravated due to vasodilatory effect of dipyridamole (oral) ;
may also be at increased risk for asystole, sinus node arrest, sinus node depression, and conduction block (IV)
- hepatic insufficiency; hepatic enzyme elevations and hepatic failure have been reported
(oral)
- hypotension; may produce peripheral vasodilation (oral)
- seizures have been reported (IV)
- unstable angina, history; may be at greater risk for severe myocardial ischemia (IV)
brand name(s) hyperstat proglycem
disopyramide phosphate brand name(s) norpace

- **Cardiovascular:** Congestive heart failure, Heart block, Hypotension, Prolonged QT
interval, Torsades de pointes
- **Endocrine metabolic:** Hypoglycemia (rare) - **Hematologic:** Agranulocytosis (rare), Thrombocytopenia (rare) - **Hepatic:** Hepatotoxicity (rare)  
- cardiogenic shock
- congenital QT prolongation
- hypersensitivity to disopyramide
- second or third degree AV block Precautions
- congestive heart failure
- digitalization to be used in patients with atrial fibrillation or flutter prior to disopyramide - dosage reductions or withdrawal if heart block develops - ECG abnormalities (ie, QRS widening /QT/QTc prolongation)
- electrolyte abnormalities (ie, hypokalemia/hyperkalemia)
- geriatrics - glaucoma - hypoglycemia
- liver disease - myasthenia gravis  
- **Cardiovascular:** Negative inotropic effect on myocardium
- **Gastrointestinal:** Constipation (11%), Nausea (3% to 9%), Xerostomia (32%)
- **Musculoskeletal:** Muscle weakness
- **Ophthalmic:** Blurred vision (3% to 9%)
- **Renal:** Delay when starting to pass urine (14% to 23%), Urinary retention (3% to 9%) - **Other:** Generalized aches and pains (3% to 9%), Malaise and fatigue (3% to 9%)  
- Patient should avoid activities requiring coordination until drug effects are realized.  
- Instruct patient to rise slowly from a sitting/supine position to minimize dizziness.  
- This drug may cause anticholinergic effects, especially xerostomia, urinary hesitancy, and constipation.  
- Instruct patient to report signs/symptoms of cardiac failure or dysrhythmia. - Tell patient to report worsening depression, hallucinations, or unusual changes in behavior.  
- Advise patient against sudden discontinuation of drug.  
- Tell patient to not drink alcohol while taking this drug. - Patient should not take this drug within 48 h before or 24 h after verapamil administration.  
- renal impairment
- sick sinus syndrome/ Wolff-Parkinson-White syndrome/bundle branch block - urinary retention (including benign prostatic hypertrophy)
brand name(s) hyperstat proglycem
docetaxel brand name(s) taxotere adverse

- **Cardiovascular:** Edema (Severe) (6.5% to 8.9%) - **Dermatologic:** Stevens-Johnson syndrome, Toxic epidermal necrolysis - **Gastrointestinal:** Colitis - **Hematologic:** Anemia, less than 8 g/dL (4.3% to 9.2%), Febrile neutropenia (5.2% to 24.7%), Leukopenia, less than 1000 cells/mm(3) (31.6% to 43.7%), Neutropenia, less than 500 cells/mm(3) (65.5% to 85.9%), Thrombocytopenia (8% to 9.2%)
- **Hepatic:** Hepatotoxicity - **Immunologic:** Anaphylaxis (rare)
- **Renal:** Renal failure
- **Respiratory:** Interstitial pneumonia, Pulmonary embolism
- **Other:** Infectious disease (21.6% to 39.4%)  
- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression. - This drug may cause edema, alopecia, diarrhea, nausea, stomatitis, vomiting, asthenia, fever, or colitis.  
- Elderly patients have an increased risk of adverse events.  
- Instruct patient to report severe edema or signs/symptoms of myelosuppression, hepatotoxicity, or neuropathy (paresthesia, dysesthesia, pain).  
- Advise patient to report signs/symptoms of cutaneous toxicity such as Stevens-Johnson syndrome (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering)
or toxic epidermal necrolysis (widespread peeling/blistering of skin).  
- neutrophil count less than 1500 cells/mm(3) - severe hypersensitivity to docetaxel or any other drugs formulated with polysorbate 80  
- **Cardiovascular:** Edema (47% to 64.1%), Vasodilatation (27%)
- **Dermatologic:** Alopecia (56.3% to 97.8%), Disorder of nail (11.4% to 18.5%), Disorder of skin AND/OR subcutaneous tissue, Nail changes (8.1% to 30.6%), Pruritus, Rash
- **Gastrointestinal:** Diarrhea (32.8% to 42.6%), Nausea (38.8% to 80.5%), Stomatitis
(41.7% to 69.4%), Vomiting (22.3% to 44.5%)
- **Hematologic:** Anemia (89.1% to 93.6%), Leukopenia (95.6% to 98.6%), Neutropenia
(71.4% to 99.5%)
- **Neurologic:** Asthenia (61.8% to 80.8%), Neuropathy
- **Reproductive:** Amenorrhea (61.7%)
- **Other:** Fever of unknown origin (31.2% to 46.5%)
brand name(s) hyperstat proglycem
precautions

- fluid retention (eg, peripheral edema, generalized edema, pleural effusion, ascites) has occurred; pretreatment with oral corticosteroids recommended prior to each dose
- hepatic impairment; increased risk of severe or life-threatening toxicities; do not use in patients in patients with a bilirubin level greater than the ULN or SGOT and/or SGPT
levels greater than 1.5 x ULN concomitant with an alkaline phosphatase (AP) level greater than 2.5 x ULN; monitor LFTs prior to each treatment cycle; dosage adjustment recommended for LFT elevations during treatment; discontinue treatment in patients who develop AST/ALT levels greater than 5 x ULN and/or AP level greater than 5 x ULN
- hypersensitivity reactions, some cases severe (eg, generalized rash/erythema, hypotension, bronchospasm, fatal anaphylaxis), have been reported despite the recommended 3 days of corticosteroids premedication
- severe (grade 4) neutropenia has been reported, with some cases associated with infection; monitor blood cell counts frequently and for signs of febrile neutropenia or neutropenic infections; dose reduction or therapy discontinuation may be warranted; do not retreat with subsequent cycles until the neutrophil count is greater than 1500 cells/mm(3)
- treatment-related mortality has been reported; increased risk in patients with abnormal liver function, receiving higher doses, and with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m(2)
- acute myeloid leukemia has been reported rarely in patients with breast cancer who received adjuvant therapy with docetaxel, doxorubicin, and cyclophosphamide; hematological follow-up recommended in this patient population
- concomitant use with CYP3A4 inhibitors should be avoided; if coadministration with a potent CYP3A4 inhibitor is necessary, closely monitor patients for toxicity and consider a docetaxel dosage adjustment
- cutaneous toxicity (eg, localized erythema of the extremities with edema followed by desquamation) has occurred; dose reduction or therapy discontinuation may be warranted if severe skin toxicity develops
- elderly patients (aged 65 yr or older); higher incidence of serious adverse events compared with younger patients
- severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) have been reported; dose reduction or therapy discontinuation may be warranted
- severe thrombocytopenia has occurred; monitor blood cell counts frequently; do not retreat with subsequent cycles until the platelet count is greater than 100,000 cells/mm(3)
- report suspected adverse events to Sanofi-Aventis US LLC at 1-800-633-1610 or the US
Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch  
| Common                                                                             | Serious                                    |              |
|------------------------------------------------------------------------------------|--------------------------------------------|--------------|
| Hypertension (3%) Diarrhea Loss of appetite Nausea Vomiting Muscle cramps Insomnia | Atrioventricular block Torsades de pointes |              |
| Version 2.0 Final                                                                  | Page 147 of 268                            | Confidential |  
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brand name(s) hyperstat proglycem
donepezil hydrochloride

- This drug may cause diarrhea, loss of appetite, nausea, vomiting, muscle cramps, insomnia, or fatigue.  
- Advise patient that adverse effects may be more frequent at dose escalation and tend to resolve with continued use.  
- Instruct patient to report signs/symptoms of gastrointestinal bleeding, especially with concomitant NSAID use.  
- Patient should take in the evening at bedtime.
brand name(s) hyperstat proglycem
doxorubicin

| Risks and side effects related to Doxorubicin include those which are:  Likely Less Likely   | Rare But Serious                                                                                                                                                                                                                                                                                    |              |                                                                                                                                                                                                             |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -                                                                                            | Nausea                                                                                                                                                                                                                                                                                              |              |                                                                                                                                                                                                             |
| -                                                                                            | Vomiting                                                                                                                                                                                                                                                                                            |              |                                                                                                                                                                                                             |
| -                                                                                            | Temporary hair loss                                                                                                                                                                                                                                                                                 |              |                                                                                                                                                                                                             |
| -                                                                                            | Pink or red color to urine,  sweat, tears, saliva                                                                                                                                                                                                                                                   |              |                                                                                                                                                                                                             |
| -                                                                                            | Fewer white blood cells,  red blood cells and  platelets in the blood. - A low number of red  blood cells can make  you feel tired and  weak - A low number of  white blood cells can  make it easier to get  infections  - A low number of  platelets causes you to  bruise and bleed more  easily |              |                                                                                                                                                                                                             |
| -                                                                                            | Slight damage to the heart  muscle that is unlikely to  have any noticeable  effects on your heart  function                                                                                                                                                                                        | -            | Inflammation and/or sores  in the mouth (and/or throat  and /or esophagus, the tube  that leads from the mouth  to the stomach) that may  make swallowing difficult  and are painful (painful  mouth sores) |
| -                                                                                            | Damage to the heart muscle  which may make you tired,  weak, feel short of breath,  and retain fluid                                                                                                                                                                                                |              |                                                                                                                                                                                                             |
| -                                                                                            | Facial Flushing                                                                                                                                                                                                                                                                                     |              |                                                                                                                                                                                                             |
| -                                                                                            | Fever/chills                                                                                                                                                                                                                                                                                        |              |                                                                                                                                                                                                             |
| -                                                                                            | Hives                                                                                                                                                                                                                                                                                               |              |                                                                                                                                                                                                             |
| -                                                                                            | High levels of uric acid in  the blood which could  damage the kidneys                                                                                                                                                                                                                              |              |                                                                                                                                                                                                             |
| -                                                                                            | Dark discoloration of the  hands, feet and under the  fingernails with possible  separation of the nail from  the nail bed.                                                                                                                                                                         |              |                                                                                                                                                                                                             |
| -                                                                                            | Damage to the skin if the  medication leaks from a  vein                                                                                                                                                                                                                                            |              |                                                                                                                                                                                                             |
| -                                                                                            | Thickening and hardening  of the veins through which  the medication is given                                                                                                                                                                                                                       |              |                                                                                                                                                                                                             |
| -                                                                                            | Reddening reaction of the  vein through which the  drug is given.                                                                                                                                                                                                                                   |              |                                                                                                                                                                                                             |
| -                                                                                            | Elevation in the blood of  certain enzymes found in  the liver which may                                                                                                                                                                                                                            | -            | Severe allergic reaction  which can be life  threatening with shortness  of breath, low blood  pressure and a rapid heart  rate                                                                             |
| -                                                                                            | Ulceration of the lower  intestinal tract                                                                                                                                                                                                                                                           |              |                                                                                                                                                                                                             |
| -                                                                                            | An irregular heart beat  which can be lifethreatening                                                                                                                                                                                                                                                                                                     |              |                                                                                                                                                                                                             |
| -                                                                                            | Severe damage to the  heart muscle which may  lead to severe heart failure                                                                                                                                                                                                                          |              |                                                                                                                                                                                                             |
| -                                                                                            | A new cancer or leukemia  resulting from this  treatment.                                                                                                                                                                                                                                           |              |                                                                                                                                                                                                             |
| Version 2.0 Final                                                                            | Page 148 of 268                                                                                                                                                                                                                                                                                     | Confidential |                                                                                                                                                                                                             |  
Page 148  
| indicate liver irritation or  damage.                                              |                                                                          |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| -                                                                                  | Tearing and inflammation  of the eyes                                    |
| -                                                                                  | Loss of appetite                                                         |
| -                                                                                  | Redness and burning at  sites which have received  radiation in the past |
| -                                                                                  | Diarrhea                                                                 |
| The risk of heart damage may be greater in very young children than in older ones. |                                                                          |
brand name(s) hyperstat proglycem
doxycycline

| Common                                                                                                                                                                                | Serious                   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Light sensitivity Drug-induced gastrointestinal disturbance Serum blood urea nitrogen raised Loss of appetite Nausea Vomiting Diarrhea Esophagitis  Glossitis Dysphagia  enterocoliti | Bulding fontanelle (rare) |  
- Instruct patient to report severe diarrhea and consult healthcare professional prior to taking anti-diarrhea medicine.  
- Drug causes sun-sensitivity. Advise patient to use sunscreen and avoid tanning beds.  
- Drug may decrease effectiveness of oral contraceptives with concurrent use. Recommend additional form of birth control.  
- This drug may cause a gastrointestinal disturbance. - Advise patient to take drug with adequate fluid to prevent esophageal irritation or ulceration.  
- Patient may take tablet and suspension with food, milk, or a carbonated beverage if gastric irritation occurs.
brand name(s) hyperstat proglycem
droperidol brand name(s) inapsine adverse

- **Cardiovascular:** Cardiac arrest, Prolonged QT interval, Torsades de pointes, Ventricular tachycardia
- **Immunologic:** Anaphylaxis - **Neurologic:** Neuroleptic malignant syndrome (very rare)  
- **Cardiovascular:** Hypotension, Tachycardia
- **Neurologic:** Somnolence, Postoperative
- **Psychiatric:** Anxiety, Dysphoric mood, Hyperactive behavior, Restlessness  
- his drug may cause extrapyramidal effects, somnolence, anxiety, or dysphoric mood.  
- Patient should report signs/symptoms of arrhythmias, hypotension, or respiratory depression.  
- any use other than for the treatment of perioperative nausea and vomiting in patients for whom other treatments are ineffective or inappropriate
- hypersensitivity to droperidol
- QT interval prolongation (greater than 440 msec, males; greater than 450 msec, females), known or suspected, including patients with congenital long QT syndrome; serious or life-threatening arrhythmias may occur
brand name(s) hyperstat proglycem
precautions

- QT prolongation, dose-dependent, and serious arrhythmias (eg, torsade de pointes, ventricular arrhythmias, cardiac arrest, and death) have been reported; risk factors include bradycardia (less than 50 beats/min), clinically significant cardiac disease, treatment with Class I and Class III antiarrhythmics, treatment with MAOIs, concomitant treatment with other drugs known to prolong the QT interval, and electrolyte imbalance (especially hypokalemia or hypomagnesemia) or concomitant treatment with drugs (eg, diuretics) that may cause electrolyte imbalance; monitoring recommended
- anesthesia, conduction (eg, spinal and some peridural); altered respiration or circulation or hypotension may occur
- concomitant use with potentially arrhythmogenic agents (eg, class I or III antiarrhythmics, antihistamines that prolong the QT interval, antimalarials, calcium channel blockers, neuroleptics that prolong the QT interval, and antidepressants); avoid use
- elderly, debilitated, or poor-risk patients, dose adjustment recommended - electroencephalogram, patterns may be slow to return to normal - hepatic impairment; risk of drug toxicity - neuroleptic malignant syndrome (altered consciousness, muscle rigidity, and autonomic instability) has occurred rarely and may be difficult to differentiate from malignant hyperpyrexia; consider treating with dantrolene
- pheochromocytoma, diagnosed or suspected, severe hypertension and tachycardia have been reported
- pulmonary arterial pressure may decrease; use caution when interpreting results - renal impairment; kidney is important in metabolizing and excreting drugs
brand name(s) hyperstat proglycem
enalapril maleate brand name(s) vasotec

- **Gastrointestinal:** Intestinal angioedema
- **Hematologic:** Agranulocytosis
- **Hepatic:** Hepatotoxicity, Liver failure (rare) - **Renal:** Acute renal failure (0.5% to 1%), Renal impairment - **Other:** Angioedema (0.1% to 1%)  
- **Cardiovascular:** Hypotension (0.9% to 6.7%) - **Endocrine metabolic:** Hyperkalemia (1% to 3.8%)
- **Neurologic:** Dizziness (4.3% to 7.9%)
- **Renal:** Serum blood urea nitrogen raised (0.2% to 11%), Serum creatinine raised (0.2%
to 11%)
- **Respiratory:** Cough (1% to 15%) - **Other:** Fatigue (3%)  
- Patient should avoid activities requiring coordination until drug effects are realized, as drug may cause dizziness.  
- Instruct patient to rise slowly from a sitting/supine position. - This drug may cause nausea, vomiting, or asthenia. - Instruct patient to report signs/symptoms of hypotension or persistent cough. - Tell patient to report signs/symptoms of angioedema (deep swelling around eyes and lips and sometimes hands and feet) or intestinal angioedema (abdominal pain).  
- Advise patient to maintain adequate hydration during therapy.  
- Patient should avoid use of potassium-sparing diuretics or potassium-containing supplements or salt substitutes, as this may cause increased potassium levels  
- angioedema, hereditary or idiopathic
- angioedema related to prior therapy with an ACE inhibitor (history of)
- hypersensitivity to enalapril or enalaprilat, an active metabolite of enalapril Precautions
- pregnancy, second and third trimesters; can cause fetal and neonatal morbidity and death; discontinue enalapril therapy
- anaphylaxis during lipid apheresis with dextran sulfate membranes and hemodialysis with high flux membranes has been reported
- angioedema, head and neck; has occurred; discontinue therapy
- angioedema (intestinal) has been reported; increased risk in patients with history of intestinal angioedema
- aortic stenosis/hypertrophic cardiomyopathy, history of; vasodilation
- cerebrovascular disease; history of; excessive hypotension may result in cerebrovascular accident
- CHF, history of; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death
- concomitant diuretic therapy, high dose; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death
- hepatic failure has occurred; discontinue therapy in patients who develop jaundice or have marked elevations in hepatic enzymes
- hyperkalemia has been reported; increased risk with renal disease, diabetes, and concomitant use of potassium supplements, potassium containing salt substitutes, and potassium-sparing diuretics
- hyponatremia, presence of; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death
- insect venom allergy, hymenoptera venom immunotherapy; may exacerbate the allergic response
- ischemic heart disease, history of; excessive hypotension may result in myocardial infarction
- renal dialysis therapy; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death
- renal impairment; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death
- renal impairment, especially in the presence of collagen vascular disease; agranulocytosis and neutropenia have occurred
- surgery/anesthesia; excessive hypotension has been reported
- volume and/or salt depletion (severe), presence of; risk for excessive hypotension sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death  
| Common                                                                                                                                                                              | Serious                                                                                                                                                                                                                             |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alopecia Rash Abnormal skin appearance  Hot sweats Diarrhea Inflammatory disease of mucous membrane Nausea Vomiting  Lethargy Amenorrhea  Fever Infection Radiation recall syndrome | Abnormal ECT Cardiotoxicity Possibly fatal CHF Tissue necrosis (skin, local) Hyperuricemia Tumor lysis syndrome Acute myeloid leukemia (secondary) Myelosupperssion (possibly severe) Anaphylaxis  Immune hypersensitivity reaction |
brand name(s) hyperstat proglycem
epirubicin

- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression.  
- Warn patient that urine may have red-discoloration for 1 to 2 days after treatment.  
- Patients with prior radiation therapy may experience an inflammatory recall reaction
(inflamed skin at the old radiation sites when a new chemotherapy drug is administered).  
- This drug may cause alopecia, hot flashes, diarrhea, inflamed mucous membranes, nausea, vomiting, lethargy, amenorrhea, or fever.  
- Instruct patient to report signs/symptoms of extravasation immediately, as drug is caustic.  
- Advise patient to report signs/symptoms of congestive heart failure, which may indicate cardiac toxicity.  
- Patient should report signs/symptoms of myelosuppression, hepatic dysfunction, or renal dysfunction.  
- Tell patient to maintain adequate hydration during drug therapy.  
ERGOCALCIFEROL
Brand Name(s): **Drisdol**
brand name(s) hyperstat proglycem
adverse effects serious

- **Endocrine metabolic:** Hypercalcemia, Hypervitaminosis D, Renal impairment, calcification of soft tissues, bone demineralization, growth retardation, nausea, constipation, mild acidosis, weight loss Common:
- **None indicated**  
- Patient should report signs/symptoms of hypercalcemia (nausea, vomiting, muscle weakness or tetany, increased thirst, confusion, abdominal pain).  
- Maintain adequate dietary intake of calcium as instructed by healthcare professional. - Patient should avoid additional supplemental sources of vitamin D, unless approved by healthcare professional.  
- abnormal sensitivity to the toxic effects of vitamin D
- hypercalcemia
- hypervitaminosis D
- malabsorption syndrome Precautions
- adequate dietary calcium; necessary for clinical response to vitamin D therapy
- evaluate vitamin D intake from fortified foods, dietary supplements, and self-administered and prescription drug sources
- hyperphosphatemia may occur; must maintain normal serum phosphorus levels by aluminum gel administration and/or dietary phosphate restriction to prevent metastatic calcification
- hypersensitivity to vitamin D, particularly in infants with idiopathic hypercalcemia
- hypoparathyroidism; dihydrotachysterol, intravenous calcium, and/or parathyroid hormone may be required during treatment
- tartrazine (FD&C Yellow No. 5) sensitivity; increased risk of allergic reactions including bronchial asthma in susceptible patients, especially in patients with concomitant aspirin sensitivity (Drisdol(R))
- vitamin D-resistant rickets; the range between therapeutic and toxic doses is narrow  
| We know about the following side effects of OSI-774:  Common (happens in 21-100  patients out of 100)   | Rare (happens in less than 5 patients out  of 100)   |                  |                                         |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------|-----------------------------------------|
| The timing of                                                                                           | Acne-like skin rash,                                 | Dry skin, dry    | Peeling of the skin, hives and itching, |
| these side effects                                                                                      | diarrhea, nausea,                                    | mouth, decreased | elevation in liver function tests,      |
| Occasional (happens in 5-20  patients out of 100)                                                       |                                                      |                  |                                         |
| Version 2.0 Final                                                                                       | Page 153 of 268                                      | Confidential     |                                         |
| Issued 12 June 2013                                                                                     |                                                      |                  |                                         |
brand name(s) hyperstat proglycem
erlotinib (tarceva/osi-774)

| vomiting, tiredness,                                                                                         | appetite, mouth   | redness/inflammation of the                                                                                                                                                                                                                                               |
|--------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| weariness, ill feeling                                                                                       | sores, heartburn  | eye/damage to the cornea, dry eye,  inward growth of eyelashes, tearing,  kidney damage, headache,  inflammation of the lungs, lung  tissue changes and damage and  scarring of lung tissues, blurry  vision, allergic reaction, changes to  taste, increase in bilirubin |
| Allergic reactions may occur with any medicine. (how soon they  happen after  taking OSI-774) is  not known. |                   |                                                                                                                                                                                                                                                                           |  
Also reported on OSI-774 trials but with the relationship to OSI-774 unknown: low levels of red blood cells, low levels of white blood cells, increased numbers of white blood cells in the blood, low number of platelets in the blood which may increase the risk of bleeding, poor blood supply to an area of bone causing bone death, blockage of the pulmonary artery (1 case), a clot blocking a vein, shaking chills, fever, hair loss, sore throat, burning or painful sensation in the tongue, inflammation and cracking of the skin of the lips, constipation, abdominal pain or cramping, sores in the stomach, too much gas produced in the intestines, difficulty swallowing, decreased blood flow to the intestines, inflammation of the pancreas, blood in the urine, nose bleed, dark, bloody bowel movement, blood in sputum or spit, bleeding in the intestines, elevated liver enzyme levels, inflammation of the lungs, urinary tract infection, infection with or without decrease in a type of white blood cell called a neutrophil, low levels of potassium and sodium in the blood, dryness in the nose, runny nose, depression, anxiety, sleeplessness, a skin sensation, such as burning, prickling, itching, or tingling, with no apparent cause, dizziness, blockage of the blood vessels of the brain (1 case), back pain, cough, difficulty breathing, too much protein in the urine, kidney failure, inflammation of the lining of the uterus, confusion, dehydration and increased levels of urea in the blood which is likely directly related to diarrhea, changes in blood clotting in patients also taking Coumadin, inflammation of the cornea causing watery painful eyes and blurred vision, inflammation of the eye, inflammation of the pancreas, the presence of air or gas in abnormal places in the body, and secondary skin infection from rash. If a person gets pregnant while receiving OSI-774, it could be dangerous for the baby. You should not become pregnant or father a baby while on this study. You should not nurse (breast feed) a baby while on this study. Ask about counseling and more information about preventing pregnancy. Women of child-bearing potential and males must agree to use an adequate form of birth control while on this protocol.
brand name(s) hyperstat proglycem
erythromycin brand name(s) ak-mycin akne-mycin

- **Gastrointestinal:** Diarrhea, Loss of appetite, Nausea, Stomach cramps, Vomiting  
- This drug may cause loss of appetite, nausea, stomach cramps, or vomiting.  
- Elderly patients are more susceptible to development of dysrhythmia and torsade de pointes.  
- Elderly patients with renal or hepatic dysfunction are at increased risk of ototoxicity.  
- Instruct patient to report severe diarrhea and consult healthcare professional prior to taking anti-diarrhea medicine.  
- Elderly patients on concomitant anticoagulant therapy should monitor for signs/symptoms of bleeding, as drug may have additive effects.  
- Patients with a history of myasthenia gravis should report signs/symptoms of disease exacerbation during therapy.  
- Patients using the topical gel should avoid contact with eyes and all mucous membranes. - Do not use with astemizole, cisapride, pimozide, terfenadine, or lovastatin  
- concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine
- hypersensitivity to erythromycin or any component of the product
brand name(s) hyperstat proglycem
precautions

- concomitant therapy with colchicine; colchicine toxicity has been reported; potential to be life-threatening and may occur at recommended doses
- concomitant therapy with lovastatin; rhabdomyolysis, with or without renal impairment, has been reported in seriously ill patients; monitoring recommended
- early syphilis in pregnancy; oral erythromycin may not prevent congenital syphilis; administer appropriate penicillin regimen to infant born to woman treated with oral erythromycin for early syphilis
- elderly patients, especially with renal or hepatic dysfunction; increased risk of erythromycin-associated hearing loss
- elderly patients; increased susceptibility to torsades de pointes arrhythmias
- hepatotoxicity (eg, increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice) has been reported with use of oral erythromycin products
- impaired hepatic function; erythromycin primarily excreted by the liver
- infantile hypertrophic pyloric stenosis has been reported - myasthenia gravis, exacerbation or new onset, has occurred - superinfection; may occur as a result of overgrowth of nonsusceptible organisms; discontinue if superinfection occurs  
| Common                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Serious                                                                                                                                                                                                                                                                                                                                            |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema (transdermal system, 0.5% to 13%) Application site irritation (transdermal spray,  1.3%; transdermal system, 5.7% to 56.7%) Chloasma  Hirsutism Persistent erythema of skin (transdermal patch,  17%)  Pruritus (topical emulsion, 4%; topical gel, 4.8%) Weight change Bloating symptom Nausea Vomiting Migraine  Depression (transderamal system, 1% to 8%) Mood disturbance  Breast tenderness (topical gel, 2.5% to 8.8%;  transdermal spray, 5% to 7%; transdermal system,  6.5% to 17%) Menstruation disorder Leucorrhea  Breast swelling Vaginal discomfort (vaginal cream, 5%; vaginal  ring, 5%) Withdrawal bleeding | Heart disease Hypertension  Myocardial infarction Body fluid retention Breast cancer Diabetes mellitus Hypercalcemia Gallbladder disorder Venous thromboembolism Anaphylaxis  Cerebrovascular accident Dementia Impaired cognition Thrombosis of retinal vein Malignant neoplasm of endometrium of corpus  uteri Ovarian cancer Pulmonary embolism |  
- This drug may cause edema, chloasma, change in weight, nausea, vomiting, headache, depression, amenorrhea, break-through bleeding, breast tenderness, swollen breast, breast cancer, or endometrial cancer. The vaginal insert formulation may also cause vaginal discomfort.  
- Instruct patient to report abnormal vaginal bleeding or signs/symptoms of a thromboembolic disorder.  
- Advise patients using the vaginal insert, tablet, or cream to report signs/symptoms of a vaginal infection.  
- Instruct patient on proper administration technique depending on form. - If the vaginal insert falls out after insertion, patient may rinse it in lukewarm water and reinsert.  
- Advise patient that the transdermal patch should never be placed on the breast or the waistline. At least 1 week should be allowed between applications to a particular site.  
- Patients should not smoke during therapy, as this increases the risk of thromboembolic events.  
- Advise patients using the topical emulsion to not use sunscreen over the application site, as this may increase the estrogen absorption.  
- Avoid eating grapefruit or drinking grapefruit juice while taking oral preparations this drug.  
| Common                                                                                                                                                                             | Serious                                                                                                                                            |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Injection site reaction (irritation, pain) Rash Abnormal electrolytes Diarrhea Dyphagia  Loss of appetite Nausea Vomiting Gout  Confusion  Headache Vertigo Blurred vision Fatigue | Pancreatitis (rare) Agranulocytosis  Neutropenia  Thrombocytopenia  Hepatotoxicity (rare) Jaundice (rare) Ototoxicity Deafness Tinnitus  Hematuria |  
This drug may cause hyper- or hypoglycemia, abdominal pain, diarrhea, dysphagia, loss of appetite, nausea, vomiting, gout, confusion, headache, vertigo, blurred vision, fatigue, pancytopenia, or hematuria.  
Instruct patient to report severe, watery diarrhea or signs/symptoms of ototoxicity.  
Patient should avoid lithium during drug therapy.
brand name(s) hyperstat proglycem
ethambutol hydrochloride brand name(s) myambutol

- **Hematologic:** Neutropenia, Thrombocytopenia
- **Immunologic:** Anaphylactoid reaction
- **Neurologic:** Peripheral neuropathy
- **Ophthalmic:** Blindness AND/OR vision impairment level, Optic neuritis (1-6%)  
- **Endocrine metabolic:** Hyperuricemia - **Gastrointestinal:** Nausea and vomiting - **Psychiatric:** Mania  
- This drug may cause nausea, vomiting, hyperuricemia, or mania.  
- Drug may cause vision impairment or loss. Instruct patient to promptly report any visual changes.  
- Patient should report signs/symptoms of neutropenia, thrombocytopenia, or peripheral neuropathy  
- hypersensitivity to ethambutol hydrochloride
- inability to appreciate and report visual side effects or changes in vision (eg, young children or unconscious patients)
- optic neuritis, unless clinical judgment determines that it may be used Precautions
- blindness, irreversible, has been reported - concomitant use of antacids that contain aluminum hydroxide should be avoided for 4 hours following administration
- liver toxicities, including fatalities, have been reported; monitoring recommended
- renal impairment; dose adjustment recommended - visual acuity has been reduced, possibly due to optic neuritis and related to dose and treatment duration
- visual defects (eg, cataracts, recurrent inflammatory conditions of the eye, optic neuritis, and diabetic retinopathy); monitoring recommended
ethionamide brand name(s) trecator
adverse effects serious

- **Hepatic:** Hepatitis
- **Neurologic:** Encephalopathy
- **Ophthalmic:** Optic neuritis (rare .) - **Psychiatric:** Psychiatric sign or symptom  
- **Gastrointestinal:** Abdominal pain, Diarrhea, Metallic taste, Nausea, Stomatitis, Vomiting  
- hypersensitivity to ethionamide or components - severe hepatic damage Precautions
- drug malabsorption may be a problem in patients with concomittant AIDS infection - diabetes control may be disrupted by ethionamide - pregnancy
ethionamide brand name(s) trecator
ethosuximide brand name(s) zarontin adverse

- **Dermatologic:** Stevens-Johnson syndrome
- **Hematologic:** Agranulocytosis, Aplastic anemia, Drug-induced eosinophilia, Leukopenia, Pancytopenia
- **Immunologic:** Systemic lupus erythematosus - **Neurologic:** Seizure  
- **Gastrointestinal:** Loss of appetite, Nausea, Stomach cramps, Vomiting - **Neurologic:** Ataxia, Dizziness, Headache, Somnolence - **Other:** Hiccoughs  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause drowsiness or dizziness.  
- This drug may cause gynecomastia, nausea, vomiting, diarrhea, metallic taste, postural hypotension, or impotence.  
- Patient should report visual changes or signs/symptoms of optic neuritis. - Advise diabetic patients to monitor for signs/symptoms of hypoglycemia and to report difficulties with glycemic control.  
- Patient should take drug with a meal to minimize gastric irritation.  
- Advise patient against excessive alcohol consumption during therapy.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized as drug may cause dizziness, drowsiness, and fatigue.  
- This drug may cause anorexia, nausea, stomach cramps, abdominal pain, diarrhea, vomiting, ataxia, and headaches.  
- Advise patient or caregiver to report worsening depression, suicidal ideation, or unusual changes in behavior.  
- Patient should report signs/symptoms of systemic lupus erythematosus (arthralgia, myalgia, fatigue, skin rash) or a severe skin reaction such as Stevens-Johnson syndrome (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering).  
- Instruct patient to report signs/symptoms of blood dyscrasias (eg, sore throat, fever, malaise, bruising, petechiae, skin rash, or epistaxis) or hepatic dysfunction.  
- Advise patient against sudden discontinuation of drug, as this may precipitate petit mal seizures.  
- hypersensitivity to succinimides
ethionamide brand name(s) trecator
precautions

- abrupt withdrawal should be avoided due to the potential for status epilepticus - blood dyscrasias, some fatal, have been reported; monitoring recommended
- grand mal seizures may occur more frequently when used as monotherapy for mixed types of epilepsy
- liver disease, preexisting; liver function abnormalities have been reported; monitoring recommended
- pregnancy; may increase risk for birth defects in newborns; assess risk/benefit
- renal disease, preexisting; renal function abnormalities have been reported; monitoring recommended
- suicidality, increased risk of; monitoring recommended - systemic lupus erythematosus has been reported  
| Common                                                                         | Serious                                                                                                                                                                                                                                                                                                                                                                                         |              |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Edema Abdominal pain Diarrhea Flatulence Indigestion  Nausea Dizziness Malaise | Congestive heartfailure (<1%) Myocardial infarction Thrombotic tendency observations Scaling eczema Stevens-Johnson syndrome (<.0.1%) Toxic epidermal necrolysis (<0.1%) Gastrointestinal hemorrhage (<1%) Gastrointestinal perfoatin (<1%) Inflammatory disorder of digestive tract Melena (<3%) Agranulocytosis (rare) Anemia (<1%) Neutropenia (rare) Thrombocytopenia (<1%) Hepatitis (<1%) |              |
| Version 2.0 Final                                                              | Page 160 of 268                                                                                                                                                                                                                                                                                                                                                                                 | Confidential |
| Issued 12 June 2013                                                            |                                                                                                                                                                                                                                                                                                                                                                                                 |              |
ethionamide brand name(s) trecator
etodolac

| Increased liver function test (up to 15%) Jaundice (<1%) Liver failure (<0.1%) Anaphylactoid reaction Immune hypersensitivity reaction (rare) Cerebrovascular accident Papillary necrosis (rare) Renal failure (rare) Bronchospasm (<2%)   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Avoid use in late pregnancy as drug may cause premature closure of ductus arteriosus. This drug may cause edema, abdominal pain, diarrhea, dyspepsia, flatulence, nausea, dizziness, or malaise.  
Instruct patients to report signs/symptoms of serious gastrointestinal adverse events such as bleeding, ulceration, perforation of stomach or intestines. Elderly and debilitated patients are at a higher risk for these effects.  
Patients should report signs/symptoms of serious cardiovascular thrombotic events, such as myocardial infarction and stroke. Patients with a cardiovascular disease history or on prolonged therapy are at a higher risk of these events.  
May be taken with food or milk to minimize stomach upset.  
Patient should avoid all other NSAIDs during therapy, unless approved by a healthcare professional.  
Patient should not drink alcohol while taking this drug.  
| Rare                                                                        |                                                                                              |                                                                              |                                                                    |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Happens to <5 children out of  every 100                                    |                                                                                              |                                                                              |                                                                    |
| Immediate:                                                                  | Nausea, vomiting                                                                             | Decreased or loss of                                                         |                                                                    |
| Within 1-2 days                                                             | appetite, drop in blood                                                                      |                                                                              |                                                                    |
| of receiving drug                                                           | pressure while receiving  this drug                                                          |                                                                              |                                                                    |
| Common                                                                      |                                                                                              |                                                                              |                                                                    |
| Happens to 21-100 children out  of every 100                                | Occasional                                                                                   |                                                                              |                                                                    |
| Happens to 5-20 children  out of every 100 Allergic reaction                |                                                                                              |                                                                              |                                                                    |
| Prompt: Within 2-3  weeks, prior to  next course                            | Decrease in the number of red  and white blood cells and  platelets made in the bone  marrow | Hair loss (L), worsens  side effects due to  radiation treatments,  diarrhea | Numbness, tingling,  clumsiness, mouth sores,  damage to the liver |
| Delayed: Any time later  during therapy Late: Any time after  completion of | A new cancer or leukemia  resulting from this treatment,  inability of the ovaries to        |                                                                              |                                                                    |
| Version 2.0 Final                                                           | Page 161 of 268                                                                              | Confidential                                                                 |                                                                    |
| Issued 12 June 2013                                                         |                                                                                              |                                                                              |                                                                    |
ethionamide brand name(s) trecator
etoposide (vepesid)

| treatment                          | produce eggs and/or hormones  resulting in inability to have  children and/or hormonal  problems   |
|------------------------------------|----------------------------------------------------------------------------------------------------|
| (L) Toxicity may also occur later. |                                                                                                    |