Acitretin (patient information)

# IMPORTANT WARNING
For female patients:
Do not take acitretin if you are pregnant or plan to become pregnant within the next 3 years. Acitretin may harm the fetus. You should not begin taking acitretin until you have taken two pregnancy tests with negative results. You must use two acceptable forms of birth control for 1 month before you begin taking acitretin, during your treatment with acitretin, and for 3 years after treatment. Your doctor will tell you which methods of birth control are acceptable. You do not need to use two methods of birth control if you have had a hysterectomy (surgery to remove the womb), if your doctor tells you that you have finished menopause (change of life), or if you practice total sexual abstinence.
If you plan to use oral contraceptives (birth control pills) while taking acitretin, tell your doctor the name of the pill you will use. Acitretin interferes with the action of microdosed progestin ('minipill') oral contraceptives (Ovrette, Micronor, Nor-QD). Do not use this type of birth control while taking acitretin.
If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, and intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive.
You will need to take pregnancy tests regularly while taking acitretin. Stop taking acitretin and call your doctor immediately if you become pregnant, miss a menstrual period, or have sex without using two forms of birth control. In some cases, your doctor can prescribe emergency contraception ('the morning after pill') to prevent pregnancy.
Do not consume foods, drinks, or prescription or nonprescription medications that contain alcohol while taking acitretin and for 2 months after treatment. Alcohol and acitretin combine to form a substance that remains in the blood for a long time and can harm the fetus. Read medication and food labels carefully and ask your doctor or pharmacist if you are not sure whether a medication contains alcohol.
Your doctor will give you a Patient Agreement/Informed Consent to read and sign before you begin treatment. Be sure to read this carefully and ask your doctor if you have any questions.
For male patients:
A small amount of acitretin is present in the semen of male patients who take this medication. It is not known whether this small amount of medication can harm the fetus. Talk to your doctor about the risks of taking this medication if your partner is pregnant or plans to become pregnant.
For male and female patients:
Do not donate blood while taking acitretin and for 3 years after treatment.
Acitretin may cause liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: upset stomach, extreme tiredness, unusual bruising or bleeding, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark urine, or flu-like symptoms.

# Why this medication is prescribed
Actitretin is used to treat severe psoriasis (abnormal growth of skin cells that causes red, thickened, or scaly skin). Acitretin is in a class of medications called retinoids. The way acitretin works is not known.

# How this medication should be used
Actitretin comes as a capsule to take by mouth. It is usually taken once a day with the main meal. Take acitretin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acitretin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of acitretin and gradually increase your dose.
Acitretin controls psoriasis but does not cure it. It may take 2-3 months or longer before you feel the full benefit of acitretin. Your psoriasis may get worse during the first few months of treatment. This does not mean that acitretin will not work for you, but tell your doctor if this happens. Continue to take acitretin even if you feel well. Do not stop taking acitretin without talking to your doctor.
After you stop taking acitretin, your symptoms may come back. Tell your doctor if this happens. Do not use leftover acitretin to treat a new flare-up of psoriasis. A different medication or dose may be needed.

# Other uses for this medicine
Acitretin is sometimes also used to treat Darier's disease (a type of skin disease), palmoplantar pustulosis (pus-filled blisters and red patches on the hands and feet), lichen sclerosus et atrophicus of the vulva (redness, scaling, and easy bleeding of the genital area in females), palmoplantar lichen nitidus (clusters of bumps on the hands and feet), and lichen planus (red, itchy bumps in various places on the body). It is also used to treat lamellar ichthyosis (scaly patches of skin that fall off the body); Sjogren-Larsson syndrome (dry, scaling skin, mental retardation, and trouble walking); and bullous and nonbullous ichthyosiform erythroderma (red, blistering, or peeling skin) in children. Talk to your doctor about the possible risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

# Special Precautions
Before taking acitretin:
- tell your doctor and pharmacist if you are allergic to acitretin, other retinoids such as adapalene (Differen), alitretinoin (Panretin), etretinate (Tegison), isotretinoin (Accutane), tazarotene (Tazorac), tretinoin (Renova, Retin-A, Vesanoid), Vitamin A, or any other medications.
- do not take methotrexate (Rheumatrex, Trexall) or tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin) while taking acitretin.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications and herbs listed in the IMPORTANT WARNING section and any of the following: glyburide (Diabeta, Glynase, Micronase), other oral retinoids such as isotretinoin (Accutane) and tretinoin (Vesanoid), phenytoin (Dilantin, Phenytek), and vitamin A. Also tell your doctor if you have ever taken etretinate (Tegison). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section; if you drink large amounts of alcohol; if you have a family history of high cholesterol or diabetes; if you have or have ever had diabetes, high cholesterol or triglycerides, spinal problems, depression, or stroke or mini-stroke; or if you have or have ever had joint, bone, kidney, or heart disease.
- do not breastfeed while taking acitretin or if you have recently stopped taking acitretin.
- you should know that acitretin may limit your ability to see at night. This problem may begin suddenly at any time during your treatment. Be very careful when driving at night.
- plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Do not use sunlamps while taking acitretin. Acitretin may make your skin sensitive to sunlight.
- if you need to have phototherapy, tell your doctor that you are taking acitretin.
- you should know that acitretin may dry your eyes and make wearing contact lenses uncomfortable during or after treatment. Remove your contact lenses and call your doctor if this happens.

# Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

# What to do if you forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

# Side Effects

## Minor Side Effects
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements

# Severe Side Effects=
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Acitretin can also cause hyperglycemia (high blood sugar). Call your doctor immediately if you have any of the following symptoms of hyperglycemia:
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:
- dry mouth
- upset stomach and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
Acitretin may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- peeling, dry, itchy, scaling, cracked, blistered, sticky or infected skin
- brittle or weak fingernails and toenails
- dandruff
- sunburn
- abnormal skin odor
- excessive sweating
- hair loss
- changes in hair texture
- dry eyes
- loss of eyebrows or eyelashes
- hot flashes or flushing
- weak nails
- chapped or swollen lips
- swollen or bleeding gums
- excessive saliva
- tongue pain, swelling, or blistering
- mouth swelling or blisters
- stomach pain
- diarrhea
- increased appetite
- difficulty falling or staying asleep
- sinus infection
- runny nose
- dry nose
- nosebleed
- joint pain
- tight muscles
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- rash
- headache
- upset stomach
- vomiting
- blurred vision
- pain, swelling, or redness of eyes or eyelids
- eye pain
- eyes sensitive to light
- swelling of hands, feet, ankles, or lower legs
- redness or swelling in one leg only
- depression
- thoughts of hurting or killing yourself
- bone, muscle, or back pain
- difficulty moving any part of your body
- loss of feeling in hands or feet
- chest pain
- slow or difficult speech
- rash
- tingling in arms and legs
- loss of muscle tone
- weakness or heaviness in legs
- confusion
- cold, gray skin
- slow or irregular heartbeat
- pale skin
- dizziness
- fast heartbeat
- weakness
- shortness of breath
Acitretin may cause bone problems and slowing or stopping of growth in children. Talk to your child's doctor about the risks of giving this medication to your child.
Acitretin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online  or by phone .

# Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- headache
- dizziness
- vomiting
- upset stomach
- dry, itchy skin
- loss of appetite
- bone or joint pain
If a female who could become pregnant takes an overdose of acitretin, she should take a pregnancy test after the overdose and use two forms of birth control for the next 3 years.

# Other information
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to acitretin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

# Brand names
- Soriatane