PATIENT INFORMATIONKRAZATI® (krah zah tee)(adagrasib)
Tablets
What is KRAZATI?
KRAZATI is a prescription medicine used in adults:
oalone to treat non-small cell lung cancer (NSCLC)
othat has spread to other parts of the body or cannot be removed by surgery, ando
whose tumor has an abnormal KRAS G12C gene, ando
who have received at least one prior treatment.
oin combination with a medicine called cetuximab to treat colon or rectal cancer (CRC)othat has spread to other parts of the body or cannot be removed by surgery, ando
whose tumor has an abnormal KRAS G12C gene, ando
who have previously received certain chemotherapy medicines.
Your healthcare provider will perform a test to make sure that KRAZATI is right for you.
It is not known if KRAZATI is safe and effective in children.
Before taking KRAZATI, tell your healthcare provider about all of your medical conditions, including
if you:ohave any heart problems, including heart failure and congenital long QT syndrome.
ohave liver problems.
oare pregnant or plan to become pregnant. It is not known if KRAZATI can harm your unborn baby.
oare breastfeeding or plan to breastfeed. It is not known if KRAZATI passes into your breastmilk. Do notbreastfeed during treatment and for 1 week after your last dose of KRAZATI.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. KRAZATI can affect the way other medicines work,and other medicines can affect how KRAZATI works.
How should I take KRAZATI?
oTake KRAZATI exactly as your healthcare provider tells you to take it. Do not change your dose or stoptaking KRAZATI unless your healthcare provider tells you to.
oYour healthcare provider may change your dose, or temporarily or permanently stop treatment withKRAZATI if you develop certain side effects.
oFor colon or rectal cancer, you will also receive cetuximab through a vein in your arm (intravenously)
given by your healthcare provider. Your healthcare provider will permanently or temporarily stop yourtreatment with cetuximab if your treatment with KRAZATI is permanently or temporarily stopped.
oTake your prescribed dose of KRAZATI 2 times each day, at about the same time each day.
oTake KRAZATI either with food or without food.
oSwallow KRAZATI tablets whole. Do not chew, crush or split tablets.
oIf you vomit after taking a dose of KRAZATI, do not take an extra dose. Take your next dose at your nextscheduled time.
o
If you miss a dose of KRAZATI, take the dose as soon as you remember. If it has been more than 4 hours,
do not take the dose. Take your next dose of KRAZATI at your next scheduled time. Do not take 2 doses
at the same time to make up for a missed dose.
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What are possible side effects of KRAZATI?
KRAZATI can cause serious side effects, including:oStomach and intestinal (gastrointestinal) problems. Stomach and intestinal side effects including
nausea, diarrhea, or vomiting, are common with KRAZATI but can also sometimes be severe. KRAZATI
can also cause serious stomach and intestinal side effects such as bleeding, obstruction, inflammation ofthe colon (colitis), and narrowing (stenosis).
oCall your healthcare provider if you develop any of the signs or symptoms of stomach or
intestinal problems listed above during treatment with KRAZATI.
oYour healthcare provider may prescribe an antidiarrheal medicine or anti-nausea medicine, or othertreatment, as needed.
oChanges in the electrical activity of your heart called QTc prolongation. Certain changes can occur inthe electrical activity of your heart during treatment with KRAZATI and can be seen on a test called anelectrocardiogram (ECG or EKG). QTc prolongation can increase your risk for irregular heartbeats thatcan be life-threatening, such as torsades de pointes, and can lead to sudden death.
oYou should not take KRAZATI if you have congenital long QT syndrome or if you currently have
QTc prolongation. See “Before taking KRAZATI, tell your healthcare provider about all of your
medical conditions, including if you:”§ Your healthcare provider should monitor the electrical activity of your heart and the levels of bodysalts in your blood (electrolytes) especially potassium and magnesium before starting and during
treatment with KRAZATI if you have heart failure, a slow heart rate, abnormal levels ofelectrolytes in your blood, or if you take a medicine that can prolong the QT interval of yourheartbeat.
§ Tell your healthcare provider if you feel dizzy, lightheaded, or faint, or if you get abnormal
heartbeats during treatment with KRAZATI.
oLiver problems. Abnormal liver blood test results are common with KRAZATI and can sometimes besevere. Your healthcare provider should do blood tests before starting and during treatment withKRAZATI to check your liver function. Tell your healthcare provider right away if you develop any signsor symptoms of liver problems, including:oyour skin or the white part of your eyes turns
onausea or vomiting
yellow (jaundice)odark or “tea-colored” urine
obleeding or bruisingolight-colored stools (bowel movements)
oloss of appetite
otiredness or weakness
opain, aching or tenderness on the right sideof your stomach area (abdomen)
oLung or breathing problems. KRAZATI may cause inflammation of the lungs that can lead to death.
Tell your healthcare provider or get emergency medical help right away if you have new or worsening
shortness of breath, cough, or fever.
The most common side effects of KRAZATI when used alone for NSCLC include:
onauseaokidney problems
odiarrhea
oswelling
ovomitingodecreased appetite
otiredness
otrouble breathing
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muscle and bone pain
The most common side effects of KRAZATI when used in combination with cetuximab for CRC
include:oskin rashostomach pain
onauseaodecreased appetite
odiarrhea
oswellingovomiting
olow red blood cell countotiredness
ocoughomuscle and bone pain
odizzinessoheadacheoconstipation
odry skin
onerve damage in the arms and legs
Certain abnormal blood test results are common during treatment with KRAZATI, when used alone or in
combination with cetuximab. Your healthcare provider will monitor you for abnormal blood tests and treat
you if needed.
KRAZATI may cause fertility problems in males and females, which may affect your ability to have children.
Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of KRAZATI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
How should I store KRAZATI?
oStore KRAZATI at room temperature between 68°F to 77°F (20°C to 25°C).
o
KRAZATI comes in a child-resistant container.
oKRAZATI comes with a desiccant (drying agent) in the container to keep the medicine dry. Do notremove the desiccant from the container after opening. Do not eat or swallow the desiccant.
Keep KRAZATI and all medicines out of the reach of children.
General information about the safe and effective use of KRAZATI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do
not use KRAZATI for a condition for which it was not prescribed. Do not give KRAZATI to other people,
even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or
healthcare provider for information about KRAZATI that is written for health professionals.
What are the ingredients in KRAZATI?
Active ingredient: adagrasib
Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate (vegetable sourced),mannitol, and microcrystalline cellulose. The tablet film coating contains hypromellose, maltodextrin,
medium chain triglycerides (vegetable sourced), polydextrose, talc, and titanium dioxide.
oDistributed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
KRAZATI and the KRAZATI logo are trademarks of Mirati Therapeutics, Inc., a Bristol Myers Squibb company.
For more information, go to www.KRAZATI.com or call 1-866-4-KRAZATI (1-866-457-2928)
This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 07/2024

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