KRAZATI is a tablet containing adagrasib as the active ingredient in a 200 mg dosage. Adagrasib is an irreversible inhibitor of KRAS G12C and part of the RAS GTPase family. It is formulated as a tablet for oral administration, with inactive ingredients such as colloidal silicon dioxide, crospovidone, and magnesium stearate. KRAZATI is intended for oral use with additional coatings that include hypromellose and titanium dioxide.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice during the first 8 days of therapy.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 4 hours late. If it is more than 4 hours late, skip the missed dose. Take the next dose at the normal time.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Dry cough, shortness of breath or trouble breathing
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Loss of appetite
• Muscle pain
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Irregular heartbeat or rhythm
• Liver disease
• Lung disease
• Stomach or intestine problems
• An unusual or allergic reaction to adagrasib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Alprazolam
• Certain medications for cholesterol, such as lovastatin, simvastatin, lomitapide
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for migraine headaches, such as eletriptan, ubrogepant
• Cisapride
• Conivaptan
• Dronedarone
• Eliglustat
• Ergot alkaloids, such as dihydroergotamine, ergotamine
• Finerenone
• Flibanserin
• Isavuconazonium
• Ivabradine
• Lonafarnib
• Lopinavir
• Lurasidone
• Mavacamten
• Naloxegol
• Pacritinib
• Pimozide
• Ranolazine
• Saquinavir
• Silodosin
• Thioridazine
• Tolvaptan
• Triazolam
• Voclosporin

This medication may also interact with the following:

• Dextromethorphan
• Digoxin
• Midazolam
• Other medications that cause heart rhythm changes
• Rifampin
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

If you get black, tarry stools or vomit up what looks like coffee grounds, call your care team right away.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Do not breast-feed while taking this medication and for 1 week after stopping treatment.