Adagrasib (a-DA-gra-sib)

Treats non-small cell lung cancer (NSCLC) and colon or rectal cancer.

Brand Name(s):

Krazati

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take the medicine at the same time each day.
• Swallow the tablet whole. Do not chew, crush, or split it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If a dose is missed by more than 4 hours or if you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how adagrasib works. Tell your doctor if you are using dextromethorphan, digoxin, midazolam, rifampin, warfarin, or medicine that may cause heart rhythm problems.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, or heart disease (including heart failure and congenital QT syndrome).
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• This medicine may cause the following problems:
  • Serious stomach and bowel problems (including bleeding, blockage, swelling, narrowing)
  • Heart rhythm problems, including QT prolongation, torsade de pointes
  • Liver problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Constipation, diarrhea, nausea, vomiting, stomach pain, blood in the stools
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Muscle or bone pain
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Cough
• Dry skin
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088