Adagrasib is used to treat adults with non-small cell lung cancer:

• that has spread to other parts of the body or cannot be removed by surgery, and

• has a specific gene marker (an abnormal "KRAS G12C" gene), and

• who have received at least one treatment for cancer.

Your doctor will perform tests to make sure adagrasib is the right treatment for you.

Adagrasib may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take adagrasib twice a day with or without food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking adagrasib, do not take another dose. Take your next dose as scheduled.

Your treatment may be changed or permanently discontinued if you have certain side effects.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using adagrasib.

You will need medical tests before and during treatment with adagrasib.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Non-Small Cell Lung Cancer:

600 mg orally twice daily

Duration of therapy: Until disease progression or unacceptable toxicity.

Comments:
-Administer this drug at the same time every day, with or without food.
-If a dose of this drug is missed by more than 4 hours, skip the dose and resume dosing at the next scheduled time.
-In case of vomiting after taking a dose, do not take another dose. Resume dosing at the next scheduled time.

Use: For the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who received at least one prior treatment for their cancer.

Tell your doctor if you have ever had:

• heart problems, including heart failure and congenital long QT syndrome; or

• liver problems.

Adagrasib may harm an unborn baby. Tell your doctor if you are pregnant.

Adagrasib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using adagrasib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Adagrasib may cause serious side effects. Call your doctor at once if you have:

• nausea, diarrhea, or vomiting;

• shortness of breath, cough or fever;

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);

• stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of adagrasib may include:

• nausea, diarrhea, vomiting;

• tiredness;

• muscle and bone pain;

• trouble breathing;

• loss of appetite; or

• swelling, urinating less, feeling tired or short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Adagrasib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect adagrasib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to adagrasib. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with adagrasib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.