Adagrasib

WHY is this medicine prescribed?

Adagrasib is used to treat certain types of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body or cannot be removed by surgery in adults who have received at least one other treatment.Adagrasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Adagrasib comes as a tablet to take by mouth. It is usually taken with or without food twice a day for as long as your doctor recommends treatment. Take adagrasib at around the same times 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 adagrasib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking adagrasib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of adagrasib, treat you with other medications, or interrupt or permanently stop your treatment depending on your response to treatment and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment with adagrasib. Continue to take adagrasib even if you feel well. Do not stop taking adagrasib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking adagrasib,

• tell your doctor and pharmacist if you are allergic to adagrasib, any other medications, or any of the ingredients in adagrasib tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal product may interact with adagrasib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking adagrasib. Do not start this medication while taking adagrasib without discussing with your healthcare provider.

• tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or another type of irregular heartbeat, or if you have or ever had heart failure or other heart problems, liver or kidney problems, or lung or breathing problems other than lung cancer.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking adagrasib, call your doctor.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment, and for 1 week after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking adagrasib.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if more than 4 hours passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Adagrasib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• muscle or bone pain
• tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• bloody vomit or vomiting blood or brown material that resembles coffee grounds
• bloody, black, or tarry stools
• abdominal pain or stomach cramps
• yellowing of skin or eyes, dark-colored urine, light-colored stools, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• shortness of breath, cough, or fever
• dizziness, lightheadedness, or fainting
• slow or irregular heartbeat
• shortness of breath, cough, or fever
• decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness

Adagrasib 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of 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).

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.