Ripretinib is used in adults to treat tumors of the stomach and intestines.

Ripretinib is for use in adults who have already been treated with at least 3 other cancer medicines.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

Take the medicine at the same time each day, with or without food.

If you vomit shortly after taking ripretinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your blood pressure will need to be checked often. Your heart function may also need to be checked.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Do not change your dose or stop taking ripretinib without your doctor's advice.

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 Gastrointestinal Stromal Tumor:

Recommended dose: 150 mg orally once daily until disease progression or acceptable toxicity

Use: For the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

You may not be able to use ripretinib if you have untreated or uncontrolled hypertension (high blood pressure).

Tell your doctor if you have ever had:

• a skin problem called palmar-plantar erythrodysesthesia syndrome;

• high blood pressure;

• heart problems; or

• if you have recently had surgery or plan to have surgery.

Using ripretinib may increase your risk of developing skin cancer. Your skin may need to be checked while you are using ripretinib. Ask your doctor about skin symptoms to watch for.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Ripretinib can harm an unborn baby if the mother or father is using this medicine.

Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ripretinib.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because ripretinib can harm an unborn baby.

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

Take the medicine as soon as you can, but skip the missed dose if you are more than 8 hours late for the dose. Do not take 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 light, excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the tablets to absorb moisture) from your bottle.

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.

Ripretinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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

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

• severe stomach pain, nausea, or vomiting;

• severe headache, blurred vision, pounding in your neck or ears;

• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;

• heart problems--tiredness, feeling short of breath, swollen veins in the sides of your neck, swelling in your stomach or lower legs;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• skin changes--a new wart, a skin sore or red bump that bleeds or does not heal, or any change in the size or color of a mole.

Common side effects of ripretinib may include:

• nausea, vomiting, stomach pain, loss of appetite;

• diarrhea, constipation;

• tiredness;

• muscle pain; or

• thinning hair, hair loss.

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.

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

Tell your doctor about all your other medicines, especially blood pressure medicine.

Other drugs may affect ripretinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and check your blood pressure to check your body's response to ripretinib. Your doctor will also check your skin for any changes before and during your treatment.

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.