Ripretinib

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

Ripretinib is for adults who have already received treatment with at least 3 other cancer medicines.

Ripretinib may also be used for reasons not mentioned in this medication guide.

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.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

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.

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

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

• severe stomach pain, nausea, or vomiting;
• severe headache, blurred vision, or a pounding sensation 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.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

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

Take the medicine as soon as you can, but if you are more than 8 hours late for the dose, skip the missed dose. Do not take two doses at the same time.

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

Ripretinib could make you more sensitive to the sun. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Sometimes, it is not safe to use certain medications together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medications work less effectively.

Tell your doctor about all the other medicines you are taking, 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 begin or stop using.