Ripretinib

Ripretinib

Ripretinib

What is Ripretinib?

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

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

Ripretinib side effects

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

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

• severe stomach pain, nausea or vomiting;

• severe headache, blurred vision, throbbing in the neck or ears;

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

• Heart problems – tiredness, shortness 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, lightheadedness or shortness of breath, cold hands and feet; or

• Skin changes - a new wart, sore skin or a red bump that bleeds or doesn't heal, or a change in the size or color of a mole.

Common ripretinib side effects may include:

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

• diarrhea, constipation;

• Fatigue;

• 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Follow all instructions on the label and packaging of your medicine. Tell each of your healthcare providers about all your medical conditions, allergies and any medications you take.

Before you take this medicine

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 are planning to have surgery.

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

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

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

Use effective contraception to prevent pregnancy while using this medication and for at least one week after the last dose. Tell your doctor immediately if pregnancy occurs while the mother or father is using ripretinib.

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

Do not breast-feed while using this medicine.and for at least 1 week after your last dose.

How should I take ripretinib?

Follow all instructions on your prescription label and read any medication guides or instructions for use. 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 every day with or without food.

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

Your blood pressure needs to be checked frequently. Your heart function may also need to be checked.

If you need surgery, tell your surgeon that you are currently using this medicine. You may need to take a short break.

If you experience certain side effects, your cancer treatments may be delayed or permanently stopped.

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

Store at room temperature, protected from moisture and heat. Store the tablets in their original container along with the package or canister containing the moisture-absorbing preservative.

Ripretinib dosage information

Usual Adult Dose for Gastrointestinal Stromal Tumors:

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 previously received treatment with 3 or more kinase inhibitors, including imatinib.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking ripretinib?

Ripretinib can cause milder sunburn. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when outdoors.

What other drugs will affect ripretinib?

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

Tell your doctor about all other medicines you take, especially blood pressure medications.

Other medications may affect ripretinib, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.