Ripretinib (rip-RE-ti-nib)

Treats gastrointestinal stromal tumor (GIST).

Brand Name(s):

Qinlock

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is less than 8 hours of your scheduled dose, take it as soon as possible and then go back to your regular dosing schedule. If you miss a dose and it is more than 8 hours of your scheduled dose, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking a dose, take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ripretinib works. Tell your doctor if you are using efavirenz, itraconazole, or rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, high blood pressure, or skin problems (including skin cancer). Tell your doctor if you had a recent surgery.
• This medicine may cause the following problems:
  • Palmar-plantar erythrodysesthesia (hand-foot skin reaction), a condition that can cause pain and blisters on your hands or feet
  • Increased risk for new skin cancers, including cutaneous squamous cell carcinoma, melanoma
  • High blood pressure
  • Heart problems, including heart failure
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Avoid exposure to direct sunlight, sunlamps, or other ultraviolet radiation during treatment and for at least 1 week after the last dose.
• If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
• This medicine may cause slow wound healing. Make sure any doctor who treats you knows that you are using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, dizziness, nervousness, headache, pounding in the ears, slow, fast, or uneven heartbeat
• Chest pain, trouble breathing, rapid weight gain, swelling in your hands, ankles, or feet
• Constipation, diarrhea, nausea, vomiting, stomach pain
• Muscle pain
• Rash, redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss or thinning
• Loss of appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088