Ripretinib

Ripretinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine [bowel], or esophagus [tube that connects the throat with the stomach]) in adults who have previously received other medications, including imatinib (Gleevec). Ripretinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Ripretinib comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take ripretinib at around the same time 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 ripretinib 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 ripretinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of ripretinib during your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with ripretinib.

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

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

Before taking ripretinib,

• tell your doctor and pharmacist if you are allergic to ripretinib, any other medications, or any of the ingredients in ripretinib 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.
• tell your doctor what nonprescription or herbal products you are taking, especially St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking ripretinib. Do not start any of these medications while taking ripretinib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had palmar-plantar erythrodysesthesia (hand-foot syndrome; a type of skin problem that causes redness, swelling, and pain on the palms of the hands or soles of the feet), high blood pressure, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant while you are taking ripretinib. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment with ripretinib and for 1 week after your final dose. If you are male, you and your female partner should use birth control during your treatment with ripretinib and for 1 week after your final dose. If you or your partner become pregnant while taking ripretinib, call your doctor immediately. Ripretinib can cause fetal harm.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking ripretinib and for 1 week after your final dose.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking ripretinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ripretinib. Your doctor may tell you not to take ripretinib at least 1 week before your surgery or procedure and will tell you when you should start taking the medication again.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment with ripretinib and for at least 1 week after your final dose. Ripretinib may make your skin sensitive to sunlight.

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

Take the missed dose as soon as you remember it. However, if it is within 8 hours of your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• muscle or joint pain
• hair loss
• dry or itchy skin
• weakness
• nausea
• vomiting
• stomach pain
• constipation
• diarrhea
• mouth sores or ulcers
• headache
• weight loss
• loss of appetite
• muscle spasms
• fatigue
• numbness or tingling in the hands, feet, arms, or legs

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

• redness, pain, blisters, bleeding, or swelling on hands or feet; or rash
• new wart
• changes in skin appearance
• skin sore or red bump that bleeds or does not heal
• change in size or color of a mole
• tiredness; swelling of stomach, legs, or ankles; shortness of breath; or neck veins sticking out

Ripretinib may increase the risk that you will develop skin cancer. Talk to your doctor about this risk.

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

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

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