Vimseltinib

Vimseltinib is used in adults to treat giant cell tumor of the tendon sheath (also called tenosynovial giant cell tumor) that is unlikely to get better with surgery.

Vimseltinib 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.

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

Vimseltinib is usually taken twice per week, with at least 72 hours between doses.

You may take vimseltinib with or without food. Follow your doctor's instructions.

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

If you vomit within 30 minutes of taking vimseltinib, take another dose. If you vomit more than 30 minutes after taking vimseltinib, do not take another dose. Take your next dose as scheduled.

You will need frequent blood tests to check your liver function before and during treatment with vimseltinib. Your next dose may be reduced, delayed, or permanently discontinued based on the results.

Your doctor will need to check your progress on a regular basis.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using vimseltinib.

Store in the original container at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• an allergy to aspirin or food dye (tartrazine or sunset yellow fcf); or
• liver disease.

Vimseltinib can harm an unborn baby if the mother or the father is using vimseltinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 month after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 month after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Vimseltinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

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

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

Vimseltinib may cause serious side effects. Contact your doctor immediately if you experience:

• rash; or
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatments may be reduced, delayed, or stopped permanently if you have certain side effects.

Common side effects of vimseltinib may include:

• abnormal lab tests;
• swelling around your eyes;
• tiredness;
• rash, itching; or
• swelling in your face, hands, or feet.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can also report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Nodular Tenosynovitis:

30 mg orally twice a weekComments:-There should be at least 72 hours between doses, as directed on the blister package.Use: For treatment of patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity

Take the medicine as soon as you can, but if you are more than 48 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.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect vimseltinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.