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Vimseltinib (By mouth)

Vimseltinib (vim-SEL-ti-nib)

Treats tenosynovial giant cell tumor (TGCT).

Brand Name(s):

Romvimza

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you have an allergic reaction to vimseltinib.

How to Use This Medicine:

Capsule

  • 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 least 72 hours apart.
  • Swallow the capsule whole. Do not open, break, or chew it.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
  • Missed dose: If you miss a dose and it is 48 hours or less, take it as soon as possible and go back to your regular dosing schedule. If you miss a dose and it is more than 48 hours, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
  • If you vomit within 30 minutes of taking a dose, take another dose. If you vomit more than 30 minutes after taking a dose, do not take another dose and take your next dose at your regular time.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not store the capsule in another container.

Drugs and Foods to Avoid:

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

  • Take this medicine at least 4 hours before taking dabigatran.

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 can 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 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 month after the last dose.
  • Do not breastfeed during treatment and for 1 month after the last dose.
  • Tell your doctor if you have kidney disease or liver disease.
  • This medicine may cause liver problems.
  • This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
  • This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Blood tests will be needed before starting this medicine, 2 times each month for the first 2 months of treatment, and then 1 time every 3 months for the first year of treatment to check for liver problems.
  • 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
  • Blurred vision, dizziness, headache, nervousness, pounding in the ears, slow or fast heartbeat
  • Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet
  • Rapid weight gain, swelling in your hands, ankles, or feet

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

  • Dry eyes, watering of the eyes
  • Swelling around the eyes, swelling or puffiness of the face
  • Tiredness

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

Last Updated: 5/4/2025

 

 
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