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Overview: Romvimza is used to treat certain people with a rare type of tumor that affects joints. Common side effects include swelling (face, hands, or feet), tiredness, itching, and rash. Serious side effects are less common, but can include liver problems and allergic reactions. You may be at increased risk for an allergic reaction to this medicine if you are allergic to aspirin or certain yellow dyes. Tell your healthcare provider about all of your allergies and medical conditions before taking this medicine.

Uses

What is Romvimza used for?

Romvimza (vimseltinib) is commonly used to treat certain people with symptoms from tenosynovial giant cell tumors.

Learn more about Romvimza for Tenosynovial Giant Cell Tumor (TGCT).

Romvimza may also be used for other conditions as determined by your healthcare provider.

How does Romvimza work (mechanism of action)?

People with tenosynovial giant cell tumors have too much of a protein called colony stimulating factor 1 (CSF1). When this protein connects with colony stimulating factor 1 receptors (CSF1R), inflammation and tumor growth happen. Romvimza is a kinase inhibitor. It keeps the CSF1 protein from connecting and working. This seems to reduce tumor growth and size in people with tenosynovial giant cell tumors. 

How is Romvimza supplied (dosage forms)?

Brands and other names

  • Romvimza

Dosage forms and strengths

  • 14 mg oral capsules
  • 20 mg oral capsules
  • 30 mg oral capsules

How should I store Romvimza?

Romvimza should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not remove capsules from blister packs until ready to take. 

Side Effects

What are the most common side effects of Romvimza?

The most common side effects of Romvimza are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Increased liver enzymes
  • Increased fluid or swelling of your face, hands, feet, or around your eyes 
  • Tiredness
  • Rash or itching
  • Increased cholesterol levels
  • Decreased white blood cell levels

There may be other side effects of Romvimza that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Romvimza?

While less common, the most serious side effects of Romvimza are described below, along with what to do if they happen.

Severe Allergic Reactions. Romvimza may cause allergic reactions, which can be serious. Sometimes this can be from the yellow dyes (FD&C Yellow Number 5 and 6, also known as tartrazine and Sunset Yellow FCF) that are in the capsules. You may be more likely to have an allergic reaction if you are allergic to aspirin. Stop taking Romvimza and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, may happen when taking Romvimza. Liver damage has been seen with other medicines that are similar to Romvimza. Keep all appointments, including lab work, while you are taking Romvimza. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching or rash
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Romvimza?

Allergies to Ingredients. People who are allergic to any of the following should not take Romvimza.

  • Romvimza
  • Vimseltinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Romvimza.

What should I know about Romvimza before using it?

Do not take Romvimza unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Do not change your dose unless you are told to do so by your healthcare provider. Take your doses on the same days each week, with at least 72 hours between doses. 

Do not share Romvimza with other people, even if they have the same condition as you. It may harm them.

Keep Romvimza out of the reach of children.

Do not chew, open, or break Romvimza capsules. They should be swallowed whole.

If you are taking Romvimza and it is possible for you or your partner to get pregnant, you should use effective birth control while taking this medicine and for one month after the last dose.

Romvimza may make it difficult for you to get pregnant or get your partner pregnant in the future. If you may want to have children one day, talk to your healthcare provider.

What should I tell my healthcare provider before using Romvimza?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Romvimza is right for you.

In particular, make sure that you discuss any of the following.

Liver Problems. Tell your healthcare provider if you have or had any problems with your liver.

Other Medicines and Supplements. Romvimza may interact with other medicines and supplements. Before taking Romvimza, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Romvimza may cause harm to an unborn baby. You may need a negative pregnancy test before you can start taking Romvimza. You should use effective birth control while you are taking this medicine and for one month after your last dose. Tell your healthcare provider right away if you are or think you may be pregnant.

Breastfeeding. Do not breastfeed while taking Romvimza and for one month after your last dose. It is not known if Romvimza passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Romvimza?

For more information about Romvimza, you can visit the manufacturer’s website at www.romvimza.com or call them at 888-724-3274.

Interactions

Does Romvimza interact with foods or drinks?

There are no known interactions between Romvimza and foods or drinks.

It is unknown if drinking alcohol will affect Romvimza, but both Romvimza and alcohol can increase your risk of liver damage. It is best to limit the amount of alcohol you drink.

Does Romvimza interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Romvimza may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Romvimza?

If you or someone else has used too much Romvimza, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Romvimza?

If you miss a dose and it is less than 48 hours later, take it as soon as you remember, and take your next dose when you normally would. Do not take double or extra doses.

If you miss a dose and it has been more than 48 hours, skip the missed dose and take your next dose when you normally would. Do not take double or extra doses.

If you throw up within 30 minutes of taking a dose, take another dose to replace it. Take your next dose when you normally would. 

If you vomit more than 30 minutes after taking your dose, do not take another dose. Take your next dose when you normally would.