ROMVIMZA- vimseltinib capsule 
Deciphera Pharmaceuticals, LLC

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 02/2025
MEDICATION GUIDE
ROMVIMZATM (rom-vim-zah)
(vimseltinib)
capsules

What is the most important information I should know about ROMVIMZA?
ROMVIMZA can cause serious side effects, including:
Liver problems. Increased liver enzymes in your blood are common with ROMVIMZA.
Your healthcare provider will do blood tests to check for liver problems:

  • before starting treatment with ROMVIMZA,
  • 2 times each month for the first 2 months of treatment,
  • then 1 time every 3 months for the first year of treatment and as clinically indicated thereafter.
If you develop liver problems during treatment with ROMVIMZA, your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your liver problems are.
Tell your healthcare provider right away if you develop any signs or symptoms of liver problems during treatment with ROMVIMZA including:
  • yellowing of your skin or the white part of your eyes
  • dark urine
  • lack or loss of appetite
  • right upper stomach-area (abdomen) pain or tenderness
  • feeling overly tired
  • nausea
  • vomiting
  • fever
  • rash
  • itching
See “What are the possible side effects of ROMVIMZA?” for more information about side effects.
What is ROMVIMZA?
ROMVIMZA is a prescription medicine used to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may make the symptoms worse or cause severe problems.
It is not known if ROMVIMZA is safe and effective in children.
Before taking ROMVIMZA, tell your healthcare provider about all of your medical conditions, including if you:
  • have or had liver problems
  • are pregnant or plan to become pregnant. ROMVIMZA can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will do a pregnancy test before you start treatment with ROMVIMZA.
    • Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant or you think you may be pregnant during treatment with ROMVIMZA.

    Males with female partners who are able to become pregnant:

    • Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose.
    • Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with ROMVIMZA.
  • are breastfeeding or plan to breastfeed. It is not known if ROMVIMZA passes into your breast milk. Do not breastfeed during treatment with ROMVIMZA and for 1 month after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking ROMVIMZA with certain other medicines may affect the way that ROMVIMZA or the other medicine works and may increase your risk of side effects. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ROMVIMZA?
  • Take ROMVIMZA exactly as your healthcare provider tells you to.
  • Do not change your dose or stop taking ROMVIMZA unless your healthcare provider tells you to.
  • Take ROMVIMZA 2 times a week with at least 72 hours between doses. Follow the dosing directions and schedule on your blister package and take ROMVIMZA on the same days each week.
  • Take ROMVIMZA with or without food.
  • Swallow ROMVIMZA capsules whole. Do not open, break, or chew the capsules.
  • If you miss a dose of ROMVIMZA by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If you miss your dose by more than 48 hours, skip the missed dose, and take the next dose on its regularly scheduled day.
  • If you vomit within 30 minutes of taking a dose of ROMVIMZA, take another dose. If you vomit more than 30 minutes after taking your dose, do not take another dose and take the next dose on its regularly scheduled day.
  • If you take more than the prescribed dose of ROMVIMZA, call your healthcare provider.

What are the possible side effects of ROMVIMZA?
ROMVIMZA can cause serious side effects.

  • See “What is the most important information I should know about ROMVIMZA?”
  • Allergic reactions to FD&C Yellow No. 5 and FD&C Yellow No. 6. ROMVIMZA 20 mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). ROMVIMZA 14 mg capsules contain the inactive ingredient FD&C Yellow No. 6 (Sunset Yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (Sunset Yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with ROMVIMZA.
The most common side effects of ROMVIMZA include:
  • swelling around your eyes
  • tiredness
  • rash
  • increased cholesterol levels in your blood
  • swelling of your hands or feet
  • swelling of your face
  • decreased white blood cells
  • itchy skin
ROMVIMZA may cause fertility problems, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of ROMVIMZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ROMVIMZA?
  • Store ROMVIMZA capsules at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Store ROMVIMZA capsules in the original blister pack until you are ready to take them. Do not store ROMVIMZA capsules in another container.
  • The blister packs are child resistant.
Keep ROMVIMZA and all medicines out of the reach of children.
General information about the safe and effective use of ROMVIMZA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ROMVIMZA for a condition for which it was not prescribed. Do not give ROMVIMZA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ROMVIMZA that is written for health professionals.
What are the ingredients in ROMVIMZA?
Active ingredient: vimseltinib
Inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate
The capsule shells contain:
14 mg capsule: Sunset Yellow FCF, gelatin, and titanium dioxide
20 mg capsule: Sunset Yellow FCF, tartrazine, gelatin, and titanium dioxide
30 mg capsule: Brilliant Blue FCF, erythrosine, gelatin, and titanium dioxide
The ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
Manufactured for and marketed by: Deciphera Pharmaceuticals, LLC, 200 Smith Street, Waltham, MA 02451
ROMVIMZA is a trademark of Deciphera, LLC.
For more information, call 1-888-724-3274 or go to www.ROMVIMZA.com

Revised: 2/2025
Document Id: f50278bc-850a-4c6f-be49-7818a8a4cdfc
Set id: f73c7a62-9601-4df0-810f-100f515d79ea
Version: 1
Effective Time: 20250218
Deciphera Pharmaceuticals, LLC