Romvimza

Romvimza is used to treat symptomatic tenosynovial giant cell tumor (TGCT) in adults when surgery may make the symptoms worse or cause severe problems. It is an oral capsule that is taken 2 times a week.

Romvimza is a kinase inhibitor with a mechanism that involves inhibition of colony-stimulating factor 1 receptor (CSF1R), a key regulator in multiple biological processes, particularly in the immune system. CSF1R signaling can become dysregulated in various conditions, including neurodegenerative diseases and cancer.

Romvimza (vimseltinib) gained FDA approval on February 14, 2025.

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. For example, if you take Romvimza on Monday at 8 am, you should not take the next dose before Thursday at 8 am.
• Take Romvimza with or without food.
• Swallow capsules whole. Do not open, break, or chew the capsules.

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.

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
• are breastfeeding or plan to breastfeed.

Pregnancy

Romvimza can harm your unborn baby. Females who can 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 can 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.

Breastfeeding

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.

The most common side effects of Romvimza are:

• 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.

Serious side effects and warnings

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.
• 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.

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 the FDA at 1-800-FDA-1088.

Recommended Adult Dosage for TGCT: 30 mg orally twice weekly, with a minimum of 72 hours between doses as described in the blister package.

See the full Romvimza Prescribing Information for dosage modifications due to liver disease and drug interactions.

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 take more than the prescribed dose of Romvimza, call your healthcare provider.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• P-glycoprotein (P-gp) substrates, for example, digoxin, dabigatran, ritonavir, saquinavir, atorvastatin, or erythromycin
• Breast cancer resistance protein (BCRP) substrates, for example, rosuvastatin, pitavastatin, methotrexate, allopurinol, ciprofloxacin
• Organic cation transporter 2 (OCT2) substrates, for example, metformin, amitriptyline, imipramine, amiloride, spironolactone, varenicline, or lamivudine.

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.

Store Romvimza capsules at room temperature between 68ºF to 77ºF (20ºC to 25ºC) in the original blister pack until you are ready to take them. Do not store in another container.

• The blister packs are child-resistant.

Keep out of the reach of children.

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.

Available as 14 mg, 20 mg, and 30 mg capsules.

Romvimza is manufactured by Deciphera Pharmaceuticals, LLC, based in Waltham, MA 02451.