Vimseltinib is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. MedsAcross supplies Vimseltinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
Source: US FDA prescribing information
Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.
Source: US FDA prescribing information
Recommended Dosage: 30 mg orally twice weekly, with a minimum of 72 hours between doses as described in the blister package. See full prescribing information for dosage modifications due to hepatotoxicity and drug interactions.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Hepatotoxicity: Elevated AST and ALT can occur. Evaluate liver tests prior to initiation of treatment and during treatment. Embryo-fetal toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. Allergic Reactions to FD&C Yellow No. 5 (tartrazine) and No. 6 (Sunset Yellow FCF): 14 mg capsule contains FD&C Yellow No. 6 (Sunset Yellow FCF), 20 mg capsule contains FD&C Yellow No.5 (tartrazine) and No. 6 (Sunset Yellow FCF) as color additives, which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. Increased serum creatinine without affecting renal function: Increases in serum creatinine can occur. Use alternative measures that are not based on serum creatinine to assess renal function.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.
Source: US FDA prescribing information
P-glycoprotein (P-gp) substrates: Avoid concomitant use with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates. Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use with BCRP substrates. Organic Cation Transporter 2 (OCT) substrates: Avoid concomitant use with OCT2 substrates.
Source: US FDA prescribing information
Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store capsules in their original blister packs until ready to be taken. Do not store ROMVIMZA in another container.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Vimseltinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Romvimza 14 mg capsuleOral | Deciphera Pharmaceuticals | US FDA | Available on request |
| Romvimza 20 mg capsuleOral | Deciphera Pharmaceuticals | US FDA | Available on request |
| Romvimza 30 mg capsuleOral | Deciphera Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 3 presentations of Vimseltinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Vimseltinib, including Romvimza.
Yes. The US FDA first approved Vimseltinib on 14 February 2025, according to Drugs@FDA.
Yes. Vimseltinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vimseltinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vimseltinib is classified under ATC code L01EX (Cancer medicines (antineoplastics), subgroup L01E, subgroup L01EX).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.