Initial US Approval:
2025
Key Clinical Studies:
MOTION (NCT05059262)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
- 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.
Dosage Administration:
- 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.
Dosage Forms and Strengths:
Capsules: 14 mg, 20 mg, 30 mg.
Contraindications:
None.
Warnings and Precautions:
- 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.
Adverse Reactions:
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.
Drug Interactions:
- P-glycoprotein (P-gp) Substrates: Avoid concomitant use of Romvimza with P-gp substrates. If concomitant use cannot be avoided, take Romvimza at least 4 hours prior to P-gp substrates. Concomitant use of vimseltinib with P-gp substrates may increase exposure of these substrates.
- Breast Cancer Resistance Protein (BCRP) Substrates: Avoid concomitant use of Romvimza with BCRP substrates. Concomitant use of vimseltinib with BCRP substrates may increase exposure of these substrates.
- Organic Cation Transporter 2 (OCT) Substrates: Avoid concomitant use of Romvimza with OCT2 substrates. Concomitant use of vimseltinib with OCT2 substrates may increase exposure of these substrates.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
Adapted from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
