Vimseltinib Dosage

Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.

Usual Adult Dose for Nodular Tenosynovitis

30 mg orally twice a week

Comments:

• There should be at least 72 hours between doses, as directed on the blister package.

Use: For treatment of patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver dysfunction (bilirubin up to 1 times the upper limit of normal [1 x ULN] and AST greater than 1 x ULN or bilirubin greater than 1 to 1.5 x ULN and any AST): No adjustment recommended
Moderate (bilirubin greater than 1.5 to 3 x ULN and any AST) or severe (bilirubin greater than 3 x ULN and any AST) liver dysfunction: Data not available
Preexisting increased serum transaminases; total bilirubin or direct bilirubin (greater than 1 x ULN); or active liver or biliary tract disease, including alkaline phosphatase: Not recommended

If Hepatotoxicity Develops During Therapy:
Dose reductions for hepatotoxicity:

• First dose reduction: 20 mg orally twice a week
• Second dose reduction: 14 mg orally twice a week
• If unable to tolerate 14 mg twice a week: Permanently discontinue this drug.

Dosage modifications for hepatotoxicity:
AST and/or ALT increases greater than 3 to 5 x ULN and total bilirubin increases up to 2 x ULN OR total bilirubin increases up to 2 x ULN: Withhold this drug until AST and ALT resolve to baseline or up to 3 x ULN, and bilirubin resolves to baseline.

• Once Hy's law has been definitively ruled out: Resume at the next lower dose level.
• If adverse reaction does not resolve within 4 weeks: Permanently discontinue.

AST and/or ALT increases greater than 3 to 5 x ULN and total bilirubin increases greater than 2 x ULN or INR greater than 1.5 and alkaline phosphatase less than 2 x ULN OR total bilirubin increases greater than 2 x ULN: Withhold this drug until AST and ALT resolve to baseline or up to 3 x ULN, and bilirubin resolves to baseline.

• Once Hy's law has been definitively ruled out: Resume at the next lower dose level.
• If adverse reaction does not resolve within 4 weeks: Permanently discontinue.

AST and/or ALT increases greater than 5 to 8 x ULN, and total bilirubin up to 1 x ULN, and without clinical symptoms: Withhold this drug until AST and ALT resolve to baseline or up to 3 x ULN.

• If adverse reaction does not resolve within 4 weeks: Permanently discontinue.

AST and/or ALT increases greater than 5 to 8 x ULN and total bilirubin increase greater than 1 x ULN, or INR greater than 1.5, or alkaline phosphatase greater than 2 x ULN: Permanently discontinue this drug.

AST and/or ALT increases greater than 8 x ULN: Permanently discontinue this drug.

Dose Adjustments

Dose Reductions for Adverse Reactions:

• First dose reduction: 20 mg orally twice a week
• Second dose reduction: 14 mg orally twice a week
• If unable to tolerate 14 mg twice a week: Permanently discontinue this drug.

Dosage Modification for P-gp substrates:

• Avoid concomitant use with P-gp substrates.
• If concomitant use is unavoidable: Administer this drug at least 4 hours before administration of the P-gp substrate unless otherwise recommended in the manufacturer product information for the substrate.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Follow the schedule on the blister package and administer this drug on the same days each week.
• Administer this drug with or without food.
• Swallow the capsules whole; do not open, break, or chew.
• If a dose is missed by 48 hours or less, administer the missed dose as soon as possible and administer the next dose on its regularly scheduled day; if a dose is missed by more than 48 hours, skip the missed dose and administer the next dose on its regularly scheduled day.
• If vomiting occurs within 30 minutes of administration, repeat that dose; otherwise, administer the next dose on its regularly scheduled day.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Store capsules in original blister packs until ready to be taken; do not store this drug in another container.

General:

• The 20 mg capsule contains FD&C Yellow 5 (tartrazine), which may cause allergic reactions (including bronchial asthma) in certain susceptible patients.
• The 14 mg and 20 mg capsules contain FD&C Yellow 6 (Sunset Yellow FCF), which may cause allergic reactions.

Monitoring:

• Hepatic: Liver tests including ALT, AST, GGT, total bilirubin, direct bilirubin, and alkaline phosphatase (before starting therapy, twice a month for first 2 months of therapy, every 3 months for first year of therapy, and as clinically indicated thereafter)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Immediately report any signs/symptoms of severe liver injury to your health care provider.
• Patients of childbearing potential:
• Inform your health care provider of a known/suspected pregnancy.
• Avoid pregnancy; use effective contraception during therapy and for 1 month after the last dose.
• Males with partners of childbearing potential: Use effective contraception during therapy and for 1 month after the last dose.
• Do not breastfeed during therapy and for 1 month after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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