Belumosudil Dosage

Medically reviewed by Drugs.com. Last updated on Jun 11, 2024.

Usual Adult Dose for Graft Versus Host Disease

200 mg orally once a day
Duration of therapy: Until progression of chronic Graft Versus Host Disease (GVHD) that requires new systemic therapy

Use: For the treatment of patients with GVHD after failure of at least two prior lines of systemic therapy

Usual Pediatric Dose for Graft Versus Host Disease

• 12 to less than 18 years:

200 mg orally once a day

• Duration of therapy: Until progression of chronic Graft Versus Host Disease (GVHD) that requires new systemic therapy

Use: For the treatment of patients with GVHD after failure of at least two prior lines of systemic therapy

Renal Dose Adjustments

Data not available

Comments:

• For patients with preexisting severe renal impairment, consider the risks and potential benefits before initiating therapy with this drug.

Liver Dose Adjustments

• Mild Liver Dysfunction (Child-Pugh Class A): No dose adjustment recommended
• Moderate or Severe Liver Dysfunction (Child-Pugh Class B or C) without liver GVHD: Avoid use

HEPATOTOXICITY:

• Grade 3 AST/ALT (5 times to 20 times upper limit of normal [ULN]) or Grade 2 bilirubin (1.5 to 3 x ULN): Withhold therapy until recovery of bilirubin, AST, and ALT to Grade 0 or 1 then resume therapy at the recommended dose.
• Grade 4 AST/ALT (more than 20 x ULN) or Grade 3 or greater bilirubin (more than 3 x ULN): Permanently discontinue therapy.

Dose Adjustments

OTHER ADVERSE REACTIONS:

• Grade 3: Withhold therapy until recovery to grade 0 or 1, then resume therapy at the recommended dose.
• Grade 4: Permanently discontinue therapy.

ADJUSTMENTS DUE TO DRUG INTERACTIONS

• Coadministration with strong CYP450 3A inducers: Increase dose to 200 mg orally twice a day
• Coadministration with proton pump inhibitors: Increase dose to 200 mg orally twice a day

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Swallow tablets whole. Do not cut, crush, or chew tablets.
• This drug should be taken with a meal at approximately the same time daily.
• If a dose is missed, the patient should take this drug as soon as possible on the same day; do not take extra doses to make up the missed dose.
• Dispense this drug to the patient in the original container.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Store in the original container to protect from moisture.

Monitoring:

• Hepatic: Bilirubin, AST, and ALT (at least monthly)

General:

• Health care professionals are encouraged to report any suspected adverse reactions at www.fda.gov/medwatch.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Inform your healthcare provider of all your medications, including herbal products, over-the-counter drugs, and vitamins.
• Women of reproductive potential should:
• Inform their health care provider if they plan to become pregnant and be advised of the potential risk to the fetus
• Contact their health care provider if they become pregnant or suspect a pregnancy
• Use effective contraception during treatment and for 1 week after the last dose
• Breastfeeding is not recommended during treatment and for at least 1 week after the last dose.
• Males and females of reproductive potential should be informed that this drug may impair fertility.
• Males with female partners of reproductive potential should use effective contraception during treatment and for at least 1 week 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.

Medical Disclaimer