Belumosudil Dosage

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

Applies to the following strengths: 200 mg

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.