Usual Adult Dose for Graft Versus Host Disease

200 mg orally once a day until progression of chronic GVHD that requires new systemic therapy

Use: For the treatment of adults with chronic graft-versus-host disease (chronic GVHD) after failure of at least 2 prior lines of systemic therapy

Usual Pediatric Dose for Graft Versus Host Disease

200 mg orally once a day until progression of chronic GVHD that requires new systemic therapy

Use: For the treatment of pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least 2 prior lines of systemic therapy

Renal Dose Adjustments

Data not available. For patients with preexisting severe renal impairment, consider the risks and potential benefits before initiating therapy with this drug.

Liver Dose Adjustments

Data not available. For patients with preexisting severe hepatic impairment, consider the risks and potential benefits before initiating therapy with this drug.

Dose Adjustments

Dose Modifications for Adverse Reactions:
HEPATOTOXICITY:

• Grade 3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) (5 times to 20 times upper limit of normal [ULN]) or Grade 2 bilirubin (1.5 x 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 or ALT (more than 20 x ULN) or Grade 3 or greater bilirubin (more than 3 x ULN): Permanently discontinue therapy.

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

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.
• Take this drug with a meal at approximately the same time each day.
• If a dose is missed, do not take extra doses to make up the missed dose.
• Dispense to patient in original container only.

• Store at room temperature (20C to 25C [68F to 77F]); excursions permitted from 15C to 30°C (59F to 86F).
• Store in original container to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant.

• Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly.

• Read the approved patient labeling.
• Inform your healthcare provider if you are or plan to become pregnant or plan to breastfeed.