Drug Detail:Belinostat (Belinostat [ be-lin-oh-stat ])
Drug Class: Histone deacetylase inhibitors
Usual Adult Dose for Lymphoma
1,000 mg/m2 IV over 30 minutes once daily on days 1 to 5 of a 21-day cycle
Duration of therapy: Repeat cycle every 21 days until disease progression or unacceptable toxicity.
Comments:
- Dose reduction, discontinuation, or interruption of therapy may be needed to manage adverse reactions.
Use: Relapsed or refractory peripheral T-cell lymphoma
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Hematologic toxicities:
- Nadir absolute neutrophil count less than 0.5 x 10(9)/L or platelet count less than 25 x 10(9)/L: Decrease dose by 25% (750 mg/m2)
Non-hematologic toxicities:
- Any Grade 3 or 4 adverse reaction: Decrease dose by 25% (750 mg/m2)
- Recurrence of Grade 3 or 4 adverse reaction after 2 dose reductions: Discontinue treatment
Patients with Reduced UGT1A1 Activity:
- Reduce the starting dose to 750 mg/m2 in patients known to be homozygous for the UGT1A1*28 allele.
Precautions
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:
- Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
Monitoring:
- Monitor for thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia during therapy; modify treatment as necessary.
- Perform liver function tests before treatment and before the start of each treatment cycle. Modify, interrupt, or discontinue treatment as necessary.
- Monitor patients with advanced stage disease and/or high tumor burden; take proper precautions and treat as appropriate.
Patient advice:
- Treatment can lower blood counts, lower resistance to infection, and cause liver problems. Contact your doctor immediately if you experience significant fatigue, unusual bleeding or bruising, fever, or yellowing of the skin/whites of the eyes.
- Fetal harm may occur with this drug; avoid pregnancy during treatment. If pregnancy occurs, contact your doctor immediately.
- Nausea, vomiting, and diarrhea are common with this drug. Contact your doctor for help in treating these side effects.