Beleodaq Injection
Generic name: belinostat
Dosage form: injection, powder, lyophilized, for solution
Drug class:Histone deacetylase inhibitors
Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information
Indications and Usage for Beleodaq Injection
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14)]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Beleodaq Injection Dosage and Administration
Dosing Information
The recommended dosage of Beleodaq is 1,000 mg/m 2 administered over 30 minutes by intravenous infusion once daily on Days 1-5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.
Dosage Modification for Hematologic and Non-Hematologic Toxicities
Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicities. Base dosage adjustments for thrombocytopenia and neutropenia on platelet and absolute neutrophil nadir (lowest value) counts in the preceding cycle of therapy.
- Absolute neutrophil count (ANC) should be greater than or equal to 1.0 x 10 9/L and the platelet count should be greater than or equal ...
