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Beleodaq Generic Name & Formulations
Legal Class
Rx
General Description
Belinostat 500mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution.
Pharmacological Class
Histone deacetylase inhibitor.
How Supplied
Single-use vial (30mL)—1
Manufacturer
Generic Availability
NO
Beleodaq Indications
Indications
Relapsed or refractory peripheral T-cell lymphoma.
Beleodaq Dosage and Administration
Adult
Give 1000mg/m2 once daily by IV infusion over 30 mins on Days 1–5 of a 21-day cycle; can repeat cycles every 21 days until disease progression or unacceptable toxicity. Dose modifications: Hematologic toxicities: if ANC nadir <0.5x109/L or platelet count <25x109/L: decrease dose by 25% (750mg/m2); discontinue if recurrent ANC <0.5x109/L or platelet count <25x109/L nadirs after 2 dose reductions; Non-hematologic toxicities: if any CTCAE Grade 3/4 reaction: decrease dose by 25% (750mg/m2); discontinue if recurrent CTCAE Grade 3/4 reaction after 2 dose reductions. Patients with homozygous UGT1A1*28 allele: initially 750mg/m2.
Children
Not established.
Beleodaq Contraindications
Not Applicable
Beleodaq Boxed Warnings
Not Applicable
Beleodaq Warnings/Precautions
Warnings/Precautions
Risk of hematologic toxicity; monitor blood counts with differential at baseline and weekly during therapy; adjust dose as necessary. Active infection: do not administer. History of extensive or intensive chemotherapy: may be at higher risk of life-threatening infections. Renal or hepatic impairment. Monitor serum chemistry, renal and hepatic function before treatment and the start of each cycle; interrupt, adjust, or discontinue dose based on severity of hepatotoxicity. Tumor lysis syndrome; monitor patients with advanced stage disease and/or high tumor syndrome. GI toxicity; may require use of antiemetics and antidiarrheals. Embryo-fetal toxicity. Advise use of effective contraception during and for 6 months (females) and for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Beleodaq Pharmacokinetics
See Literature
Beleodaq Interactions
Interactions
Avoid concomitant use of strong UGT1A1 inhibitors.
Beleodaq Adverse Reactions
Adverse Reactions
Nausea, fatigue, pyrexia, anemia, vomiting; hematologic toxicity, infection, hepatotoxicity, tumor lysis syndrome, GI toxicity.
Beleodaq Clinical Trials
See Literature
Beleodaq Note
Not Applicable
Beleodaq Patient Counseling
See Literature
