HIGHLIGHTS OF PRESCRIBING INFORMATION

 

These highlights do not include all the information needed to use

BELEODAQ safely and effectively. See full prescribing information for BELEODAQ. BELEODAQ® (belinostat) for injection, for intravenous use

 

Initial U.S. Approval: 2014 

 

 

INDICATIONS AND USAGE

 

Beleodaq is a histone deacetylase inhibitor indicated for the treatment of 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. 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. 

 

DOSAGE AND ADMINISTRATION

 

Recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on days 1-5 of a 21-day cycle. Cycles can be repeated until disease progression or unacceptable toxicity. 

 

 Treatment discontinuation or interruption with or without dosage reductions by 25% may be needed to manage adverse reactions 

 

DOSAGE FORMS AND STRENGTHS

-For injection: 500 mg, lyophilized powder in single-dose vial for reconstitution 

 

---------------------------CONTRAINDICATIONS--------------------------------- None. (4) 

 

---------------------------CONTRAINDICATIONS--------------------------------- None. (4) 

 

---------------------WARNINGS AND PRECAUTIONS

 

-------------------------? Hematologic Toxicity: Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. (2.2, 5.1) ? Infection: Serious and fatal infections (e.g., pneumonia and sepsis) (5.2) ? Hepatotoxicity: Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and omit or modify dosage for hepatic toxicities. (2.2, 5.3) ? Tumor lysis syndrome: Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions (5.4) ? Embryo-fetal toxicity:  Beleodaq may cause fetal harm when administered to a pregnant woman. Advise women of potential harm to the fetus and to avoid pregnancy while receiving Beleodaq (5.6) 

 

---------------------------ADVERSE REACTIONS---------------------------------The most common adverse reactions (>25%)  are nausea, fatigue, pyrexia, anemia, and vomiting. (6) 

To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 

 

---------------------USE IN SPECIFIC POPULATIONS-------------------------Nursing Mothers: Women should be advised against breastfeeding while being treated with Beleodaq. (8.3) 

See 17 for PATIENT COUNSELING