Indication:
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. (1) ---------------------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. (2.1) ? Treatment discontinuation or interruption with or without dosage reductions by 25% may be needed to manage adverse reactions (2.2) --------------------DOSAGE FORMS AND STRENGTHS---------------------- For injection: 500 mg, lyophilized powder in single-dose vial for reconstitution (3) ---------------------------
CONTRAINDICATIONS--------------------------------- None. (4)
Proprietary Name- BELEODAQ*
Established Name- Belinostat
Applicant- SPECTRUM PHARMACEUTICALS INC.
Indication- For the treatment of Patients with relapsed or refractory
Peripheral T-cell Lymphoma (PTCL)
Approval Date- 3/7/2014
Approved by U.S.FDA (Ref- FDA approved List- 2014)
Contra-Indications:
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)
CONTRAINDICATIONS--------------------------------- None. (4)
Dosages/ Overdosage Etc:
Indication- For the treatment of Patients with relapsed or refractory
Peripheral T-cell Lymphoma (PTCL)
