Indications and Usage
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Beleodaq® is a HDAC inhibitor indicated for the treatment of patients with R/R PTCL.
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This indication is approved under accelerated approval based on tumor response rate and DoR. 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.
Warnings and Precautions
Hematologic Toxicity: Beleodaq® can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment and modify dosage as necessary.
Infections: Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq®. Do not administer Beleodaq® to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at a higher risk of life-threatening infections.
Hepatotoxicity: Beleodaq® can cause fatal hepatotoxicity and liver function test abnormalities. Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq® based on the severity of the hepatic toxicity.
Tumor Lysis Syndrome: Tumor lysis syndrome has occurred in Beleodaq®-treated patients in the clinical trial of patients with relapsed or refractory PTCL. Monitor patients with advanced stage disease and/or high tumor burden, and take appropriate precautions.
Gastrointestinal Toxicity: Nausea, vomiting, and diarrhea occur with Beleodaq® and may require the use of antiemetic and antidiarrheal medications.
Embryo-Fetal Toxicity: Beleodaq® can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with Beleodaq® and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Beleodaq® and for 3 months after the last dose.
Adverse Reactions
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The most common adverse reactions observed in more than 25% of patients with relapsed or refractory PTCL in the trial, who were treated with Beleodaq®, were nausea (42%), fatigue (37%), pyrexia (35%), anemia (32%), and vomiting (29%).
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Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq® or within 30 days after their last dose of Beleodaq®. The most common serious adverse reactions (>2%) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure.
Drug Interactions: Avoid concomitant administration of Beleodaq® with UGT1A1 inhibitors. If concomitant use of a UGT1A1 inhibitor is unavoidable, modify the Beleodaq® dose.
Belinostat is primarily metabolized by UGT1A1. Concomitant use with a UGT1A1 inhibitor increases belinostat exposure which may increase risk of adverse reactions.
Use in Specific Populations
Pregnancy: Beleodaq® can cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells. There are no available data on Beleodaq® use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Lactation: Due to the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with Beleodaq® and for 2 weeks after the last dose.
Females and Males of Reproductive Potential: Beleodaq® can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended for females of reproductive potential prior to initiating Beleodaq®. Advise females of reproductive potential to use effective contraception during treatment with Beleodaq® and for 6 months after the last dose. Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with Beleodaq® and for 3 months after the last dose.
Pediatric Use: The safety and effectiveness of Beleodaq® in pediatric patients have not been established.
Patients with Hepatic Impairment: Reduce the Beleodaq® dosage in patients with moderate hepatic impairment (total bilirubin > 1.5 to 3 x ULN, any AST). Avoid use of Beleodaq® in patients with severe hepatic impairment (total bilirubin >3 x upper limit of normal (ULN).
Renal Impairment: Reduce the Beleodaq® dosage in patients with moderate renal impairment (CLcr 30 to <60 mL/min).
Please see full Prescribing Information for Beleodaq®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). You also may contact Acrotech Biopharma Inc. at 1-888-292-9617.
References
1. Beleodaq® [Prescribing Information], Acrotech Biopharma Inc.
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