Indications and Usage
-
Beleodaq® is a HDAC inhibitor indicated for the treatment of patients with R/R PTCL.
-
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
-
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%).
-
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
Use in Specific Populations
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.
Pregnancy Testing: Beleodaq® can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended for females of reproductive potential prior to initiating Beleodaq®.
Pediatric Use: The safety and effectiveness of Beleodaq® in pediatric patients have not been established.
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. 2. O’Connor O, et al. J Clin Oncol. 2015;33:2492-2499. 3. Vose JM, et al. J Clin Oncol. 2008;26:4124-4130. 4. Carson KR, et al. Cancer. 2017;123:1174-1183. 5. Lansigan F, et al. Acta Haematol. 2020;143:40-50. 6. Bellei M, et al. Haematologica. 2018;103:1191-1197. 7. Li W, et al. Int J Mol Sci. 2019;20. doi:10.3390/ijms20071616. 8. Milazzo G, et al. Genes. 2020;11. doi:10.3390/genes11050556. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas V.1.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Savage KJ, et al. Blood. 2014:124:3075. doi.org/10.1182/blood.V124.21.3075.3075.