What Is Beleodaq®?
Beleodaq® (belinostat) is a prescription medicine used to treat people with a type of cancer called peripheral T-cell lymphoma (PTCL) that comes back or does not respond to previous treatment. 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.
It is not known if Beleodaq® is safe and effective in children.
What Should I Tell My Doctor Before Receiving Beleodaq®?
Before receiving Beleodaq®, tell your doctor about all of your medical conditions, including if you:
- Have an infection
- Have had chemotherapy treatment
- Have liver or kidney problems
- Have nausea, vomiting, or diarrhea
- Are pregnant or plan to become pregnant. Beleodaq® can harm your unborn baby. You should not become pregnant while receiving Beleodaq®. Tell your doctor right away if you become pregnant while receiving Beleodaq®.
- Are breastfeeding or plan to breastfeed. It is not known if Beleodaq® passes into your breast milk. You and your doctor should decide if you will receive Beleodaq® or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What Are the Possible Side Effects of Beleodaq®?
Beleodaq® may cause serious side effects, including:
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Low Blood Cell Counts: Patients may experience low blood cell counts. Your doctor will do weekly blood tests to check your blood counts.
- Low platelet counts can cause unusual bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away if this happens.
- Low red blood cell counts may make you feel weak, feel tired, and/or get tired easily. You may appear pale and be short of breath. Contact your doctor if you experience any of these symptoms following treatment with Beleodaq®.
- Low white blood cell counts can cause you to get infections, which may be serious.
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Serious Infections: People receiving Beleodaq® may develop serious infections that can sometimes lead to death. You should not receive Beleodaq® if you have an ongoing active infection. You may have a greater risk of life-threatening infections if you have had chemotherapy in the past. Tell your doctor right away if you have any of the following signs or symptoms of an infection: fever, flu-like symptoms, cough, shortness of breath, burning with urination, muscle aches, or worsening skin problems.
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Liver Problems: Beleodaq® may cause liver problems, which can lead to death. Your doctor will do blood tests during your treatment with Beleodaq® to check for liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or the white part of your eyes, dark urine, itching, or pain in the right upper stomach area.
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Tumor Lysis Syndrome (TLS): Beleodaq® can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor will check you for TLS during treatment with Beleodaq®.
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Nausea, Vomiting, and Diarrhea: These side effects are common with Beleodaq® and can sometimes be serious. Tell your doctor if you develop nausea, vomiting, or diarrhea.
Other Common Side Effects May Include:
These are not all of the potential side effects of Beleodaq®. If you have any side effect that bothers you or that doesn’t go away, be sure to talk with your healthcare professional.
References
- Beleodaq® [Prescribing Information], Acrotech Biopharma Inc.
- O’Connor OA, et al. J Clin Oncol. 2015;33:2492-2499.
- Referenced with permission from the NCCN Guidelines for Patients® Peripheral T-cell Lymphoma. V.1.2016. ©2016 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed March 12, 2021.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas V.1.2021. ©2021 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed March 12, 2021. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available.
- National Institutes of Health, National Human Genome Research Institute. Chromosome fact sheet. Accessed March 12, 2021. https://www.genome.gov/about-genomics/fact-sheets/Chromosomes-Fact-Sheet.
- National Cancer Institute website. NCI dictionary of cancer terms. Accessed March 12, 2021. https://www. cancer.gov/publications/dictionaries/cancer-terms.
- Mak V, et al. J Clin Oncol. 2013;31:1970-1976.
- Stuver RN, et al. Am J Hematol. 2019;94:641-649.
- Bristol Myers Squibb Statement on Istodax® (romidepsin) Relapsed/Refractory Peripheral T-cell Lymphoma U.S. Indication. Press Release. Bristol Myers Squibb. August 2, 2021. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Statement-on-Istodax-romidepsin-Relapsed-Refractory-Peripheral-T-cell-Lymphoma-U.S.-Indication/default.as px.
- National Cancer Institute. Support for People with Cancer When Cancer Returns. February 2019. NIH Publication No. 19-6287.
- National Cancer Institute. Support for People With Cancer: Taking Time. January 2019. NIH Publication No. 18-2059.
- American Society of Clinical Oncology. ASCO® Answers: Caring for a Loved One With Cancer. 2021.
- National Cancer Institute. When Someone You Love Is Being Treated for Cancer. May 2014. NIH Publication No. 14-5726.
©2021 Acrotech Biopharma Inc. All rights reserved.
Information on this website is intended for U.S. residents.
BEL-0176. August 2021.