Beleodaq
Beleodaq (belinostat) is an anticancer medication used to treat relapsed or advanced peripheral T-cell lymphoma (PTCL) in adults. It’s given as an intravenous (IV) infusion, usually once daily for five days in a 21-day treatment cycle. Your oncology team will decide how many cycles you need based on how well this medication treats the cancer and whether you have any serious side effects. Some common side effects of Beleodaq (belinostat) include nausea and tiredness. It can also cause a rare, but serious condition called tumor lysis syndrome.
What is Beleodaq (belinostat)?
What is Beleodaq (belinostat) used for?
Relapsed or advanced peripheral T-cell lymphoma (PTCL)
How Beleodaq (belinostat) works
In some cancer cells, such as lymphoma cells, certain proteins help send messages that tell the cells to grow and spread. One of these proteins is called histone deacetylase (HDAC).
Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor. It blocks the histone deacetylase protein, which stops it from sending messages to the cell. When this protein is blocked, cancer cells don’t grow and spread as well.
Drug Facts
What are the side effects of Beleodaq (belinostat)?
Common Side Effects
- Nausea (42%)
- Tiredness (37%)
- Fever (35%)
- Low red blood cells (32%)
- Vomiting (29%)
- Constipation (23%)
- Diarrhea (23%)
- Trouble breathing (22%)
- Rash (20%)
- Swelling in the arms and legs (20%)
Other Side Effects
- Cough
- Itching
- Chills
- Not feeling hungry
- Headache
- Pain at the infusion site
Serious Side Effects
- Low white blood cells and infection: fever, chills, cough, muscle aches, very fast heartbeat, severe tiredness
- Low platelets: bruising, nosebleeds, blood in urine, blood in stool
- Serious liver problems: yellow skin, yellow eyes, sudden stomach pain, swollen belly
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Beleodaq (belinostat)
Pros
Recommended treatment option for peripheral T-cell lymphoma
Doesn’t typically cause hair loss
Works in a way that targets cancer cells more specifically, so might have less severe side effects than some other chemotherapy medications
Cons
Taken five days in a row, so less convenient
Given as an intravenous injection, so requires a needle
Might raise your risk for infection
Pharmacist tips for Beleodaq (belinostat)
Beleodaq (belinostat) might cause nausea. Your oncologist will prescribe antiemetics for you to take in between doses to manage this side effect, such as prochlorperazine (Compazine) or ondansetron (Zofran). If you have nausea or vomiting that doesn’t get better with medication, contact your healthcare team.
You might experience diarrhea while taking Beleodaq (belinostat). Your oncologist might recommend an over-the-counter medication such as loperamide (Imodium A-D) to help manage diarrhea. If you experience diarrhea it’s important to drink a lot of fluids, but try to avoid sugary sports drinks because they can make diarrhea worse.
This medication can raise your risk for getting sick, so you should check your temperature regularly. Call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. This means you have a fever, and this might be the only sign that you’re sick.
If you’re a male, Beleodaq (belinostat) might affect your fertility, or ability to have children, in the future. Talk with your provider about fertility preservation options such as sperm banking.
Sometimes, taking Beleodaq (belinostat) can cause your liver to become irritated. Your oncologist will order lab tests to check your liver health before the start of each treatment cycle because people who experience this side effect often don’t feel any symptoms. But if you have stomach pain, yellowish skin, or yellow around the whites of your eyes, call your oncologist right away.
We don’t know if Beleodaq (belinostat) passes into human milk. But, based on the way this medication works, it might harm a nursing infant. You shouldn’t breastfeed while taking Beleodaq (belinostat) and for 2 weeks after the last dose.
Frequently asked questions about Beleodaq (belinostat)
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What are the risks and warnings for Beleodaq (belinostat)?
Beleodaq (belinostat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low blood cell counts
People taking Beleodaq (belinostat) have experienced low blood cells, such as white blood cells, red blood cells, and platelets. When your blood cell counts are low, you’re at higher risk for certain conditions, such as serious infections or bleeding that’s difficult to stop.
To be safe, your oncologist will monitor your blood cell counts with lab tests weekly while you’re taking Beleodaq (belinostat). If your results are too low, they’ll adjust your dose or ask you to pause taking Beleodaq (belinostat) until your blood cell counts are within a safe range. Contact your healthcare team if you have symptoms of low blood cells such as fever, severe tiredness, or bruising that won’t go away or bleeding that’s difficult to stop.
Infections
Risk factors: Previous chemotherapy
People taking Beleodaq (belinostat) have reported serious infections, including pneumonia and sepsis. You might be at higher risk for serious infections if you’ve previously received chemotherapy. Your healthcare team will monitor you closely for infections. Get medical help right away if you have symptoms of a serious infection such as fever, body aches, or chills.
Serious liver problems
Beleodaq (belinostat) can cause liver problems. People who experience this might not notice any symptoms, but will have higher liver enzymes levels on their lab work, which suggests liver irritation. Rarely, liver problems can become life-threatening.
Your oncologist will check your liver health with lab tests before you start Beleodaq (belinostat) and at the start of each treatment cycle. If your liver enzyme level is too high, your oncologist might adjust your dose of Beleodaq (belinostat) or pause treatment until the levels return to a safe range. But if you develop severe liver problems, your oncologist will ask you to stop taking Beleodaq (belinostat) and talk with you about other options. Contact your oncology team as soon as possible if you have symptoms of liver damage, such as tiredness, stomach pain, and yellowing of the skin or whites of the eyes.
Tumor lysis syndrome
It’s possible for people taking Beleodaq (belinostat) to develop a complication called tumor lysis syndrome (TLS). This happens when cancer cells are destroyed and release what’s inside of them into your blood. This can cause high levels of potassium and uric acid in your blood, which can cause problems in your heart and kidneys.
Your oncology team will monitor you closely for signs of TLS. They might also give you extra fluids or medications such as allopurinol (Zyloprim) to prevent this complication. Let your care tea know right away if you experience symptoms of TLS, such as nausea, tiredness, and dark-colored urine.
Nausea, vomiting, and diarrhea
Some people taking Beleodaq (belinostat) experienced stomach and intestine problems such as nausea, vomiting, and diarrhea. To manage nausea and vomiting, your oncologist might give you medications through your IV before each dose of Beleodaq (belinostat). They might also send home oral antiemetics for you to take in between doses.
If you experience diarrhea while taking Beleodaq (belinostat), ask your oncology team whether it’s safe for you to take over-the-counter medications to ease your symptoms. Make sure you drink plenty of fluids if you have diarrhea. If you have nausea, vomiting, or diarrhea that doesn’t get better with medications, contact your healthcare team.
Harm to unborn baby
Risk factors: Pregnancy
Beleodaq (belinostat) might harm an unborn baby or raise the risk of pregnancy loss (miscarriage). If you’re a female who is able to have babies, your oncologist might ask you to take a pregnancy test before you start treatment to check that you’re not pregnant. You should use effective birth control while taking Beleodaq (belinostat) and for 6 months after the last dose. If you’re a male who is sexually active with a female, you should use birth control such as condoms while taking Beleodaq (belinostat) and for 3 months after the last dose.
Beleodaq (belinostat) dosage forms
Typical dosing for Beleodaq (belinostat)
Your oncologist will calculate your dose of Beleodaq (belinostat) based on your body surface area (BSA), which takes into account your height and weight.
The typical dose is 1000 mg/m2 infused through the veins over 30 minutes once daily for the first 5 days of the 21-day cycle.
Your oncologist might change your dose based on your blood cell counts, liver or kidney problems, genetics, or if you're taking other medications that interact with Beleodaq (belinostat).
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References
Best studies we foundAcrotech Biopharma Inc. (2024). Beleodaq- belinostat injection, powder, lyophilized, for solution [package insert]. DailyMed.
American Cancer Society. (2024). Fevers.
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El Ridi, R., et al. (2017). Physiological functions and pathogenic potential of uric acid: A review. Journal of Advanced Research.
Eunice Kennedy Shriver National Institute of Child Health and Human Development. (2017). What is fertility preservation?
Gryder, B. E., et al. (2012). Targeted cancer therapy: Giving histone deacetylase inhibitors all they need to succeed. Future Medicinal Chemistry.
Gupta, A., et al. (2018). Tumor lysis syndrome. Journal of the American Medical Association Oncology.
Howard, S. C., et al. (2011). The tumor lysis syndrome. The New England Journal of Medicine.
Lane, A. A., et al. (2009). Histone deacetylase inhibitors in cancer therapy. Journal of Clinical Oncology.
LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. (2020). Belinostat. National Institute of Diabetes and Digestive and Kidney Diseases.
Lymphoma Research Foundation. (n.d.). Peripheral T-cell lymphoma.
Lymphoma Research Foundation. (n.d.). Relapsed and refractory lymphoma.
National Cancer Institute. (n.d.). Belinostat.
National Cancer Institute. (n.d.). HDAC.
National Cancer Institute. (2022). Chemotherapy to treat cancer.
National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.
National Comprehensive Cancer Network. (2022). Peripheral T-cell lymphoma.
Sawas, A., et al. (2015). Belinostat in patients with refractory or relapsed peripheral T-cell lymphoma: A perspective review. Therapeutic Advances in Hematology.
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