Belinostat

Belinostat is a prescription medication used for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

Belinostat belongs to a group of drugs called pan HDAC inhibitors. Belinostat works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory).

Belinostat is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Belinostat is given one time a day on Days 1 through 5 of a 21-day cycle of treatment.

Common side effects of belinostat include nausea, fatigue, fever, low red blood cells (anemia), and vomiting.

Belinostat is a prescription/over-the-counter] medication used for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Belinostat may be found in some form under the following brand names:

• Beleodaq

Serious side effects have been reported with belinostat. See the “Belinostat Precautions” section.

Common side effects of belinostat include the following:

• nausea
• fatigue
• fever
• low red blood cells (anemia)
• vomiting

This is not a complete list of belinostat side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• inhibitors of UGT1A1 such as atazanavir (Reyataz) and indinavir (Crixivan)
• warfarin (Coumadin, Jantoven)

This is not a complete list of belinostat drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with belinostat including the following:

• Low blood cell counts. Your doctor will do blood tests to check your blood counts during your treatment with belinostat.
  • Low platelet counts can cause unusual bleeding or bruising under your skin.
  • Low red blood cell counts may make you feel weak, tired, or you get tired easily, you look pale, or you feel short of breath.
  • Low white blood cell counts can cause you to get infections, which may be serious.
• Serious infections. People receiving belinostat may develop serious infections that can sometimes lead to death. 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
• worsening skin problems
• Liver problems. Belinostat may cause liver problems which can lead to death. Your doctor will do blood tests during your treatment with belinostat 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 (jaundice)
  • dark urine
  • itching
  • pain in the right upper stomach area
• Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. Your doctor will check you for TLS during treatment with belinostat.
• Nausea, vomiting, and diarrhea are common with belinostat and can sometimes be serious. Tell your doctor if you develop nausea, vomiting or diarrhea. Your doctor may prescribe medicines to help prevent or treat these side effects.

Do not take belinostat if you are allergic to belinostat or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of belinostat, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking belinostat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to belinostat or to any of its ingredients
• have an infection
• have had chemotherapy treatment
• have liver or kidney problems
• have nausea, vomiting, or diarrhea
• are pregnant or plan to become pregnant. Belinostat, can harm your unborn baby. You should not become pregnant while receiving belinostat. Tell your doctor right away if you become pregnant while receiving belinostat.
• are breastfeeding or plan to breastfeed. It is not known if belinostat passes into your breast milk. You and your doctor should decide if you will receive belinostat or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Belinostat falls into category D. Belinostat may cause birth defects or may halt the pregnancy because it targets actively dividing cells. Women should avoid pregnancy while receiving belinostat. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug ,the patient should know the potential hazard to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if belinostat crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using belinostat.

Take belinostat exactly as prescribed.

Belinostat is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. Belinostat is given one time a day on Days 1 through 5 of a 21-day cycle of treatment.

If you miss a dose, be sure to make a follow up appointment

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have (reduced UGT1A1 activity)
• how you respond to this medication
• your blood counts
• your body surface area

The recommended dosage of belinostat is 1,000 mg/m2 administered over 30 minutes given directly into a vein (IV) once daily on Days 1 -5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.

If belinostat is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• You should have regular blood tests before and during your treatment with belinostat.
• Your doctor may change your dose of belinostat, change when you receive your treatment, or stop treatment if you have certain side effects while receiving belinostat.
• Keep all of your doctor and laboratory appointments.