March 16, 2015



Class: Biological Therapy

Generic Name: belinostat

Trade Name: Beleodaq®

For which conditions is this drug approved? Beleodaq is approved for the treatment of peripheral T-cell lymphoma (PTCL) that comes back or does not respond to treatment.

What is the mechanism of action? Beleodaq is an agent known as a histone deacetylase inhibitor. It works by blocking the activity of the histone deacetylase enzyme, which is involved the growth and spread of cancer cells.

How is Beleodaq typically given (administered)? Beleodaq is given by intravenous injection. The injection, or infusion, usually takes over 30 minutes and is given one time a day on days 1 through 5 of a 21-day cycle of treatment.

How are patients typically monitored? Patients will have blood counts measured regularly to monitor for blood-related complications and undergo regular liver function tests.

What are the common (occur in 30% or more of patients) side effects of treatment with Beleodaq?

  • Nausea
  • Fatigue
  • Fever
  • Anemia

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Beleodaq?

  • Vomiting
  • Constipation
  • Diarrhea
  • Shortness of breath or breathlessness
  • Rash
  • Peripheral edema
  • Cough
  • Thrombocytopenia (low numbers of platelets)
  • Itching
  • Chills
  • Increased blood levels of an enzyme (lactate dehydrogenase) that indicated damage to cells or tissues
  • Decreased appetite
  • Headache
  • Pain at the infusion site
  • Low levels of potassium in blood (hypokalemia)
  • Prolonged heart rhythm disorder that can potentially cause fast, chaotic heartbeats (QT syndrome).
  • Abdominal pain
  • Low blood pressure
  • Vein inflammation (phlebitis)
  • Dizziness

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Before you start treatment with 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
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbals supplements.

 Are there any special precautions patients should be aware of before starting treatment? Beleodaq may not be safe for women who are pregnant because it can harm an unborn baby, so tell your doctor if:

  • You are pregnant or plan to become pregnant. You should not become pregnant while receiving Beleodaq. Tell your doctor right away if you become pregnant.
  • You are breastfeeding or plan to breastfeed. It is not known if Beleodaq passes into your breast milk. You should not breastfeed while receiving Beleodaq. You and your doctor should decide if you will receive Beleodaq or breastfeed.

When should patients notify their physician?

  • Tell your doctor if you have any side effects that bother you or don’t go away.

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Tags: B, Biological Therapy, Drug Dictionary, peripheral T-cell lymphoma, Uncategorized