Beleodaq

Generic name: belinostat
Drug class: Histone deacetylase inhibitors

Medically reviewed by A Ras MD.

What is Beleodaq?

Beleodaq is a prescription medicine that is used to treat T-cell lymphoma.

Description

Beleodaq is a histone deacetylase inhibitor with a sulfonamide-hydroxamide structure. The chemical name of belinostat is (2E)- N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide. The structural formula is as follows:

The molecular formula is C 15H 14N 2O 4S and the molecular weight is 318.35 g/mol.

Belinostat is a white to off-white powder. It is slightly soluble in distilled water (0.14 mg/mL) and polyethylene glycol 400 (about 1.5 mg/mL), and is freely soluble in ethanol (> 200 mg/mL). The pKa values are 7.87 and 8.71 by potentiometry and 7.86 and 8.59 by UV.

Beleodaq (belinostat) for injection is supplied as a sterile lyophilized yellow powder containing 500 mg belinostat as the active ingredient. Each vial also contains 1000 mg L-Arginine, USP as an inactive ingredient. The drug product is supplied in a single-dose 30 mL clear glass vial with a coated stopper and aluminum crimp seal with “flip-off” cap. Beleodaq is intended for intravenous administration after reconstitution with 9 mL Sterile Water for injection, and the reconstituted solution is further diluted with 250 mL of sterile 0.9% Sodium Chloride injection prior to infusion

Mechanism of Action

Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).

Before taking Beleodaq, tell your doctor:

If you are allergic to Beleodaq; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have an infection.
If you have any of these health problems: Kidney disease or liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Beleodaq with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Beleodaq?

Tell all of your health care providers that you take Beleodaq. This includes your doctors, nurses, pharmacists, and dentists.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
This medicine may cause harm to an unborn baby. Women must use birth control while taking Beleodaq. If you get pregnant, call your doctor right away.
Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Beleodaq best taken?

Use Beleodaq as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

Call your doctor to find out what to do.

What are the side effects of Beleodaq that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
Very bad dizziness or passing out.
A heartbeat that does not feel normal.
Pale skin.
Shortness of breath.
Swelling in the arms or legs.
Very bad and sometimes deadly liver problems have happened with Beleodaq. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Patients with cancer who take Beleodaq may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS).This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.

What are some other side effects of Beleodaq?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
Feeling dizzy, tired, or weak.
Headache.
Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Beleodaq?

If you need to store Beleodaq at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68152-108-09
Beleodaq® (belinostat) for injection
500 mg/vial
For Intravenous Infusion Only
Single-Dose Vial

SRC: NLM .

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