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.

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.

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.

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.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe or continued vomiting or diarrhea;

• fever, chills, flu symptoms, swollen gums, painful mouth sores, pain when swallowing, skin sores;

• stabbing chest pain, wheezing, trouble breathing, cough with yellow or green mucus;

• pain or burning when you urinate;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common side effects may include:

• nausea, vomiting;

• fever;

• tired feeling; or

• anemia (low red blood cells)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Metabolized principally (80–90%) by UGT1A1.1

Belinostat and its metabolites, including belinostat glucuronide, belinostat amide, and methyl belinostat, inhibit CYP2C8 and CYP2C9.1 Other metabolites, including 3-(anilinosulfonyl)-benzenecarboxylic acid (3-ASBA) and belinostat acid, inhibit CYP2C8.1

Likely substrate, but unlikely inhibitor, of P-glycoprotein (P-gp).1

Drugs Affecting Uridine Diphosphate-glucuronosyltransferase (UGT)

Potent UGT1A1 inhibitors: Possible pharmacokinetic interaction (increased systemic exposure of belinostat).1 Avoid concomitant use.1

Specific Drugs

Storage

Parenteral

Unreconstituted drug: 20–25°C (may be exposed to 15–30°C).1

Reconstituted drug: 15–25°C for up to 12 hours.1

Diluted infusion solution: 15–25°C for up to 36 hours (including infusion time).1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Use this medicine 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.

Peripheral T-cell lymphoma, relapsed or refractory: Treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).