Belinostat, Injection

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KEY POINTS

• This medicine is given by IV to treat peripheral T-cell lymphoma.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause a serious problem called tumor lysis syndrome. Talk with your healthcare provider about this. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); histone deacetylase (HDAC) inhibitor

Generic and brand names: belinostat, injection; Beleodaq

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat peripheral T-cell lymphoma (PTCL). It is used when the PTCL gets worse, does not go away, or comes back after treatment with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease

Tell your provider if you currently have an infection, or problems with nausea, vomiting, or diarrhea.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

The infusions are given by your healthcare provider. You will be monitored closely while you are receiving this medicine. Keep all appointments for these infusions.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause diarrhea, nausea, or vomiting and may increase the risk of dehydration. Contact your healthcare provider if you have severe nausea, vomiting, or diarrhea while you are taking this medicine. Be careful when exercising, especially in hot weather.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause a serious problem called tumor lysis syndrome. Tumor lysis syndrome is caused by a fast breakdown of cancer cells. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; severe nausea, vomiting, or diarrhea; fever, chills, sore throat, or cough; trouble urinating or burning with urination; sores that do not heal or get worse; severe dizziness or fainting; unexplained swelling in arms or legs; severe tiredness or weakness; shortness of breath; dark urine; light-colored bowel movements; yellowing of your skin or eyes; fast or irregular heartbeat; severe muscle pain, cramps, or weakness.

Other: Mild diarrhea, nausea, or vomiting; loss of appetite; constipation; mild tiredness; mild dizziness; headache; itching; stomach pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Gemfibrozil (Lopid)
• HIV medicines such as atazanavir (Reyataz) and indinavir (Crixivan)
• Ketoconazole (Nizoral)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.