Pronunciation:

be-LIN-oh-stat

Brand Names:

• Beleodaq

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Histone Deacetylase Inhibitor

Uses of This Medicine:

Belinostat injection is used to treat peripheral T-cell lymphoma in patients who have been treated with other medicines that did not work well.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of belinostat injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of belinostat injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Leukopenia (low number of white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine can temporarily lower the number of white blood cells and platelets in your blood, increasing the chance of getting an infection. Avoid being near people who are sick or have infections. Wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Belinostat can cause diarrhea, nausea, or vomiting. Your doctor may give you medicines to help prevent this. Call your doctor if you continue to have diarrhea, nausea, or vomiting after your dose.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bluish color

blurred vision

changes in skin color

chest pain

confusion

cough

decreased urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fainting

fast heartbeat

fever or chills

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pale skin

pinpoint red spots on the skin

rapid, shallow breathing

sore throat

sweating

tenderness

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Abdominal or stomach pain or tenderness

clay colored stools

dark urine

decreased appetite

headache

joint pain, stiffness, or swelling

lower back or side pain

skin rash or itching

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Constipation

diarrhea

dizziness

pain at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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