belinostat

What is the most important information I should know about belinostat?

What is belinostat?

Belinostat is used to treat peripheral T-cell lymphoma after other cancer treatments did not work or have stopped working.

Belinostat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Belinostat may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving belinostat?

Tell your doctor if you have ever had:

• an infection;
• high-dose or intensive chemotherapy;
• liver or kidney disease; or
• if you are sick with vomiting and diarrhea.

• If you are a woman, do not use belinostat if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using belinostat.

How is belinostat given?

Belinostat is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Belinostat is given in a 21-day treatment cycle. You may need to use the medicine only during the first 5 days of each cycle. Your doctor will determine how long to treat you with this medicine.

You may be given medication to prevent nausea, vomiting, or diarrhea while you are receiving belinostat.

Belinostat affects your immune system. You may get infections more easily, even serious or fatal infections.

Your blood will need to be tested every week during each treatment cycle. Your cancer treatments may be delayed based on the results.

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while receiving belinostat?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of belinostat?

• severe ongoing nausea, vomiting, or diarrhea;
• a fever, chills, muscle aches, flu-like symptoms,
• cough with mucus, chest pain, fast heartbeats, rapid breathing or shortness of breath;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• pain or burning when you urinate;
• confusion, severe drowsiness, feeling very ill;
• liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• signs of tumor cell breakdown --tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

• nausea, vomiting, diarrhea;
• anemia;
• fever; or
• tiredness.

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.

What other drugs will affect belinostat?

Other drugs may affect belinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about belinostat.