Beleodaq is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

Beleodaq was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, non-small cell lung tumors responded to this medicine. However, it has not been shown that belinostat can improve symptoms or lengthen survival time.

Beleodaq affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, flu-like symptoms, or unusual bleeding or bruising.

Belinostat can harm your unborn baby. You should not become pregnant while receiving Beleodaq. Tell your doctor right away if you become pregnant while receiving this medicine.

Before taking this medicine

To make sure Beleodaq is safe for you, 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.

Belinostat can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Beleodaq 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 Beleodaq.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Beleodaq injection 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.

Beleodaq 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 Beleodaq.

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.

Usual Adult Dose for Lymphoma:

1,000 mg/m2 IV over 30 minutes once daily on days 1 to 5 of a 21-day cycle

Duration of therapy: Repeat cycle every 21 days until disease progression or unacceptable toxicity.

Comments:
-Dose reduction, discontinuation, or interruption of therapy may be needed to manage adverse reactions.

Use: Relapsed or refractory peripheral T-cell lymphoma

To make sure Beleodaq is safe for you, 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.

Belinostat can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Beleodaq 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 Beleodaq.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your Beleodaq injection.

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

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.

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

Call your doctor at once if you have:

• 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 Beleodaq 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.

Other drugs may interact with 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.