beleodaq

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

Beleodaq is used to treat peripheral T-cell lymphoma that has relapsed or has not responded to other treatments.

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.

Important information

You should not use Beleodaq if you have an active infection.

Before taking this medicine

You should not use Beleodaq if you are allergic to belinostat, or if you have:

• an active infection.

To make sure Beleodaq is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• if you have received high-dose or intensive chemotherapy in the past.

FDA pregnancy category D. Do not use Beleodaq if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether belinostat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is Beleodaq given?

Beleodaq is injected into a vein through an IV. A healthcare provider will give you this injection.

The injection must be administered slowly, and the IV infusion can take at least 30 minutes to complete.

Beleodaq is given in a 21-day treatment cycle, and you may only receive the medicine during the first 5 days of each cycle. Your doctor will determine how long your treatment will last.

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

You will need frequent medical tests to be sure this medicine is not causing harmful effects. Your blood will need to be tested every week during each treatment cycle. Your cancer treatments may be delayed based on the results of these tests.

Beleodaq can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Beleodaq dosing information

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra Beleodaq to make up the missed 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 Beleodaq?

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.

Beleodaq side effects

Get emergency medical help if you have any of these 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 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 Beleodaq 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.

See also: Side effects (in more detail)

What other drugs will affect Beleodaq?

Other drugs may interact with belinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.