Beleodaq

Beleodaq is a prescription medication used for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

Beleodaq belongs to a group of drugs called pan HDAC inhibitors. Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory).

Beleodaq is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Beleodaq is given one time a day on Days 1 through 5 of a 21-day cycle of treatment.

Common side effects of Beleodaq include nausea, fatigue, fever, low red blood cells (anemia), and vomiting.

Beleodaq is a prescription/over-the-counter] medication used for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Spectrum Pharmaceuticals, Inc.

Serious side effects have been reported with Beleodaq. See the “Beleodaq Precautions” section.

Common side effects of Beleodaq include the following:

• nausea
• fatigue
• fever
• low red blood cells (anemia)
• vomiting

This is not a complete list of Beleodaq side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• inhibitors of UGT1A1 such as atazanavir (Reyataz) and indinavir (Crixivan)
• warfarin (Coumadin, Jantoven)

This is not a complete list of Beleodaq drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Beleodaq including the following:

• Low blood cell counts. Your doctor will do blood tests to check your blood counts during your treatment with Beleodaq.
  • Low platelet counts can cause unusual bleeding or bruising under your skin.
  • Low red blood cell counts may make you feel weak, tired, or you get tired easily, you look pale, or you feel short of breath.
  • Low white blood cell counts can cause you to get infections, which may be serious.
• Serious infections. People receiving Beleodaq may develop serious infections that can sometimes lead to death. You may have a greater risk of life-threatening infections if you have had chemotherapy in the past. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
• fever
• flu-like symptoms
• cough
• shortness of breath
• burning with urination
• muscle aches
• worsening skin problems
• Liver problems. Beleodaq may cause liver problems which can lead to death. Your doctor will do blood tests during your treatment with Beleodaq to check for liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems:
  • yellowing of the skin or the white part of your eyes (jaundice)
  • dark urine
  • itching
  • pain in the right upper stomach area
• Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. Your doctor will check you for TLS during treatment with Beleodaq.
• Nausea, vomiting, and diarrhea are common with Beleodaq and can sometimes be serious. Tell your doctor if you develop nausea, vomiting or diarrhea. Your doctor may prescribe medicines to help prevent or treat these side effects.

Do not take Beleodaq if you are allergic to Beleodaq or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Beleodaq, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Beleodaq, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Beleodaq or to any of its ingredients
• have an infection
• have had chemotherapy treatment
• have liver or kidney problems
• have nausea, vomiting, or diarrhea
• are pregnant or plan to become pregnant. Beleodaq, can harm your unborn baby. You should not become pregnant while receiving Beleodaq. Tell your doctor right away if you become pregnant while receiving Beleodaq.
• are breastfeeding or plan to breastfeed. It is not known if Beleodaq passes into your breast milk. You and your doctor should decide if you will receive Beleodaq or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Beleodaq falls into category D. Beleodaq may cause birth defects or may halt the pregnancy because it targets actively dividing cells. Women should avoid pregnancy while receiving Beleodaq. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug ,the patient should know the potential hazard to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Beleodaq crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Beleodaq.

Take Beleodaq exactly as prescribed.

Beleodaq is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. Beleodaq is given one time a day on Days 1 through 5 of a 21-day cycle of treatment.

If you miss a dose, be sure to make a follow up appointment

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have (reduced UGT1A1 activity)
• how you respond to this medication
• your blood counts
• your body surface area

The recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes given directly into a vein (IV) once daily on Days 1 -5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.

If Beleodaq is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• You should have regular blood tests before and during your treatment with Beleodaq.
• Your doctor may change your dose of Beleodaq, change when you receive your treatment, or stop treatment if you have certain side effects while receiving Beleodaq.
• Keep all of your doctor and laboratory appointments.