Generic Name: belinostat
Date of Approval: July 3, 2014
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Peripheral T-Cell Lymphoma
FDA Approves Beleodaq
Read this Patient Information before, and each time you receive treatment. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.
What is Beleodaq?
Beleodaq is a prescription medicine used to treat people with a type of cancer called peripheral T-cell Lymphoma (PTCL) that comes back or does not respond to cancer treatment. It is not known if it is safe and effective in children.
What should I tell my doctor before receiving treatment?
Before receiving treatment, tell your doctor about all of your medical conditions, including if you:
- have an infection
- have had chemotherapy treatment
- have liver or kidney problems
- have nausea, vomiting, or diarrhea
- are pregnant or plan to become pregnant. This drug can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this drug 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 over-the-counter medicines, vitamins, and herbals supplements.
How will I receive Beleodaq?
- The dose will be given to you by intravenous (IV) injection into your vein, usually over 30 minutes.
- It is given once a day on Days 1 through 5 of a 21- day cycle of treatment.
- You should have regular blood tests before and during your treatment.
- Your doctor may change your dose, change when you receive your treatment, or stop treatment if you have certain side effects.
Beleodaq side effects
Beleodaq may cause serious side effects, including:
- Low blood cell counts. Your doctor will do blood tests to check your blood counts during your treatment.
- 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 or worsening skin problems.
- Liver problems. Beleodaq may cause liver problems which can lead to death. Your doctor will do blood tests during your treatment 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, or 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.
- 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.
Common side effects of Beleodaq include fatigue, fever, and low red blood cell count. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side of effects of Beleodaq. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.
General information about Beleodaq
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Beleodaq that is written for health professionals.
What are the ingredients?
Active ingredient: belinostat
Inactive ingredients: L-Arginine