Brand Names: Beleodaq
Generic Name: belinostat
- What is belinostat (Beleodaq)?
- What are the possible side effects of belinostat (Beleodaq)?
- What is the most important information I should know about belinostat (Beleodaq)?
- What should I discuss with my healthcare provider before receiving belinostat (Beleodaq)?
- How is belinostat given (Beleodaq)?
- What happens if I miss a dose (Beleodaq)?
- What happens if I overdose (Beleodaq)?
- What should I avoid while receiving belinostat (Beleodaq)?
- What other drugs will affect belinostat (Beleodaq)?
- Where can I get more information (Beleodaq)?
What is belinostat (Beleodaq)?
Belinostat is used to treat peripheral T-cell lymphoma that has relapsed or has not responded to other treatments.
Belinostat 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.
Belinostat may also be used for purposes not listed in this medication guide.
What are the possible side effects of belinostat (Beleodaq)?
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 side effects may include:
- nausea, vomiting;
- 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.
What is the most important information I should know about belinostat (Beleodaq)?
You should not use belinostat if you have an active infection.
What should I discuss with my healthcare provider before receiving belinostat (Beleodaq)?
You should not use belinostat if you are allergic to it, or if you have:
- an active infection.
To make sure belinostat 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.
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 belinostat given (Beleodaq)?
Belinostat is injected into a vein through an IV. A healthcare provider will give you this injection.
Belinostat must be injected slowly, and the IV infusion can take at least 30 minutes to complete.
Belinostat 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 to treat you with belinostat.
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.
Belinostat 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.
What happens if I miss a dose (Beleodaq)?
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 take extra medicine to make up the missed dose.
What happens if I overdose (Beleodaq)?
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 (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.
This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What other drugs will affect belinostat (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.
Where can I get more information (Beleodaq)?
Your pharmacist can provide more information about belinostat.
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