Belinostat

Belinostat is a prescription medication used for the treatment of relapsed or refractory peripheral T-cell lymphoma.

• Belinostat is available under the following different brand names: Beleodaq

Common side effects of Belinostat include:

• nausea
• fatigue
• fever
• anemia
• vomiting
• constipation
• diarrhea
• shortness of breath
• rash
• swelling of extremities
• cough
• itching
• chills
• loss of appetite
• headache
• infusion site pain
• abdominal pain
• low blood pressure
• dizziness
• low blood platelets (thrombocytopenia)
• low blood potassium (hypokalemia)
• phlebitis
• prolonged QT
• pneumonia
• infection

Serious side effects of Belinostat include:

• fever, cough, chills, muscle aches, worsening skin problems, flu-like symptoms, or other signs of infection
• painful, frequent, burning, or difficult urination
• unusual bleeding or bruising
• dizziness
• weakness
• excessive tiredness
• pale skin, or shortness of breath
• yellowing of the skin or eyes
• pain in the right upper stomach area
• dark urine or itching

Rare side effects of Belinostat include:

none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, of lyophilized powder for reconstitution

• 500 mg/vial

Peripheral T-cell lymphoma

Adult dosage

• 1000 mg/m² IV once a day on days 1 to 5 of a 21-day cycle
• Infuse IV over 30 minutes
• Cycles can be repeated every 21 days until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Belinostat has severe interactions with no other drugs
• Belinostat has serious interactions with the following drugs:
  • atazanavir
  • gemfibrozil
  • indinavir
  • ketoconazole
  • levoketoconazole
  • milk thistle
  • palifermin
  • ropeginterferon alfa 2b
  • valerian
• Belinostat has moderate interactions with the following drugs:
  • apalutamide
  • cholera vaccine
  • dengue vaccine
  • dichlorphenamide
  • ponesimod
  • siponimod
• Belinostat has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Belinostat?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Belinostat?”

Cautions

• Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia may occur; monitor blood cell counts and modify dosage for hematologic toxicities
• Serious and fatal infections (e.g., pneumonia and sepsis) reported; do not administer if the patient has an active infection
• May cause hepatic toxicity and liver function test abnormalities; monitor liver function tests before treatment and before each treatment cycle; omit or modify dosage for hepatic toxicities
• Tumor lysis syndrome reported; monitor patients with advanced-stage disease and/or high tumor burden and take appropriate precautions
• Nausea, vomiting, and diarrhea commonly occur and may require the use of antiemetic and antidiarrheal medications
• Belinostat can cause fetal harm when administered to a pregnant woman; advise women of potential harm to the fetus and to avoid pregnancy

Pregnancy and Lactation

• Based on the mechanism of action, the drug can cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells
• There are no available data on drug use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; no animal reproduction studies conducted; advise pregnant women of the potential risk to the fetus
• Pregnancy testing is recommended for women of reproductive potential before initiating therapy
• Based on findings from animal studies, the drug may impair male fertility; the reversibility of its effect on fertility is unknown
• Contraception
  • Females: The drug can cause embryo-fetal harm when administered to a pregnant woman; advise women of reproductive potential to use effective contraception during treatment with the drug and for 6 months after the last dose
  • Males: Based on genotoxicity findings, advise male with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
• Lactation
  • There is no data on the presence of the drug in human milk, its effects on breastfed children, or milk production; because of the potential for serious adverse reactions in breastfed children, advise patients that breastfeeding is not recommended during treatment with and for 2 weeks after the last dose