Beleodaq

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.

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.

Pregnancy Category: D

Lactation: Unknown if distributed in human breast milk; a decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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

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.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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.

Contraindications

• No known contraindications.1

Warnings/Precautions

Hematologic Effects

Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia may occur.1

Monitor CBC weekly during therapy.1 (See Dosage Modification under Dosage and Administration.)

Infectious Complications

Serious and sometimes fatal infections, including pneumonia and sepsis, reported.1

Risk for life-threatening infections may be increased in patients with history of extensive or intensive chemotherapy.1

Patients with active infection should not receive belinostat.1

Hepatic Toxicity

Fatal hepatotoxicity and liver function test abnormalities may occur.1

Perform liver function tests prior to initiation of therapy and prior to each cycle.1 (See Dosage Modification under Dosage and Administration.)

Tumor Lysis Syndrome

Tumor lysis syndrome, including at least 1 death, reported.1

Increased risk of tumor lysis syndrome in patients with advanced stage disease and/or large tumor burden.1 Monitor closely and take appropriate precautions.1

GI Effects

Nausea, vomiting, and diarrhea occur frequently.1

Antiemetic and antidiarrheal therapy may be necessary.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 Based on mechanism of action, embryo and fetal lethality and teratogenicity may occur.1 Avoid pregnancy during therapy.1 If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.1

Impairment of Fertility

Animal studies suggest belinostat may impair male fertility.1

Specific Populations

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Not known whether belinostat is distributed into milk.1 Discontinue nursing or the drug.1

Safety and efficacy not established.1

In patients with PTCL, overall response rate was 36% in patients ≥65 years of age compared with 16% in patients <65 years of age.1 No substantial differences in overall response rate in patients ≥75 years of age relative to younger adults.1

No clinically important differences in safety relative to younger adults.1

Data lacking in patients with moderate or severe hepatic impairment (total bilirubin concentration >1.5 times the ULN).1 (See Elimination under Pharmacokinetics.)

Systemic exposure not affected by Clcr >39 mL/minute.1

Data lacking in patients with Clcr ≤39 mL/minute.1 (See Elimination under Pharmacokinetics.)

Common Adverse Effects

Nausea,1 3 fatigue,1 pyrexia,1 anemia,1 vomiting,1 3 constipation,1 diarrhea,1 dyspnea,1 rash,1 peripheral edema,1 cough,1 thrombocytopenia1 , pruritus,1 chills,1 elevated concentrations of serum LDH,1 decreased appetite,1 headache,1 infusion site pain,1 3 hypokalemia,1 prolonged QT interval,1 abdominal pain,1 hypotension,1 phlebitis,1 dizziness.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store Beleodaq at home, talk with your doctor, nurse, or pharmacist about how to store it.

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.

Data not available