Belinostat

Name: Belinostat

What Is Belinostat?

Belinostat is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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.

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

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.

Do not use belinostat if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant during treatment.

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.

Other Requirements

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

What is belinostat?

Belinostat is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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 should I discuss with my healthcare provider before receiving belinostat?

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.

Do not use belinostat if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant during treatment.

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.

What should I avoid while receiving belinostat?

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.

Belinostat dosing information

Usual Adult Dose for Lymphoma:

1,000 mg/m2 IV over 30 minutes once daily on days 1 to 5 of a 21-day cycle

Duration of therapy: Repeat cycle every 21 days until disease progression or unacceptable toxicity.

Comments:
-Dose reduction, discontinuation, or interruption of therapy may be needed to manage adverse reactions.

Use: Relapsed or refractory peripheral T-cell lymphoma

Cautions for Belinostat

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

Pregnancy

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

Lactation

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

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

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

Hepatic Impairment

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

Renal Impairment

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.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Beleodaq: 500 mg (1 ea)

Pharmacologic Category

  • Antineoplastic Agent, Histone Deacetylase (HDAC) Inhibitor

Special Populations Hepatic Function Impairment

Belinostat exposure is expected to be increased in hepatic impairment.

Adverse Reactions

>10%:

Cardiovascular: Peripheral edema (20%), prolonged Q-T interval on ECG (11%; grades 3/4: 4%)

Central nervous system: Fatigue (37%; grades 3/4: 5%), chills (16%; grades 3/4: 1%), headache (15%)

Dermatologic: Skin rash (20%; grades 3/4: 1%), pruritus (16%; grades 3/4: 3%)

Endocrine & metabolic: Increased lactate dehydrogenase (16%; grades 3/4: 2%), hypokalemia (12%; grades 3/4: 4%)

Gastrointestinal: Nausea (42%; grades 3/4: 1%), vomiting (29%; grades 3/4: 1%), constipation (23%; grades 3/4: 1%), diarrhea (23%; grades 3/4: 2%), decreased appetite (15%; grades 3/4: 2%), abdominal pain (11%; grades 3/4: 1%)

Hematologic & oncologic: Anemia (32%; grades 3/4: 11%), thrombocytopenia (16%; grades 3/4: 7%)

Local: Pain at injection site (14%)

Respiratory: Dyspnea (22%; grades 3/4: 6%), cough (19%)

Miscellaneous: Fever (35%; grades 3/4: 2%)

1% to 10%:

Cardiovascular: Hypotension (10%; grades 3/4: 3%), phlebitis (10%; grades 3/4: 1%)

Central nervous system: Dizziness (10%)

Infection: Infection (>2%)

Renal: Increased serum creatinine (>2%)

Respiratory: Pneumonia (>2%)

Miscellaneous: Multi-organ failure (>2%)

<1% (Limited to important or life-threatening): Hepatic failure, leukopenia, sepsis, tumor lysis syndrome, ventricular fibrillation

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