BELEODAQ Powder for solution for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Acrotech Biopharma LLC

Λέξεις κλειδιά

72893-002

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1. Indications and Usage

Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate ...

2. Dosage and Administration

2.1 Dosing Information The recommended dosage of Beleodaq is 1,000 mg/m² administered over 30 minutes by intravenous infusion once daily on Days 1-5 of a 21-day cycle. Cycles can be repeated every 21 days ...

3. Dosage Forms and Strengths

For injection: 500 mg, lyophilized powder in single-dose vial for reconstitution.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Hematologic Toxicity Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary ...

6. Adverse Reactions

The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information. Hematologic Toxicity [see Warnings and Precautions (5.1)] ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Beleodaq may not reflect the rates observed in practice. Adverse Reactions ...

7. Drug Interactions

7.1 UGT1A1 Inhibitors Belinostat is primarily metabolized by UGT1A1. Avoid concomitant administration of Beleodaq with strong inhibitors of UGT1A1 [see Clinical Pharmacology (12.3)].

8.1. Pregnancy

Risk Summary Based on its mechanism of action, Beleodaq can cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells [see Clinical Pharmacology ...

8.2. Lactation

Risk Summary There are no data on the presence of belinostat in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating Beleodaq. Contraception Females Beleodaq can cause embryo-fetal harm when administered to a ...

8.4. Pediatric Use

The safety and effectiveness of Beleodaq in pediatric patients have not been established.

8.5. Geriatric Use

In the single-arm trial, 48% of patients (n=62) were ≥65 years of age and 10% of patients (n=13) were ≥75 years of age [see Clinical Studies (14)]. The median age of the trial population was 63 ...

8.6. Hepatic Impairment

Belinostat is metabolized in the liver and hepatic impairment is expected to increase exposure to belinostat. Patients with moderate and severe hepatic impairment (total bilirubin >1.5 x upper limit of ...

8.7. Renal Impairment

Belinostat exposure is not altered in patients with Creatinine Clearance (CLcr) >39 mL/min. There is insufficient data to recommend a dose of Beleodaq in patients with CLcr ≤39 mL/min [see Clinical ...

10. Overdosage

No specific information is available on the treatment of overdosage of Beleodaq. There is no antidote for Beleodaq and it is not known if Beleodaq is dialyzable. If an overdose occurs, general supportive ...

11. Description

Beleodaq is a histone deacetylase inhibitor with a sulfonamide-hydroxamide structure. The chemical name of belinostat is (2E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide. The structural ...

12.1. Mechanism of Action

Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused ...

12.2. Pharmacodynamics

Cardiac Electrophysiology Multiple clinical trials have been conducted with Beleodaq, in many of which ECG data were collected and analyzed by a central laboratory. Analysis of clinical ECG and belinostat ...

12.3. Pharmacokinetics

The pharmacokinetic characteristics of belinostat were analyzed from pooled data from phase ½ clinical studies that used doses of belinostat ranging from 150 to 1,200 mg/m². The total mean plasma clearance ...

12.5. Pharmacogenomics

UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism. Approximately 20% of the black population, 10% of the white ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with belinostat. Belinostat was genotoxic in a bacterial reverse mutation test (Ames assay), an in vitro mouse lymphoma cell mutagenesis assay, and an in ...

14. Clinical Studies

Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) In an open-label, single-arm, non-randomized international trial conducted at 62 centers, 129 patients with relapsed or refractory PTCL were treated ...

15. References

1 OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16.1. How Supplied

Beleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat. NDC 72893-002-01: Individual carton of ...

16.2. Storage and Handling

Store Beleodaq (belinostat) for injection at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Retain in original package until use. [see USP ...

17. Patient Counseling Information

Physicians should discuss the FDA approved Patient Information Leaflet with patients prior to treatment with Beleodaq. Instruct patients to read the Patient Information Leaflet carefully. Advise the patient ...