Belinostat (1 brand name, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- BELEODAQ
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 and duration of response [see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Dosage and Administration
The recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on Days 1 through 5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.
Contraindications
None
Warnings and Precautions
Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration (2.2 ) and Adverse Reactions(6.1)].
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)] •Infection [see Warnings and Precautions (5.2)] •Hepatotoxicity [see Warnings and Precautions (5.3)] •Tumor Lysis Syndrome [see Warnings and Precautions (5.4)] •Gastrointestinal Toxicity [see Warnings and Precautions (5.5)]
Drug Interactions
Avoid concomitant administration of Beleodaq with UGT1A1inhibitors. If concomitant use of a UGT1A1 inhibitor is unavoidable, modify the Beleodaq dose [see Dosage and Administration (2.6)]. Belinostat is primarily metabolized by UGT1A1. Concomitant use with a UGT1A1 inhibitor increases belinostat exposure [see Clinical Pharmacology (12.3)], which may increase the risk of Beleodaq adverse reactions.
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 the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).
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 measures should be instituted as deemed necessary by the treating physician. The elimination half-life of belinostat is 1.1 hours [see Clinical Pharmacology ( 12.3)].