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Belinostat
Overview
What is Beleodaq?
Beleodaq is a histone deacetylase inhibitor with a sulfonamide-hydroxamide structure. The chemical name of belinostat is (2E)--hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide. The structural formula is as follows:
The molecular formula is CHNOS and the molecular weight is 318.35 g/mol.
Belinostat is a white to off-white powder. It is slightly soluble in distilled water (0.14 mg/mL) and polyethylene glycol 400 (about 1.5 mg/mL), and is freely soluble in ethanol (> 200 mg/mL). The pKa values are 7.87 and 8.71 by potentiometry and 7.86 and 8.59 by UV.
Beleodaq (belinostat) for injection is supplied as a sterile lyophilized yellow powder containing 500 mg belinostat as the active ingredient. Each vial also contains 1000 mg L-Arginine, USP as an inactive ingredient. The drug product is supplied in a single-dose 30 mL clear glass vial with a coated stopper and aluminum crimp seal with “flip-off” cap. Beleodaq is intended for intravenous administration after reconstitution with 9 mL Sterile Water for injection, and the reconstituted solution is further diluted with 250 mL of sterile 0.9% Sodium Chloride injection prior to infusion .
What does Beleodaq look like?
What are the available doses of Beleodaq?
For injection: 500 mg, lyophilized powder in single-dose vial for reconstitution ()
What should I talk to my health care provider before I take Beleodaq?
Nursing Mothers:
How should I use Beleodaq?
Beleodaq is indicated for the treatment of 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 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.
The recommended dosage of Beleodaq is 1,000 mg/m 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 until disease progression or unacceptable toxicity.
What interacts with Beleodaq?
Sorry No Records found
What are the warnings of Beleodaq?
Sorry No Records found
What are the precautions of Beleodaq?
Sorry No Records found
What are the side effects of Beleodaq?
Sorry No records found
What should I look out for while using Beleodaq?
None
What might happen if I take too much Beleodaq?
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 (.
How should I store and handle Beleodaq?
Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures 16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures 16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures 16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures 16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures 16.1 How SuppliedBeleodaq (belinostat) for injection is supplied in single vial cartons; each 30 mL clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat.NDC 68152-108-09Individual carton of Beleodaq 30 mL single-dose vial containing 500 mg belinostat.16.2 Storage and HandlingStore 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 Controlled Room Temperature]. Beleodaq is a cytotoxic drug. Follow special handling and disposal procedures
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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. , 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).
Non-Clinical Toxicology
NoneAmphotericin B Injection and Potassium-Depleting AgentsWhen corticosteroids are administered concomitantly with potassium-depleting agents (e.g., ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
AntibioticsMacrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (See Hepatic Enzyme Inducers, Inhibitors and Substrates).
AnticholinesterasesConcomitant use of anticholinesterase agents (e.g., ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.
Anticoagulants, OralCo-administration of corticosteroids and usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
AntidiabeticsBecause corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular DrugsSerum concentrations of may be decreased.
BupropionSince systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.
CholestyramineCholestyramine may increase the clearance of corticosteroids.
CyclosporineIncreased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis GlycosidesPatients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, Including Oral ContraceptivesEstrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
FluoroquinolonesPost-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.
Hepatic Enzyme Inducers, Inhibitors and SubstratesDrugs which cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which CYP 3A4 (e.g., ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., ) may increase their clearance, resulting in decreased plasma concentration.
KetoconazoleKetoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.
Nonsteroidal Anti-Inflammatory Agents (NSAIDS)Concomitant use of (or other ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.
PhenytoinIn post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.
QuetiapineIncreased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.
Skin TestsCorticosteroids may suppress reactions to skin tests.
ThalidomideCo-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
VaccinesPatients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (See Vaccination).
Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary ) and .
The following serious adverse reactions are described in more detail in other sections of the prescribing information.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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