Belinostat
Generic Name: belinostat
Brand Names:
Beleodaq
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 formula is as follows: The molecular formula is C 15 H 14 N 2 O 4 S and the molecular weight is 318.35 g/mol. Belinostat is a white to off-white powder.
Overview
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 formula is as follows: The molecular formula is C 15 H 14 N 2 O 4 S and the molecular weight is 318.35 g/mol. Belinostat is a white to off-white powder.
Uses
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 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. Beleodaq is a histone deacetylase inhibitor 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.
Dosage
2 DOSAGE AND ADMINISTRATION Recommended dosage of Beleodaq is 1,000 mg/m 2 administered over 30 minutes by intravenous infusion once daily on days 1 through 5 of a 21-day cycle. Cycles can be repeated until disease progression or unacceptable toxicity. ( 2.1 ) Treatment discontinuation or interruption with or without dosage reductions by 25% may be needed to manage adverse reactions ( 2.2 ) Reduce dosage in patients with moderate hepatic or renal impairment. ( 2.3 , 2.4 , 8.6 , 8.7 ) Avoid use in patients with severe hepatic or renal impairment. ( 2.3 , 2.4 , 8.6 , 8.7 ) Modify dosage in patients known to be homozygous for the UGT1A1*28 allele. ( 2.5 ) See the full prescribing information for preparation and administration instructions.
Side Effects
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 )] • 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 )] The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting.
Interactions
7 DRUG INTERACTIONS UGT1A1 Inhibitors: Avoid use or modify dosage if use is unavoidable. ( 2.6 , 7.1 ) 7.1 UGT1A1 Inhibitors 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.
Warnings
5 WARNINGS AND PRECAUTIONS Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) Infection : Serious and fatal infections (e.g., pneumonia and sepsis) ( 5.2 ) Hepatotoxicity : Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and omit or modify dosage for hepatic toxicities. ( 2.2 , 5.3 ) Tumor lysis syndrome : Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions ( 5.4 ) Gastrointestinal Toxicity : Nausea, vomiting and diarrhea occur with Beleodaq and may require antiemetic and antidiarrheal medications ( 5.5 ). Embryo-Fetal Toxicity : Can cause fetal harm. 4 CONTRAINDICATIONS None None. ( 4 )
Pregnancy
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 ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] . There are no available data on Beleodaq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No animal reproduction studies were conducted with Beleodaq. Advise pregnant women of the potential risk to a fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Beleodaq (belinostat) for injection is supplied in single vial cartons; each clear vial contains sterile, lyophilized powder equivalent to 500 mg belinostat. NDC 72893-002-01: Individual carton of Beleodaq single-dose vial containing 500 mg belinostat.
Frequently Asked Questions
What is Belinostat used for?▼
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 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. Beleodaq is a histone deacetylase inhibitor 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.
What are the side effects of Belinostat?▼
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 )] • 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 )] The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting.
Can I take Belinostat during pregnancy?▼
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 ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] . There are no available data on Beleodaq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No animal reproduction studies were conducted with Beleodaq. Advise pregnant women of the potential risk to a fetus.
What are the important warnings for Belinostat?▼
5 WARNINGS AND PRECAUTIONS Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) Infection : Serious and fatal infections (e.g., pneumonia and sepsis) ( 5.2 ) Hepatotoxicity : Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and omit or modify dosage for hepatic toxicities. ( 2.2 , 5.3 ) Tumor lysis syndrome : Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions ( 5.4 ) Gastrointestinal Toxicity : Nausea, vomiting and diarrhea occur with Beleodaq and may require antiemetic and antidiarrheal medications ( 5.5 ). Embryo-Fetal Toxicity : Can cause fetal harm. 4 CONTRAINDICATIONS None None. ( 4 )
Related Medications
Bilastine (form-ii)
bilastine (form-ii)
Dosage form: POWDER. Active ingredients: BILASTINE (1 kg/kg). Category: BULK INGREDIENT.
Iloprost
iloprost
Prostacycline [EPC]
11 DESCRIPTION AURLUMYN contains iloprost, a synthetic analog of prostacyclin PGI 2 . The chemical name for iloprost is (5 E )-[3a S ,4 R ,5 R ,6a S )-5-hydroxy-4-[(1 E )-(3 S ,4 RS )-3-hydroxy-4-methyloct-1-en-6-ynyl]-hexahydropentalen-2(1 H )-ylidene]pentanoic acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47.
Acetaminophen, Lidocaine, Menthol
acetaminophen, lidocaine, menthol
Purpose Pain reliever/fever reducer
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.