Beleodaq 500 mg/10mL
Belinostat · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Acrotech Biopharma Inc
Beleodaq (belinostat) is an intravenous medication used to treat peripheral T-cell lymphoma, a type of blood cancer. It works by inhibiting histone deacetylase, an enzyme involved in cancer cell growth.
Key Facts
- Brand Name
- Beleodaq
- Generic Name
- Belinostat
- NDC Code (Product)
72893-002- Manufacturer
- Acrotech Biopharma Inc
- Strength
- 500 mg/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA206256
- Drug Class
- Histone Deacetylase Inhibitor [EPC]
- Marketing Start
- 07/21/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. 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.( 1 )
Dosage & Administration
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. ( 2.7 ) 2.1 Recommended Dosage The 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 every 21 days until disease progression or unacceptable toxicity. 2.2 Dosage Modification for Hematologic and Non-Hematologic Toxicities Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicitie…
Contraindications
4 CONTRAINDICATIONS None None. ( 4 )
Drug 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.
Adverse Reactions
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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 in Patients with Peripheral T-Cell Lymphoma The safety of Beleodaq was evaluated in 129 patients with relapsed or refractory PTCL in the single arm clinical trial in which patients were administered Beleodaq at a dosage of 1,000 mg/m 2 administered over 30 minutes by IV infusi…
Frequently Asked Questions
What is Beleodaq used for?
Beleodaq (belinostat) is an intravenous medication used to treat peripheral T-cell lymphoma, a type of blood cancer. It works by inhibiting histone deacetylase, an enzyme involved in cancer cell growth.
Is Beleodaq a controlled substance?
Beleodaq is not classified as a controlled substance by the DEA.
What is the generic name for Beleodaq?
The generic name for Beleodaq is Belinostat. There are no other listed brand versions of Belinostat.
What is the NDC code for Beleodaq 500 mg/10mL?
The NDC (National Drug Code) for Beleodaq 500 mg/10mL is 72893-002, listed by Acrotech Biopharma Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)