Beleodaq (belinostat)
Spectrum Pharmaceuticals · HDAC Inhibitor (Histone Deacetylase Inhibitor)
What is Beleodaq? Beleodaq (belinostat) is an HDAC inhibitor by Spectrum Pharmaceuticals approved for relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least one prior systemic therapy.
About Beleodaq
| Brand Name | Beleodaq |
| Generic / INN | belinostat |
| Drug Class | HDAC Inhibitor (Histone Deacetylase Inhibitor) |
| Manufacturer | Spectrum Pharmaceuticals |
| Administration | Intravenous (IV) infusion |
| FDA Approval | 2014 |
FDA-Approved Uses
- Relapsed or refractory peripheral T-cell lymphoma (PTCL) — adults after at least one prior therapy
How Does Beleodaq Work?
Belinostat inhibits histone deacetylase (HDAC) enzymes, causing hyperacetylation of histones and non-histone proteins. This results in altered gene expression including upregulation of tumor suppressor genes, cell cycle arrest, and apoptosis in malignant T cells. HDAC inhibitors are particularly active in T-cell lymphomas.
Dosage & Administration
1000 mg/m² IV over 30 minutes on days 1–5 of each 21-day cycle. Dose reduce to 750 mg/m² for UGT1A1*28 homozygous patients. Continue until disease progression or unacceptable toxicity.
Dosing is individualized by the treating oncologist. Do not adjust without medical guidance. This page is educational only.
Warnings & Side Effects
- Myelosuppression
- Serious infections
- Hepatotoxicity
- Tumor lysis syndrome
- Embryo-fetal toxicity
- UGT1A1*28 — dose reduction required
Common Side Effects
- Nausea
- Fatigue
- Pyrexia
- Anemia
- Vomiting
- Constipation
- Diarrhea
- Dyspnea
- Thrombocytopenia
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). Reconstituted solution stable 12 hours at room temperature.
💰 Medication Cost & Insurance Coverage
Approximate Wholesale Acquisition Cost (WAC / List Price)
~$15,000–$20,000/cycle
1000 mg/m² days 1-5
Insurance & Prior Authorization
Beleodaq requires prior authorization from all major insurance plans. BiologicHealthPlus handles the full PA process — clinical documentation, peer-to-peer reviews, and appeals — at no cost to patients or providers.
Prior Authorization Guide Patient Assistance Insurance & Savings
Frequently Asked Questions — Beleodaq
Beleodaq (belinostat) is an HDAC inhibitor approved for relapsed or refractory peripheral T-cell lymphoma (PTCL). It alters gene expression in malignant T cells, causing cell death.
PTCL is a group of aggressive non-Hodgkin lymphomas derived from mature T cells. It generally has a worse prognosis than B-cell lymphomas and limited treatment options, making Beleodaq a valuable option after first-line failure.
Patients homozygous for UGT1A1*28 metabolize belinostat more slowly, leading to higher drug exposure. These patients should receive a reduced starting dose of 750 mg/m² to avoid excessive toxicity.
Beleodaq is covered by Medicare Part B and commercial insurance for relapsed/refractory PTCL with prior authorization.
Related Medications & Conditions
Related Medications
Romidepsin (Istodax) · Vorinostat (Zolinza) · Brentuximab vedotin (Adcetris) · Pralatrexate (Folotyn)
Related Conditions
Peripheral T-cell lymphoma (PTCL) · T-cell lymphoma · Relapsed/refractory lymphoma