Belinostat

BELEODAQ

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Pronunciation: be-LIN-oe-stat

Belinostat ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Belinostat ballicule

What it isHistone deacetylase inhibitor; relapsed or refractory peripheral T-cell lymphoma.

Why this oneIt offers an IV epigenetic salvage option without the folate and B12 supplementation required by pralatrexate.

What limits itMyelosuppression and infection can end treatment; UGT1A1 poor metabolizers need dose reduction.

Belinostat molecular structure (skeletal formula) — Molecular structure: Belinostat

FDA-approved for

peripheral T-cell lymphoma (2014)

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
Relapsed or refractory peripheral T-cell lymphoma	Adult	1000 mg/m² IV over 30 min QD on Days 1-5 of a 21-day cycle	repeat every 21 days until progression/unacceptable toxicity	1000 mg/m²/day

Renal Reduce to 500 mg/m² for moderate impairment (CLcr 30 to <60); avoid in severe (CLcr <30); no adjustment for mild

Hepatic Reduce to 500 mg/m² for moderate impairment (bilirubin >1.5-3x ULN); avoid in severe (>3x ULN); no adjustment for mild

Dose reductions in 25% decrements (to 750 mg/m²) for hematologic/non-hematologic toxicity

Instructions

IV infusion over 30 min (may extend to 45 min for infusion-site pain)
ANC ≥1×10⁹/L and platelets ≥50×10⁹/L required before each cycle
Hazardous drug — use special handling; reduce starting dose to 750 mg/m² for UGT1A1*28 homozygotes

Available strengths

inj 500 mg

Cautions

Myelosuppression (thrombocytopenia, leukopenia, anemia) — monitor CBC weekly
Serious/fatal infections (pneumonia, sepsis) — do not give with active infection
Hepatotoxicity (can be fatal) — monitor liver tests
Tumor lysis syndrome; GI toxicity (nausea, vomiting, diarrhea)
Embryo-fetal toxicity

Adverse reactions

Nausea (42%)
Fatigue (37%)
Pyrexia (35%)
Anemia (32%)
Vomiting (29%)

Pregnancy Can cause fetal harm (genotoxic); advise effective contraception

Lactation Breastfeeding not recommended during and for 2 weeks after the last dose

Cost

Belinostat (BELEODAQ)

Strength		#/mo	generic $/unit	CostPlus
500 mg	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Belinostat is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskMyelosuppression; UGT1A1 poor metabolizers need less

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Sedation liability0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Open Belinostat in the interactive console ↗