Belinostat

BELEODAQ

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.

FDA-approved for

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

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

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

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

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

NO BOXED WARNINGS

Principal riskMyelosuppression; UGT1A1 poor metabolizers need less

Direct muscarinic antagonism0 / 4