Beleodaq Injection

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with belinostat.

Belinostat was genotoxic in a bacterial reverse mutation test (Ames assay), an in vitro mouse lymphoma cell mutagenesis assay, and an in vivo rat micronucleus assay.

Beleodaq may impair male fertility. Fertility studies using belinostat were not conducted. However, belinostat effects on male reproductive organs observed during the 24-week repeat-dose dog toxicology study included reduced organ weights of the testes/epididymides that correlated with a delay in testicular maturation.

Applies to belinostat: intravenous powder for injection

General

The most commonly observed adverse reactions included nausea, fatigue, pyrexia, anemia, and vomiting.

The most commonly reported reasons for treatment discontinuation included anemia, febrile neutropenia, fatigue, and multi-organ failure.[Ref]

Hematologic

Very common (10% or more): Anemia (32%), thrombocytopenia (16%)[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (20%), prolonged QT (11%), hypotension (10%), phlebitis (10%)[Ref]

Dermatologic

Very common (10% or more): Rash (20%), pruritus (16%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (43%), vomiting (29%), constipation (23%), diarrhea (23%), decreased appetite (15%), abdominal pain (11%)[Ref]

Metabolic

Very common (10% or more): Hypokalemia (12%)[Ref]

Nervous system

Very common (10% or more): Headache (15%), dizziness (10%)[Ref]

Other

Very common (10% or more): Fatigue (37%), pyrexia (35%), chills (16%)[Ref]

Respiratory

Very common (10% or more): Dyspnea (22%), cough (19%)[Ref]

Some side effects of belinostat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.