Belinostat Brand Name– Beleodaq
What is Belinostat
Belinostat (PXD-101) is a class I/II intravenous histone deacetylase (HDAC) inhibitor.
HDAC plays an important role in the epigenetic silencing of tumor suppressor genes.
The overall response rate was 25% following a median of 2 cycles of belinostat in 24 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in a multinational, 2-cohort, phase II trial.
In July 2014, belinostat (Beleodaq) was approved by the FDA for the treatment of relapsed or refractory PTCL.
It was an accelerated approval based on tumor response rate and duration of response; however, continued approval may be dependent upon verification and description of clinical benefit in confirmatory trials.
Indications
- peripheral T-cell lymphoma (PTCL)
For the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL)
Side Effects
- abdominal pain
- anemia
- anorexia
- chills
- constipation
- cough
- diarrhea
- dizziness
- dyspnea
- elevated hepatic enzymes
- fatigue
- fever
- headache
- hepatic failure
- hypokalemia
- hypotension
- infection
- nausea
- neutropenia
- peripheral edema
- phlebitis
- pruritus
- QT prolongation
- rash
- renal failure (unspecified)
- thrombocytopenia
- tumor lysis syndrome (TLS)
- ventricular fibrillation
- vomiting
Monitoring Parameters
- CBC with differential
- LFTs
- pregnancy testing
- serum creatinine/BUN
Contraindications
- anemia
- Asian patients
- Black patients
- bone marrow suppression
- breast-feeding
- Caucasian patients
- chemotherapy
- contraception requirements
- hepatic disease
- infection
- infertility
- leukopenia
- male-mediated teratogenicity
- neutropenia
- pregnancy
- pregnancy testing
- reproductive risk
- sepsis
- thrombocytopenia
- tumor lysis syndrome (TLS)
Interactions
- Atazanavir
- Atazanavir; Cobicistat
- Clozapine
- Gemfibrozil
- Palifermin
- Penicillamine
- Tuberculin Purified Protein Derivative, PPD
