Adult Dosing
Peripherial T-Cell Lymphoma
- Recommended dose: 1000 mg/m(2) IV (administered over 30 mins) once daily on days 1-5 of a 21-day cycle
- Repeat cycles q21 days if the patient tolerates the therapy and until disease progression
- Dosage modification based on toxicities
- Hematologic toxicities
- Platelet count
25 x 10(9)/L and nadir ANC 0.5 x 10(9)/L : No change in dose - Nadir ANC < 0.5 x 10(9)/L and any platelet count: Decrease dose by 25% i.e., 750 mg/m(2)
- Platelet count < 25 x 10(9)/L and any nadir ANC : Decrease dose by 25% i.e., 750 mg/m(2)
- Non-hematologic toxicities
- Grade 3 or 4 adverse reactions : Decrease dose by 25% i.e., 750 mg/m(2)
- Nausea, vomiting, diarrhea of Grade 3 or 4 for > 7 days: Decrease dose by 25% i.e., 750 mg/m(2)
- Recurrent Grade 3 or 4 adverse reactions after two dosage reductions: Discontinue therapy
- Reduced UGT1A1 activity
- Patients known to be homozygous for UGT1A1*28 allele: Decrease the starting dose to 750 mg/m(2)
Note:
- Monitor complete blood counts at baseline and weekly
- Perform serum chemistry tests, including renal and hepatic functions before starting the first dose of each cycle
- For thrombocytopenia and neutropenia, adjust the dosage based on platelet and nadir absolute neutrophil counts (ANC) in the preceding cycle of therapy
- Before initiating each cycle and prior to resuming treatment following toxicity, the ANC should be 1.0 x 10(9)/L and the platelet count should be 50 x 10(9)/L
- Discontinue therapy in patients who have recurrent ANC nadirs < 0.5 x 10(9)/L and/or recurrent platelet count nadirs < 25 x 10(9)/L after two dosage reductions
- Other toxicities should be
NCI-CTCAE Grade 2 before initiating re-treatment
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Thrombocytopenia, leukopenia (neutropenia and lymphopenia) and/or anemia have been reported. Monitor blood counts weekly during treatment and modify dose as required
- Serious infections, including pneumonia and sepsis, have been reported. Therapy is contraindicated in patients with active infection. Risk of life threatening infections is higher in patients with history of extensive or intensive chemotherapy
- Fatal hepatotoxicity and liver function test abnormalities may occur. LFTs should be monitored before treatment and before initiating each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue treatment based on severity of hepatotoxicity
- Tumor lysis syndrome has been reported in the clinical trial of patients with relapsed or refractory PTCL; monitor patients with advanced stage disease and/or high tumor burden; take appropriate precautions
- Antiemetic/antidiarrheal medications may be required to treat therapy-associated nausea, vomiting and diarrhea
- Teratogenicity and/or embryo-fetal lethality have been reported because belinostat is genotoxic and targets actively dividing cells; advise women of the potential harm to the fetus and to avoid pregnancy while receiving belinostat
- Avoid coadministration with strong UGT1A1 inhibitors
Cautions: Use cautiously in
- Tumor lysis syndrome
- Women of childbearing potential
- Hx of intensive or extensive chemotherapy
- Prolonged QT syndrome
Pregnancy Category:D
Breastfeeding: Safety unknown; however, due to the potential for possible serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
