Leukemias, lymphomas, and other hematologic cancers:
Indications for: TREANDA
Chronic lymphocytic leukemia (CLL). Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
CLL: Give by IV infusion over 30mins. 100mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Hematologic toxicity (≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 25mg/m2 on Days 1 and 2. Non-hematologic toxicity (clinically significant ≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle. Subsequent cycles: may consider dose re-escalation. NHL: Give by IV infusion over 60mins. 120mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles. Hematologic toxicity (Grade 4) or non-hematologic toxicity (≥Grade 3): reduce dose to 90mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 60mg/m2 on Days 1 and 2. Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity.
Myelosuppression; monitor CBCs including leukocytes, platelets, hemoglobin, neutrophils frequently; restart treatment based on ANC and platelet count recovery. Monitor for signs of infection or reactivation of infections (eg, hepatitis B, CMV, tuberculosis, herpes zoster); prophylaxis and treat prior to therapy if occur. Discontinue treatment and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressives if progressive multifocal leukoencephalopathy (PML) develops. Monitor for infusion or skin reactions (may be fatal), tumor lysis syndrome, secondary malignancies. Perform dermatologic evaluations. Monitor LFTs prior to and during therapy. Renal impairment (CrCl <30mL/min): not recommended. Hepatic impairment (total bilirubin 1.5–3×ULN and AST or ALT 2.5–10×ULN, or total bilirubin >3×ULN): not recommended. Avoid extravasation. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or for ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
May be potentiated CYP1A2 inhibitors or antagonized by CYP1A2 inducers; if needed, consider alternatives.
Lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, pyrexia, nausea, vomiting, fatigue, diarrhea, constipation, anorexia, cough, headache, weight loss, dyspnea, rash (if severe or progressive, withhold dose or discontinue), stomatitis; infection, PML, infusion reactions (discontinue if severe), tumor lysis syndrome, hepatotoxicity, other malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, bronchial carcinoma, non-melanoma skin cancer).
Generic Drug Availability: