ALKERAN FOR INJECTION Rx
Generic Name and Formulations:
Melphalan HCl 50mg/vial; pwd for IV infusion after reconstitution and dilution.
Indications for ALKERAN FOR INJECTION:
Palliative treatment of multiple myeloma when oral therapy is not appropriate.
Give by IV infusion over 15–20 minutes. 16mg/m2 every 2 weeks for a total of 4 doses, then at 4-week intervals. Continue treatment as hematological recovery permits. Renal insufficiency (BUN≥30mg/dL): consider reducing dose by 50%.
Prior resistance to melphalan.
Should be administered under the supervision of an experienced physician in cancer chemotherapeutic agents. May cause severe bone marrow suppression with resulting infection or bleeding. Intravenous (IV) form may be more myelosuppressive than oral form. Leukemogenic in humans. Potentially mutagenic.
Prior irradiation or chemotherapy. Bone marrow suppression. Azotemia. Monitor platelets, hemoglobin, WBC and differential at start of therapy and prior to each course; discontinue if WBC <3,000cells/µL or platelets <100,000cells/µL. Moderate to severe renal impairment. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended.
Radiotherapy potentiates antineoplastic effect. For IV: caution with cyclosporine, cisplatin, BCNU, nalidixic acid.
Bone marrow suppression, GI upset, hepatic dysfunction, anemia, blood dyscrasias, secondary malignancies (eg, nonlymphocytic leukemia), rash, alopecia, pulmonary fibrosis, interstitial pneumonitis, gonadal toxicity (amenorrhea, infertility); hypersensitivity reactions, cardiac arrest (rare).
Tabs—50; single-use vial—1 (w. diluent)