Gynecologic cancers:
Indications for: Melphalan
For the palliation of non-resectable epithelial ovarian cancer.
Adult Dosage:
0.2mg/kg per day for 5 days; repeat course every 4–5 weeks. Continue treatment as hematological recovery permits (esp. WBCs and platelets); for other regimens: see full labeling.
Children Dosage:
Not recommended.
Melphalan Contraindications:
Prior resistance to melphalan.
Boxed Warning:
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. Leukemogenic in humans. Potentially mutagenic.
Melphalan Warnings/Precautions:
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.
Melphalan Classification:
Alkylating agent.
Melphalan Interactions:
Radiotherapy potentiates antineoplastic effect. For IV: caution with cyclosporine, cisplatin, BCNU, nalidixic acid.
Adverse Reactions:
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).
Note:
Formerly known under the brand name Alkeran.
Drug Elimination:
Half-life: 1.5 ± 0.83 hours.
How Supplied:
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Leukemias, lymphomas, and other hematologic cancers:
Indications for: Melphalan
Palliative treatment for multiple myeloma.
Adult Dosage:
6mg once daily for 2–3 weeks; stop for up to 4 weeks, maintenance 2mg per day. Continue treatment as hematological recovery permits (esp. WBCs and platelets); for other regimens: see full labeling.
Children Dosage:
Not recommended.
Melphalan Contraindications:
Prior resistance to melphalan.
Boxed Warning:
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. Leukemogenic in humans. Potentially mutagenic.
Melphalan Warnings/Precautions:
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.
See Also:
Melphalan Classification:
Alkylating agent.
Melphalan Interactions:
Radiotherapy potentiates antineoplastic effect. For IV: caution with cyclosporine, cisplatin, BCNU, nalidixic acid.
Adverse Reactions:
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).
Note:
Formerly known under the brand name Alkeran.
Drug Elimination:
In 18 patients given a single oral dose of 0.6 mg/kg of Melphalan Tablets USP, the terminal elimination plasma half-life of parent drug was 1.5 ± 0.83 hours. The 24-hour urinary excretion of parent drug in these patients was 10% ± 4.5%, suggesting that renal clearance is not a major route of elimination of parent drug. In a separate study in 18 patients given single oral doses of 0.2 mg/kg to 0.25 mg/kg of Melphalan Tablets USP, Cmax and plasma concentration-time curves (AUC), when dose adjusted to a dose of 14 mg, were (mean ± SD) 212 ± 74 ng/mL and 498 ± 137 ng•hr/mL, respectively. Elimination phase half-life in these patients was approximately 1 hour and the median half-life was 1 hour. Melphalan is eliminated from plasma primarily by chemical hydrolysis to monohydroxymelphalan and dihydroxymelphalan.
How Supplied:
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