Melphalan

Indications

INDICATIONS AND USAGE: Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION: The usual IV dose is 16 mg/m 2 . Dosage reduction of up to 50% should be considered in patients with renal insufficiency (BUN ≥ 30 mg/dL) (see PRECAUTIONS , General ). The drug is administered as a single infusion over 15 to 20 minutes. Melphalan hydrochloride for injection is administered at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4‑week intervals. Available evidence suggests about one-third to one-half of the patients with multiple myeloma show a favorable response to the drug.

Contraindications

CONTRAINDICATIONS: Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent. Patients who have demonstrated hypersensitivity to melphalan should not be given the drug.

Warnings and precautions

WARNINGS: Melphalan hydrochloride may cause local tissue damage should extravasation occur, and consequently it should not be administered by direct injection into a peripheral vein. It is recommended that melphalan hydrochloride for injection be administered by injecting slowly into a fast-running IV infusion via an injection port, or via a central venous line (see DOSAGE AND ADMINISTRATION , Administration Precautions ).

Storage and supply

HOW SUPPLIED: Melphalan hydrochloride for injection is supplied as follows: Product No. NDC No. Strength 762020 63323-760-20 50 mg per vial One carton containing one single use clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.

Source: Melphalan Hydrochloride (Melphalan) — US FDA prescribing information, 2026-01-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.