ALKERAN

What it is

ALKERAN INJECTION is a composite pack containing melphalan hydrochloride equivalent to 50 mg melphalan and a vial of sterile diluent. It is supplied as a powder for injection. ALKERAN INJECTION is administered intravenously.

Approved indications

— Treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Dosing overview

The usual intravenous dose is 16 mg/m², administered as a single infusion over 15 to 20 minutes. ALKERAN INJECTION is administered at 2-week intervals for four doses, then, after adequate recovery from toxicity, at 4-week intervals. Dosage reduction of up to 50% should be considered in patients with moderate to severe renal impairment and subsequent dosage determined according to the degree of haematological suppression.

Key safety warnings

Severe bone marrow suppression with resulting infection or bleeding may occur. ALKERAN INJECTION is a potent myelosuppressive agent, and careful attention should be paid to the monitoring of blood counts to avoid the possibility of excessive myelosuppression and the risk of irreversible bone marrow aplasia. Platelet count, haemoglobin, white blood cell count, and differential should be performed at the start of therapy and prior to each subsequent dose. Melphalan in combination with lenalidomide and prednisone or in combination with thalidomide and prednisone or dexamethasone is associated with an increased risk of venous thromboembolism. Hypersensitivity reactions including anaphylaxis have occurred in approximately 2% of patients who received the intravenous formulation. These reactions usually occur after multiple courses of treatment. Use of alkylating agents has been linked with the development of second primary malignancy. In particular, melphalan in combination with lenalidomide and prednisone and, to a lesser extent, thalidomide and prednisone has been associated with increased risk of solid second primary malignancy in elderly newly diagnosed multiple myeloma patients.

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. Lactation is a contraindication.

PBS listing

ALKERAN tablet 2 mg is listed on the PBS with 1 item, unrestricted restriction, and an ex-manufacturer price of A$48.32.

Regulatory history

ALKERAN tablets 5 mg were first listed on the ARTG on 2 August 1991. ALKERAN INJECTION melphalan 50 mg powder for injection composite pack was first listed on the ARTG on 26 October 2001. ALKERAN melphalan 2 mg tablets were first listed on the ARTG on 17 June 2002.