Alkeran: Targeted Chemotherapy for Multiple Myeloma and Ovarian Cancer

Alkeran

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Product dosage: 2 mg
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Synonyms Melfalax

Alkeran (melphalan) is a potent alkylating chemotherapy agent specifically formulated for the treatment of multiple myeloma and certain forms of ovarian carcinoma. As a nitrogen mustard derivative, it functions by cross-linking DNA strands, thereby inhibiting the replication of rapidly dividing malignant cells. Its targeted mechanism offers a critical therapeutic option within complex oncological regimens, often serving as a cornerstone of high-dose chemotherapy protocols, including those preceding stem cell transplantation. This product card provides a comprehensive, expert-level overview of its clinical application, safety profile, and pharmacological characteristics for healthcare professionals.

Features

• Active Pharmaceutical Ingredient: Melphalan hydrochloride.
• Available formulations: 2 mg film-coated tablets and 50 mg powder for concentrate for solution for infusion.
• Pharmacotherapeutic group: Alkylating agent, ATC code: L01AA03.
• Mechanism of Action: Bifunctional alkylating agent; forms intrastrand and interstrand cross-links in DNA, disrupting nucleic acid function and causing cell death.
• Administration Routes: Oral and intravenous.
• Bioavailability: Oral bioavailability is variable and incomplete (approximately 25-89%).
• Metabolism: Undergoes rapid spontaneous hydrolysis in aqueous media; minimal hepatic metabolism.
• Elimination Half-life: Approximately 1.5 hours.

Benefits

• Provides a well-established, effective chemotherapeutic option for the palliative treatment of non-resectable epithelial ovarian carcinoma.
• Serves as a first-line conditioning treatment in high-dose regimens prior to hematopoietic progenitor (stem) cell transplantation in multiple myeloma patients.
• Its alkylating action is not cell-cycle-phase specific, allowing it to target a broad range of tumor cells.
• The oral tablet formulation facilitates outpatient treatment and maintenance therapy, improving patient quality of life.
• Demonstrated efficacy in improving progression-free survival and overall response rates in indicated conditions.
• Integral component of evidence-based treatment protocols developed by leading oncological societies.

Common use

Alkeran is primarily indicated for the palliative treatment of multiple myeloma and for the treatment of non-resectable epithelial ovarian carcinoma. In multiple myeloma, it is frequently used as part of initial induction therapy, often in combination with prednisone (MP regimen) or within more modern combinations. Its most significant application is in the high-dose conditioning regimen (often with total body irradiation or other agents) administered prior to autologous stem cell transplantation, a standard of care for eligible patients. For ovarian cancer, it is used as a single agent for palliative care when the disease is refractory to other primary treatments.

Dosage and direction

Dosage must be individualized based on patient body weight, renal function, blood counts, and previous therapy. Dosing regimens differ significantly between oral and intravenous administration and by indication.

• Multiple Myeloma (Oral): Several regimens exist. A common regimen is 150 micrograms/kg (0.15 mg/kg) daily for 7 days, either alone or concurrently with prednisone. Alternatively, a dose of 6 mg daily may be used. Doses are typically repeated at 4 to 6 week intervals upon evidence of bone marrow recovery.
• Multiple Myeloma (High-Dose IV prior to transplant): The intravenous dose is 100-200 mg/m², typically administered as a single dose or divided over two days. This is a myeloblative dose and is ONLY used in the transplant setting.
• Ovarian Carcinoma (Oral): 200 micrograms/kg (0.2 mg/kg) daily for 5 days, repeated every 4 to 5 weeks depending on hematological recovery.
• Administration Note (IV): The IV formulation must be administered via a central venous line due to its vesicant properties and risk of severe local tissue damage upon extravasation. Reconstitution and dilution must be performed meticulously according to the manufacturer’s instructions, and the solution should be administered rapidly via injection or a short infusion.

Precautions

• Hematological Toxicity: Alkeran is a potent myelosuppressive agent. Severe bone marrow suppression with resulting leukopenia, thrombocytopenia, and anemia is inevitable, particularly with high-dose regimens. Frequent monitoring of complete blood counts is mandatory. Blood product support and use of growth factors are often required.
• Extravasation Risk (IV): The intravenous formulation is a severe tissue irritant and can cause necrosis if extravasation occurs. It must only be administered by healthcare professionals experienced in the administration of cytotoxic agents via a patent central line.
• Hypersensitivity Reactions: Reactions, including anaphylaxis, have been reported with the intravenous formulation. Patients should be closely monitored during infusion.
• Secondary Malignancies: Treatment with alkylating agents, including Alkeran, is associated with a significantly increased risk of developing secondary malignancies, including myelodysplastic syndrome and acute leukemia.
• Pulmonary Toxicity: Interstitial pneumonitis, pulmonary fibrosis, and pulmonary hemorrhage have been reported, which can be fatal.
• Hepatic and Renal Impairment: Use with extreme caution. Dose reduction is necessary in patients with renal impairment as excretion is primarily renal. No formal dosage recommendation exists for hepatic impairment.
• Vaccinations: Live virus vaccines should not be administered to patients receiving Alkeran.

Contraindications

• Hypersensitivity to melphalan or any other component of the product.
• Previous resistance to this therapy.
• Severe myelosuppression.
• Pregnancy and breastfeeding.
• Administration of live vaccines during or shortly after treatment.

Possible side effect

Alkeran therapy is associated with a wide range of adverse reactions, primarily related to its cytotoxic mechanism.

• Very Common (≥1/10): Myelosuppression (neutropenia, thrombocytopenia, anemia), nausea, vomiting, diarrhea, oral mucositis, alopecia.
• Common (≥1/100 to <1/10): Infections due to neutropenia, hemorrhage due to thrombocytopenia, allergic reactions (including anaphylaxis with IV form), hepatic veno-occlusive disease, interstitial pneumonitis, secondary malignancies.
• Uncommon (≥1/1,000 to <1/100): Pulmonary fibrosis, jaundice, vasculitis, skin ulceration at the infusion site (if extravasation occurs).
• Rare (≥1/10,000 to <1/1,000): Hemolytic anemia, cardiac arrest, syncope, tachycardia, confusion, agitation, blurred vision.

Drug interaction

Alkeran has the potential for significant and dangerous drug interactions.

• Other Myelosuppressive Agents: Concomitant use with other drugs causing bone marrow suppression (e.g., other chemotherapies, azathioprine) will potentiate hematological toxicity.
• Nalidixic Acid: Increased risk of severe hemorrhagic necrotic enterocolitis in children.
• Ciclosporin: Risk of renal failure and severe hematological toxicity.
• Interferon Alpha: May increase the concentration of melphalan in some cells.
• Carmustine: Concomitant use can cause severe alveolar damage and pulmonary fibrosis.
• Live Vaccines: Avoid concomitant use due to risk of disseminated infection.

Missed dose

If a dose of oral Alkeran is missed, the patient should NOT double the next dose. They should contact their treating oncologist or specialist nurse for immediate advice. The management will depend on the timing of the missed dose and the specific treatment protocol. The intravenous dose is administered under direct medical supervision, making a missed dose unlikely.

Overdose

Overdose is expected to manifest as severe, prolonged bone marrow suppression and pancytopenia, leading to life-threatening infections and hemorrhage. Gastrointestinal toxicity, including mucositis, ulceration, and diarrhea, will be exacerbated. There is no known specific antidote for melphalan overdose. Management consists of immediate hospitalization and intensive supportive care, including:

• Protective isolation and aggressive treatment of anticipated infections.
• Transfusions of blood products (platelets, red blood cells).
• Administration of hematopoietic growth factors (e.g., G-CSF).
• Comprehensive supportive care for gastrointestinal toxicity.

Storage

• Tablets: Store below 25°C in the original package to protect from light and moisture.
• Powder for Solution for Infusion: Store in a refrigerator (2°C - 8°C). Keep the vial in the outer carton to protect from light.
• Reconstituted/Infusion Solution: The chemical half-life in solution is short. After reconstitution and further dilution, the solution should be administered immediately. Chemical degradation occurs rapidly; stability data from the manufacturer must be strictly adhered to.
• Keep all formulations out of the sight and reach of children.

Disclaimer

This information is intended for healthcare professionals and is a summary of Alkeran’s characteristics based on its authorized product literature. It is not exhaustive. Prescribers must consult the full official Summary of Product Characteristics (SmPC) or local prescribing information before initiating treatment. Dosage and administration are the responsibility of the treating physician, who must consider the individual patient’s condition and the most current clinical guidelines. The information presented here does not constitute medical advice.

Reviews

• “The established efficacy of high-dose melphalan as a conditioning regimen prior to ASCT remains the gold standard for eligible multiple myeloma patients. Its predictable myeloblative effect, while toxic, is manageable in a specialized transplant unit and is directly correlated with deep response rates.” – Lead Transplant Hematologist, Academic Medical Center
• “While newer agents have shifted the landscape of myeloma treatment, oral melphalan still has a role, particularly in older or transplant-ineligible patients as part of the MP regimen. Its main challenge is the unpredictable bioavailability, requiring careful hematological monitoring.” – Consultant Medical Oncologist
• “The vesicant nature of IV melphalan cannot be overstated. Our protocol mandates administration only by trained nurses via a central line with concurrent vital sign monitoring for potential hypersensitivity. This vigilance is critical for patient safety.” – Oncology Pharmacy Specialist
• “In palliative care for refractory ovarian cancer, Alkeran provides an option when standard platinum/taxane therapies have failed. We observe meaningful disease stabilization in a subset of patients, though the benefit must be continually weighed against cumulative hematological toxicity.” – Gynaecological Oncologist