Melphalan Waymade B.V. (Melphalan)

• Melphalan is an alkylating chemotherapy agent used in several oncologic disease categories.
• Multiple myeloma: reduces malignant plasma‑cell proliferation, delays disease progression, and can improve overall survival when administered as part of standard regimens.
• Ovarian cancer: contributes to tumor cell kill, especially in platinum‑sensitive disease, and is used in combination with other agents to enhance response rates.
• Malignant melanoma: provides cytotoxic activity against melanoma cells, particularly in high‑dose regimens for advanced or refractory disease.
• Bone‑marrow transplantation conditioning: used as part of high‑dose therapy to eradicate residual malignant cells before autologous stem‑cell rescue.

• Melphalan exerts its antineoplastic effect by forming covalent bonds with the N7 nitrogen of guanine bases in DNA. This alkylation creates intra‑ and interstrand cross‑links that block DNA replication and transcription, ultimately triggering apoptosis in rapidly dividing tumor cells. The cross‑linking interferes with the cell cycle, particularly the S phase, and overwhelms DNA repair mechanisms, leading to accumulation of lethal damage.

Melphalan may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects

• Nausea and vomiting
• Fatigue or weakness
• Decreased blood cell counts (anemia, neutropenia, thrombocytopenia)
• Mucositis or oral ulceration

Serious or Rare Side Effects

• Secondary malignancies such as therapy‑related leukemia
• Severe pulmonary toxicity (interstitial pneumonitis)
• Renal impairment or hemolytic‑uremic syndrome

• When using melphalan, clinicians should observe several safety measures to minimize risk.
• Monitor blood counts: perform regular complete blood count tests to detect cytopenias early.
• Assess organ function: evaluate hepatic and renal function before each treatment cycle.
• Avoid use in active infections: postpone administration if the patient has uncontrolled infection.
• Use protective measures: employ anti‑emetic prophylaxis and hydration to reduce nausea and renal toxicity.
• Pregnancy and lactation: contraindicated in pregnancy; advise effective contraception and avoid breastfeeding.
• Store at controlled room temperature: keep below 25°C, in original packaging, protected from light and moisture.

Melphalan can interact with other medicines, altering its efficacy or toxicity.

Major Interactions (Avoid)

• Live vaccines: concurrent use may increase risk of vaccine‑derived infection due to immunosuppression.
• Highly nephrotoxic agents (e.g., cisplatin): combined use can exacerbate renal damage.

Moderate Interactions (Monitor Closely)

• CYP450 inducers (e.g., rifampin): may reduce melphalan plasma levels.
• Anticoagulants (e.g., warfarin): increased risk of bleeding due to thrombocytopenia.
• Allopurinol: may enhance melphalan toxicity; dose adjustment may be required.