Product image of Melphalan Hikma (Melphalan) supplied by GNH India

Melphalan Hikma

Active Ingredient:
Melphalan
Origin:
EU

Melphalan Hikma (Melphalan)

Melphalan, the active ingredient in Melphalan Hikma, is an alkylating agent presented as an injectable solution for intravenous use. It is employed in the treatment of certain hematologic and solid tumors, including multiple myeloma, ovarian cancer, melanoma and neuroblastoma, in adult patients.

GNH India supplies Melphalan Hikma as a licensed, GDP‑compliant international pharmaceutical supplier, adhering to EU quality standards and providing the product to hospitals, oncology centres, transplant units and pharmacies worldwide through regulated distribution channels for cancer therapy and patient care.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Melphalan is an alkylating antineoplastic agent used in the management of several malignancies.

  • Multiple myeloma: reduces tumor burden and prolongs survival in eligible patients.
  • Ovarian cancer: improves response rates when combined with other chemotherapeutics.
  • Melanoma: provides cytoreductive activity in advanced disease.
  • Neuroblastoma: contributes to disease control in high‑risk pediatric cases.

How It Works

  • Melphalan exerts its antineoplastic effect by forming covalent cross‑links between DNA strands. As an alkylating agent, it transfers its chloroethyl group to the N7 position of guanine bases, creating interstrand and intrastrand bonds that impede DNA replication and transcription, ultimately triggering apoptosis in rapidly dividing tumor cells. The resulting DNA damage also overwhelms cellular repair pathways, reinforcing the cytotoxic outcome.

Side Effects

Melphalan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea and vomiting: frequent gastrointestinal upset that may require anti‑emetic therapy.
  • Myelosuppression: reduction in white blood cells, red blood cells and platelets leading to anemia, infection risk and bleeding.
  • Fatigue: persistent tiredness affecting daily activities during and after treatment.
  • Mucositis: inflammation and ulceration of the oral cavity and gastrointestinal tract causing pain and difficulty eating.

Serious or Rare Side Effects

  • Secondary malignancies: potential development of therapy‑related leukemia or other cancers years after exposure.
  • Severe infection: life‑threatening bacterial or fungal infections due to profound neutropenia.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis that may impair breathing.
  • Cardiotoxicity: rare episodes of cardiac dysfunction, including arrhythmias or reduced ejection fraction.

Precautions & Warnings

When using Melphalan, several precautions should be observed to minimize risks.

  • Pregnancy: contraindicated in pregnancy (Category D) due to fetal toxicity.
  • Renal impairment: dose adjustment may be required in patients with reduced kidney function.
  • Hepatic dysfunction: monitor liver enzymes and consider dose modification.
  • Concomitant myelosuppressive therapy: avoid combining with other agents that further suppress bone marrow.
  • Monitoring: regular complete blood counts and organ function tests are essential.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Melphalan can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Live vaccines: risk of severe infection; avoid administration during treatment.
  • Strong CYP inducers: agents such as rifampin may lower melphalan exposure.
  • High-dose radiation: combined use may increase tissue toxicity.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: enhanced bleeding risk; monitor coagulation parameters.
  • Nephrotoxic drugs: concurrent use may worsen renal impairment.
  • Other alkylating agents: additive myelosuppression; adjust dosing as needed.

Frequently Asked Questions

Melphalan Hikma is an intravenous alkylating chemotherapy used in the treatment of certain cancers. It is indicated for adult patients with multiple myeloma, ovarian cancer, melanoma and high‑risk neuroblastoma, where it helps to reduce tumor burden and improve survival outcomes as part of a broader oncologic regimen.

Melphalan works by attaching a chloroethyl group to the N7 position of guanine bases in DNA, creating covalent cross‑links between DNA strands. These cross‑links block DNA replication and transcription, leading to accumulation of DNA damage that the cell cannot repair, ultimately triggering apoptosis of rapidly dividing cancer cells.

The specific dose of Melphalan Hikma is individualized by the prescribing oncologist based on factors such as the type of cancer, disease stage, patient body surface area, renal and hepatic function, and prior treatment history. Dosing regimens are calculated to achieve therapeutic exposure while balancing the risk of toxicity, and are administered under close medical supervision.

Melphalan is classified as Pregnancy Category D, indicating evidence of fetal risk and that it should not be used during pregnancy unless the potential benefit justifies the risk. It is also excreted in breast milk, so breastfeeding is generally contraindicated while receiving treatment. Women of child‑bearing potential should use effective contraception throughout therapy and for a defined period after the last dose.

To order Melphalan Hikma from GNH India, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide and will request verification of trade or institutional credentials. After validation, the sales team provides pricing, availability, shipping details—including cold‑chain handling if required—and assists with the necessary import documentation to complete the purchase.

Compared with other alkylating agents such as cyclophosphamide, melphalan has a higher propensity for forming DNA cross‑links, which can result in greater cytotoxic potency but also a higher risk of myelosuppression. Unlike some newer targeted therapies, melphalan is non‑selective, affecting both cancerous and normal rapidly dividing cells, making its safety profile more comparable to traditional chemotherapy rather than to monoclonal antibodies or kinase inhibitors.

Melphalan Hikma should be stored at 2‑8 °C (refrigerated) in its original packaging, protected from light, and must not be frozen or shaken. Maintaining the cold‑chain ensures drug stability and potency. If the product is inadvertently exposed to temperatures outside this range, it should be discarded.

Melphalan Hikma is administered by slow intravenous infusion, typically over 30–60 minutes, in a clinical setting such as an oncology centre or hospital. The infusion is prepared under aseptic conditions, and patients are monitored for infusion‑related reactions, vital signs, and blood counts before, during, and after administration.

The most serious risks associated with Melphalan include severe myelosuppression leading to life‑threatening infections, anemia or bleeding; secondary malignancies such as therapy‑related leukemia; pulmonary toxicity manifesting as interstitial pneumonitis; and rare cardiac dysfunction. Prompt recognition of infection signs, regular blood count monitoring, and appropriate supportive care are essential to mitigate these potentially fatal complications.

Melphalan should not be used in patients with known hypersensitivity to melphalan or any component of the formulation, in pregnant women unless absolutely necessary, in individuals with severe renal or hepatic impairment without dose adjustment, and in patients with uncontrolled active infections. Caution is also advised for those with pre‑existing cardiac or pulmonary disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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