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

Melfalán Hikma

Active Ingredient:
Melphalan
Origin:
EU

Melfalán Hikma (Melphalan)

Melphalan, the active ingredient in Melfalán Hikma, is an alkylating agent presented as a sterile powder for intravenous use. It is employed in the treatment of certain hematologic and solid tumours, particularly in patients requiring high‑dose chemotherapy regimens.

GNH India supplies Melfalán Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Melphalan is an alkylating chemotherapy used in several malignant disease groups.

  • Multiple myeloma: incorporated into conditioning regimens or combination therapy to eradicate malignant plasma cells.
  • Ovarian cancer: administered as part of high‑dose chemotherapy protocols for advanced or recurrent disease.
  • Melanoma: used in isolated limb perfusion or systemic regimens for metastatic lesions.

How It Works

  • Melphalan alkylates DNA by forming covalent cross‑links between guanine bases, which obstructs DNA replication and transcription. The resulting DNA damage triggers cell‑cycle arrest and apoptosis, preferentially affecting rapidly dividing cancer cells while sparing most normal tissues.

Side Effects

Melphalan may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset commonly observed during treatment.
  • Myelosuppression: neutropenia, anemia and thrombocytopenia may develop.
  • Fatigue: persistent tiredness often reported by patients.
  • Alopecia: reversible hair loss affecting scalp and body hair.
  • Mucositis: inflammation of the oral and gastrointestinal mucosa.
  • Diarrhea: loose stools may occur during therapy.

Serious or Rare Side Effects

  • Secondary malignancies: risk of therapy‑related cancers such as leukemia.
  • Severe infection: due to profound neutropenia and immune suppression.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis in rare cases.
  • Renal toxicity: impaired kidney function may develop.
  • Cardiac arrhythmia: occasional disturbances in heart rhythm.
  • Anaphylactic reaction: rare but potentially life‑threatening hypersensitivity.

Precautions & Warnings

Prior to initiating melphalan therapy, several safety considerations should be addressed.

  • Renal function: evaluate baseline creatinine and adjust dosing if necessary.
  • Hematologic monitoring: perform regular complete blood counts to detect myelosuppression.
  • Pregnancy: avoid use unless the potential benefit justifies the risk to the fetus.
  • Concomitant myelosuppressive agents: use with caution due to additive bone‑marrow toxicity.
  • Infection risk: monitor closely for signs of febrile neutropenia and initiate prompt antimicrobial therapy.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the product.

Avoid Interactions

Melphalan can interact with other medicines, influencing efficacy or safety.

Major Interactions (Avoid)

  • Live vaccines: contraindicated because of immunosuppression.
  • Strong CYP450 inducers (e.g., rifampin): may reduce melphalan exposure.
  • Other alkylating agents: additive toxicity to bone marrow and mucosa.

Moderate Interactions (Monitor Closely)

  • Antiemetics (e.g., ondansetron): may affect nausea control and QT interval.
  • Nephrotoxic drugs (e.g., cisplatin): increase risk of renal impairment.
  • Radiation therapy: combined use can enhance tissue damage and fibrosis.

Frequently Asked Questions

Melfalán Hikma contains melphalan, an alkylating chemotherapy indicated for the treatment of multiple myeloma, ovarian cancer and melanoma. It is administered intravenously as part of high‑dose regimens or combination protocols designed to destroy malignant cells.

Melphalan forms covalent bonds with DNA bases, creating cross‑links that block DNA replication and transcription. This damage triggers cell‑cycle arrest and apoptosis, especially in rapidly dividing cancer cells, thereby reducing tumor burden.

The specific dose of melphalan is individualized by the treating physician based on the patient’s diagnosis, disease stage, body surface area and renal function. Prescribers determine the appropriate amount and schedule for each clinical situation.

Melphalan is classified as contraindicated in pregnancy because it can cause fetal harm. It is also excreted in breast milk, so breastfeeding is not recommended while receiving treatment. Women of child‑bearing potential should use effective contraception.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where needed) and necessary import documentation.

Melphalan shares the DNA‑cross‑linking mechanism of other alkylators such as cyclophosphamide, but it is often preferred for high‑dose conditioning regimens because of its potency and pharmacokinetic profile. Compared with newer targeted therapies, melphalan has a broader cytotoxic effect but also a higher risk of myelosuppression and secondary malignancies.

Melfalán Hikma should be stored refrigerated between 2 °C and 8 °C, protected from light, and never frozen or shaken. The product must be kept in its original packaging until reconstitution, and any unused portion should be discarded according to local regulations.

The drug is supplied as a sterile powder for intravenous infusion. It is reconstituted with the appropriate diluent, filtered if required, and administered by a qualified healthcare professional under controlled conditions, typically over a period of minutes to hours depending on the prescribed protocol.

Serious risks include severe myelosuppression leading to infection or bleeding, secondary leukemias, pulmonary toxicity, renal impairment and rare anaphylactic reactions. Patients should be monitored closely for signs of infection, respiratory distress, renal dysfunction and unexpected allergic responses.

Melphalan is contraindicated in patients with known hypersensitivity to the drug, those who are pregnant, and individuals with severe renal impairment that cannot be corrected. Caution is also advised for patients receiving live vaccines or other myelosuppressive therapies.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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