Uses
Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 2
- Manufacturers
- 2
- Available from stock
- 0
Melphalan is an alkylating drug indicated as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Melphalan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Alkylating Drug, Alkylating Activity
- ATC classification
- L01AA03 Melphalan · Nitrogen mustard
- US FDA first approval
- 17 January 1964
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Intravenous
- Dosage forms
- Injection, Powder for injection
- Identifiers
- UNII Q41OR9510PRxCUI 6718CAS 148-82-3DrugBank DB01042Q2298283
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N 7 position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.
Source: US FDA prescribing information
Dosing overview
For Conditioning Treatment, the recommended dose of Evomela is 100 mg/m 2 /day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0).
Source: US FDA prescribing information
Contraindications
History of serious allergic reaction to melphalan.
Source: US FDA prescribing information
Warnings and precautions
Boxed warning (severe bone marrow suppression, hypersensitivity, and leukemogenicity): Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur, provide supportive care using antiemetic and antidiarrheal medications as needed. Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Infertility: Melphalan may cause ovarian function suppression or testicular suppression.
Source: US FDA prescribing information
Side effects
Most common adverse reactions observed in at least 50% of patients treated with Evomela are neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting. The following serious adverse reactions are described in more detail in other sections of the prescribing information. • Bone Marrow Suppression • Gastrointestinal Toxicity • Hepatotoxicity • Hypersensitivity • Secondary Malignancies
Source: US FDA prescribing information
Interactions
No formal drug interaction studies have been conducted. The development of severe renal impairment has been reported in patients treated with a single dose of intravenous melphalan 140-250 mg/m 2 followed by standard oral doses of cyclosporine. Intravenous melphalan may also reduce the threshold for BCNU lung toxicity.
Source: US FDA prescribing information
Storage
Store Evomela at room temperature 25°C (77°F). Temperature excursions are permitted between 15- 30°C (59-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Melphalan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Evomela 50 mg/10 mL powder for injectionIntravenous | Acrotech Biopharma | US FDA | Available on request |
| Ivra 270 mg/3 mL injectionIntravenous Cold chain | Apotex | US FDA | Available on request |
Brands by market
2 brand names across 1 markets.
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions
Conditions linked to Melphalan in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Melphalan available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Melphalan and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Melphalan have?
The catalogue lists 2 brand names for Melphalan, including Evomela, Ivra.
Is Melphalan approved by the US FDA?
Yes. The US FDA first approved Melphalan on 17 January 1964, according to Drugs@FDA.
Is Melphalan authorised in the European Union?
Yes. Melphalan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Melphalan need cold chain shipping?
At least one listed presentation of Melphalan must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Melphalan in?
Melphalan is classified under ATC code L01AA03 (Melphalan).
References
- EVOMELA prescribing information (Acrotech Biopharma). U.S. National Library of Medicine, DailyMed. Retrieved 15 September 2026
- Phelinun: European public assessment report (EPAR). European Medicines Agency. Retrieved 18 June 2025
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