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Melphalan

Also known as: Evomela

Route: Intravenous

4 interactions on record⛔ Black Box Warning

Melphalan has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Carmustine, Cyclosporine. Patients taking Melphalan should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Minor: 2

Major (2)

Melphalan + Carmustine— Intravenous melphalan may reduce the threshold for BCNU-induced lung toxicity.
Melphalan + Cyclosporine— Severe renal impairment reported in patients treated with high-dose IV melphalan followed by standard oral cyclosporine …

Minor (2)

Melphalan + Bortezomib— No clinically significant drug interactions observed when coadministered with bortezomib in combination with prednisone.
Melphalan + Ibandronate Sodium— No interaction observed between intravenous ibandronate (6 mg) and intravenous melphalan (10 mg/m²).

Melphalan + Carmustine⚠️Major

Intravenous melphalan may reduce the threshold for BCNU-induced lung toxicity.

Melphalan + Cyclosporine⚠️Major

Severe renal impairment reported in patients treated with high-dose IV melphalan followed by standard oral cyclosporine doses.

Melphalan + Bortezomib🟢Minor

No clinically significant drug interactions observed when coadministered with bortezomib in combination with prednisone.

Melphalan + Ibandronate Sodium🟢Minor

No interaction observed between intravenous ibandronate (6 mg) and intravenous melphalan (10 mg/m²).

⛔ FDA Black Box Warning

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. [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. [see Warnings and Precautions ( 5.4 )] Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans. [see Warnings and Precautions ( 5.5 )] WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY See full prescribing information for complete boxed warning. 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. ( 5.1 ) Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. ( 5.4 ) Melphalan produces chromosomal aberrations in vitro and in vivo . Evomela should be considered potentially leukemogenic in humans. ( 5.5 )

Contraindications

4 CONTRAINDICATIONS History of serious allergic reaction to melphalan. History of serious allergic reaction to melphalan

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on its mechanism of action, Evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see Clinical Pharmacology ( 12.1 )] . Melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see Nonclinical Toxicology ( 13.1 )] . In animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see Data] . Advise a pregnant woman of the potential risk to a fetus.. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data Adequate animal studies have not been conducted with intravenous melphalan. Melphalan was embryolethal and teratogenic in rats following oral administration of 6 to 18 mg/m 2 /day for 10 days (0.06 to 0.18 times the highest recommended clinical dose of 100 mg/m 2 /day) and intraperitoneal administration of 18 mg/m 2 (0.18 times the highest recommended clinical dose). Malformations resulting from melphalan administration included alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, and hepatocele (exomphaly).

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.