Intravenous melphalan may reduce the threshold for BCNU-induced lung toxicity.
Source: NLP:melphalan
Melphalan Interactions
Brand names: Evomela
Route: Intravenous
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).
4 interactions on record
Severe renal impairment reported in patients treated with high-dose IV melphalan followed by standard oral cyclosporine doses.
Source: NLP:melphalan
No clinically significant drug interactions observed when coadministered with bortezomib in combination with prednisone.
Source: NLP:bortezomib
No interaction observed between intravenous ibandronate (6 mg) and intravenous melphalan (10 mg/m²).
Source: NLP:ibandronate sodium