Monograph

L01AA03 - Melphalan

Propably not porphyrinogenic

Rationale

Non-CYP metabolism. No data pointing to clinical CYP induction or inhibition. Side effects such as nausea and vomiting may be potentially porphyrinogenic through reduction in caloric intake.

Chemical description

Melphalan is a nitrogen mustard derivative that acts as a bifunctional alkylating agent.

Therapeutic characteristics

Melphalan is an antineoplastic used in the treatment of myeloma, advanced ovarial cancer, breast cancer, neuroblastoma, Hodgkins disease, in polycythaemia vera, malignant melanoma and soft-tissue sarcomas. It is administered orally; however, melphalan also can be used intravenously. Common adverse reactions of melphalan that can be confused with an acute porphyric attack are nausea, diarrhoea and vomiting. Side effects such as nausea and vomiting may be potentially porphyrinogenic through reduction in caloric intake.

Metabolism and pharmacokinetics

Melphalan is apparently eliminated from plasma mainly by spontaneous hydrolysis, forming the monohydroxy and dihydroxy derivatives of the drug; no other metabolites have been identified in humans. Excreted in urine and feces. No data pointing to clinical CYP induction or inhibition.

Preclinical data

No hepatic porphyrin accumulation was observed in chick embryo model (Cochon, 1997).

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References

#	Citation details	PMID
*	Scientific articles
1.	Evaluation of the porphyrinogenic risk of antineoplastics. Cochón AC, Aldonatti C, et al. J Appl Toxicol. 1997;17(3):171-7.	9250538
*	Drug reference publications
2.	McEvoy GK, editor. Melphalan. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (07.07.10).
3.	Sweetman SC, editor. Martindale: The complete drug reference. Melphalan. Pharmaceutical Press 2009.
*	Summary of Product Characteristics
4.	Norwegian medicines agency. Summary of Product Characteristics (SPC). Alkeran.

Citation details

PMID

Scientific articles

Evaluation of the porphyrinogenic risk of antineoplastics.

Cochón AC, Aldonatti C, et al. J Appl Toxicol. 1997;17(3):171-7.

9250538

Drug reference publications

McEvoy GK, editor. Melphalan. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (07.07.10).

Sweetman SC, editor. Martindale: The complete drug reference. Melphalan. Pharmaceutical Press 2009.

Summary of Product Characteristics

Norwegian medicines agency. Summary of Product Characteristics (SPC). Alkeran.

Tradenames

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Alkeran 2 mg tabletten, filmomhulde tabletten · Alkeran 2 mg, filmomhulde tabletten · Alkeran 50 mg Infuus, poeder en oplosmiddel voor oplossing voor infusie · Melfalan Amarox 50 mg poeder en oplosmiddel voor oplossing voor injectie/infusie · Melfalan Eugia 50 mg, poeder en oplosmiddel voor oplossing voor injectie of infusie · Melfalan Hikma 50 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie · Melfalan Tillomed 50 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie · Melfalanhydrochloride SUN 50 mg poeder en oplosmiddel voor oplossing voor injectie/infusie · Melfalanhydrochloride Teva 50 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie · PHELINUN 200 mg poeder en oplosmiddel voor concentraat voor oplossing voor infusie · PHELINUN 50 mg poeder en oplosmiddel voor concentraat voor oplossing voor infusie

Alkeran · Alkeran 2 mg comp. · Alkeran 50 mg sol. perf. (pdr. + solv.) i.art?r./i.v. flac. · Melphalan · Melphalan Hikma 50 mg sol. inj./perf. (pdr. + solv.) i.art?r./i.v. flac. · Melphalan Tillomed 50 mg sol. inj./perf. (pdr. + solv.) i.art?r./i.v. flac. · Phelinun · Phelinun 200 mg sol. perf. (pdr. + solv., ? diluer) i.v. flac. · Phelinun 50 mg sol. perf. (pdr. + solv., ? diluer) i.v. flac.

Alkeran 2 mg Comprimidos Recubiertos con Pelicula · Alkeran 50 mg Polvo y Disolvente Para Solucion Para Perfusion · Melfal?n Aspen 50 mg Polvo y Disolvente Para Soluci?n Inyectable y Para Perfusi?n · Melfalan · Melfalán · MELFALAN ASPEN 2 mg · Melfalan Medac 50 mg Polvo y Disolvente Para Solucion Inyectable y Para Perfusion efg · Melfalan Tarbis 50 mg Polvo y Disolvente Para Solucion Inyectable y Para Perfusion efg · Melfalan Zentiva 50 mg Polvo y Disolvente Para Solucion Inyectable y Para Perfusion efg