Monograph

D11AX16 - Eflornithine

Propably not porphyrinogenic

Rationale

Eflornithine is administered topically and hepatic exposure is insignificant. Eflornithine is excreted in urine as unchanged drug and no metabolism is recognized.

Chemical description

Ornithine decarboxylase inhibitor, alpha-difluoromethylornitine

Therapeutic characteristics

Eflornithine is used in the treatment of facial hirsutism in women. It is applied topically.

Hepatic exposure

Cmax of efornithine is approximately 10 ng/mL (Malhotra 2001). This is equivalent to 0.05 µM and hepatic exposure is insignificant.

Metabolism and pharmacokinetics

Eflornithine is not known to be metabolized and is eliminated in the urine as unchanged drug (SPC). Less than 1 % of the drug is absorbed following topical application (Martindale).

References

#	Citation details	PMID
*	Scientific articles
1.	Percutaneous absorption and pharmacokinetics of eflornithine HCl 13.9% cream in women with unwanted facial hair. Malhotra B, Noveck Rm, et al. J Clin Pharmacol. 2001 Sep;41(9):972-8.	11549102
*	Drug reference publications
2.	Martindale in Micromedex® 2.0 (electronic version). Eflornithine. (12.05.2015).
*	Summary of Product Characteristics
3.	The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Vaniqa).

Citation details

PMID

Scientific articles

Percutaneous absorption and pharmacokinetics of eflornithine HCl 13.9% cream in women with unwanted facial hair.

Malhotra B, Noveck Rm, et al. J Clin Pharmacol. 2001 Sep;41(9):972-8.

11549102

Drug reference publications

Martindale in Micromedex® 2.0 (electronic version). Eflornithine. (12.05.2015).

Summary of Product Characteristics

The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Vaniqa).

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Netherlands