Monograph

L01CA05 - Vinflunine

Propably not porphyrinogenic

Rationale

Vinflunine is a substrate of CYP3A4, but lacking capacity for induction or inhibition of CYP-enzymes. However, side effects such as nausea and vomiting may be potentially porphyrinogenic through reduction in carbohydrate intake.

Chemical description

Vinflunine is a vinca alkaloid.

Therapeutic characteristics

Vinflunine is indicated for the treatment of urotelial transitionepitelial cancer after platrinium therapy failure. Common side effects of vinflunine that can be confused with an acute porphyria attack are nausea, vomiting, obstipation, diarrhoea and abdominal pain. Other common side effects are anorexia and infections.

Hepatic exposure

Significant

Metabolism and pharmacokinetics

Vinflunine is metabolized primarily by CYP3A4 (Ng 2011, Zhao 2007) while the only active metabolite, 4-O-deacetyl vinflunine (DVFL), is formed by multiple esterases (Campone 2011). Vinflunine and its metabolites are being excreted in faeces and in urine (Schutz 2011). The elimination half-life is 40 hours. In vitro studies indicate absence of capacity for induction or inhibition of any of the drug metabolizing CYPs (SPC). In clinical use there are no pharmacokinetic drug interactions observed with vinflunine as perpetrator.

References

#	Citation details	PMID
*	Scientific articles
1.	A phase I study of vinflunine in combination with capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Campone M, Isambert N, et al. Cancer Chemother Pharmacol. 2012 Apr;69(4):871-9.	22045498
2.	Vinflunine: review of a new vinca alkaloid and its potential role in oncology. Ng JS. J Oncol Pharm Pract. 2011 Sep;17(3):209-24.	20584744
3.	Vinflunine: drug safety evaluation of this novel synthetic vinca alkaloid. Schutz FA, Bellmunt J, et al. Expert Opin Drug Saf. 2011 Jul;10(4):645-53.	21524237
4.	CYP3A4 mediated in vitro metabolism of vinflunine in human liver microsomes. Zhao XP, Zhong J, et al. Acta Pharmacol Sin. 2007 Jan;28(1):118-24.	17184591
*	Summary of Product Characteristics
5.	Norwegian medicines agency. Summary of Product Characteristics (SPC). (vinflunin).

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Netherlands