Argatroban

There are no adequate data from the use of argatroban in pregnant women. Animal studies are insufficient with respect to reproductive toxicity, as technical issues have limited systemic exposure. The increased bleeding risk with argatroban may constitute a risk in treatment during pregnancy. Argatroban contains ethanol. A 70kg patient administered the maximum recommended daily dose (10 microgram/kg/min) would receive a dose of approximately 4g ethanol per day.

Argatroban should be used during pregnancy only if treatment is clearly necessary.

It is unknown whether argatroban/metabolites are excreted in human milk. Animal studies using radiolabelled argatroban have shown that radioactivity reaches greater levels in breast milk than in maternal blood. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from argatroban therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on potential effects of argatroban on fertility.

In theory, the presence of ethanol in the formulation (200 mg per vial) may impair the patient’s ability to drive or operate machinery. However, this is unlikely to be of clinical relevance in patients receiving argatroban.