Generic Vaniqa

 

While a dose of 225 and 450 mg/kg(15X and 29X the MRHD based on BSA, respectively) of vaniqa eflornithine hydrochloride cream, 13.9% was applied in pregnant rats, it resulted in maternal toxicity and fetal effects including reduced numbers of live fetuses, decreased fetal weights, and delayed ossification and development of the viscera. In this dermal embryo-fetal development study no precautions were taken to thwart intake of drug from application sites.

The study was repeated again. And this time precaution was taken to avoid ingestion from application sites. In this case it brought no maternal, fetal or teratogenic effects at doses up to 450 mg/kg (29X the MRHD based on BSA).

In the first study which devoid any precaution to check ingestion, circulating plasma levels were 11- to 14-fold more than in the second study in which ingestion was prevented.

Another study made on rabbit showed different results. The study on a dermal embryo-fetal development in rabbits treated with VANIQA (eflor- nithine hydrochloride) Cream, 13.9% reported no adverse maternal or fetal effects at doses up to 90 mg/kg (11X the MRHD based on BSA).

Another dose of 300 mg/kg/day (36X the MRHD based on BSA) led to significant dermal irritation, in addition to possible ingestion of VANIQA and brought rise to maternal deaths, abortions, increased fetal resorptions, and reduced fetal weights.

Oral studies conducted on vaniqa eflornithine showed no effects of maternal toxicity, however caused fetotoxicity with fetal no-effect doses of 80 mg/kg in rats and 45 mg/kg in rabbits. In these studies, no proof of teratogenicity was experimental in rats administered up to 200 mg/kg or in rabbits given up to 135 mg/kg.

It has not been conducted on patients during pregnancy. On the other hand, 22 women got pregnant during the trials, out of which nineteen pregnancies occurred while patients were using Vaniqa Eflornithine . Out of the 19 pregnancies, 9 patients reported healthy infants, 4 patients reported spontaneous abortions, 5 of induced/ elective abortions, and 1 reported birth defect (Down's Syndrome to a 35-year-old). So there are no adequate and well-controlled studies in pregnant women. As a result the risk/benefit ratio of using Vaniqa Eflornithine in pregnant women should be weighed carefully. These women have two options. They can either avoid using or stop use of Vaniqa Eflornithine.

Besides vaniqa eflornithine HCl 13.9% cream also does not have contact sensitising, photocontact allergic or phototoxic properties. It can cause irritation under exaggerated conditions of use. Vaniqa eflornithine HCl 13.9% cream, consequently, has a positive dermal safety profile. It can be applied regularly as a right topical treatment.