Vablys® Safety Profile
Vablys® is generally well tolerated1
- Vablys® was generally well-tolerated with the most common adverse events being local reactions including vaginal discharge (9.2%), vulvovaginal pruritus (4.9%), vaginal candidiasis (4.9%), vulvovaginal burning sensation (1.8%) and bacterial vulvovaginitis (0.6%)1.
- Limited data from clinical studies did not demonstrate any adverse effect of Vablys® on the pregnancy or the foetus/neonate1.
- Limited data is available with Vablys® use in pregnancy.
- Data from 7 clinical studies involving 481 pregnant patients did not demonstrate any adverse effect on the pregnancy or the foetus/neonate.
- Vablys® should not be used within 12 hours before birth to minimize exposure of the newborn.