שאלה

אין מחקרים שמורים כי התרופה בטוחה לשימוש בהריון, ומאחר והיא עוברת את השליה,השימוש בה מוצדק רק אם הרופא השתכנע שהטיפול חיוני לאם למרות סיכון אפשרי לעובר. Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate AND well-controlled studies of topically administered tacrolimus in pregnant women. The experience with PROTOPIC Ointment when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Reproduction studies were carried out with systemically administered tacrolimus in rats AND rabbits. Adverse effects on the fetus were observed mainly at oral dose levels that were toxic to dams. Tacrolimus at oral doses of 0.32 AND 1.0 mg/kg (0.04X-0.12X MRHD based on BSA) during organogenesis in rabbits was associated with maternal toxicity as well as an increase in incidence of abortions. At the higher dose only, an increased incidence of malformations AND developmental variations was also seen. Tacrolimus, at oral doses of 3.2 mg/kg during organogenesis in rats, was associated with maternal toxicity AND caused an increase in late resorptions, decreased numbers of live births, AND decreased pup weight AND viability. Tacrolimus, given orally at 1.0 AND 3.2 mg/kg (0.04X-0.12X MRHD based on BSA) to pregnant rats after organogenesis AND during lactation, was associated with reduced pup weights. No reduction in male OR female fertility was evident. There are no adequate AND well-controlled studies of systemically administered tacrolimus in pregnant women. Tacrolimus is transferred across the placenta. The use of systemically administered tacrolimus during pregnancy has been associated with neonatal hyperkalemia AND renal dysfunction. PROTOPIC Ointment should be used during pregnancy only if the potential benefit to the mother justifies a potential risk to the fetus.