Check out the essential information about Pregnancy and Lactation period while taking Tagrisso (osimertinib).

 

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Pregnancy

Risk Summary

Based on data from animal studies and its mechanism of action, Tagrisso (osimertinib) can cause fetal harm when administered to a pregnant woman. There are no available data on Tagrisso (osimertinib) use in pregnant women.

Administration of Tagrisso (osimertinib) to pregnant rats was associated with embryolethality and reduced fetal growth at plasma exposures 1.5 times the exposure at the recommended human dose (click here). Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

 

Animal Data

When administered to pregnant rats prior to embryonic implantation through the end of organogenesis (gestation days 2-20) at a dose of 20 mg/kg/day, which produced plasma exposures of approximately 1.5 times the clinical exposure, Tagrisso (osimertinib) caused post-implantation loss and early embryonic death. When administered to pregnant rats from implantation through the closure of the hard palate (gestation days 6 to 16) at doses of 1 mg/kg/day and above (0.1-times the AUC observed in patients at the recommended dose of 80 mg), an equivocal increase in the rate of fetal malformations and variations was observed in treated litters relative to those of concurrent controls. When administered to pregnant dams at doses of 30 mg/kg/day during organogenesis through lactation Day 6, Tagrisso (osimertinib) caused an increase in total litter loss and postnatal death. At a dose of 20 mg/kg/day, Tagrisso (osimertinib) administration during the same period resulted in increased postnatal death as well as a slight reduction in mean pup weight at birth that increased in magnitude between lactation days 4 and 6.

 

Lactation

Risk Summary

There are no data on the presence of Tagrisso (osimertinib) in human milk, the effects of Tagrisso (osimertinib) on thebreastfed infant or on milk production. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. Because of the potential for serious adverse reactions in breastfed infants from Tagrisso (osimertinib), advise a lactating woman not to breastfeed during treatment with Tagrisso (osimertinib) and for 2 weeks after the final dose.

Searching where to buy brand original Tagrisso 80 mg (osimertinib)? Order Tagrisso (osimertinib) right now in MTO Pharma online pharmacy. Click here to redirect to the product page.

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