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Forsteo Summary of Product Characteristics (SmPC)
Forsteo® (teriparatide): Pregnancy During Treatment
Forsteo is contraindicated for use in women who are pregnant. If pregnancy occurs, Forsteo should be discontinued.
Information
from Summary of Product Characteristics
Forsteo
is contraindicated for use during pregnancy.1
Women
of childbearing potential should use effective methods of
contraception during use of Forsteo. If pregnancy occurs, Forsteo
should be discontinued.1
Clinical
Data in Humans
The
effect of teriparatide on human fetal development has not been
studied and the potential risk for humans is unknown.
Data
from Studies in Animals
Teriparatide
was not genotoxic in a standard battery of tests. It produced no
teratogenic effects in rats, mice or rabbits. There were no important
effects observed in pregnant rats or mice administered teriparatide
at daily doses of 30 to 1000 µg/kg. However, fetal resorption
and reduced litter size occurred in pregnant rabbits administered
daily doses of 3 to 100 µg/kg. The embryotoxicity observed in
rabbits may be related to their much greater sensitivity to the
effects of PTH on blood ionised calcium compared with rodents.1
References
1.
Forsteo [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Date of Last Review:February 05, 2020
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