Somatropin Pregnancy and Breastfeeding Warnings
Somatropin is also known as: Accretropin, Genotropin, HumatroPen, Humatrope, Norditropin, Norditropin FlexPro, Norditropin Nordiflex, Nutropin, Nutropin AQ, Nutropin Depot, Omnitrope, Saizen, Serostim, Tev-Tropin, Zorbtive
Somatropin Pregnancy Warnings
Animal studies did not show any teratogenicity or adverse effects on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring; a slight increase in fetal death and increased body weight of pups, and reduced pregnancy rate, increased litter size, irregular estrus cycles, and decreased sperm motility in the parents were seen. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C Comments: -Women of childbearing potential should use contraception. -Some formulations are AU TGA pregnancy category B1 or US FDA pregnancy category B: the manufacturer product information should be consulted.
Somatropin Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown
Following subcutaneous administration of radiolabeled medication in animal studies, radioactivity was transferred to milk reaching four times the concentration found in maternal plasma. However, absorption of the intact protein in the gastrointestinal tract of the infant is considered extremely unlikely.
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