Fertility: The risk of infertility in males and females of reproductive potential has not been studied in humans. In a rat study, the fertility in males and females was not affected (see Pharmacology: Toxicology: Preclinical safety data under Actions).
There was an increase in estrous cycle length, copulatory interval, and number of corpora lutea but no effects on mating indices, fertility, or early embryonic development in rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: There are no studies in pregnant women. Animal reproduction studies have not shown evidence of harmful effects on the fetus (see Pharmacology: Toxicology: Preclinical safety data under Actions). Because animal reproduction studies are not always predictive of human response, NGENLA should be used during pregnancy only if clearly needed.
Somatrogon has been shown not to interfere with blood or urine pregnancy tests.
Lactation: Lactation studies have not been conducted with somatrogon. It is not known whether somatrogon is excreted in human milk. NGENLA should be administered to lactating women only if clearly needed.
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