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Pregnancy: There are no adequate and well-controlled studies in pregnant women. In the post-marketing experience data on a limited number of exposed pregnancies have been reported in patients with acromegaly, however, in half of the cases the pregnancy outcomes are unknown. Most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100-300 microgram/day of Sandostatin s.c. or 20-30 mg/month of Sandostatin LAR. In approximately two-thirds of the cases with known outcome, the women elected to continue octreotide therapy during their pregnancies. In most of the cases with known outcome, normal newborns were reported but also several spontaneous abortions during the first trimester, and a few induced abortions.
There were no cases of congenital anomalies or malformations due to octreotide usage in the cases that reported pregnancy outcomes.
Studies in laboratory animals have not shown reproductive toxicological effects. A transient growth retardation of offspring was observed in rats, possibly consequent upon the specific endocrine profile of the species tested (see PHARMACOLOGY: TOXICOLOGY: NON-CLINICAL SAFETY DATA under ACTIONS).
Sandostatin should only be prescribed to pregnant woman under compelling circumstances (see PRECAUTIONS).
Breast-feeding: It is unknown whether octreotide is excreted in human breast milk. Animal studies have shown excretion of octreotide in breast milk. Patients should not breast-feed during Sandostatin treatment.
Fertility: It is not known whether octreotide has an effect on human fertility. Octreotide did not impair fertility in male and female rats at doses of up to 1 mg/kg body weight per day (see PHARMACOLOGY: TOXICOLOGY: NON-CLINICAL SAFETY DATA under ACTIONS).
