Sandostatin LAR Use In Pregnancy & Lactation

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 1st trimester of pregnancy at doses ranging from 100-300 mcg/day of Sandostatin SC or 20-30 mg/month of Sandostatin LAR. In approximately ⅔ 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 1st 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.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development apart from some transient retardation of physiological growth (see Pharmacology: Toxicology under Actions).
Sandostatin should only be prescribed to pregnant women under compelling circumstances (see Precautions).
Lactation: It is unknown whether octreotide is excreted in human breast milk. Animal studies have shown excretion of octreotide in breast milk. Patients should not breastfeed during Sandostatin treatment.