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Octreotide Pregnancy and Breastfeeding Warnings

Octreotide is also known as: Sandostatin, Sandostatin LAR Depot

Medically reviewed on Jan 8, 2018

Octreotide Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: B

Comments:
-Use of this product could potentially restore fertility in women with acromegaly.
-Advise females of childbearing potential to use adequate contraception.

Animal studies at doses up to 16 times the recommended human dose have shown no fetal harm, although fetal and post-natal growth retardation was seen. There are no controlled data in human pregnancy. A limited number of pregnancy exposures resulted in mostly normal newborns, and no cases of congenital anomalies or malformations, however there were several spontaneous abortions during the first trimester.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Octreotide Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Sandostatin (octreotide)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  4. "Product Information. SandoSTATIN LAR Depot (octreotide)." Novartis Consumer Health, Parsippany, NJ.

References for breastfeeding information

  1. "Product Information. SandoSTATIN LAR Depot (octreotide)." Novartis Consumer Health, Parsippany, NJ.
  2. "Product Information. Sandostatin (octreotide)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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