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Octreotide Pregnancy and Breastfeeding Warnings

Octreotide is also known as: Bynfezia Pen, Mycapssa, Sandostatin, Sandostatin LAR Depot

Medically reviewed by Drugs.com. Last updated on Sep 2, 2020.

Octreotide Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-Limited data in pregnancy are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
-Animal reproductive studies did not show adverse developmental effects at doses above the maximum recommended human dose; transient growth retardation was seen with no impact on postnatal development.
-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. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Octreotide Breastfeeding Warnings

Lactating rats given 1 mg/kg of this drug subcutaneously showed a low milk concentration relative to plasma (milk/plasma ratio of 0.009).

Breastfeeding is not recommended during use of this drug.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-This drug passed into the milk of lactating rats when given subcutaneously; animal data may not predict human milk drug levels reliably.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

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

References for breastfeeding information

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

Further information

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