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Pasireotide Pregnancy and Breastfeeding Warnings

Pasireotide is also known as: Signifor, Signifor LAR

Medically reviewed by Drugs.com. Last updated on Jul 13, 2020.

Pasireotide Pregnancy Warnings

Animal studies of subcutaneous administration throughout organogenesis showed an increase in early/total resorptions and malrotated limbs at the highest dose of 10 mg/kg/day (approximately 144 times the highest recommended human dose), all doses were maternotoxic. Pre- and post-natal development studies (gestation through weaning) showed retardation of physiological growth (attributed to growth hormone inhibition) with weight gains similar to controls after weaning. 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 B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

According to some authorities, use is not recommended in pregnancy or women of childbearing potential not using contraception.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Comments:
-Limited data available in pregnant women are inadequate to inform a drug-associated risk for major birth defects and miscarriage; animal studies showed developmental delay at doses less than the highest recommended human dose.
-Use of adequate methods of contraception should be encouraged.
-Discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in levels of growth hormone and normalization of insulin-like growth factor (IGF-1) in acromegalic females treated with this drug may lead to improved fertility.

See references

Pasireotide Breastfeeding Warnings

Some authorities advise against breastfeeding 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.
-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.

Animal studies showed excretion of this drug in milk after subcutaneous administration with a milk/plasma exposure of 0.28; growth hormone inhibition was seen in pre- and post-natal studies, but after weaning body weight gains were comparable to control groups, showing reversibility.

See references

References for pregnancy information

  1. "Product Information. Signifor (pasireotide)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Signifor (pasireotide)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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