Skip to Content
Learn about Adcetris a treatment of Hodgkin Lymphoma

Pasireotide Pregnancy and Breastfeeding Warnings

Pasireotide is also known as: Signifor, Signifor LAR

Medically reviewed on Aug 14, 2018

Pasireotide Pregnancy Warnings

Animal studies have revealed evidence of increased early/total resorptions, meliorated limbs, developmental retardation, decreased fetal weight, and skeletal malformations. There are no controlled data in human pregnancy.

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.

Use is recommended only if clearly needed and benefit outweighs potential risk.
-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.

Risk summary: Limited data available in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.

Comments:
-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

Use is not recommended.

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

Comments: Breastfeeding should be discontinued during treatment.

Animal studies showed excretion of this drug in milk at levels 30% of the plasma level; growth retardation 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. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

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

Further information

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

Hide