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Etonogestrel Pregnancy and Breastfeeding Warnings

Etonogestrel is also known as: Implanon, Nexplanon

Etonogestrel Pregnancy Warnings

Animal studies have shown that high doses may cause masculinization of female fetuses; doses of this drug up to 2 mg/kg/day (approximately 1.6 to 3 times the human dose) showed no embryotoxic or fetotoxic effects. There are no controlled data in human pregnancy. Epidemiological studies have not shown increased birth defects or teratogenicity when combined oral contraceptives are used prior to or during pregnancy, but it is not clear if this applies for this medication also. 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 contraindicated. (AU, US) Use is not indicated during pregnancy. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned Comments: - Remove implant if pregnancy occurs.

See references

Etonogestrel Breastfeeding Warnings

Use is considered acceptable after 4 weeks postpartum. Excreted into human milk: Yes Comments: -May be used during breastfeeding after the fourth postpartum week; use prior to this time has not been studied. -Plasma drug levels are highest the first month after insertion, and during that time may expose the breastfed infant to approximately 0.2% of the estimated maternal dose. -A small breastfeeding study comparing this drug (started 4 to 8 weeks postpartum) to non-hormonal IUD use found no physical or psychomotor development differences at 36 months of age, nor any differences in milk quality or production. -Carefully monitor the child's development.

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. Implanon (etonogestrel)." Organon Pharmaceuticals, West Orange, NJ.
  4. "Product Information. Nexplanon (etonogestrel)." Organon Pharmaceuticals, West Orange, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals, West Orange, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Nexplanon (etonogestrel)." Organon Pharmaceuticals, West Orange, NJ.

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