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Afamelanotide Pregnancy and Breastfeeding Warnings

Afamelanotide is also known as: Scenesse

Medically reviewed by Drugs.com. Last updated on Jan 21, 2021.

Afamelanotide Pregnancy Warnings

Subcutaneous administration of doses up to 12 times the maximum recommended human dose (MRHD) throughout the period of organogenesis revealed no adverse embryofetal developmental effects in rats; administration of these same doses during the period of organogenesis through lactation revealed no treatment-related effects. There are no controlled data in human pregnancy

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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.

Benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: There are no data in pregnant women to assess for drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome; no adverse developmental effects have been observed in animal studies in doses up to 12 times the maximum recommended human dose.

Comments:
-Some authorities advise against use in women of childbearing potential not using effective contraception during treatment and for 3 months following.

See references

Afamelanotide Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-Some authorities advise against breastfeeding during the treatment period due to lack of data.

See references

References for pregnancy information

  1. "Product Information. Scenesse (afamelanotide)." Clinuvel, Inc., West Menlo Park, CA.
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Scenesse (afamelanotide)." Clinuvel, Inc., West Menlo Park, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

Further information

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