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Naldemedine Pregnancy and Breastfeeding Warnings

Naldemedine is also known as: Symproic

Medically reviewed by Drugs.com. Last updated on Mar 28, 2019.

Naldemedine Pregnancy Warnings

Animal studies have shown decreased maternal weight loss/body weight gain, decreased food consumption, fetal loss, premature delivery, and decreased fetal body weight at doses believed to be maternotoxic (i.e., daily doses of 400 mg/kg). This drug crosses the placenta, and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. There are no controlled data in human pregnancy.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk Summary: There are no available data to inform of drug-associated major birth defects and/or miscarriage.

Comment: There is a potential for fetal opioid withdrawal when this drug is used in pregnancy.

See references

Naldemedine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother

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

Comments:
-A potentially serious side effect in the breastfed infant includes opioid withdrawal.
-Women may resume breastfeeding 3 days after the final dose of this drug.

Animal studies have shown excretion of radiolabeled drug into milk following a single, 1 mg/kg oral dose given during lactation.

See references

References for pregnancy information

  1. "Product Information. Symproic (naldemedine)." Shionogi USA Inc, Florham Park, NJ.
  2. 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. "Product Information. Symproic (naldemedine)." Shionogi USA Inc, Florham Park, NJ.

Further information

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