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Tacrolimus Pregnancy and Breastfeeding Warnings

Tacrolimus is also known as: Astagraf XL, Envarsus XR, Hecoria, Prograf

Medically reviewed on September 15, 2017

Tacrolimus Pregnancy Warnings

This drug should be used during pregnancy only if there is no safer alternative and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

This drug crosses the placenta. Use in human pregnancy has been associated with premature delivery risk, neonatal hyperkalemia, and renal dysfunction. Animal studies revealed maternal toxicity, and decreases in pup weight, viability, and live births, and increases in abortions, late resorptions, fetal death in utero, fetal malformations, and developmental variations. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Tacrolimus Breastfeeding Warnings

Use is not recommended and 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: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Prograf (tacrolimus)." Fujisawa, Deerfield, IL.
  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. "Product Information. Prograf (tacrolimus)." Fujisawa, Deerfield, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  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.

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