Is Pimecrolimus compatible with breastfeeding? Do we have alternatives for Pimecrolimus?

Pimecrolimus

July 31, 2018 (Very Low Risk)

An immunomodulator and calcineurin inhibitor related to tacrolimus. Used in the treatment of atopic dermatitis.
Used topically as a cream and orally in research studies.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (moderately high molecular weight, high percentage of protein binding and very little systemic absorption with topical use (less than 2 micrograms/L in plasma) (AEMPS 2013, FDA 2001) make it unlikely that will be transferred to milk in significant quantities (AEMPS 2013).

Do not apply on the breast in order to prevent the infant from swallowing it (AEMPS 2013, Barret 2013, Butler 2014); if necessary, apply after a feed and clean well with water before the next feed.

It is advisable to avoid the application of creams, gels and other local application products containing paraffin (mineral oil) on the nipple so that the infant does not absorb them (Noti 2003, Concin 2008).

Alternatives

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Πιμεκρόλιμους (Greek)
  • بيميكروليموس (Arabic)
  • Пимекролимус (Cyrillic)
  • 吡美莫司 (Chinese)
  • ピメクロリムス (Japanese)
  • Pimécrolimus (French)
  • C43 H68 ClNO11 (Molecular formula)
  • D11AH02 (ATC Code/s)

Drug trade names

References

  1. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014Abstract
  2. AEMPS. Pimecrolimus. Ficha técnica. 2013 Full text (in our servers)
  3. Barrett ME, Heller MM, Fullerton Stone H, Murase JE. Dermatoses of the breast in lactation. Dermatol Ther. 2013Abstract
  4. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008Abstract
  5. Scott G, Osborne SA, Greig G, Hartmann S, Ebelin ME, Burtin P, Rappersberger K, Komar M, Wolff K. Pharmacokinetics of pimecrolimus, a novel nonsteroid anti-inflammatory drug, after single and multiple oral administration. Clin Pharmacokinet. 2003Abstract
  6. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003Abstract
  7. FDA. Pimecrolimus. Drug Summary. 2001 Full text (in our servers)