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Mycophenolate mofetil Pregnancy and Breastfeeding Warnings

Mycophenolate mofetil is also known as: CellCept

Medically reviewed on Aug 30, 2018

Mycophenolate mofetil Pregnancy Warnings

AU: Use is contraindicated.
UK, US: Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can harm a fetus.
-Females and males of reproductive potential should be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and should be counseled regarding pregnancy prevention and planning.
-Prior to starting therapy with this drug, female patients of childbearing potential should have 2 negative serum or urine pregnancy tests with a sensitivity of at least 25 milli-international units per milliliter (mIU/mL). The second test should be performed 8 to 10 days after the first one and immediately before starting therapy. Repeat pregnancy tests should be performed during routine follow-up visits.
-Women of child bearing potential should use 2 reliable forms of contraception simultaneously, including at least one highly effective method, before beginning therapy, during therapy, and for 6 weeks following discontinuation of therapy, unless abstinence is the chosen method of contraception.
-Sexually active men should use condoms during treatment and for at least 90 days after cessation of treatment. Condom use applies for both reproductively competent and vasectomized men, because the risks associated with the transfer of seminal fluid also apply to men who have had a vasectomy.
-Female partners of male patients should use highly effective contraception during treatment and for a total of 90 days after the last dose.

-Use of this drug during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
-Healthcare professionals and patients should be aware that this drug reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Mycophenolate mofetil Breastfeeding Warnings

AU, UK: Contraindicated
US: 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

Because no information is available on the use of this drug during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. "Product Information. CellCept (mycophenolate mofetil)." Roche Laboratories, Nutley, NJ.
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. CellCept (mycophenolate mofetil)." Roche Laboratories, Nutley, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

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

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