AU, UK: Contraindicated
US: This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

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

Comments:
-This drug is a powerful human teratogen.
-An alternative immunosuppressant with less potential for embryofetal toxicity should be used, if possible.
-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.
-Females should not become pregnant while receiving this drug and for at least 6 weeks following termination of therapy.
-Women of child bearing potential should have pregnancy excluded prior to beginning therapy.
-Women of child bearing potential should use 2 types of contraception while receiving this drug, unless abstinence is the chosen method. Contraception should extend to at least 6 weeks following completion of therapy. Patients should be aware that this drug theoretically reduces the effectiveness of oral contraceptives.
-Patients should be instructed to consult their physician immediately if they become pregnant.
-Use of this drug during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations (e.g., external ear and other facial abnormalities including cleft lip and palate; anomalies of the distal limbs, heart, esophagus, kidney, and nervous system; abnormalities of the eye such as coloboma and microphthalmia; polydactyly; syndactyly; trachea-esophageal malformations; nervous system malformations such as spina bifida; renal abnormalities; congenital choroid plexus cyst; septum pellucidum agenesis; olfactory nerve agenesis).

-This drug is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations when used during pregnancy.
-Spontaneous abortions were reported in 45% to 49% of pregnant women exposed to this drug, compared to 12% and 33% in solid organ transplant patients treated with other immunosuppressants.
-Fetal malformations occurred in 23% to 27% of live births in women exposed to this drug during pregnancy (compared to 2% to 3% of live births in the overall population and approximately 4% to 5% of live births in solid organ transplant recipients treated with other immunosuppressants).

US: To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-800-617-8191.

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

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

Comments:
-The effects in the nursing infant are unknown.

See references