Use is not recommended during pregnancy or in patients of childbearing potential not using contraception.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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 harm to the fetus.
-Before starting this drug, pregnancy status should be verified in patients of childbearing potential.
-Patients of childbearing potential should be advised to use effective nonhormonal contraception during therapy and for 90 days after the last dose.
---Dexamethasone is a weak to moderate inducer of CYP450 3A4 as well as other enzymes and transporters; because this drug is administered with dexamethasone, the risk for reduce efficacy of contraceptives should be considered.
---Women using oral hormonal contraceptives should add a barrier method of contraception.
-Male patients with partners of childbearing potential should be advised to use effective contraception during therapy and for 90 days after the last dose.

Animal studies have revealed evidence of embryofetal toxicity. In pregnant rabbits, increases in fetal skeletal variations/abnormalities (fused caudal vertebrae, number of lumbar vertebrae, full supernumerary ribs) were observed at doses that were also maternally toxic (0.3 mg/kg or greater); exposures in rabbits at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In rats, decreases in fetal weights, a trend towards decreased fetal viability, and increased postimplantation losses were observed at doses that were maternally toxic (0.6 mg/kg); exposures in rats at 0.6 mg/kg were 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg. 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 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.

See references

Because its half-life is about 9.5 days, this drug is likely to accumulate in the infant. In addition, this drug is used in combination with leflunomide and dexamethasone, which may increase the risk to the infant.

Breastfeeding is not recommended during use of this drug and for 90 days after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for adverse reactions in breastfed children.

See references