Animal studies have revealed evidence of embryotoxicity and teratogenicity. Evidence of fetal blood vessel malformations were reported in animal studies. The receptor affected by this drug (sphingosine-1-phosphate) has been demonstrated to have an important role in embryogenesis, including vascular and neural development. There are no controlled data in human pregnancy.

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 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.

Use is contraindicated.

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

Risk Summary: Studies in pregnant animals revealed adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Women of childbearing potential should use effective contraception during therapy and for 3 months after.

See references

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Animal studies revealed that this drug was detected in the milk of lactating animals at levels higher than those in maternal plasma.

See references