This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Risk Summary: There are no adequate data on the developmental risk associated with the use of this drug in pregnant women. In animal studies, it demonstrated developmental toxicity, including an increase in malformations and embryolethality, when given to pregnant animals. The highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a mg/m2 basis. The most common fetal visceral malformations were persistent truncus arteriosus and ventricular septal defect. The receptor affected by this drug is known to be involved in vascular formation during embryogenesis.

Comments:
-A pregnancy exposure registry is available.
-Women of childbearing potential should be encouraged to use adequate methods of contraception during and for at least 2 months after 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.

Animal studies have shown teratogenicity and embryolethality including organ defects, notably persistent truncus arteriosus. and ventricular septal defect. When administered during organogenesis, increased fetal malformations and embryofetal deaths were observed. There was reduced perinatal survival, and a neurobehavioral deficit was seen in the offspring. The receptor affected by this drug (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis. There are no adequate and well-controlled studies in pregnant women.

A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to this drug. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves by visiting www.gilenyapregnancyregistry.com or by calling 1-877-598-7237.

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.

See references

In animal models, this drug was excreted in the milk at concentrations 2- to 3-fold higher than that found in maternal plasma. There were no effects on body weight, development, behavior, or fertility in the nursing animals. Reduced immunocompetence was seen in juvenile animals after oral administration.

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

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

See references