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Fingolimod Pregnancy and Breastfeeding Warnings

Fingolimod is also known as: Gilenya

Fingolimod Pregnancy Warnings

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: C

Comments: Women of childbearing potential should be encouraged to use adequate methods of contraception during and for at least 2 months after therapy.

This drug and/or its metabolites crossed the placental barrier in animal models. 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 embryo-fetal deaths were observed. There was reduced perinatal survival, and a neurobehavioral (learning) 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.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Fingolimod Breastfeeding Warnings

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.

Use is not recommended and 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: There is a potential for serious adverse effects in nursing infants.

See references

References for pregnancy information

  1. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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