Siponimod Pregnancy and Breastfeeding Warnings

Brand names: Mayzent

Medically reviewed by Drugs.com. Last updated on Apr 7, 2023.

Siponimod Pregnancy Warnings

Use is not recommended.

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. Based on animal data and its mechanism of action, it can cause fetal harm when administered to a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-Since it takes approximately 10 days to eliminate this drug from the body after stopping therapy, the potential risk to the fetus may persist and both women and men of reproductive potential should use effective contraception during this period.
-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 revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity. Increased incidences of postimplantation loss and fetal abnormalities (external, urogenital, and skeletal), embryofetal death, abortions and fetal variations (skeletal and visceral) were observed starting at a dose 2 times the exposure in humans at the highest recommended dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Siponimod Breastfeeding Warnings

Safety has not been established.

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

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

See references

Further information

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