Risdiplam Pregnancy and Breastfeeding Warnings

Brand names: Evrysdi

Medically reviewed by Drugs.com. Last updated on Jan 23, 2024.

Risdiplam Pregnancy Warnings

Use is not recommended.
-According to some authorities: This drug should not be used during pregnancy unless the benefit to mother outweighs the risk to the fetus.

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

Risk Summary: No adequate data available on use of this drug in pregnant women to inform a drug-related risk. Based on animal data, this drug may cause fetal harm.

Comments:
-Pregnancy status of females of reproductive potential should be verified prior to initiating therapy.
-Pregnant women should be advised of the potential risk to the fetus.
-A pregnancy exposure registry is available.
-Women of childbearing potential should be advised to use effective contraception during treatment and for at least 1 month after the last dose.
-Because male fertility may be compromised by treatment, male patients may consider sperm preservation prior to treatment.
-Advise male patients with female partners of childbearing potential should both use highly effective contraception during treatment and for at least 4 months after his last dose.

Animal studies have revealed evidence of embryofetal harm and teratogenicity. In animal studies, adverse effects on development (e.g., embryofetal mortality, malformations, and decreased fetal body weights) were observed at or above clinically relevant drug exposures. Studies in pregnant rats showed that this drug crosses the placenta barrier. There are no controlled data in human pregnancy.

In pregnant rats, receiving this drug throughout pregnancy and lactation, gestation was prolonged in the dams, and delayed sexual maturation (vaginal opening) and impaired reproductive function (decreased numbers of corpora lutea, implantation sites, and live embryos) were observed in the female offspring.

Administration of this drug to male rats resulted in histopathological effects in the testis (degenerated spermatocytes, degeneration, or atrophy of the seminiferous tubules) and epididymis (degeneration or necrosis of the ductular epithelium).

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting https://www.evrysdipregnancyregistry.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 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

Risdiplam Breastfeeding Warnings

Safety has not been established. Benefit should outweigh risk.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The potential of this drug to harm a nursing infant is unknown.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.

This drug has been found in the milk of lactating rats.

See references

Further information

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

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