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Risdiplam Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Aug 8, 2022.

Risdiplam is also known as: Evrysdi

Risdiplam Pregnancy Warnings

In animal studies, embryofetal mortality, malformations, decreased fetal body weights, and reproductive impairment in offspring were observed at or above clinically relevant drug exposures. 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. Studies in pregnant rats showed that this drug crosses the placenta barrier. There are no controlled data in human pregnancy.

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

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.

Not recommended

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; based on animal data, this drug may cause fetal harm; pregnant women should be advised of the potential risk to the fetus.

Comments:
-Pregnancy status of females of reproductive potential should be verified prior to initiating therapy.
-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.
-Some authorities advise male patients with female partners of childbearing potential both use highly effective contraception during treatment and for at least 4 months after his last dose.

See references

Risdiplam Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-Some authorities recommend against breastfeeding during treatment as the potential for harm to the breastfed infant is not known.

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

See references

References for pregnancy information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid" (2007):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Evrysdi (risdiplam)." Genentech (2020):

References for breastfeeding information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid" (2007):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Evrysdi (risdiplam)." Genentech (2020):

Further information

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