Osilodrostat Pregnancy and Breastfeeding Warnings

Brand names: Isturisa

Medically reviewed by Drugs.com. Last updated on Apr 26, 2024.

Osilodrostat Pregnancy Warnings

This drug should not be used during pregnancy and in patients of childbearing potential not using contraception.

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

Risk summary: Based on preclinical data, this drug may cause fetal harm; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There are risks to the mother and fetus associated with active Cushing's syndrome during pregnancy.
-According to some authorities: A pregnancy test before starting therapy is recommended in patients of childbearing potential; these patients should be apprised of the potential harm to the fetus.
-According to some authorities: Patients of childbearing potential should use effective contraception during therapy and for at least 1 week after the last dose.
---If hormonal contraceptives other than the oral combination of ethinyl estradiol and levonorgestrel are used, an additional barrier method is recommended.

Animal studies have revealed evidence of embryofetal lethality, embryofetal toxicity, and teratogenicity at maternotoxic doses. In 1 study in pregnant Wistar Han rats, embryofetal development was not adversely affected at doses up to 5 mg/kg (8 times the 30 mg twice daily maximum clinical dose, by AUC); maternal toxicity, increased embryonic and fetal deaths, decreased fetal weights, and malformations occurred at 50 mg/kg (118 times the maximum clinical dose, by AUC). In a study in pregnant New Zealand rabbits, embryofetal development was not adversely affected at 3 mg/kg (0.5 times the 30 mg twice daily maximum clinical dose, by AUC); maternal toxicity, increased embryo resorption, and decreased fetal viability was seen at 10 mg/kg and greater (at least 7 times the maximum clinical dose, by AUC). In another study in pregnant Wistar Han rats, behavioral, developmental, and reproductive parameters were not adversely affected at doses up to 5 mg/kg (about 8 times the 30 mg twice daily maximum clinical dose, by AUC); delayed parturition and dystocia in maternal rats and decreased pup survival were seen at 20 mg/kg (43 times the maximum clinical dose, by AUC). There are no controlled data in human pregnancy.

Active Cushing's syndrome during pregnancy has been associated with increased risk of maternal and fetal morbidity and mortality (including gestational diabetes, gestational hypertension, preeclampsia, maternal death, miscarriage, fetal loss, preterm birth).

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

Osilodrostat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 week after the last dose.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions (e.g., adrenal insufficiency) in the breastfed infant.
-A risk to neonates/infants cannot be excluded.

See references

Further information

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