By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo

TheMediTary.Com

Medical Information, Documents, News - TheMediTary.Com

  • Home
  • News
  • Drugs
  • Drugs A-Z
  • Medical Answers
  • About Us
  • Contact
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo
Search Drugs
  • Drugs
    • Latest Drugs
    • Drugs A-Z
    • Medical Answers
  • News
    • FDA Alerts
    • Medical News
    • Health
    • Consumer Updates
    • Children's Health
  • More TheMediTary.Com
    • About Us
    • Contact
Follow US
Home > Drugs > Adrenal corticosteroid inhibitors > Isturisa > Isturisa Pregnancy and Breastfeeding Warnings
Adrenal corticosteroid inhibitors

Osilodrostat Pregnancy and Breastfeeding Warnings

Contents
Isturisa Pregnancy Warnings Isturisa Breastfeeding Warnings

Isturisa Pregnancy Warnings

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.

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.

See references

Isturisa 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

Share this Article
Latest News
Medical News

Seed oils: Omega-6 fatty acids may lower diabetes, heart disease risk

Jun 01, 2025
Type 2 diabetes: Sugary drinks may significantly raise risk
COVID-19: Who do the new vaccine guideline changes affect?
Vitamin D supplements may help slow down aging by 3 years
Aging: Exercise timing, consistency can affect heart and lung fitness
Heart health: Exercise not enough to offset effects of poor sleep
Related Drugs
Fidanacogene Elaparvovec
Cerave Anti-Itch
Centrum Adult
Crovalimab
Cyltezo Prefilled Syringe
Zepbound Pen
Mylanta One
Uretron Ds
Medihoney Wound And Burn Dressing
Lidotrode

Other drugs

Name Drug Class Updated
Fidanacogene Elaparvovec Drugs 03-Oct-2024
Cerave Anti-Itch Drugs 02-Oct-2024
Centrum Adult Drugs 02-Oct-2024
Crovalimab Drugs 02-Oct-2024
Cyltezo Prefilled Syringe Drugs 01-Oct-2024
Zepbound Pen Drugs 30-Sep-2024
Mylanta One Drugs 27-Sep-2024
Uretron Ds Drugs 27-Sep-2024
Medihoney Wound And Burn Dressing Drugs 26-Sep-2024
Lidotrode Drugs 26-Sep-2024
Libervant Drugs 26-Sep-2024
Moderna Covid-19 Drugs 25-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024

Categories

  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health

About US

Welcome to TheMediTary.Com

Our website provides reliable and up-to-date information on various medical topics. We empower individuals to take charge of their health by simplifying complex medical jargon and providing practical tips and advice. We prioritize the privacy and confidentiality of our users and welcome feedback to improve our services.

Website use data of FDA and other sources

DMCA.com Protection Status Truste Protection Status Trust Mark Protection Status
HONcode logo We comply with the HONcode standard for trustworthy health information.
Quick Link
  • About Us
  • Contact Us
  • Editorial Policy
  • Privacy Policy
  • Accessibility Policy
  • Terms & Conditions
  • Disclaimer
  • DMCA
  • Do Not Sell My Personal Information
  • Sitemap
  • Care Notes
  • Health Guide
  • Professional
Drugs
  • New Drugs
  • Medical Answers
  • Drugs A-Z
  • Drug Classes
  • Drug Dosage
  • Pill Identifier
  • Consumer Infor
  • Side Effects
  • Inactive Ingredients
  • Pregnancy Warnings
  • Patient Tips
  • Treatments
News
  • Latest News
  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health
Find US
  • Medium
  • Google Site
  • Blogspot
  • API
  • Reddit
  • Tumblr
  • Scoop.it
  • Substack
  • Wordpress
  • Wix
  • Behance

© 2025 TheMediTary.Com All rights reserved. Operated by