Leuprolide / norethindrone Pregnancy and Breastfeeding Warnings
Leuprolide / norethindrone is also known as: Lupaneta Pack
Medically reviewed by Drugs.com. Last updated on Dec 31, 2020.
Leuprolide / norethindrone Pregnancy Warnings
Administration of leuprolide acetate for depot suspension at doses of 1/300 to 1/3 the human dose on day 6 of pregnancy in rabbits produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. Increased fetal mortality and decreased fetal weights were observed with 2 higher doses in rabbits and with the highest dose of 0.024 mg/kg in rats. There are no controlled data in human pregnancy.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Use is contraindicated
US FDA pregnancy category: X
Comments:
-Leuprolide acetate for depot suspension may cause fetal harm when administered to a pregnant women.
-Pregnancy should be ruled out prior to initiating therapy
-While therapy will usually inhibit ovulation and stop menstruation, conception may occur; in women of reproductive potential, a nonhormonal method of contraception should be used.
Leuprolide / norethindrone Breastfeeding Warnings
Use is contraindicated
Excreted into human milk: Unknown (leuprolide); Yes (norethindrone)
Excreted into animal milk: Unknown
Comments:
-This combination therapy should not be used in nursing mothers because of the effects of leuprolide on lactation and/or the breast-fed infant.
References for pregnancy information
- "Product Information. Lupaneta Pack (leuprolide-norethindrone)." Abbott Pharmaceutical, Abbott Park, IL.
References for breastfeeding information
- "Product Information. Lupaneta Pack (leuprolide-norethindrone)." Abbott Pharmaceutical, Abbott Park, IL.
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Further information
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