Leuprolide / norethindrone Pregnancy and Breastfeeding Warnings

Brand names: Lupaneta Pack

Leuprolide / norethindrone Pregnancy Warnings

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.

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.

See references

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.

See references

Further information

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