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Goserelin Pregnancy and Breastfeeding Warnings

Goserelin is also known as: Zoladex

Goserelin Pregnancy Warnings

Before starting treatment, pregnancy must be excluded. Goserelin 10.8 mg is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. When used every 28 days, goserelin 3.6 mg usually inhibits ovulation and stops menstruation. However, contraception is not ensured. During treatment, pregnancy must be avoided by use of nonhormonal methods of contraception. Following the last injection, nonhormonal methods of contraception must be continued until the return of menses or for at least twelve weeks. The drug may cause fetal harm when administered to pregnant women. Studies in rats and rabbits administered goserelin during the period of organogenesis have confirmed dose-related increased pregnancy loss. In rats, the incidence of umbilical hernia was significantly increased (at doses greater than one-half the recommended human dose on a mg/m2 basis). In studies on male rats (at approximately 30 to 60 times the recommended human dose), atrophic histological changes were observed in the testes, epididymis, seminal vesicle and prostate gland with complete suppression of spermatogenesis. In female rats (receiving approximately 3 to 60 times the recommended human dose), suppression of ovarian function led to decreased size and weight of ovaries and secondary sex organs; follicular development was arrested at the antral stage and the corpora lutea were reduced in size and number.

Goserelin has been assigned by the FDA to pregnancy category X for the treatment of endometriosis and pregnancy category D for the treatment of advanced breast cancer in pre- and perimenopausal women. Animal studies have revealed evidence of teratogenicity, embryotoxicity, fetotoxicity, and atrophic histological changes consistent with gonadal suppression in both male and female reproductive organs. There are no controlled data in human pregnancy. Goserelin use is considered contraindicated during pregnancy. If the drug is used during pregnancy in a patient with advanced breast cancer or the patient becomes pregnant while receiving the drug, the patient must be apprised of the potential risk for loss of the pregnancy due to possible hormonal imbalance as a result of the expected pharmacologic action of goserelin therapy.

Goserelin Breastfeeding Warnings

There are no data on the excretion of goserelin into human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from goserelin in nursing infants, mothers should discontinue nursing prior to taking the drug.

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