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Zoladex

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Zoladex 10.8 mg

Warnings
Precautions

WARNINGS

Initially, ZOLADEX, like other LHRH agonists, causes transient increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostatic cancer, may occasionally develop during the first few weeks of ZOLADEX treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. As with other LHRH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

PRECAUTIONS

General

Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with LHRH agonist analogues. Of 115 women worldwide treated with ZOLADEX 3.6 mg and tested for development of binding to goserelin following treatment with ZOLADEX, one patient showed low-titer binding to goserelin. On further testing of this patient's plasma obtained following treatment, her goserelin binding component was found not to be precipitated with rabbit antihuman immunoglobulin polyvalent sera. These findings suggest the possibility of antibody formation.

Glucose Tolerance

A reduction in glucose tolerance has been observed in males receiving LHRH agonists, including ZOLADEX. This may manifest as diabetes or loss of glycemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving ZOLADEX.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Subcutaneous implant of ZOLADEX in male and female rats once every 4 weeks for 1 year and recovery for 23 weeks at doses of about 80 and 150 μg/kg (males) and 50 and 100 μg/kg (females) daily (about 3 to 9 times the recommended human dose on a mg/m²basis) resulted in an increased incidence of pituitary adenomas. An increased incidence of pituitary adenomas was also observed following subcutaneous implant of ZOLADEX in rats at similar dose levels for a period of 72 weeks in males and 101 weeks in females. The relevance of the rat pituitary adenomas to humans has not been established. Subcutaneous implants of ZOLADEX every 3 weeks for 2 years delivered to mice at doses of up to 2400 μg/kg/day (about 70 times the recommended human dose on a mg/m²basis) resulted in an increased incidence of histiocytic sarcoma of the vertebral column and femur.

Mutagenicity tests using bacterial and mammalian systems for point mutations and cytogenetic effects have provided no evidence for mutagenic potential.

Administration of goserelin led to changes that were consistent with gonadal suppression in both male and female rats as a result of its endocrine action. In male rats administered 500-1000 μg/kg/day (about 30-60 times the recommended human dose on a mg/m²basis), a decrease in weight and atrophic histological changes were observed in the testes, epididymis, seminal vesicle and prostate gland with complete suppression of spermatogenesis. In female rats administered 50-1000 μg/kg/day (about 3-60 times the recommended daily human dose on a mg/m²basis), 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. Except for the testes, almost complete histologic reversal of these effects in males and females was observed several weeks after dosing was stopped; however, fertility and general reproductive performance were reduced in those that became pregnant after goserelin was discontinued. Fertile matings occurred within 2 weeks after cessation of dosing, even though total recovery of reproductive function may not have occurred before mating took place; and, the ovulation rate, the corresponding implantation rate, and number of live fetuses were reduced.

Based on histological examination, drug effects on reproductive organs seem to be completely reversible in male and female dogs when drug treatment was stopped after continuous administration for 1 year at 100 times the recommended monthly dose.

Pregnancy

Teratogenic Effects
Pregnancy Category X

See CONTRAINDICATIONS section. ZOLADEX 10.8 mg is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. Studies in both rats and rabbits at doses of 2, 10, 20, and 50 μg/kg/day and 20, 250, and 1,000 μg/kg/day, respectively (about 1/10 to 3 times and 2 to 100 times the daily maximum recommended human dose, respectively, on a mg/m²basis), administered during the period of organogenesis, have confirmed that ZOLADEX will increase pregnancy loss in a dose-related manner. While there was no evidence that ZOLADEX possessed the potential to cause teratogenicity in rabbits, in rats the incidence of umbilical hernia was significantly increased at doses greater than 10 mg/kg/day (about ½ the recommended dose on a mg/m²basis).

Nursing Mothers

It is not known if this drug is excreted in human milk. Many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants of mothers receiving ZOLADEX (See CONTRAINDICATIONS).

Pediatric Use

Safety and efficacy of ZOLADEX in pediatric patients have not been established.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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