Monograph Details
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Neoplasms
> Hormones and antagonists
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ZOLADEX 3-MONTH 10.8mg |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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GnRH analogue. |
| Generic Name |
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Goserelin (as acetate) 10.8mg; SC implant. |
| Also |
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• ZOLADEX
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| Indications |
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Palliative treatment of advanced breast cancer in pre- and perimenopausal women. Palliative treatment of advanced prostate carcinoma. In combination with flutamide for management of locally confined Stage T2b-T4 (Stage B2-C) prostate carcinoma. |
| Children |
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Not applicable. |
| Adults |
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Implant SC into anterior abdominal wall. Breast cancer: one 3.6mg implant every 28 days. Prostate cancer: one 3.6mg implant every 28 days or one 10.8mg implant every 12 weeks. Stage B2-C prostatic carcinoma (in combination with flutamide): Treat 8 weeks prior to and during radiotherapy. Initially one 3.6mg implant, followed in 28 days by one 10.8mg implant; or may use one 3.6mg implant every 28 days. |
| Contraindications |
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Pregnancy (Cat.D). Nursing mothers. |
| Precautions |
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Nondiagnosed abnormal vaginal bleeding: not recommended. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Premenopausal women: use nonhormonal contraception during and for 12 weeks after therapy or until menses resume. Males: risk of ureteral obstruction or spinal cord compression (monitor during 1st month of therapy). |
| Interactions |
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May affect tests of pituitary-gonadotropic and gonadal functions. |
| Adverse Reactions |
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Females: hypoestrogenism (eg, hot flashes, headache, vaginal dryness, decreased libido, risk of decreased bone mineral density). Males: decreased testosterone levels (eg, hot flashes, sexual dysfunction, decreased erections, gynecomastia), lower urinary tract symptoms. Both: transient worsening of symptoms (eg, bone pain), tumor flare, GI upset, edema, malaise. |
| How Supplied |
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Implant (in syringe)—1 |
| Additional Resources |
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• Related Prescribing Note |
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