Zoladex LA 10.8mg Injection

Goserelin Acetate is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women Stage B2-C Prostatic Carcinoma Goserelin Acetate is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with Goserelin Acetate and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Prostatic Carcinoma Goserelin Acetate is indicated in the palliative treatment of advanced carcinoma of the prostate. Endometriosis Goserelin Acetate is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with Goserelin Acetate for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Endometrial Thinning Goserelin Acetate is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Advanced Breast Cancer Goserelin Acetate is indicated for use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women. The estrogen and progesterone receptor values may help to predict whether Goserelin Acetate therapy is likely to be beneficial. The automatic safety feature of the syringe aids in the prevention of needlestick injury.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Women of Childbearing Potential and Pregnancy: Pregnancy must be excluded for use in benign gynecological conditions. Women should avoid pregnancy Tumor Flare Phenomenon: Transient worsening of tumor symptoms may occur during the first few weeks of treatment with Goserelin Acetate, which may include ureteral obstruction and spinal cord compression. Monitor patients at risk for complications of tumor flare Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice Hypercalcemia: Hypercalcemia has been reported in patients with bone metastases treated with Goserelin Acetate. Monitor and manage appropriately Hypersensitivity: Systemic hypersensitivity has been reported in patients receiving goserelin/Goserelin Acetate implants Severe Cutaneous Adverse Reactions: Goserelin Acetate can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis. Interrupt Goserelin Acetate if signs or symptoms of SCARs develop. Permanently discontinue Goserelin Acetate if SCARs are confirmed. Cervical Resistance: Increase in cervical resistance may occur. Caution is recommended when dilating the cervix for endometrial ablation Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits Injection Site Injury: Injection site injury and vascular injury have been reported during administration of Goserelin Acetate Depression: Depression may occur or worsen in women receiving GnRH agonists. Monitor and manage appropriately Women of Childbearing Potential and Pregnancy Before starting treatment with Goserelin Acetate, pregnancy must be excluded for women using Goserelin Acetate for benign gynecological conditions. Women of childbearing potential should be advised to avoid becoming pregnant. Effective nonhormonal contraception must be used by all premenopausal women during Goserelin Acetate therapy and for 12 weeks following discontinuation of therapy. When used every 28 days, Goserelin Acetate usually inhibits ovulation and stops menstruation; however, pregnancy prevention is not ensured. Effects on reproductive function are expected to occur with chronic administration as a result of the anti-gonadotrophic properties of the drug. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, Goserelin Acetate can cause fetal harm when administered to a pregnant woman. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms The adverse event profile was similar for women treated for breast cancer, dysfunctional uterine bleeding or endometriosis and included (>20%): hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, and peripheral edema Tumor flare can occur on the initiation of Goserelin Acetate for both men and women being treated for cancer Stage B2-C Prostatic Carcinoma Treatment with Goserelin Acetate and flutamide did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Goserelin Acetate + flutamide + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below: Table 1 ADVERSE EVENTS DURING ACUTE RADIATION THERAPY (within first 90 days of radiation therapy) (n=231) flutamide + Goserelin Acetate + Radiation % All (n=235) Radiation Only % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Table 2 ADVERSE EVENTS DURING LATE RADIATION PHASE (after 90 days of radiation therapy) (n=231) flutamide + Goserelin Acetate + Radiation % All (n=235) Radiation Only % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Prostatic Carcinoma Goserelin Acetate has been found to be generally well tolerated in clinical trials. Adverse reactions reported in these trials were rarely severe enough to result in the patients’ withdrawal from Goserelin Acetate treatment. As seen with other hormonal therapies, the most commonly observed adverse events during Goserelin Acetate therapy were due to the expected physiological effects from decreased testosterone levels. These included hot flashes, sexual dysfunction and decreased erections. Tumor Flare Phenomenon: Initially, Goserelin Acetate, like other GnRH agonists, causes transient increases in serum levels of testosterone. A small percentage of patients experienced a temporary worsening of signs and symptoms, usually manifested by an increase in cancer-related pain which was managed symptomatically. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.