All Names: Goserelin
Indications:1. Stage B2-C Prostatic Carcinoma; 2. Prostatic Carcinoma; 3. Endometriosis; 4. Endometrial Thinning; 5. Advanced Breast Cancer
Manufacturer:AstraZeneca,Britain
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INDICATIONS AND USAGE(适应症)
Stage B2-C Prostatic Carcinoma
ZOLADEX 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 ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Prostatic Carcinoma
ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.
Endometriosis
ZOLADEX is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.
Endometrial Thinning
ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.
Advanced Breast Cancer
ZOLADEX 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 ZOLADEX therapy is likely to be beneficial.
The automatic safety feature of the syringe aids in the prevention of needlestick injury.
DOSAGE(服用剂量)
ZOLADEX, at a dose of 3.6 mg, should be administered subcutaneously every 28 days into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician [see Dosage and Administration (2.7)].
While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule.
Stage B2-C Prostatic Carcinoma
When ZOLADEX is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiation therapy. A treatment regimen using a ZOLADEX 3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by the ZOLADEX 10.8 mg depot, can be administered. Alternatively, four injections of 3.6 mg depot can be administered at 28-day intervals, two depots preceding and two during radiotherapy.
Prostatic Carcinoma
For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
Endometriosis
For the management of endometriosis, the recommended duration of administration is 6 months.
Currently, there are no clinical data on the effect of treatment of benign gynecological conditions with ZOLADEX for periods in excess of 6 months.
Retreatment cannot be recommended for the management of endometriosis since safety data for retreatment are not available. If the symptoms of endometriosis recur after a course of therapy, and further treatment with ZOLADEX is contemplated, consideration should be given to monitoring bone mineral density. Clinical studies suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to ZOLADEX is effective in reducing the bone mineral loss which occurs with ZOLADEX alone without compromising the efficacy of ZOLADEX in relieving the symptoms of endometriosis. The addition of Hormone Replacement Therapy may also reduce the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism. The optimal drugs, dose and duration of treatment has not been established.
Endometrial Thinning
For use as an endometrial-thinning agent prior to endometrial ablation, the dosing recommendation is one or two depots (with each depot given four weeks apart). When one depot is administered, surgery should be performed at four weeks. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.
Breast Cancer
For the management of advanced breast cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
Renal or Hepatic Impairment
No dosage adjustment is necessary for patients with renal or hepatic impairment.
ADVERSE REACTIONS(不良反应)
Rectum/Large Bowel
Bladder
Skin
Diarrhea
Cystitis
Rectal Bleeding
Proctitis
Hematuria
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/294b168b-6e5f-4db9-bf70-d599271458b3/spl-doc?hl=zoladex
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