ZOLADEX (goserelin acetate implant) 3.6 mg - America[美国药品]

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ZOLADEX (goserelin acetate implant) 3.6 mg

2015-09-10 11:50:07 来源: 作者: 【大中小】浏览:362次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOLADEX safely and effectively. See full prescribing information for ZOLADEX. ZOLADEX ® (goserelin acetate implant) 3.6 mg Initial U.S. Approval: 1989 RECENT MAJOR CHANGES Dosage and Administration, Administration Technique (2.7) 02/2015 Warnings and Precautions, Effect on QT/QTc Interval (5.8) 10/2014 Warnings and Precautions, Injection Site Injury (5.9) 02/2015 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: • Use in combination with flutamide for the management of locally confined carcinoma of the prostate (1.1) • Palliative treatment of advanced carcinoma of the prostate (1.2) • The management of endometriosis (1.3) • Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding (1.4) • Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women (1.5) DOSAGE AND ADMINISTRATION • ZOLADEX 3.6 mg should be administered subcutaneously every 28 days ( 2.1, 2.7) • For the management of endometriosis, the recommended duration of administration is 6 months for women 18 years of age and older ( 2.3) DOSAGE FORMS AND STRENGTHS Implant 3.6 mg (3) CONTRAINDICATIONS • Hypersensitivity (4.1) • Pregnancy unless used for treatment of advanced breast cancer (4.2) WARNINGS AND PRECAUTIONS • Women of Childbearing Potential and Pregnancy: Pregnancy must be excluded for use in benign gynecological conditions. Women should avoid pregnancy (5.1) • Tumor Flare Phenomenon: Transient worsening of tumor symptoms may occur during the first few weeks of treatment with ZOLADEX, which may include ureteral obstruction and spinal cord compression. Monitor patients at risk for complications of tumor flare ( 5.2, 6.2) • 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 (5.3) • 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 (5.4) • Hypercalcemia: Hypercalcemia has been reported in patients with bone metastases treated with ZOLADEX. Monitor and manage appropriately (5.5) • Hypersensitivity: Systemic hypersensitivity has been reported in patients receiving goserelin/ZOLADEX implants ( 4.1, 5.6) • Cervical Resistance: Increase in cervical resistance may occur. Caution is recommended when dilating the cervix for endometrial ablation (5.7) • Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits (5.8) • Injection Site Injury: Injection site injury and vascular injury have been reported during administration of ZOLADEX (5.9) ADVERSE REACTIONS The most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms (6) 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 (6) Tumor flare can occur on the initiation of ZOLADEX for both men and women being treated for cancer (6) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. DRUG INTERACTIONS • None USE IN SPECIFIC POPULATIONS • Nursing mothers: Discontinue drug or nursing taking into account the importance of drug to the mother (8.3) • No information available for use in Pediatric Patients (8.4) • Geriatric (8.5) • Renal and Hepatic Impairment: No dose adjustment is necessary ( 2.6, 8.6, 8.7) See 17 for PATIENT COUNSELING INFORMATION. Revised: 2/2015 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Stage B2-C Prostatic Carcinoma 1.2 Prostatic Carcinoma 1.3 Endometriosis 1.4 Endometrial Thinning 1.5 Advanced Breast Cancer 2 DOSAGE AND ADMINISTRATION 2.1 Stage B2-C Prostatic Carcinoma 2.2 Prostatic Carcinoma 2.3 Endometriosis 2.4 Endometrial Thinning 2.5 Breast Cancer 2.6 Renal or Hepatic Impairment 2.7 Administration Technique 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Hypersensitivity 4.2 Pregnancy 5 WARNINGS AND PRECAUTIONS 5.1 Women of Childbearing Potential and Pregnancy 5.2 Tumor Flare Phenomenon 5.3 Hyperglycemia and Diabetes 5.4 Cardiovascular Diseases 5.5 Hypercalcemia 5.6 Hypersensitivity 5.7 Cervical Resistance 5.8 Effect on QT/QTc Interval 5.9 Injection Site Injury 6 ADVERSE REACTIONS 6.1 Stage B2-C Prostatic Carcinoma 6.2 Prostatic Carcinoma 6.3 Females 6.4 Endometriosis 6.5 Endometrial Thinning 6.6 Breast Cancer 6.7 Hormone Replacement Therapy 6.8 Changes in Bone Mineral Density 6.9 Changes in Laboratory Values During Treatment 6.10 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drug/Laboratory Test Interactions 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Insufficiency 8.7 Hepatic Insufficiency 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Stage B2-C Prostatic Carcinoma 14.2 Prostatic Carcinoma 14.3 Endometriosis 14.4 Endometrial Thinning 14.5 Breast Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Males 17.2 Females * Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 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 [see Dosage and Administration (2.1)and Clinical Studies (14.1)]. 1.2 Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration (2.2) and Clinical Studies (14.2)]. 1.3 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 [see Dosage and Administration (2.3) andClinical Studies (14.3)]. 1.4 Endometrial Thinning ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding [see Dosage and Administration (2.4) and Clinical Studies (14.4)]. 1.5 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 [seeDosage and Administration (2.6), Clinical Pharmacology (12.1), and Clinical Studies (14.5)]. The automatic safety feature of the syringe aids in the prevention of needlestick injury. 2 DOSAGE AND ADMINISTRATION 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. 2.1 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.
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