ZOLADEX, at a dose of 10.8 mg, should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician [see Dosage and Administration (2.5)].
While a delay of a few days is permissible, every effort should be made to adhere to the 12-week 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 one ZOLADEX 3.6 mg depot, followed in 28 days by one ZOLADEX 10.8 mg depot, should be administered.
2.2 Prostatic Carcinoma
For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
2.3 Renal or Hepatic Impairment
No dosage adjustment is necessary for patients with renal or hepatic impairment.
2.4 Women
ZOLADEX 10.8 mg implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. For female patients requiring treatment with goserelin, refer to prescribing information for ZOLADEX 3.6 mg implant.
2.5 Administration Technique
The proper method of administration of ZOLADEX is described in the instructions that follow.
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1.
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Put the patient in a comfortable position with the upper part of the body slightly raised. Prepare an area of the anterior abdominal wall below the navel line with an alcohol swab.
NOTE: Caution should be taken while inserting ZOLADEX into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.
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2.
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Examine the foil pouch and syringe for damage. Remove the syringe from the opened foil pouch and hold the syringe at a slight angle to the light. Check that at least part of the ZOLADEX implant is visible.
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3.
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Grasp the blue plastic safety tab and pull away from the syringe, and discard. Remove needle cover. Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the ZOLADEX implant.
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4.
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Holding the syringe around the protective sleeve, using an aseptic technique, pinch the skin of the patient’s anterior abdominal wall below the navel line. With the bevel of the needle facing up, insert the needle at a 30 to 45 degree angle to the skin in one continuous deliberate motion until the protective sleeve touches the patient’s skin.
NOTE: The ZOLADEX syringe cannot be used for aspiration. If the hypodermic needle penetrates a large vessel, blood will be seen instantly in the syringe chamber. If a vessel is penetrated, withdraw the needle and inject with a new syringe elsewhere. Use extra care when administering ZOLADEX to patients with low BMI and/or who are receiving full anticoagulation medication [see Warnings and Precautions (5.6) ].
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5.
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Do not penetrate into muscle or peritoneum.
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6.
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To administer the ZOLADEX implant and to activate the protective sleeve, grasp the barrel at the finger grip and depress the plunger until you cannot depress it any further. If the plunger is not depressed fully, the protective sleeve will NOT activate. When the protective sleeve ‘clicks’, the protective sleeve will automatically begin to slide to cover the needle.
NOTE: The needle does not retract.
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7.
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Withdraw the needle and allow protective sleeve to slide and cover needle. Dispose of the syringe in an approved sharps collector.
NOTE: In the unlikely event of the need to surgically remove ZOLADEX, it
