Prostatic Carcinoma: ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial.

In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks.

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.

The automatic safety feature of the syringe aids in the prevention of needlestick injury.

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.

While a delay of a few days is permissible, every effort should be made to adhere to the 12-week schedule.

Prostatic Carcinoma: For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.

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.

Renal or Hepatic Impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Females: 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 the prescribing information for ZOLADEX 3.6 mg implant.

Administration Technique: The proper method of administration of ZOLADEX is described in the instructions that follow.

1. 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.

2.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.

3.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.

4.Holding the syringe around the protective sleeve, using an aseptic technique, pinch the skin of the patients 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 patients 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.

5.Do not penetrate into muscle or peritoneum.

6.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.

7.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 may be localized by ultrasound.

ZOLADEX 10.8 mg implant is supplied as a sterile and totally biodegradable D,L-lactic and glycolic acids copolymer (12.82-14.76 mg/dose) impregnated with goserelin acetate equivalent to 10.8 mg of goserelin in a disposable syringe device fitted with a 14-gauge x 36 +/- 0.5 mm siliconized hypodermic needle with protective sleeve (SafeSystemÃ? Syringe) (NDC 0310-0951-30). The unit is sterile and comes in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule. Store at room temperature (do not exceed 25°C[77°F]).

Bookmark this page: