Zoladex

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 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 and Clinical Studies ].
  )
• Palliative treatment of advanced carcinoma of the prostate (
  1.2 Prostatic Carcinoma

  ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate

  [see Dosage and Administration and Clinical Studies ].
  )
• The management of endometriosis (
  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 and Clinical Studies ].
  )
• Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding (
  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 and Clinical Studies ].
  )
• Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women (
  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

  [see Dosage and Administration , Clinical Pharmacology , and Clinical Studies ].

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

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

While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule.

ZOLADEX is supplied as a sterile and totally biodegradable D,L-lactic and glycolic acids copolymer impregnated with 3.8 mg goserelin acetate, equivalent to 3.6 mg of goserelin, in a disposable syringe device fitted with a 16-gauge x 36 +/- 0.5 mm siliconized hypodermic needle with protective needle sleeve [SafeSystem^® Syringe] (NDC 70720-950-36).

• Nursing mothers: Discontinue drug or nursing taking into account the importance of drug to the mother (
  8.3 Nursing Mothers

  It is not known if goserelin is excreted in human milk. Goserelin is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ZOLADEX, a decision should be made to either discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  )
• No information available for use in Pediatric patients (
  8.4 Pediatric Use

  Safety and effectiveness in pediatric patients have not been established.
  )
• Geriatric (
  8.5 Geriatric Use

  There is no need for any dosage adjustment when administering ZOLADEX to male geriatric patients. ZOLADEX has not been studied in women over 65 years.
  )
• Renal and Hepatic Impairment: No dose adjustment is necessary (
  2.6 Renal or Hepatic Impairment

  No dosage adjustment is necessary for patients with renal or hepatic impairment.
  ,
  8.6 Renal Insufficiency

  In clinical trials with the solution formulation of goserelin, male patients with impaired renal function (creatinine clearance < 20 mL/min) had a total body clearance and serum elimination half-life of 31.5 mL/min and 12.1 hours, respectively, compared to 133 mL/min and 4.2 hours for subjects with normal renal function (creatinine clearance > 70 mL/min). In females, the effects of reduced goserelin clearance due to impaired renal function on drug efficacy and toxicity are unknown. Pharmacokinetic studies in patients with renal impairment do not indicate a need for dose adjustment with the use of the depot formulation.
  ,
  8.7 Hepatic Insufficiency

  The total body clearances and serum elimination half-lives were similar between normal subjects and patients with moderate hepatic impairment (alanine transaminase < 3xULN and asparate aminotransferase < 3xULN) when treated with a 250 mcg subcutaneous formulation of goserelin. This pharmacokinetic study indicates that no dose adjustment is needed in patients with moderately impaired liver function.

  There is no pharmacokinetic data with goserelin in patients with severe hepatic insufficiency.
  )