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Brand Name
Zoladex
Generic Name
Goserelin
View Brand Information FDA approval date: January 26, 2018
Classification: Gonadotropin Releasing Hormone Receptor Agonist
Form: Implant
What is Zoladex (Goserelin)?
ZOLADEX is a Gonadotropin Releasing Hormone agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate.
Approved To Treat
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Related Latest Advances
Brand Information
ZOLADEX (goserelin)
1DOSAGE 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
While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule.
1.1Stage 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.
1.2Prostatic Carcinoma
For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
1.3Endometriosis
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.
1.4Endometrial 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.
1.5Breast Cancer
For the management of advanced breast cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.
1.6Renal or Hepatic Impairment
No dosage adjustment is necessary for patients with renal or hepatic impairment.
1.7Administration Technique
The proper method of administration of ZOLADEX is described in the instructions that follow.
- 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.
- 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.
- Grasp the red 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.
- 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,
- Do not penetrate into muscle or peritoneum.
- 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
- 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.
2DOSAGE FORMS AND STRENGTHS
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
3DRUG INTERACTIONS
No formal drug-drug interaction studies have been performed. No confirmed interactions have been reported between ZOLADEX and other drugs.
3.1Drug/Laboratory Test Interactions
Administration of ZOLADEX in therapeutic doses results in suppression of the pituitary-gonadal system. Because of this suppression, diagnostic tests of pituitary-gonadotropic and gonadal functions conducted during treatment and until the resumption of menses may show results which are misleading. Normal function is usually restored within 12 weeks after treatment is discontinued.
4OVERDOSAGE
The pharmacologic properties of ZOLADEX and its mode of administration make accidental or intentional overdosage unlikely. There is no experience of overdosage from clinical trials. Animal studies indicate that no increased pharmacologic effect occurred at higher doses or more frequent administration. Subcutaneous doses of the drug as high as 1 mg/kg/day in rats and dogs did not produce any nonendocrine related sequelae; this dose is up to 250 times the estimated human daily dose based on the body surface area. If overdosage occurs, it should be managed symptomatically.
5DESCRIPTION
ZOLADEX (goserelin implant) is a GnRH agonist. Goserelin acetate is chemically described as an acetate salt of [D-Ser(Bu
Goserelin acetate is an off-white powder with a molecular weight of 1269 Daltons (free base). It is freely soluble in glacial acetic acid. It is soluble in water, 0.1M hydrochloric acid, 0.1M sodium hydroxide, dimethylformamide and dimethyl sulfoxide. Goserelin acetate is practically insoluble in acetone, chloroform and ether.
ZOLADEX is supplied as a sterile, biodegradable product containing 3.8 mg goserelin acetate, equivalent to 3.6 mg of goserelin. ZOLADEX is designed for subcutaneous injection with continuous release over a 28-day period. Goserelin acetate, containing up to 12% goserelin-related substances, is dispersed in a matrix of D,L-lactic and glycolic acids copolymer (to a total implant weight of 18.0 mg, containing less than 2.5% total acetic acid) and presented as a sterile, white to cream colored 1-mm diameter cylinder, preloaded in a special single use syringe with a 16-gauge x 36 +/- 0.5 mm siliconized needle with protective needle sleeve (SafeSystem
6HOW SUPPLIED/STORAGE AND HANDLING
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