ZOLADEX- goserelin implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

goserelin acetate (UNII: 6YUU2PV0U8) (goserelin - UNII:0F65R8P09N)

Available from:

TerSera Therapeutics LLC

INN (International Name):

goserelin acetate

Composition:

goserelin 3.6 mg

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration (2.2) and Clinical Studies (14.2)]. 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) and Clinical Studies (14.3)]. 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 Cl

Product summary:

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). 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]).

Authorization status:

New Drug Application

Summary of Product characteristics

ZOLADEX- GOSERELIN IMPLANT
TERSERA THERAPEUTICS LLC
----------
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 IMPLANT) 3.6 MG
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions (5.10)
3/2023
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