ZOLADEX- goserelin acetate implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GOSERELIN ACETATE (UNII: 6YUU2PV0U8) (GOSERELIN - UNII:0F65R8P09N)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

GOSERELIN ACETATE

Composition:

GOSERELIN 10.8 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)] . 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 wit

Product summary:

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 [SafeSystem™ 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]).

Authorization status:

New Drug Application

Summary of Product characteristics

ZOLADEX- GOSERELIN ACETATE IMPLANT
ASTRAZENECA PHARMACEUTICALS LP
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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 ACETATE IMPLANT) 10.8 MG
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated
for:
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DOSAGE AND ADMINISTRATION
ZOLADEX, at a dose of 10.8 mg, should be administered subcutaneously
every 12 weeks into the anterior abdominal wall
below the navel line (2.1, 2.5)
DOSAGE FORMS AND STRENGTHS
Implant 10.8 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common, clinically significant adverse reactions occurring in
>10% of men: hot flashes, sexual dysfunction,
decreased erections and lower urinary tract symptoms (6)
Tumor flare can occur on the initiation of ZOLADEX therapy (5.1, 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2016
®
Use in combination with flutamide for the management of locally
confined carcinoma of the prostate (1.1)
Use as palliative treatment of advanced carcinoma of the prostate
(1.2)
Hypersensitivity (4.1)
Pregnancy (4.2, 8.1)
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 (5.1, 6.1)
Hypersensitivity: Systemic hypersensitivity has been reported in
patients receiving goserelin implants (4.1, 5.2)
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 cl