Prostate cancer, advanced:
Palliative treatment of advanced carcinoma of the prostate.

Prostate cancer, stage B2 to C:
Management of locally confined stage T2b to T4 (stage B2 to C) prostate cancer (in combination with an antiandrogen [eg, flutamide]); begin goserelin and antiandrogen therapy 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Breast cancer in premenopausal women, advanced：
Palliative treatment of advanced breast cancer.<20201126>

#仿單變更2020

Goserelin acetate is a synthetic decapeptide luteinizing hormone-releasing hormone (LHRH) agonist analogue. It inhibits and suppresses the pituitary gonadotropin secretion.

Distribution:
Vd: (females), 20.3 L +/- 4.1 L
Vd: (males), 44.1 L +/- 13.6 L
Metabolism:
Hepatic; hydrolysis of C-terminal amino acids
Excretion:
Renal: more than 90%, approximately 20% unchanged
Elimination Half Life:
females: 2.3 h +/- 0.6 h
males: 4.2 h +/- 1.1 h

Hypersensitivity to goserelin, gonadotropin releasing hormone (GnRH), GnRH agonist analogues, or any component of the product
Pregnancy in females with endometriosis or endometrial thinning, as drug may cause fetal harm and has increased risk of pregnancy loss; must exclude pregnancy prior to therapy and use nonhormonal contraception during therapy and 12 weeks after discontinuation

X (FDA) D (AUS)

Infant risk cannot be ruled out.(MDX)

Common:
Cardiovascular: Peripheral edema (21% )
Dermatologic: Acne (42% ), Seborrhea (26% ), Sweating (1% to 45% )
Endocrine metabolic: Atrophy of breast (33% )
Neurologic: Headache (men, greater than 1% to less than 5%; women, 32% to 75% )
Psychiatric: Depression (men, greater than 1% to less than 5%; women, 54% ), Mood swings (60% )
Reproductive: Erectile dysfunction (18% ), Flushing (46% to 96% ), Reduced libido (47.7% to 61% ), Sexual dysfunction (21% ), Vaginitis (5% to 75% )
Other: Pain (8% to 17% )
Serious:
Cardiovascular: Cardiovascular event risk, Congestive heart failure (5% ), Hemorrhagic shock, Myocardial infarction (greater than 1% to less than 5% ), Prolonged QT interval
Dermatologic: Injection site hemorrhage
Endocrine metabolic: Diabetes mellitus (10.9% to 22.2% ), Pituitary apoplexy (rare ), Pituitary tumor (rare ), Tumor flare (23% )
Hematologic: Hemorrhage
Immunologic: Anaphylaxis, Hypersensitivity reaction (1% or greater )
Neurologic: Cerebrovascular accident (greater than 1% to less than 5% )
Renal: Renal impairment (greater than 1% to less than 5% )
Respiratory: Chronic obstructive pulmonary disease (5% )
Other: Tumor flare (23% )

Prostate cancer, advanced:
28-day implant: 3.6 mg every 28 days
12-week implant: 10.8 mg every 12 weeks

Prostate cancer, stage B2 to C (in combination with an antiandrogen and radiotherapy; begin 8 weeks prior to radiotherapy):
Combination 28-day/12-week implant: 3.6 mg implant, followed in 28 days by 10.8 mg implant
28-day implant (alternate dosing): 3.6 mg; repeated every 28 days for a total of 4 doses