Zoladex

Zoladex

goserelin

Manufacturer:

AstraZeneca

Marketer:

AstraZeneca
Concise Prescribing Info
Contents
Goserelin acetate
Indications/Uses
Management of prostate cancer suitable for hormonal manipulation; breast cancer in premenopausal & perimenopausal women suitable for hormonal manipulation; endometriosis including alleviation of symptoms eg, pain & reduction in size & number of lesions. Prethinning of the uterine endometrium prior to endometrial ablation or resection. Assisted reproduction: Pituitary downregulation in prep for superovulation.
Dosage/Direction for Use
1 depot inj SC into the anterior abdominal wall every 28 days. Assisted reproduction Administered as defined by serum oestradiol levels. Take between 7 & 21 days. Endometriosis Duration of treatment: 6 mth. Endometrial thinning 2 depot inj to be administered 4 wk apart w/ surgery timed for between 0 & 2 wk after 2nd depot inj.
Contraindications
Hypersensitivity to goserelin acetate or other LHRH analogues. Pregnancy & lactation.
Special Precautions
Monitor affected patients for signs or symptoms of abdominal haemorrhage. Patient w/ low BMI &/or receiving full anticoagulation medications. Consider & monitor closely men at risk of developing ureteric obstruction or spinal cord compression in the 1st mth of therapy. Increased risk of MI & sudden cardiac death; monitor for CV disease. Reduced bone mineral density. Reduction in glucose tolerance in male receiving LHRH agonists. Monitor blood glucose; stimulation cycle carefully to identify patients at risk of developing OHSS. Women w/ known metabolic bone disease. Androgen therapy may prolong QT interval. Patient w/ history of or risk factors for QT prolongation, receiving medicinal products that may prolong QT interval; assess the benefit-risk ratio including potential for Torsade de Pointes prior to initiation of therapy. Assisted reproduction regimen in patients w/ polycystic ovarian syndrome. Use non-hormonal contraceptive methods during therapy until menses resume. Not to be used during pregnancy. Not recommended during lactation. Not indicated for use in childn.
Adverse Reactions
Decreased libido; hot flush; hyperhydrosis; inj site reactions. Paresthesia, abnormal BP; rash; decreased bone density, increased wt. Male: Erectile dysfunction. Impaired glucose tolerance; mood swings; spinal cord compression; cardiac failure, MI; bone pain; gynecomastia. Female: Acne; vulvovag dryness, breast enlargement. Altered mood, depression; headache; alopecia; arthralgia, tumour flare & pain.
Drug Interactions
Medicinal products known to prolong QT interval or induce Torsades de Pointes.
MIMS Class
Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs
ATC Classification
L02AE03 - goserelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Zoladex depot inj 3.6 mg
Packing/Price
(single-dose syringe) 1's (Rp2,349,721/boks)
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