Zoladex/Zoladex LA

Zoladex/Zoladex LA

goserelin

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Goserelin acetate
Indications/Uses
Management of prostate cancer suitable for hormonal manipulation; endometriosis including alleviation of symptoms (eg, pain & reduction in size & number of endometrial lesions). Zoladex Management of breast cancer in pre- & perimenopausal women suitable for hormonal manipulation. Prethinning of the uterine endometrium prior to endometrial ablation or resection. In conjunction w/ Fe therapy in haematological improvement of anaemic patients w/ uterine fibroids prior to surgery. Assisted reproduction (pituitary downregulation for superovulation prep). Zoladex LA Management of fibroids including shrinkage of lesions, improvement of patient's haematological status & reduction of symptoms (eg, pain); adjunct to surgery to facilitate operative technique & reduce operative blood loss. Management of estrogen-receptor +ve breast cancer in premenopausal women.
Dosage/Direction for Use
Zoladex Adult 1 depot SC into the anterior abdominal wall every 28 days. Assisted reproduction 1 depot to downregulate pituitary gland. Endometriosis Treatment duration: 6 mth. Endometrial thinning Administer 2 depot 4 wk apart w/ surgery timed between 0 & 2 wk after the 2nd depot. Anaemic women due to uterine fibroids 1 depot w/ supplementary Fe for up to 3 mth before surgery. Zoladex LA Adult men 1 depot SC into the anterior abdominal wall every 3 mth. Adult women 1 depot SC into the anterior abdominal wall every 12 wk.
Contraindications
Hypersensitivity to goserelin acetate or other LHRH analogues. Pregnancy & lactation.
Special Precautions
Possible inj site injury including events of pain, haematoma, haemorrhage & vascular injury; monitor affected patients for signs or symptoms of abdominal haemorrhage. Take extra care when administering in patients w/ low BMI &/or receiving full anticoagulants. Carefully consider & closely monitor men at risk of developing ureteric obstruction or spinal cord compression during the 1st mth of therapy. May reduce bone mineral density. Possible reduced glucose tolerance in males receiving LHRH agonists; may manifest as diabetes or loss of glycaemic control in those w/ pre-existing DM; consider blood glucose monitoring. Prolonged treatment in benign gynaecological conditions >6 mth. May increase uterine cervical resistance. Assess benefit-risk ratio including potential for Torsade de Pointes prior to initiating treatment in patients w/ history of or who have QT prolongation risk factors & in those receiving concomitant medicinal products that may prolong QT interval. Increased risk of MI & sudden cardiac death associated w/ GnRH analogs in men. Not indicated for use in childn. Zoladex Women w/ known metabolic bone disease. Possible ovarian hyperstimulation syndrome (OHSS) associated in combination w/ gonadotrophin. Carefully monitor stimulation cycle to identify patients at risk of developing OHSS. Assisted reproduction regimens in patients w/ PCOS. Zoladex LA Only indicated for use in endometriosis, fibroids & breast cancer in premenopausal women. Return of menses after cessation of therapy may be prolonged. May consider multiple treatments in case of disease progression w/o anti-tumour effect of Zoladex.
Adverse Reactions
Decreased libido; hot flush; hyperhidrosis, acne (female); erectile dysfunction (male), vulvovag dryness & breast enlargement (female); inj site reactions (female). Impaired glucose tolerance (male); mood swings (male), altered mood & depression (female); paraesthesia, spinal cord compression (male), headache (female); cardiac failure & MI (male); abnormal BP; rash, alopecia (female); bone pain (male), arthralgia (female); gynaecomastia (male); tumour flare or pain (female), inj site reaction (male); decreased bone density, increased wt. Zoladex LA Depression (male).
Drug Interactions
Concomitant use w/ medicinal products known to prolong QT interval or able to induce Torsade 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
1's
Form
Zoladex LA depot inj 10.8 mg
Packing/Price
1's
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