Zoladex 3.6mg and 10.8 mg Implant

Generic Name: Goserelin acetate
Product Name: Zoladex 3.6mg and 10.8 mg Implant

Indication

The 10.8mg Zoladex implant is used in the palliative treatment of metastatic or locally extensive prostate cancer, where hormonal manipulation is suitable. It is not suitable for use in women.

The 3.6mg implant is useful in the following conditions:

• Treatment of advanced breast cancer in premenopausal women, where hormonal manipulation is appropriate.
• Adjuvant therapy of early breast cancer, where hormonal manipulation is appropriate.
• Visually proven endometriosis – to reduce symptoms and reduce number of endometrial lesions.
• Uterine fibroids – to shrink lesions and reduce symptoms.
• Increasing haemoglobin and haematocrit in women with anaemia attributable to menorrhagia.
• For endometrial thinning prior to endometrial ablation.
• Pituitary down-regulation in preparation for controlled ovarian superstimulation (assisted reproduction).

Action

Goserelin acetate is a hormonal antineoplastic agent known as a LHRH or GnRH agonist. It inhibits the release of luteinizing hormone, the molecule that is important in the control of further hormone release by the ovaries and testes. When used chronically, Goserelin may result in a testosterone level equivalent to that seen in surgically castrated men. This may be desirable in the treatment of testosterone-dependent prostate cancer.

Dose advice

10.8mg Implant

• Indicated for use in men only.
• One implant should be injected subcutaneously into the anterior abdominal wall every three months.
• Implant must be visible in window of applicator before injection.
• Plunger should be fully depressed to ensure adequate implantation.
• Testosterone levels may rise if an injection is delayed.¹

3.6mg Implant

Prostate cancer:

• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days.
• Testosterone levels may rise if an injection is delayed.

Early breast cancer – When Zoladex is used as an alternative to combination chemotherapy:

• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days.
• Treatment should continue for two years. When Zoladex is used post combination chemotherapy:
• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days.
• Treatment should continue for five years.

Advanced breast cancer:

• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days. Endometrial thinning:
• One implant should be injected subcutaneously 4 weeks prior to surgery.
• A course of two implants inserted 4 weeks apart may also be used, with surgery taking place within 2-4 weeks of insertion of the second implant.

Benign gynaecological disorders:

• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days.
• Recommended duration of therapy is 6 months.
• Uterine fibroids may require treatment for 3-6 months. Assisted reproduction:
• One implant should be injected subcutaneously into the anterior abdominal wall every 28 days.
• Continue until pituitary down-regulation has been achieved.
• Ovarian superstimulation and oocyte retrieval should then be carried out.

Schedule

Schedule 4

Common side effects

Males:

• Decreased erections.
• Decreased libido.
• Hot flushes.
• Swelling of extremities.
• Nausea.
• Breathlessness.
• Diarrhoea.
• Urinary tract infection.

Females:

• Decreased libido.
• Hot flushes
• Headache.
• Vaginal dryness.
• Mood changes.
• Abdominal pain.

Uncommon side effects

Males:

• Breast tenderness.
• Breast swelling.
• Sweating.
• Initial increase in bone pain if metastases are present.
• Decrease in bone density (increased risk of osteoporosis).
• Ureteric obstruction.

Females:

• Sweating.
• Change in breast size.
• Temporary increase in signs and symptoms.
• Nausea.
• Diarrhoea.
• Dysmenorrhoea.

Both:

• Skin rash.
• Joint aches.
• Tenderness at the injection site.
• Changes in blood pressure.

References

1. AstraZeneca Pty Ltd (Australia). Zoladex Implant Product Information. North Ryde, 2002.
2. AstraZeneca Pty Ltd (Australia). Zoladex Implant Consumer Medicine Information. North Ryde, 2001.

For further information talk to your doctor.