Zoladex (TM), implant/depot, 10.8 mg

ZOLADEX (TM), implant, 10.8mg

ZOLADEX is a trademark of the AstraZeneca group.

Abbreviated Prescribing Information

See local Prescribing Information for full details, as Prescribing Information may vary from country to country.

Indications:

Prostate cancer suitable for hormonal manipulation. Endometriosis. Uterine fibroids.

Dosage:

One 10.8mg depot injected subcutaneously into the anterior abdominal wall every 3 months for men and every 12 weeks for women. Children: Not indicated.

Contra-indications:

Pregnancy, lactation and known hypersensitivity to ZOLADEX.

Warnings and precautions:

In men: Reduction in bone mineral density. Bone mineral loss may be reduced by the use of bisphosphonate in combination with an LHRH agonist.  Use in men at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully and patients closely monitored during first month of therapy.  Reduction in glucose tolerance which may manifest as diabetes or loss of glycaemic control in patients with pre-existing diabetes mellitus.  Consideration should therefore be given to monitoring blood glucose.
In women: Indicated for use only in endometriosis and fibroids. There are no data on use for periods in excess of six months. Reduction in bone mineral density which may recover on cessation of therapy. Time to return of menses may be prolonged. Increase in cervical resistance requiring care if dilating the cervix.

Interactions:

None known.

Pregnancy and lactation:

ZOLADEX is contra-indicated in pregnancy. Exclude pregnancy before treatment, non-hormonal contraception should be employed during therapy until menses resume.

Undesirable effects:

Rare incidents of hypersensitivity have been reported. Arthralgia, non-specific paraesthesias, skin rashes (generally mild), changes in blood pressure. Very rarely pituitary apoplexy, after initial administration.  Reduction in bone mineral density.
Males: Hot flushes and sweating, decrease in potency, infrequently breast swelling and tenderness, temporary increase in bone pain and isolated cases of ureteric obstruction and spinal cord compression and reduction in glucose tolerance which may manifest as diabetes or loss of glycaemic control in patients with pre-existing diabetes mellitus.
Females: Hot flushes and sweating, change in libido, headaches, mood changes including depression, vaginal dryness, change in breast size, degeneration of fibroids and formation of ovarian cysts.

Presentation:

A sterile implant/depot containing goserelin 10.8mg (as acetate).

For further information please contact the local AstraZeneca subsidiaries.

Date of preparation: February 2008