ZOLADEX DEPOT INJECTION 3.6 MG/SYRINGE [SIN01506P]

Product Info

ZOLADEX DEPOT INJECTION 3.6 MG/SYRINGE

[SIN01506P]

4.1 Therapeutic indications

1. Prostate cancer: ZOLADEX 3.6 mg is indicated in the management of prostate cancer suitable for hormonal manipulation.

2. Breast cancer: ZOLADEX 3.6 mg is indicated in the management of breast cancer in premenopausal and perimenopausal women suitable for hormonal manipulation.

3. Endometriosis: In the management of endometriosis, ZOLADEX 3.6 mg alleviates symptoms, including pain, and reduces the size and number of endometrial lesions.

4. Endometrial thinning: ZOLADEX 3.6 mg is indicated for the prethinning of the uterine endometrium prior to endometrial ablation or resection.

5. Uterine fibroids: In conjunction with iron therapy in the haematological improvement of anaemic patients with fibroids, prior to surgery.

6. Assisted reproduction: Pituitary downregulation in preparation for superovulation.

4.2 Posology and method of administration

Caution should be taken while inserting ZOLADEX 3.6 mg into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.

Use extra care when administering ZOLADEX 3.6 mg to patients with a low body mass index and/or who are receiving full anticoagulation medication.

For correct administration of ZOLADEX 3.6 mg, see instructions on instruction card – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Adults

One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall, every 28 days.

Assisted reproduction: ZOLADEX 3.6 mg is administered to downregulate the pituitary gland, as defined by serum oestradiol levels similar to those observed in the early follicular phase (approximately 150 pmol/l). This will usually take between 7 and 21 days.

When downregulation is achieved, superovulation (controlled ovarian stimulation) with gonadotrophin is commenced. The downregulation achieved with a depot agonist is more consistent suggesting that, in some cases, there may be an increased requirement for gonadotrophin. At the appropriate stage of follicular development, gonadotrophin is stopped and human chorionic gonadotrophin (hCG) is administered to induce ovulation. Treatment monitoring, oocyte retrieval and fertilisation techniques are performed according to the normal practice of the individual clinic.

No dosage adjustment is necessary for patients with renal impairment.

No dosage adjustment is necessary for patients with hepatic impairment.

No dosage adjustment is necessary in the elderly.

Endometriosis should be treated for a period of six months only, since at present there are no clinical data for longer treatment periods. Repeat courses should not be given due to concern about loss of bone mineral density. In patients receiving ZOLADEX 3.6 mg for the treatment of endometriosis, the addition of hormone replacement therapy (a daily oestrogenic agent and a progestogenic agent) has been shown to reduce bone mineral density loss and vasomotor symptoms.

For use in endometrial thinning; two depots to be administered 4 weeks apart, with surgery timed for between zero and two weeks after the second depot.

For women who are anaemic as a result of uterine fibroids, ZOLADEX 3.6 mg depot with supplementary iron may be given for up to three months before surgery.

Children

ZOLADEX 3.6 mg is not indicated for use in children.

4.3 Contraindications

ZOLADEX 3.6 mg should not be given to patients with a known hypersensitivity to the active substance, to other LHRH analogues, or to any excipients of this product.

ZOLADEX 3.6 mg should not be used during pregnancy or lactation.