ELIGARD ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 45MG [SIN14513P]

Product Info

ELIGARD ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 45MG

[SIN14513P]

4.1 Therapeutic indications
ELIGARD is indicated for the palliative treatment of hormone-dependent advanced prostate cancer.

4.2 Posology and method of administration
Posology
Adult Males
ELIGARD should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment.

ELIGARD 7.5 mg is administered as a single subcutaneous injection every month. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate for one month.

ELIGARD 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a three-month period.

ELIGARD 45 mg is administered as a single subcutaneous injection every six months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a six-month period.

As a rule, therapy of advanced prostate cancer with ELIGARD entails long-term treatment and therapy should not be discontinued when remission or improvement occurs.

Response to ELIGARD should be monitored by clinical parameters and by measuring prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone levels increased during the first 3 days of treatment in the majority of non-orchiectomised patients and then decreased to below medical castration levels within 3 – 4 weeks. Once attained, castrate levels were maintained as long as medicinal product therapy continued (<1% testosterone breakthroughs). In case the patient’s response appears to be sub-optimal, it should be confirmed that serum testosterone levels have reached or are remaining at castrate levels. As lack of efficacy may result from incorrect preparation, reconstitution, or administration, testosterone levels should be evaluated in cases of suspected or known handling errors (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy in children aged 0 to 18 years have not been established (see also section 4.3).

Specific Patient Populations
No clinical studies were performed in patients with either liver or kidney impairment.

Method of administration
ELIGARD should be prepared, reconstituted and administered only by healthcare professionals who are familiar with these procedures. Instructions for reconstitution and administration must be strictly followed (see section 4.4 and 6.6. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If the product is not prepared appropriately, it should not be administered.

The contents of the two pre-filled sterile syringes must be mixed immediately prior to administration of ELIGARD by subcutaneous injection.

Based on data from animal experience, intra-arterial or intravenous injection, respectively, has to be strictly avoided.

As with other medicinal products administered by subcutaneous injection, the injection site should be varied periodically. The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair. In clinical trials, the injection was administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (e.g. with a belt or clothing waistband).

4.3 Contraindications
ELIGARD is contraindicated in women and in paediatric patients.

Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

In patients who previously underwent orchiectomy (as with other GnRH agonists, ELIGARD does not result in further decrease of serum testosterone in case of surgical castration).

As sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).