Eligard Dosage/Direction for Use

Dosage for 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 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.
ELIGARD may be used as neoadjuvant or adjuvant therapy in combination with radiotherapy in high-risk localised and locally advanced prostate cancer.
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.
In patients with metastatic castration resistant prostate cancer not surgically castrated receiving a GnRH agonist, such as leuprorelin, and eligible for treatment with androgen biosynthesis inhibitors or androgen receptor inhibitors, treatment with a GnRH agonist may be continued.
Paediatric population: Safety and efficacy in children aged 0 to 18 years have not been established (see also Contraindications).
Administration: The contents of the two pre-filled sterile syringes must be mixed immediately prior to administration of ELIGARD by subcutaneous injection.
Regarding the mixing procedure, see Special precautions for disposal and other handling under Cautions for Usage.
Lack of clinical efficacy may occur due to incorrect reconstitution of the product.
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.
Dose Adjustment in Specific Patient Populations: No clinical studies were performed in patients with either liver or kidney impairment.