CAMCEVI PROLONGED-RELEASE SUSPENSION FOR INJECTION 42 MG PER SYRINGE [SIN17580P]
Active ingredients: LEUPRORELIN MESILATE EQV TO LEUPRORELIN
Last updated on 9 October 2026
Product Info
CAMCEVI PROLONGED-RELEASE SUSPENSION FOR INJECTION 42 MG PER SYRINGE
[SIN17580P]
Product information
Active Ingredient and Strength | LEUPRORELIN MESILATE EQV TO LEUPRORELIN - 42 MG/SYRINGE |
Dosage Form | INJECTION, SUSPENSION, EXTENDED RELEASE |
Manufacturer and Country | FAREVA PAU - FRANCE |
Registration Number | SIN17580P |
Licence Holder | GENSCI SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02AE02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
CAMCEVI is indicated for the palliative treatment of hormone dependent advanced prostate cancer.
Dosing
4.2 Posology and method of administration
Posology
Adult prostate cancer patients
CAMCEVI should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment.
CAMCEVI 42 mg is administered as a single subcutaneous injection every six months. The injected suspension forms a solid medicinal product delivery depot and provides continuous release of leuprorelin over a six-month period.
As a rule, therapy of advanced prostate cancer with leuprorelin entails long-term treatment and therapy should not be discontinued when remission or improvement occurs.
Response to leuprorelin 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 to 4 weeks. Once attained, castrate levels were maintained as long as leuprorelin 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.
Special populations
Renal/hepatic impairment
No clinical studies were performed in patients having either renal or hepatic impairment.
Paediatric population
The safety and efficacy of leuprorelin in children aged 0 to 18 years have not been established (see also section 4.3). No data are available.
Method of administration
CAMCEVI should be administered subcutaneously only by healthcare professionals who are familiar with these procedures. For instructions on administration of the medicinal product, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
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.
Contraindications
4.3 Contraindications
CAMCEVI is contraindicated in women and paediatric patients.
Hypersensitivity to the active substance, 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.
Patients who previously underwent orchiectomy (as with other GnRH agonists, leuprorelin 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).