CAMCEVI

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. Dosage and administration 2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for instructions on the preparation and administration of the injectable emulsion in a pre-filled syringe. ( 2 ) Recommended Dosage: 42 mg subcutaneously every 6 months. ( 2 ) 2.1 Recommended Dosage The recommended dose of CAMCEVI is 42 mg administered subcutaneously once every 6 months. 2.2 Preparation and Administration CAMCEVI must be administered by a healthcare provider. Important: Read the instructions completely before you administer Camcevi for the first time. Do NOT substitute any of the components from the kit for administration. CAMCEVI is packaged in a blister in the kit. Check to make sure the kit contains: One sterile, single-dose pre-filled syringe with plunger rod and backstop One sterile 18-gauge, 5/8-inch needle One Point-Lok ® Needle Protection Device Prescribing Information Follow the detailed instructions to ensure correct preparation of CAMCEVI prior to administration: STEP 1 Remove CAMCEVI kit from refrigerator. Keep the contents in their original, sealed blister carton and allow to sit at room temperature for 30 minutes before use. Return to refrigerator after 30 minutes if not used. STEP 2 On a clean, dry surface, open carton and remove the contents. Examine all contents of the package. Do not use if any component is damaged. Check the expiration date on the syringe. Do not use if the expiration date has passed. The use of gloves is recommended during syringe assembly and administration. STEP 3 Remove pre-filled syringe (A) and needle cartridge (B) from the blister tray. Visually inspect the syringe for particulate matter prior to administration. The emulsion should appear off-white to pale yellow, viscous, and opalescent. Do not use if particulate matter is observed prior to administration. STEP 4 Remove the gray cap from the syringe (A). Twist the clear cap off the bottom of the needle cartridge (B). Attach the needle (B) to the end of the syringe (A) by pushing and turning the needle until firmly connected to the syringe. Do not over twist the needle and strip the threading. See figure of assembled pre-filled syringe below. STEP 5 Choose an injection site on the upper- or mid-abdominal area with sufficient soft or loose subcutaneous tissue that has not recently been used. Clean the injection site with an alcohol swab. Do NOT inject in areas with brawny or fibrous subcutaneous tissue or locations that can be rubbed or compressed (i.e., with a belt or clothing waistband). In addition, avoid applying heat directly to the site of Camcevi injection. STEP 6 Pull the blue cover off the needle (B). Use standard sharps safety techniques to avoid needle sticks. STEP 7 Use standard aseptic technique when performing the injection. Grab and bunch the skin around the injection site with one hand. Insert the needle at a 90° angle to the skin surface, and then release the bunched skin. STEP 8 Inject the full contents of the syringe with a slow and steady push on the plunger, and then withdraw the needle at the same 90° angle used for insertion. STEP 9 Do not remove the needle from the syringe. Use the enclosed Point-Lok ® device to prevent needle sticks. Retrieve the Point-Lok ® needle protection device from the Camcevi kit and place it on a secured, flat surface with its largest surface base touching the surface as shown in the diagram. Immediately after use of the needle, gently insert the exposed needle into the Point-Lok ® device opening at the top of the Point-Lok ® device. (see Figure 1) Push the needle into the top opening until it is fully inserted into the Point-Lok ® device. This action will seal the needle tip and lock the needle firmly into the Point-Lok ® device. (see Figure 2) STEP 10 After use, discard all components safely in a suitable sharps container. Dispose of the syringe and contaminated products according to local regulations/procedures. camcevi-inj-image-3 camcevi-inj-image-2 camcevi-inj-image-4 camcevi-inj-image-5 camcevi-inj-image-6 camcevi-inj-image-7 camcevi-inj-image-8 camcevi-inj-image-9 Warnings and cautions 5 WARNINGS AND PRECAUTIONS Tumor Flare: Transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer may develop during the first few weeks of treatment. Monitor patients closely and manage symptoms. ( 5.1 ) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose levels and manage according to current clinical practice. ( 5.2 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death, and s