Simponi® I.V. Concentrate for Solution for Infusion 12.5mg/1 ml

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INFUSION, SOLUTION CONCENTRATE

**2 DOSAGE AND ADMINISTRATION** **2.1 Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis** The SIMPONI® I.V. dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI® I.V. \[ _see Dosage and Administration (2.4)_\]. For patients with rheumatoid arthritis (RA), SIMPONI® I.V. should be given in combination with methotrexate. The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established. **2.2 Dosage in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis** The SIMPONI® I.V. dosage regimen, based on body surface area (BSA), is 80 mg/m2 given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI® I.V. _\[see Dosage and Administration (2.4)\]._ **2.3 Evaluation for Tuberculosis and Hepatitis B Prior to Dosage** Prior to initiating SIMPONI® I.V. and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection _\[see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Prior to initiating SIMPONI® I.V., test patients for hepatitis B viral infection _\[see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.4 Important Administration Instructions** SIMPONI® I.V. solution for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows: 1. Calculate the dosage and the number of SIMPONI® I.V. vials needed based on the recommended adult dosage of 2 mg/kg and the patient’s weight for RA, PsA and AS. Calculate the dosage and number of SIMPONI® I.V. vials needed based on the recommended pediatric dosage of 80 mg/m2 and the patient’s body surface area (BSA), for pJIA and pediatric patients with PsA. Each 4 mL vial of SIMPONI® I.V. contains 50 mg of golimumab. 2. Check that the solution in each vial is colorless to light yellow. The solution may develop a few fine translucent particles, as golimumab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present. 3. Dilute the total volume of the SIMPONI® I.V. solution with 0.9% Sodium Chloride Injection, USP to a final volume of 100 mL. For example, this can be accomplished by withdrawing a volume of the 0.9% Sodium Chloride Injection, USP from the 100-mL infusion bag or bottle equal to the total volume of SIMPONI® I.V.. Slowly add the total volume of SIMPONI® I.V. solution to the 100-mL infusion bag or bottle. Gently mix. Discard any unused solution remaining in the vials. Alternatively, SIMPONI® I.V. can be diluted using the same method described above with 0.45% Sodium Chloride Injection, USP. 4. Prior to infusion, visually inspect the diluted SIMPONI® I.V. solution for particulate matter or discoloration. Do not use if these are present. 5. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer or less). 6. Do not infuse SIMPONI® I.V. concomitantly in the same intravenous line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI® I.V. with other intravenous agents in the same intravenous line. 7. Infuse the diluted solution over 30 minutes. 8. Once diluted, the infusion solution can be stored for up to 4 hours at room temperature.