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SIMPONI ARIA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
DOSAGE AND ADMINISTRATION
The SIMPONI ARIA dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.
SIMPONI ARIA should be given in combination with methotrexate. Other non-biologic DMARDs, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with SIMPONI ARIA.
The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.
Evaluation for Tuberculosis and Hepatitis B Prior to Dosage
Prior to initiating SIMPONI ARIA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see WARNINGS AND PRECAUTIONS]. Prior to initiating SIMPONI ARIA, test patients for hepatitis B viral infection [see WARNINGS AND PRECAUTIONS].
Important Administration Instructions
SIMPONI ARIA solution for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:
- Calculate the dosage and the number of SIMPONI ARIA vials needed based on the recommended dosage of 2 mg/kg and the patient's weight. Each 4 mL vial of SIMPONI ARIA contains 50 mg of golimumab.
- Check that the solution in each vial is colorless to light yellow and opalescent. 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.
- Dilute the total volume of the SIMPONI ARIA solution with 0.9% w/v sodium chloride for infusion to a final volume of 100 ml. For example, this can be accomplished by withdrawing a volume of the 0.9% w/v sodium chloride solution from the 100-mL infusion bag or bottle equal to the total volume of SIMPONI ARIA. Slowly add the total volume of SIMPONI ARIA solution to the 100-mL infusion bag or bottle. Gently mix. Discard any unused solution remaining in the vials.
- Prior to infusion, visually inspect the diluted SIMPONI ARIA solution for particulate matter or discoloration. Do not use if these exist.
- Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer or less).
- Do not infuse SIMPONI ARIA concomitantly in the same intravenous line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI ARIA with other intravenous agents in the same intravenous line.
- Infuse the diluted solution over 30 minutes.
- Once diluted, the infusion solution can be stored for 4 hours at room temperature.
Dosage Forms And Strengths
Injection: 50 mg of golimumab per 4 mL of solution (12.5 mg of golimumab per mL) in each vial.
Storage And Handling
SIMPONI ARIA is available in packs of 1 vial NDC 57894-350-01
Each vial contains 50 mg of SIMPONI ARIA per 4 mL of solution.
Storage and Stability
SIMPONI ARIA must be refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI ARIA beyond the expiration date (EXP) on the vial label.
Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland. Revised: July 2013
Last reviewed on RxList: 8/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Simponi Aria Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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