May 25, 2017
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Simponi Aria

"Research funded in part by the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases has identified an enzyme that modulates inflammation and joint damage in rheumatoid arthritis. The results, which appeared in the journal, "...


Simponi Aria

How Supplied


Rheumatoid Arthritis

SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.


Rheumatoid Arthritis

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:

  1. 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.
  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 ARIA 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 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. Alternatively, SIMPONI ARIA 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 ARIA solution for particulate matter or discoloration. Do not use if these exist.
  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 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.
  7. Infuse the diluted solution over 30 minutes.
  8. Once diluted, the infusion solution can be stored for 4 hours at room temperature.


Dosage Forms And Strengths

Injection: 50 mg/4 mL colorless to light yellow solution (12.5 mg/mL) in a single-use vial.

Storage And Handling

SIMPONI ARIA (golimumab) Injection is a colorless to light yellow solution available in packs of 1 vial NDC 57894-350-01.


Each single-use 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.

Manufactured by: Janssen Biotech, Inc. Horsham, PA 19044. Revised: Jan 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/6/2017

How Supplied

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