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Simponi (Golimumab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Rheumatoid Arthritis

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

Psoriatic Arthritis

SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.

Ankylosing Spondylitis

SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.

DOSAGE AND ADMINISTRATION

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

The SIMPONI dose regimen is 50 mg administered by subcutaneous (SC) injection once a month.

For patients with rheumatoid arthritis (RA), SIMPONI should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), SIMPONI may be given with or without methotrexate or other non-biologic DMARDs. For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with SIMPONI.

Monitoring to Assess Safety

Prior to initiating SIMPONI and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [ see Warnings and Precautions ].

General Considerations for Administration

SIMPONI is intended for use under the guidance and supervision of a physician. After proper training in subcutaneous injection technique, a patient may self inject with SIMPONI if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide [ see Medication Guide ]. To ensure proper use, allow the prefilled syringe or autoinjector to sit at room temperature outside the carton for 30 minutes prior to subcutaneous injection. Do not warm SIMPONI in any other way.

Prior to administration, visually inspect the solution for particles and discoloration through the viewing window. SIMPONI should be clear to slightly opalescent and colorless to light yellow. The solution should not be used if discolored, or cloudy, or if foreign particles are present. Any leftover product remaining in the prefilled syringe or prefilled autoinjector should not be used. NOTE: The needle cover on the prefilled syringe as well as the prefilled syringe in the autoinjector contains dry natural rubber (a derivative of latex), which should not be handled by persons sensitive to latex.

Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.

DOSAGE FORMS AND STRENGTHS

SmartJect™ Autoinjector

Each single dose SmartJect autoinjector contains a prefilled glass syringe (27 gauge inch) providing 50 mg of SIMPONI per 0.5 mL of solution.

Prefilled Syringe

Each single dose prefilled glass syringe (27 gauge inch) contains 50 mg of SIMPONI per 0.5 mL of solution.

HOW SUPPLIED/STORAGE AND HANDLING

Each SIMPONI prefilled autoinjector or prefilled syringe is packaged in a light-blocking, cardboard outer carton. SIMPONI is available in packs of 1 prefilled syringe NDC 57894-070-01 or 1 prefilled SmartJect autoinjector NDC 57894-070-02.

Prefilled SmartJect Autoinjector

Each single dose SmartJect autoinjector contains a prefilled glass syringe (27 gauge inch) providing 50 mg of SIMPONI per 0.5 mL of solution.

Prefilled Syringe

Each single dose prefilled glass syringe (27 gauge inch) contains 50 mg of SIMPONI per 0.5 mL of solution.

Storage and Stability

SIMPONI must be refrigerated at 2C to 8C (36F to 46F) 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 beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.

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