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SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.
SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.
SIMPONI is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for:
DOSAGE AND ADMINISTRATION
Dosage In Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
The SIMPONI dose regimen is 50 mg administered by subcutaneous 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 nonbiologic Disease-Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with SIMPONI.
Dosage In Moderately To Severely Active Ulcerative Colitis
The recommended SIMPONI induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.
Monitoring To Assess Safety
Prior to initiating SIMPONI and periodically during therapy, evaluate patients for active tuberculosis and tested for latent infection [see WARNINGS AND PRECAUTIONS]. Prior to initiating SIMPONI, patients should be tested for hepatitis B viral infection [see WARNINGS AND PRECAUTIONS].
Important Administration Instructions
SIMPONI is intended for use under the guidance and supervision of a healthcare provider. After proper training in subcutaneous injection technique, a patient may self-inject with SIMPONI if a physician determines that it is appropriate. Instruct patients to follow the directions provided below [see Instructions For Use]:
- 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 is clear to slightly opalescent and colorless to light yellow. Do not use SIMPONI, if the solution is discolored, or cloudy, or if foreign particles are present.
- Do not use any leftover product remaining in the prefilled syringe or prefilled autoinjector.
- Instruct patients sensitive to latex not to handle the needle cover on the prefilled syringe or the needle cover of the prefilled syringe within the autoinjector cap because it contains dry natural rubber (a derivative of latex).
- At the time of dosing, if multiple injections are required, administer the injections at different sites on the body.
- Rotate injection sites and never give injections into areas where the skin is tender, bruised, red, or hard.
Dosage Forms And Strengths
The SIMPONI dosage form is for subcutaneous injection. SIMPONI is available in 50-mg and 100-mg strengths.
- Each 50-mg single-dose SmartJect autoinjector contains a prefilled glass syringe (27-gauge ½-inch) providing 50 mg of SIMPONI per 0.5 mL of solution.
- Each 100-mg single-dose SmartJect autoinjector contains a prefilled glass syringe (27-gauge ½-inch) providing 100 mg of SIMPONI per 1 mL of solution.
- Each 50-mg single-dose prefilled glass syringe (27-gauge ½-inch) contains 50 mg of SIMPONI per 0.5 mL of solution.
- Each 100-mg single-dose prefilled glass syringe (27-gauge ½-inch) contains 100 mg of SIMPONI per 1 mL of solution.
Each SIMPONI prefilled autoinjector or prefilled syringe is packaged in a light-blocking, cardboard outer carton. SIMPONI is available in packs of 1 single-dose prefilled syringe or 1 single-dose prefilled SmartJect autoinjector. Both the prefilled syringe and the SmartJect autoinjector are for single use and are not to be divided.
Prefilled SmartJect Autoinjector
Each 50-mg single-dose SmartJect autoinjector contains a prefilled glass syringe (27 gauge ½ inch) providing 50 mg of SIMPONI per 0.5 mL of solution. The NDC number for the 50-mg prefilled SmartJect autoinjector is 57894-070-02.
Each 100-mg single-dose SmartJect autoinjector contains a prefilled glass syringe (27-gauge ½-inch) providing 100 mg of SIMPONI per 1 mL of solution. The NDC number for the 100 mg prefilled SmartJect autoinjector is 57894-071-02.
Each 50-mg single-dose prefilled glass syringe (27-gauge ½-inch) contains 50 mg of SIMPONI per 0.5 mL of solution. The NDC number for the 50-mg prefilled syringe is 57894-070-01.
Each 100-mg single-dose prefilled glass syringe (27-gauge ½-inch) contains 100 mg of SIMPONI per 1 mL of solution. The NDC number for the 100-mg prefilled syringe is 57894-071-01.
Storage And Handling
SIMPONI 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 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.
Manufactured by: Janssen Biotech, Inc. Horsham, PA 19044. Revised: January 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/3/2016
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