Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Simponi, in combination with methotrexate (MTX), is indicated for:
Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis. Patients treated with Simponi should be given the Patient Reminder Card.
Simponi 50 mg given once a month, on the same date each month. Simponi should be given concomitantly with MTX.
Simponi 50 mg given once a month, on the same date each month.
For all of the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Patients with body weight greater than 100 kg
For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter (see section 5.1).
Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter (see section 5.1).
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers. Patients should be instructed not to inject a double dose to make up for the forgotten dose.
The next dose should be administered based on the following guidance:
No dose adjustment is required in the elderly.
Simponi has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. A 45 mg/0.45 mL pre-filled pen is available for administration to children with polyarticular juvenile idiopathic arthritis weighing less than 40 kg.
Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Simponi is for subcutaneous use. After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow-up as necessary. Patients should be instructed to inject the full amount of Simponi according to the comprehensive instructions for use provided in the package leaflet. If multiple injections are required, the injections should be administered at different sites on the body.
For administration instructions, see section 6.6.
Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity. In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.
Shelf life: 24 months.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the pre-filled pen or pre-filled syringe in the outer carton in order to protect it from light. Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton. The new expiry date must be written on the carton (up to 30 days from the date removed from the refrigerator).
Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage. Simponi must be discarded if not used within the 30 days of room temperature storage.
Simponi 50 mg solution for injection in pre-filled pen: 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens.
Simponi 50 mg solution for injection in pre-filled syringe: 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex). Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Simponi is supplied in a single use pre-filled pen called SmartJect or as a single use pre-filled syringe. Each pack is provided with instructions for use that fully describe the use of the pen or the syringe. After removing the pre-filled pen or the pre-filled syringe from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi. The pen or the syringe should not be shaken.
The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for solutions containing protein. Simponi should not be used if the solution is discoloured, cloudy or containing visible foreign particles.
Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen or the pre-filled syringe are given in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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