SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/1.0 ML (SMARTJECT INJECTOR) [SIN14735P]

Product Info

SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/1.0 ML (SMARTJECT INJECTOR)

[SIN14735P]

4.1 Therapeutic Indications

Rheumatoid arthritis (RA)
Simponi®, by subcutaneous (SC) administration, in combination with methotrexate (MTX), is indicated for:

• the treatment of adult patients with moderately to severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including MTX has been inadequate.

• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

(see clinical efficacy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis (pJIA)
Simponi® in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.

Psoriatic arthritis (PsA)
Simponi®, by subcutaneous (SC) administration, alone or in combination with methotrexate, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Simponi® has also been shown to inhibit the progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and improve physical function.

Axial spondyloarthritis
Ankylosing spondylitis (AS)
Simponi®, by subcutaneous (SC) administration, is indicated for the treatment of active ankylosing spondylitis in adult patients who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis (nr-Axial SpA)
Simponi®, by subcutaneous (SC) administration, 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).

Ulcerative Colitis (UC)
Simponi®, by subcutaneous (SC) administration, 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.

4.2 Posology and method of administration

Simponi® 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.

Posology

Rheumatoid arthritis
Simponi® 50 mg given once a month, on the same date each month.
Simponi® should be given concomitantly with MTX.

Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis
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 bodyweight 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 drug reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.

Ulcerative colitis
Patients with body weight less than 80 kg
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with body weight greater than or equal to 80 kg
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Missed dose
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:

• if the dose is less than 2 weeks late, the patient should inject his/her forgotten dose and stay on his/her original schedule.

• if the dose is more than 2 weeks late, the patient should inject his/her forgotten dose and a new schedule should be established from the date of this injection.

Special populations
Elderly patients (≥ 65 years)
No dosage adjustment is required in the elderly.

Renal and hepatic impairment
Simponi® has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population
The safety and efficacy of Simponi® in patients aged less than 18 for indications other than pJIA have not been established.

Polyarticular juvenile idiopathic arthritis
Simponi® 50 mg administered once a month, on the same date each month, for children with a body weight of at least 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.

Method of Administration
Simponi® is for subcutaneous use. After proper training in subcutaneous injection technique, patients may self-inject with Simponi® 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 administration provided in the package leaflet. If multiple injections are required, the injections should be administered at different sites on the body.

For preparation and administration instructions, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Concurrent administration of Simponi® with anakinra or abatacept (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Active tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Moderate or severe heart failure (NYHA class III/IV) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).