SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED PEN 45MG/0.45ML [SIN16118P]

Product Info

SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED PEN 45MG/0.45ML

[SIN16118P]

4.1 Therapeutic indications

Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis (pJIA)
Simponi in combination with methotrexate (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.

4.2 Posology and method of administration

Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated.

Posology

The 45 mg/0.45 mL pre-filled pen is for paediatric patients. Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.

Paediatric population

Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg
The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m² body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month. The prescribed volume of injection should be selected according to patient’s height and weight as shown in Table 1.

Polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg
For children with body weight of at least 40 kg, a 50 mg pre-filled pen or pre-filled syringe is available. For the posology of the 50 mg dosing regimen, see section 4.2 of the Simponi Solution for Injection in Pre-filled Syringe 50mg/0.5ml Product Insert.

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.

There is no relevant use of Simponi in patients aged less than 2 years for the indication of pJIA.

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 the forgotten dose and stay on the original schedule.

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

Special populations
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 golimumab have not been established in patients with pJIA below the age of 2 years. No data are available.

Method of administration
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 prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack.

For 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 (TB) 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).