SIMPONI 45 mg/0.45 mL Solution for injection in pre-filled pen Ref.[116710] Active ingredients: Golimumab

Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated. Patients treated with Simponi should be given the Patient Card which is included in the pack.

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.

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.

Table 1. Simponi dose in millilitres (mL) by height and weight of patients with pJIA:

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 50 mg pre-filled pen or pre-filled syringe SmPC.

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.

Ulcerative colitis

Paediatric ulcerative colitis (pUC) in children 2 years of age and older with a body weight of at least 15 kg

The recommended dose of Simponi for patients from 2 to 17 years of age with ulcerative colitis is based on body weight.

For patients with body weight of at least 15 kg to less than 40 kg who are in remission at or after week 54, the physician may consider decreasing the maintenance dose to 25 mg every 4 weeks. To administer this dose, the 45 mg pre-filled pen is available. The prescribed volume of injection to meet this dose is 0.25 mL

For induction and maintenance treatment a 50 mg pre-filled syringe or 100 mg pre-filled syringe is available. For the posology of the 50 mg or 100 mg dosing regimen, see section 4.2 of the Simponi 50 mg or 100 mg pre-filled syringe SmPC.

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

There is no relevant use of Simponi in children aged less than 2 years in pJIA or pUC.

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. Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.

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.

2 years.

Store in a refrigerator (2°C–8 °C).

Do not freeze.

Keep the pre-filled pen 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 45 mg/0.45 mL solution for injection:

0.45 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. Each pre-filled pen can deliver 0.1 mL to 0.45 mL in increments of 0.05 mL.

Pack size of 1 pre-filled pen.

Simponi is supplied in a single use pre-filled pen. Each pack is provided with instructions for use that fully describe the use of the pen. After removing the pre-filled pen from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi. The pen 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 are included in the pack.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.