TOFIDENCE treatment must be initiated and supervised by qualified healthcare professionals experienced in the diagnosis and treatment of RA, pJIA, sJIA, and COVID-19. TOFIDENCE should be administered intravenously. All patients treated with tocilizumab should be given the Patient Alert Card.
Recommended infusion time and follow-up in the practice:
TOFIDENCE should be administered intravenously over a 1‑hour period
* Not all pack sizes are available in all countries.
Vials are not actual sizes.
Visually inspect the solution for particulate matter or discoloration prior to administration. Only solutions which are clear to opalescent, colorless to pale yellow, and free of visible particles should be diluted. Use a sterile needle and syringe to prepare TOFIDENCE.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from an infusion bag equal to the volume of TOFIDENCE concentrate required for the patient’s dose (shown in the table below), under aseptic conditions.
Indication/Patient weight | Infusion bag volume | TOFIDENCE concentrate |
Final volume |
---|---|---|---|
pJIA and sJIA patients weighing ≥30 kg and RA patients | 100 mL | 0.4 mL/kg | 100 mL |
pJlA patients weighing <30 kg | 50 mL | 0.5 mL/kg | 50 mL |
sJlA patients weighing <30 kg | 50 mL | 0.6 mL/kg | 50 mL |
COVID-19 | 100 mL | 0.4 mL/kg | 100 mL |
The required amount of tocilizumab concentrate (0.4-0.6 mL/kg) should be withdrawn from the vial and placed in the 50/100 mL infusion bag. This should be a final volume of 50/100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
Administer the infusion solution over a period of at least 1 hour. Do not mix TOFIDENCE with other medicinal agents except those for dilution (see section 6.6 of the Summary of Product Characteristics). After dilution, tocilizumab should be administered as an intravenous infusion over 1 hour. If signs and symptoms of an infusion-related reaction occur, slow or stop the infusion and administer appropriate medication supportive care immediately. Do not store any unused portion of the infusion solution for reuse.
Once the infusion is completed, remove the catheter and dispose of all supplies in accordance with local requirements, clean and bandage the infusion site and check the patient’s vital signs.
In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded. Each TOFIDENCE vial contains 80 mg, 200 mg, or 400 mg of tocilizumab. To calculate the dose and the number of TOFIDENCE vials needed, you can use our dosing calculator.
Patients treated with TOFIDENCE should be given the package leaflet and patient reminder card.
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Abbreviations: COVID-19, Coronavirus disease 2019; IV, intravenous; pJIA, polyarticular juvenile idiopathic arthritis; RA, rheumatoid arthritis; sJIA, systemic juvenile idiopathic arthritis.