Dosing TOFIDENCE
Dosing TOFIDENCE for IV infusions1
Dosing of TOFIDENCE is based on each patient’s weight and the indication for which they are treated. The treatment frequency varies by indication.
Vials are not actual sizes.
TOFIDENCE treatment is to be initiated and supervised by qualified healthcare professionals experienced in the diagnosis and treatment of RA, pJIA, sJIA and COVID‑19.
TOFIDENCE is for intravenous administration.
TOFIDENCE infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Patients treated with TOFIDENCE should be given the package leaflet and the patient reminder card.
| Indication | Dosage | Once every 4 weeks or 2 weeks |
|---|---|---|
| Moderate-to-severe RAa (Adult patients aged 18 years and older) |
8 mg/kg | 4-weeks |
| pJIAb (Patients aged 2-17 years) |
<30 kg: 10 mg/kg | 4-weeks |
| ≥30 kg: 8 mg/kg | 4-weeks | |
| sJIAb (Patients aged 2-17 years) |
<30 kg: 12 mg/kg | 2-weeks |
| ≥30 kg: 8 mg/kg | 2-weeks | |
| COVID-19a (Adult patients aged 18 years and older) |
8 mg/kg | One-time treatmentc |
Dose adjustments must be made in patients with laboratory abnormalities such as liver enzyme abnormalities, low absolute neutrophil count (ANC) and low platelet count. Please refer to sections 4.2 and 4.4 of the Summary of Product Characteristics.
All patients treated with tocilizumab should be given the Patient Alert Card.
a For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended.
b The dose should be calculated based on the patient’s body weight at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time.
c If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion of tocilizumab 8 mg/kg may be administered. The interval between the two infusions should be at least 8 hours.
Dosing TOFIDENCE in adults1
Moderate-to-severe rheumatoid arthritis
The recommended posology is 8 mg/kg body weight, given once every 4 weeks.
For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended (see sections 4.2 and 5.2 of the Summary of Product Characteristics).
Doses above 1.2 g have not been evaluated in clinical studies (see sections 4.2 and 5.1 of the Summary of Product Characteristics).
For dose adjustments due to laboratory abnormalities values, please see sections 4.2 and 4.4 of the Summary of Product Characteristics.
Dosing TOFIDENCE in children and adolescents1
Polyarticular juvenile idiopathic arthritis
The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg. The dose should be calculated based on the patient’s body weight at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time.
The safety and efficacy of intravenous tocilizumab in children below 2 years of age have not been established.
For dose adjustments due to laboratory abnormalities values, please see sections 4.2 and 4.4 of the Summary of Product Characteristics.
Systemic juvenile idiopathic arthritis
The recommended posology in patients above 2 years of age is 8 mg/kg once every 2 weeks in patients weighing greater than or equal to 30 kg or 12 mg/kg once every 2 weeks in patients weighing less than 30 kg. The dose should be calculated based on the patient’s body weight at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time.
The safety and efficacy of intravenous tocilizumab in children below 2 years of age have not been established.
For dose adjustments due to laboratory abnormalities values, please see sections 4.2 and 4.4 of the Summary of Product Characteristics.
Dosing TOFIDENCE in other special populations1
Elderly
No dose adjustment is required in elderly patients >65 years of age.
Renal impairment
No dose adjustment is required in patients with mild renal impairment. Tocilizumab has not been studied in patients with moderate to severe renal impairment (see sections 4.2 and 5.2 of the Summary of Product Characteristics). Renal function should be monitored closely in these patients.
Hepatic impairment
Tocilizumab has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made.
Contraindications1
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics.
Active, severe infections with the exception of COVID‑19 (see section 4.4 of the Summary of Product Characteristics)
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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.
