Not actual size.
For RA, PJIA, and SJIA, TOFIDENCE may be used alone or in combination with methotrexate, and in RA, other DMARDs may be used. Avoid using TOFIDENCE with biological DMARDs.
For GCA, TOFIDENCE can be used alone following discontinuation of glucocorticoids.
Obtain and assess baseline complete blood count (CBC) and liver function tests prior to treatment.
TOFIDENCE is administered as a 60-minute single intravenous drip infusion. Do not administer as an intravenous push or bolus.
RA, GCA, PJIA, and SJIA—It is recommended that TOFIDENCE not be initiated in patients with an ANC below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the ULN.
COVID-19—It is recommended that TOFIDENCE not be initiated in patients with an ANC below 1000 per mm3, platelet count below 50,000 mm3, or ALT or AST above 10 times ULN.
For patients with RA or COVID-19, TOFIDENCE doses exceeding 800 mg/infusion are not recommended.
For patients with GCA, TOFIDENCE doses exceeding 600 mg/infusion are not recommended.
For patients with RA, GCA, COVID-19, and PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
Hold TOFIDENCE treatment if a patient develops a serious infection until the infection is controlled.
Dose modifications are recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia. Interruption of dosing may be needed.
Indication1 | Dosage1 | Dosing Schedule1 |
---|---|---|
Moderately to severely active RA in adult patients with inadequate response to one or more DMARDs | Starting at 4 mg/kg followed by an increase to 8 mg/kg based on clinical response* | Every 4 weeks |
GCA Adult patients |
6 mg/kg | Every 4 weeks, in combination with a tapering course of glucocorticoids† |
PJIA (active)
Patients 2 years of age or older |
Patients weighing <30 kg: 10 mg/kg |
Every 4 weeks |
Patients weighing ≥30 kg: 8 mg/kg |
Every 4 weeks | |
SJIA (active)
Patients 2 years of age or older |
Patients weighing <30 kg: 12 mg/kg |
Every 2 weeks |
Patients weighing ≥30 kg: 8 mg/kg |
Every 2 weeks | |
Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive
or invasive mechanical ventilation, or ECMO |
8 mg/kg | Single dose, one additional dose after 8 hours if needed‡ |
*When used in combination with DMARDs or as monotherapy.
†TOFIDENCE can be used alone following discontinuation of glucocorticoids.
‡If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion of TOFIDENCE may be administered at least 8 hours after the initial infusion.
ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; COVID-19=coronavirus disease 2019; DMARD=disease-modifying anti-rheumatic drug; ECMO=extracorporeal membrane oxygenation; GCA=giant cell arteritis; PJIA=polyarticular juvenile idiopathic arthritis; RA=rheumatoid arthritis; SJIA=systemic juvenile idiopathic arthritis; ULN=upper limit of normal