Table 2 mAbs authorized for the treatment of RA or IBD (CD and UC) in the US (up until September 2022): administration routes, dosing regimens and product presentations (adult indications)
From: Customer-centric product presentations for monoclonal antibodies
Indication | mAb | Administration route and dosing regimena | IV product presentationsa | SC product presentationsa | |
|---|---|---|---|---|---|
IV | SC | ||||
RA | Rituximab | 2*1000 mg separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation (not sooner than every 16 weeks) | -b | 100 mg/10 mL, 500 mg/50 mL in single-dose vials | -b |
Tocilizumab | 4 mg/kg q4w followed by 8 mg/kg q4w based on clinical response | Patients < 100 kg: 162 mg q2w, followed by increase to q1w based on clinical response Patients ≥ 100 kg: 162 mg q1w | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL in single-dose vials | 162 mg/0.9 mL in single-dose prefilled syringe or single-dose prefilled autoinjector | |
Sarilumab | - | 200 mg q2w | - | 150 mg/1.14 mL or 200 mg/1.14 mL solution in single-dose prefilled syringe or prefilled pen | |
IBD | Ustekinumab | Induction: < 55 kg: 260 mg > 55 kg to 85 kg: 390 mg > 85 kg: 520 mg Maintenance: 90 mg 8 weeks after the initial dose, then q8w (SC) | 90 mg 8 weeks after the initial IV induction dose, then q8w | 130 mg/26 mL solution in single-dose vial | 45 mg/0.5 mL or 90 mg/mL solution in single-dose prefilled syringe 45 mg/0.5 mL in single-dose vial |
Vedolizumab | 300 mg at weeks 0, 2 and 6, then q8w | -c | 300 mg of lyophilized powder in single-use 20 mL vial | -c | |
Natalizumab | 300 mg q4w | -d | 300 mg/15 mL solution in single-dose vial | -d | |
RA & IBD | Infliximab | RA: 3 mg/kg at weeks 0, 2 and 6, then q8w (may be increased to 10 mg/kg q8w or to dosing frequency of q4w) CD: 5 mg/kg at weeks 0, 2 and 6, then q8w (may be increased to 10 mg/kg q8w if loss of response) UC: 5 mg/kg at weeks 0, 2 and 6, then q8w | -e | 100 mg of lyophilized powder in single-dose vial | -e |
Adalimumab | - | RA: 40 mg q2w (some patients not receiving methotrexate may benefit from dose increase to 40 mg q1w or 80 mg q2w) CD: 160 mg on day 1 (given in one day or split over two consecutive days); 80 mg on day 15 and 40 mg q2w starting on Day 29 UC: 160 mg on day 1 (given in one day or split over two consecutive days); 80 mg on day 15 and 40 mg q2w starting on Day 29 | - | 80 mg/0.8 mL, 40 mg/0.8 mL, and 40 mg/0.4 mL in single-dose prefilled pen 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL, 10 mg/0.1 mL in single-dose prefilled glass syringe 40 mg/0.8 mL in single-dose glass vial for institutional use only | |
Golimumab | RA: 2 mg/kg at weeks 0 and 4, then q8w | RA: 50 mg q1m UC: 200 mg at week 0, 100 mg at week 2 and then 100 mg q4w | 50 mg/4 mL solution in single-dose vial | 50 mg/0.5 mL in single-dose prefilled syringe or single-dose prefilled autoinjector 100 mg/1.0 mL in single-dose prefilled syringe or single-dose prefilled autoinjector | |
Certolizumab pegol | - | RA: 400 mg initially and at weeks 2 and 4, followed by 200 mg q2w; for maintenance dosing, 400 mg q4w can be considered CD: 400 mg initially and at weeks 2 and 4. If response occurs, 400 mg q4w | - | 200 mg lyophilized powder in single-dose vial 200 mg/mL solution in single-dose prefilled syringe |