Table 3.
mAb | Administration route and dosing regimena | IV product presentationsa | SC product presentationsa | |
---|---|---|---|---|
IV | SC | |||
Natalizumab | 300 mg q4w | -b | 300 mg/15 mL in single-dose vial | -b |
Alemtuzumab |
Initial treatment (2 courses): First course of 12 mg/day on 5 consecutive days; second course of 12 mg/day on 3 consecutive days 12 months after first treatment course Subsequent treatment courses: 12 mg/day on 3 consecutive days as needed, at least 12 months after the previous course |
- | 12 mg/1.2 mL in single-dose vial | - |
Ocrelizumab |
Start dose: 2*300 mg separated by two weeks Subsequent doses: 600 mg q6m |
- | 300 mg/10 mL in single-dose vial | |
Ofatumumab | - |
Initial dosing: 20 mg administered at weeks 0, 1, and 2 Subsequent dosing: 20 mg q1m starting at week 4 |
- | 20 mg/0.4 mL solution in single-dose prefilled pen or single-dose prefilled syringe |
IV intravenous, mg milligram, mL milliliter, qXd every X day, qXm every X month, qXw every X week, SC subcutaneous
aThis table lists FDA-approved products; deviations with EMA-approved product presentations are indicated as a footnote
bA SC formulation for natalizumab in MS is approved in the EU