Table 4.
High-dose subcutaneous single-active mAb formulations and fixed-dose combinations authorized for the treatment oncological indications in the US (up until September 2022): administration routes, dosing regimens and product presentations
| mAb | Administration route and dosing regimena | IV product presentationsa | SC product presentationsa | |
|---|---|---|---|---|
| IV | SC | |||
| Trastuzumab |
Adjuvant HER2 + BC: Loading dose: 4 mg/kg Maintenance dose: 2 mg/kg q1w for 12 weeks followed by 6 mg/kg q3w to complete a total of 52 weeks or Loading dose: 8 mg/kg Maintenance dose: 6 mg/kg q3w for 52 weeks HER2 + mBC: Loading dose: 4 mg/kg Maintenance dose: 2 mg/kg q1w HER2 + GC: Loading dose: 8 mg/kg Maintenance dose: 6 mg/kg q3w |
HER2 + BC: 600 mg trastuzumab and 10,000 units hyaluronidase q3w |
150 mg lyophilized powder in single-dose vial 420 mg lyophilized powder in single-dose vial |
600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL solution in single-dose vial |
| Rituximab |
NHL: 375 mg/mb (indication-dependent schedule) CLL: Cycle 1: 375 mg/mb Cycles 2 − 6: 500 mg/mb q28d |
The first dose is administered IV NHL: 1400 mg rituximab and 23,400 units hyaluronidase (indication-dependent schedule) CLL: 1600 mg rituximab and 26,800 units hyaluronidase (indication-dependent schedule) |
100 mg/10 mL solution in single-dose vial 500 mg/50 mL solution in single-dose vial |
1400 mg rituximab and 23,400 units hyaluronidase human per 11.7 mL solution in single-dose vial 1600 mg rituximab and 26,800 units hyaluronidase human per 13.4 mL solution in single-dose vial |
| Daratumumab |
MM: 16 mg/kg; may be split over two consecutive days with 8 mg/kg on day 1 and day 2 (indication-dependent schedule) |
MM: 1800 mg daratumumab and 30,000 units hyaluronidase (indication-dependent schedule) |
100 mg/5 mL solution in single-dose vial 400 mg/20 mL solution in single-dose vial |
1800 mg daratumumab and 30,000 units hyaluronidase per 15 mL solution in single-dose vial |
| Pertuzumab |
Adjuvant HER2 + BC: Loading dose: 840 mg Maintenance dose: 420 mg q3w (combination with trastuzumab IV or SC) for up to 18 cycles Neo-adjuvant HER2 + BC: Loading dose: 840 mg Maintenance dose: 420 mg q3w (combination with trastuzumab IV or SC) for 3 to 6 cycles HER2 + mBC: Loading dose: 840 mg Maintenance dose: 420 mg q3w |
- | 420 mg/14 mL in single-dose vial | - |
| Pertuzumab + trastuzumab FDC | For single-active formulations see above |
Adjuvant HER2 + BC: Loading dose: 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase Maintenance dose: 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase for up to 18 cycles Neo-adjuvant HER2 + BC: Loading dose: 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase Maintenance dose: 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase for 3 to 6 cycles HER2 + mBC: Loading dose: 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase Maintenance dose: 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase |
For single-active formulations see above |
1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase/15 mL in single-dose vial 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase/10 mL in single-dose vial |
| Nivolumab |
Various cancer indications: Indication-dependent dose and schedule |
- | 40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL, and 240 mg/24 mL solution in single-dose vial | - |
| Relatlimabb | - | - | - | - |
| Nivolumab + relatlimab FDC |
UMM: 480 mg nivolumab and 160 mg relatlimab q4w (adverse event-dependent dose modifications) |
- | 240 mg of nivolumab and 80 mg of relatlimab per 20 mL in single-dose vial | - |
CLL chronic lymphocytic leukemia, FDC fixed-dose combination, HER2 + BC HER2-overexpressing breast cancer, HER2 + GC HER2-overexpressing gastric cancer, HER2 + mBC metastatic, HER2 + BC HER2-overexpressing breast cancer, IVintravenous, mg milligram, mL milliliter, MM multiple myeloma, NHL non-Hodgkin’s lymphoma, qXd every X day, qXm, every X month, qXw every X week, SC subcutaneous, UMM unresectable or metastatic melanoma
aThis table lists FDA-approved products
bRelatlimab is only available in the FDC with nivolumab