What is the vial size of Ogivri (trastuzumab)?

Ogivri Vial Sizes

Ogivri (trastuzumab-dkst) is available in two vial sizes: 150 mg single-dose vials and 420 mg multiple-dose vials. 1

Available Formulations

150 mg Single-Dose Vial

• Contains: 150 mg trastuzumab-dkst per vial 1
• Type: Single-dose vial - discard unused portion 1
• NDC: 83257-001-11 1
• Packaging: Each carton contains one single-dose vial only (no diluent provided) 1

420 mg Multiple-Dose Vial

• Contains: 420 mg trastuzumab-dkst per vial 1
• Type: Multiple-dose vial 1
• NDC Options:
  • 83257-004-12 (includes 20 mL Bacteriostatic Water for Injection with 1.1% benzyl alcohol) 1
  • 83257-003-01 (vial only, no diluent provided) 1
• Reconstitution: When reconstituted with 20 mL BWFI, yields 21 mg/mL concentration delivering 20 mL (420 mg total) 1
• Stability after reconstitution: Store refrigerated at 2° to 8°C; discard unused solution after 28 days 1

Storage Requirements

• All vials must be stored refrigerated at 2° to 8°C (36° to 46°F) until reconstitution 1
• Do not freeze 1
• Do not shake after reconstitution 1

Clinical Context

The dosing regimens for trastuzumab typically involve either weekly dosing (loading dose 4 mg/kg IV followed by 2 mg/kg IV weekly) or every-3-week dosing (loading dose 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks) 2, 3. The 420 mg multiple-dose vial is particularly suited for the weekly maintenance dosing regimen given its 28-day stability after reconstitution 1.