Name of the medicinal product
□ Obetuzumab Beta Injection
Posology and method of administration
□ The recommended dose is 1000 mg administered intravenously, given on Day 1 of Week 1,
Week 3, Week 25 and Week 27.
Subsequent doses should be administered every 26 weeks.
□ Following the initiation of the first dose of obetuzumab beta, concomitant oral glucocorticoid
therapy for up to 8 weeks is required:
Prednisone 20 mg daily (or an equivalent dose of another oral glucocorticoid) for 4 weeks, followed
by a tapering period of no more than 4 weeks.
Therapeutic indications
□ This product is indicated for the treatment of adult patients with neuromyelitis optica spectrum
disorder (NMOSD) who are positive for anti‑aquaporin 4 (AQP4) antibodies.
Special precautions for storage
□ Store and transport at 2 °C to 8 °C, protected from light.
□ Do not freeze.
Do not shake.
Strength
□ 200 mg (8 mL) per vial
Shelf life
□ 18 months
