Kesimpta Ofatumumab Injection

1. Indications and Usage
Chronic Lymphocytic Leukemia (CLL):
Indicated for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab, and those who are refractory to fludarabine and have translocation t(14;14) (Arzerra indication).
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage (CLL):
Cycle 1, Day 1: 300 mg IV. (Second infusion: 1000 mg IV on Day 8).
Cycles 2–7: 1000 mg IV on Day 1 of each cycle.
Schedule: 28-day cycles.
Premedication:
Mandatory premedication with corticosteroids, acetaminophen, and antihistamines prior to each infusion to reduce infusion-related reactions (IRR).
Dilution:
Dilute in 0.9% Sodium Chloride Injection.
3. Mechanism of Action
CD20 Antigen Binding:
Ofatumumab is an IgG1k human monoclonal antibody that binds to a specific epitope on the CD20 antigen (both small and large extracellular loops).
Cytotoxicity:
It induces cell lysis through complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).
4. Safety and Warnings
Infusion-Related Reactions (IRR):
Can be severe, including hypotension, bronchospasm, and angioedema. Most frequent and severe during the first infusion.
Infections:
Increased risk of serious bacterial, viral (including HBV reactivation), and fungal infections.
Hepatitis B Reactivation:
Screening for HBV is required prior to initiation.
Tumor Lysis Syndrome (TLS):
Monitor electrolytes and renal function.
5. Adverse Reactions
Most Common:
Infusion-related reactions, neutropenia, upper respiratory tract infections, cough, pyrexia, and anemia.
6. Drug Interactions
Live Vaccines:
Contraindicated during and after treatment until immune reconstitution.
Immunosuppressants:
Additive immunosuppressive effects.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ofatumumab.
Appearance: Clear, colorless solution.
Storage: Store at 2°C–8°C.