Daily Medication Pearl: Obinutuzumab (Gazyva)

Medication Pearl of the Day: Obinutuzumab (Gazyva)

Indication: Obinutuzumab (Gazyva) is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL); in combination with chemotherapy followed by obinutuzumab alone in patients who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL treatment; and used with bendamustine followed by obinutuzumab alone for FL in adults who did not respond to a rituximab-containing regimen, or whose FL returned.

Insight:

• Dosing: The dose for CLL is 100 mg on day 1 and 900 mg on day 2 of cycle 1, 1000 mg on day 8 and 15 of cycle 1, and 1000 mg on day 1 of cycles 2–6.
• Dosage forms: 1000 mg/40 mL (25 mg/mL) single-dose vial.
• Adverse events: The most common adverse reactions (incidence ≥ 10% and ≥ 2% greater in the obinutuzumab-treated arm) were previously untreated CLL: infusion reactions, neutropenia, thrombocytopenia, and diarrhea.
• Mechanism of action: Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysis through (1) engagement of immune effector cells, (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
• Manufacturer: Genentech

Source:

LABEL (fda.gov)