Gazyva
Generic: Obinutuzumab
Daily Dose:
Course Duration:
Cheaper & Alternative Brands (1000 mg/40 ml)
Same active generic (Obinutuzumab), same form (Injection), exact same strength (1000 mg/40 ml)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Chronic Lymphocytic Leukemia (CLL)
: Gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Follicular Lymphoma (FL)
: Gazyva in combination with chemotherapy, followed
... Read more
Chronic Lymphocytic Leukemia (CLL)
: Gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Follicular Lymphoma (FL)
: Gazyva in combination with chemotherapy, followed by Gazyva maintenance is indicated for the treatment of patients with previously untreated follicular lymphoma. Gazyva in combination with bendamustine, followed by Gazyva maintenance, is indicated for the treatment of patients with FL who did not respond to, or who progressed during or after treatment with rituximab or a rituximab-containing regimen.
Contraindications
Obinutuzumab is contraindicated in patients with a known hypersensitivity to obinutuzumab or to any of the excipients.
Side Effects & Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label:
Hepatitis B reactivation
Progressive multifocal leukoencephalopathy
Infusion reactions
Tumor lysis syndrome
Infections
Neutropenia
Thrombocytopenia
Warnings & Precautions
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Pharmacology & 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 lysisthrough (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 (ADCC) and antibodydependent cellular phagocytosis.
As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines. Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab. Obinutuzumab binds to FcγRIII using purified proteins with a higher affinity than rituximab. Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.