GAZYVA (obinutuzumab) injection, for intravenous infusion. Initial U.S. Approval: 2013

GAZYVA (obinutuzumab) injection, for intravenous infusion. Initial U.S. Approval: 2013

INDICATIONS AND USAGE
GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated:
• in combination with chlorambucil, for the treatment of patients withpreviously untreated chronic lymphocytic leukemia.
• in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen.
• in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.
DOSAGE FORMS & STRENGTHS
1000 mg/40 mL (25 mg/mL) single-dose vial
Manufactured By: Genentech
Prescribing Information URL: Click Here

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Obinutuzumab (called afutuzumab until 2009)[1] is a humanized anti-CD20 monoclonal antibody, originated by GlycArt Biotechnology AG and developed by Roche as a cancer treatment.
It can be used as a first-line treatment for chronic lymphocytic leukemia in combination with chemotherapy or with venetoclax, as a first-line treatment for follicular lymphoma in combination with chemotherapy, and as treatment for relapsed or refractory follicular lymphoma in combination with bendamustine chemotherapy.

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