Gazyva® (obinutuzumab) injection - 1,000mg/40mL
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Gazyva®

Understanding Gazyva®
Gazyva® (obinutuzumab) is a monoclonal antibody used to treat certain blood cancers and autoimmune kidney disease. It is indicated for adults with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and active lupus nephritis, in combination with specified background therapies depending on the condition.

How Gazyva® Works:

  • Targets CD20‑positive B cells: Gazyva® is a CD20‑directed cytolytic monoclonal antibody that binds to the CD20 antigen on B lymphocytes.
  • Leads to B‑cell depletion: Binding to CD20 triggers B‑cell lysis through mechanisms such as antibody‑dependent cell‑mediated cytotoxicity and complement‑dependent cytotoxicity, reducing malignant or disease‑driving B cells.
  • Administered by intravenous infusion: Gazyva® is supplied as an injection, solution, concentrate for intravenous use and is given as an IV infusion by healthcare professionals.
  • Used with other therapies: It is used with chlorambucil for previously untreated CLL, with bendamustine or other chemotherapy regimens in certain types of FL, and with background immunosuppressive therapy in adults with active lupus nephritis.

FDA Approval:

2013 –  Gazyva (obinutuzumab) injection for intravenous use received its initial U.S. approval in 2013.

2025 – The FDA label lists Lupus Nephritis (1.3) as a recent major change in 10/2025, reflecting an expanded indication for adults with active lupus nephritis.

For more information, please visit the Gazyva® patient website. Speak with your healthcare provider to determine if Gazyva® is the right treatment option for you.

Referral Form:
WHAT IT TREATS:
MANUFACTURER:

Genentech

CLASS:
CD20‑directed cytolytic monoclonal antibody
PRESCRIBED BY:
HOW ADMINISTERED:
Infusion
FREQUENCY:
Frequency for Chronic Lymphocytic Leukemia (CLL)

Gazyva is given in 6 treatment cycles, each lasting 28 days.

Cycle 1 (28 days) — More frequent dosing

  • Day 1: 100 mg
  • Day 2: 900 mg
  • Day 8: 1,000 mg
  • Day 15: 1,000 mg (These split doses reduce infusion‑related reactions.)

Cycles 2–6 (28‑day cycles) — Once per cycle

  • Day 1 of each cycle: 1,000 mg IV infusion

Total treatment duration for CLL is about 6 months.

Frequency for Follicular Lymphoma (FL)

Induction phase (with chemotherapy):

  • Gazyva is given in 6 or 8 treatment cycles in combination with chemotherapy.
  • Each cycle is typically 28 days (cycle length is aligned to the chemotherapy regimen).
  • Within those cycles, Gazyva is given on specific days, but the key frequency pattern is:
    • Regular infusions during each 28‑day cycle for 6–8 cycles.

Maintenance phase (monotherapy):

  • For patients who achieve a complete or partial response to the initial 6 or 8 cycles, Gazyva 1,000 mg is then given alone (monotherapy) once every 2 months for up to 2 years.
  • Monotherapy is started about 2 months after the last induction dose, and then:
    • 1 infusion every 2 months
    • For a total maintenance duration of up to 2 years
Frequency for Lupus Nephritis

4 infusions in the first year, then 2 infusions per year (every 6 months) after that

Length of infusion:
3 - 5 hours
FOR MORE INFORMATION:

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