Obinutuzumab Injection
Obinutuzumab injection (Gazyva) is a targeted antibody used to treat chronic lymphocytic leukemia, follicular lymphoma, and active lupus nephritis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Gazyva carries two critical warnings that apply to all patients.
Hepatitis B reactivation: Gazyva can cause a dormant (inactive) hepatitis B virus infection to become active again — even in people who were told their hepatitis B was resolved. This reactivation can lead to severe liver damage, liver failure, and death. Every patient must be tested for hepatitis B before starting treatment. If you test positive for past or current infection, your doctors will monitor you closely and may prescribe antiviral medicine. Watch for signs of liver problems: yellowing of the skin or eyes, unusual tiredness, or dark urine — and report them immediately.
Progressive multifocal leukoencephalopathy (PML): A rare but serious and potentially fatal brain infection caused by the JC virus has been reported in patients taking Gazyva. Symptoms can include new or worsening confusion, memory problems, difficulty walking, vision changes, or weakness on one side of the body. Tell your doctor right away if you notice any new neurological symptoms.
📖 Obinutuzumab Injection: Patient Information Guide
A plain-language walkthrough of Obinutuzumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Obinutuzumab injection is a targeted antibody treatment approved for blood cancers and an immune-related kidney disease. All approved uses in the U.S. are for the brand Gazyva, given intravenously.
- Chronic lymphocytic leukemia (CLL): Gazyva is used in combination with chlorambucil for adults with CLL who have not previously been treated.
- Follicular lymphoma — relapsed or refractory: Gazyva is used in combination with bendamustine, followed by Gazyva alone as maintenance, for adults whose follicular lymphoma came back or stopped responding to a rituximab-containing regimen.
- Follicular lymphoma — previously untreated (advanced stage): Gazyva is used with chemotherapy for adults with previously untreated stage II bulky, III, or IV follicular lymphoma, followed by Gazyva alone as maintenance for patients who achieve at least a partial response.
- Active lupus nephritis: Gazyva is used for adults with active lupus nephritis who are already receiving standard therapy for the condition.
⚙️How it works▾
Obinutuzumab is a monoclonal antibody — a precisely engineered protein — that targets a molecule called CD20 on the surface of B lymphocytes (a type of white blood cell). In CLL and follicular lymphoma, these B cells are cancerous. In lupus nephritis, overactive B cells drive an immune attack on the kidneys. Once obinutuzumab binds to CD20, it destroys these cells in three ways: it flags them for attack by immune effector cells (through a process called antibody-dependent cellular cytotoxicity), it triggers the cells' own internal death program, and it activates a protein cascade called the complement system that punches holes in the cell membrane.
Compared to the related drug rituximab, obinutuzumab has a modified structure that gives it stronger immune-cell-recruiting activity and a greater ability to trigger direct cell death, which may enhance its effectiveness.
💊How it's taken▾
Gazyva is given only as an intravenous (IV) infusion in a clinical or hospital setting — never self-administered at home. The dosing schedule varies by condition:
- CLL: Given over six 28-day cycles; the first cycle involves multiple infusions (split across the first two days, then additional doses on days 8 and 15), followed by one infusion per cycle for cycles 2–6.
- Follicular lymphoma: Given over 6–8 treatment cycles with infusions on days 1, 8, and 15 of the first cycle, then once per cycle, followed by maintenance infusions once every two months for up to two years.
- Lupus nephritis: Given at the first infusion, again two weeks later, then at around months 6 and 6.5, and every 6 months after that.
Pre-medications are required before every infusion. If a dose is missed, contact your care team right away — do not skip to the next scheduled dose without guidance.
🤒Side effects — in detail▾
The most common side effects reported with Gazyva include:
- Infusion-related reactions — fever, chills, nausea, flushing, low or high blood pressure, headache, or shortness of breath, most often during the first infusion
- Neutropenia (dangerously low white blood cell counts, raising infection risk)
- Thrombocytopenia (low platelet counts, raising bleeding risk)
- Fatigue
- Upper respiratory tract infections and cough
- Diarrhea or constipation
- Urinary tract infections
- Fever (pyrexia)
Serious reactions — including severe infections, life-threatening infusion reactions, hepatitis B reactivation, a rare brain infection (PML), tumor lysis syndrome, and dangerous clotting disorders — require immediate medical attention. Call your doctor or seek emergency care if anything feels sudden or severe.
⚠️Warnings & precautions▾
- Hepatitis B reactivation: Gazyva can cause a previously controlled hepatitis B infection to flare dangerously, leading to liver failure or death. All patients are screened before treatment. Watch for jaundice (yellowing skin or eyes), dark urine, or sudden fatigue.
- Progressive multifocal leukoencephalopathy (PML): A rare, potentially fatal brain infection has occurred in Gazyva patients. Report any new confusion, memory loss, vision changes, or weakness immediately.
- Severe infusion reactions: Most patients experience some kind of infusion-related reaction, especially during the first infusion. Reactions can range from mild (chills, flushing) to life-threatening. Patients are pre-medicated and closely monitored during every infusion.
- Serious infections: Gazyva suppresses the immune system, raising the risk of bacterial, fungal, and viral infections — some fatal. It should not be started during an active infection.
- Neutropenia and thrombocytopenia: Low blood counts can be severe and long-lasting. Regular blood tests are needed throughout treatment.
- Tumor lysis syndrome (TLS): In CLL and follicular lymphoma, rapid cancer cell death can release harmful substances into the bloodstream. Patients at risk receive preventive fluids and medications.
- Embryo-fetal toxicity: Gazyva can deplete B cells in a developing baby. Effective contraception is required during treatment and for 6 months after the last dose.
- Live vaccines: Must be avoided during treatment and until the immune system (B-cell counts) recovers.
🔀What it interacts with▾
Gazyva does not have a long list of drug-drug interactions in the traditional sense, but several important cautions apply:
- Antihypertensive medications (blood pressure drugs): Because Gazyva infusions can lower blood pressure, your care team may advise holding these medicines for 12 hours before and during each infusion and for one hour after — discuss this with your provider before making any changes.
- Live vaccines: Gazyva suppresses B-cell-mediated immunity, making live vaccines potentially dangerous; they are contraindicated during treatment and until B-cell recovery is confirmed.
- Anticoagulants and platelet inhibitors (blood thinners and anti-clotting drugs): These increase the risk of bleeding, especially during the first treatment cycle when platelet counts may drop significantly; extra caution and monitoring are needed.
- Chemotherapy partners (chlorambucil, bendamustine, CHOP, CVP): Gazyva is used in combination with these regimens; the combined immune suppression raises infection risk, and the specific chemotherapy used affects the overall safety profile.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B history: All patients must be tested for hepatitis B before starting — tell your doctor about any past exposure or infection, even if you were told it resolved.
- Active infection: Gazyva must not be started while you have an active infection; tell your doctor about any current illness.
- History of recurring infections: Patients with chronic or repeated infections are at higher risk and need close monitoring.
- Hypersensitivity or prior reaction to obinutuzumab: Gazyva is contraindicated in anyone with a known allergic reaction (including anaphylaxis or serum sickness) to obinutuzumab or any of its ingredients.
- Pregnancy: Gazyva can deplete B cells in an unborn baby. Pregnant women should be informed of the risk; females of reproductive potential must use effective contraception during treatment and for 6 months after the last dose.
- Breastfeeding: Women should not breastfeed during treatment or for 6 months after the last dose due to potential risk to the infant.
- Children: Safety and effectiveness have not been established in pediatric patients.
- Older adults: Patients aged 75 and older with CLL or NHL had higher rates of serious adverse reactions; close monitoring is especially important in this group.
- Kidney impairment: Patients with severe renal impairment have not been formally studied in the lupus nephritis setting; discuss your kidney function with your doctor.
- Heart or lung conditions: These patients may be at greater risk of severe infusion reactions and will be monitored more closely during and after each infusion.
🚑If you take too much▾
There is no documented experience with Gazyva overdose in human clinical trials. If an overdose is suspected, treatment involves immediately stopping or slowing the infusion and providing supportive medical care. Contact your healthcare team or emergency services right away if you think too much medication has been given.
📡Pharmacodynamics — effects in the body▾
Gazyva works by depleting B lymphocytes — the white blood cells it targets via CD20. In CLL patients, it reduces B-cell counts to very low levels, and some patients still show depleted B cells 18 months after their last dose. In lupus nephritis patients, nearly all had B-cell counts fall below a defined low threshold within 4 weeks and most remained suppressed through 76 weeks of follow-up. Treatment in lupus nephritis patients also improved certain immune markers — including complement proteins (C3 and C4) and antibodies linked to lupus activity (anti-dsDNA) — though the direct clinical meaning of these lab changes is not fully established.
🔬Pharmacokinetics — how your body processes it▾
Obinutuzumab is eliminated from the body through two parallel pathways: a steady linear clearance and a time-varying non-linear process, likely related to the drug's target (CD20 on B cells) becoming saturated over the course of treatment. In CLL and NHL patients, the drug's terminal half-life — how long it takes the body to clear half of the drug — is roughly 25 to 35 days. In lupus nephritis patients, the median half-life is about 22 days. The drug distributes into a relatively small volume, suggesting it stays largely within the blood and lymphatic tissue. Age and mild-to-moderate kidney impairment do not significantly affect how the body handles the drug; it has not been formally studied in patients with severe liver impairment.
📦How to store it▾
Store at 2°C to 8°C (36°F to 46°F). Protect from light. DO NOT FREEZE.
📄 Written from Obinutuzumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Obinutuzumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Gazyva and why has my doctor prescribed it for me? ▾
What should I expect during my infusion appointments? ▾
I had hepatitis B years ago — is it safe for me to take this? ▾
What side effects should I call my doctor about right away? ▾
Can I get my flu shot or other vaccines while on Gazyva? ▾
Is it safe to get pregnant or breastfeed while taking Gazyva? ▾
Is Obinutuzumab Injection available over the counter? ▾
When was Obinutuzumab Injection first available? ▾
💬 Answers drafted from Obinutuzumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Obinutuzumab Injection comes
Obinutuzumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Gazyva is used intravenously in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL)
- Gazyva is used intravenously in combination with bendamustine, then alone as maintenance, for follicular lymphoma that has relapsed or stopped responding to a rituximab-based regimen
- Gazyva is used intravenously in combination with chemotherapy, then alone as maintenance, for previously untreated advanced follicular lymphoma
- Gazyva is used intravenously for active lupus nephritis in adults already receiving standard therapy
- Gazyva must be administered only as an intravenous infusion through a dedicated line — never as an IV push or bolus
- Gazyva infusions are given in a healthcare setting by a trained professional who can manage serious infusion reactions
- Patients must receive pre-medications (including a glucocorticoid, acetaminophen, and an antihistamine) before each Gazyva infusion to reduce the risk of reactions
- If a scheduled Gazyva dose is missed, contact your care team right away to reschedule and maintain the appropriate interval between doses
📊 Obinutuzumab Injection across the U.S. market
How Obinutuzumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Obinutuzumab Injection is used
A general measure of how commonly Obinutuzumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Obinutuzumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Obinutuzumab Injection prescribed? Of the 1,596 medications we measure, Obinutuzumab Injection ranks #1,206 by Medicaid prescriptions — more than 24% of them.
Utilization by Obinutuzumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
40 ML obinutuzumab 25 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1442693
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Obinutuzumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Obinutuzumab Injection NDCs with Medicaid activity.
🔍 Compare Obinutuzumab Injection products
A representative set of FDA-listed product records for Obinutuzumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1000 mg/40 mL | Intravenous | Genentech, Inc. × 3 listings | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Obinutuzumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Obinutuzumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Obinutuzumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Obinutuzumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 974779 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1656294In current FDA listingsClinical drug / strength (SCD) 40 ML obinutuzumab 25 MG/MLRxCUI 1442693
Look up RxCUI 974779 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Obinutuzumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Obinutuzumab Injection belongs to the CD20-directed Cytolytic Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.