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Gazyva
Obinutuzumab
$5560.00
1000mg/40ml · 1 vial
BrandBranded medicine· By Roche
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FDA boxed warningHepatitis b virus reactivation and progressive multifocal leukoencephalopathy
Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation.
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA.
Progressive Multifocal Leukoencephalopathy (PML) resulting in death.
About Gazyva
Overview
Gazyva (obinutuzumab) is a monoclonal antibody medicine used with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL). It also treats follicular lymphoma: with bendamustine, then on its own, when the disease has returned or not responded to rituximab-containing treatment; or with chemotherapy, then on its own after at least a partial remission, in adults with previously untreated stage II bulky, III or IV disease. Gazyva is also used to treat adults with active lupus nephritis who are receiving standard therapy. It works by attaching to a protein called CD20 on B cells, helping the immune system destroy these cells and directly triggering their death.
What it treats
- Previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil. - Follicular lymphoma that has returned or has not responded to a rituximab-containing regimen, in combination with bendamustine followed by Gazyva alone. - Previously untreated stage II bulky, stage III or stage IV follicular lymphoma in adults, in combination with chemotherapy, followed by Gazyva alone if at least partial remission is achieved. - Active lupus nephritis in adults receiving standard therapy.
Safety information
Side effects
Common side effects vary by the condition being treated. They include infusion-related reactions, low levels of infection-fighting white blood cells (neutropenia), upper respiratory tract infections, cough, tiredness, muscle and bone pain, constipation and diarrhea. In people treated for lupus nephritis, common side effects also include COVID-19, urinary tract infections, bronchitis and pneumonia. Serious side effects that warrant contacting a doctor include: - Infusion-related reactions and hypersensitivity reactions, including serum sickness. - Serious infections, which can be fatal, and reactivation of hepatitis B. - Progressive multifocal leukoencephalopathy (PML), a serious brain infection. - Tumor lysis syndrome, involving changes in blood chemistry that require monitoring of kidney function and fluid balance. - Low white blood cell counts (neutropenia), which require monitoring for infection. - Low platelet counts (thrombocytopenia), which may cause bleeding. - Disseminated intravascular coagulation, a serious blood-clotting disorder that may involve both bleeding and blood clots. Gazyva can also harm an unborn baby. Contact your doctor if you become pregnant during treatment.
FDA boxed warning
Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy
Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation.
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA.
Progressive Multifocal Leukoencephalopathy (PML) resulting in death.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not receive Gazyva if you have a known allergy to obinutuzumab or any other ingredient, including a previous severe allergic reaction (anaphylaxis), or if you have had serum sickness after obinutuzumab. It should not be given if you have an active infection. Tell your healthcare team if you have recurring or chronic infections, kidney impairment, low white blood cell or platelet counts, or bleeding or clotting problems. Gazyva can cause serious, sometimes fatal infections, infusion reactions, severe allergic reactions and blood cell abnormalities. Close monitoring is needed. In people with chronic lymphocytic leukemia (CLL) or follicular lymphoma (FL), a high tumour burden, high circulating lymphocyte count or kidney impairment increases the risk of tumour lysis syndrome, a complication of rapid cancer-cell breakdown. Avoid live virus vaccines during treatment and until B cells have recovered. Gazyva can harm an unborn baby; use effective contraception if you could become pregnant. Do not breastfeed.
Using Gazyva
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] (DailyMed, retrieved 19 September 2026).
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