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GAZYVA® (obinutuzumab)
[H2] For Patients & Caregivers

[IMG: GAZYVA® (obinutuzumab) info for Patients and Caregivers]

Active Lupus Nephritis

Previously Untreated Follicular Lymphoma

Relapsed or Refractory Follicular Lymphoma

Previously Untreated Chronic Lymphocytic Leukemia

GAZYVA® (obinutuzumab)
[H2] For US Healthcare Professionals

[IMG: GAZYVA® (obinutuzumab) info for US Healthcare Professionals]

Active Lupus Nephritis

Previously Untreated Follicular Lymphoma

Relapsed or Refractory Follicular Lymphoma

Previously Untreated Chronic Lymphocytic Leukemia

GAZYVA® (obinutuzumab) is a prescription medication designed to treat previously untreated follicular lymphoma (FL), relapsed/refractory follicular lymphoma (R/R FL), chronic lymphocytic leukemia (CLL), and active lupus nephritis (LN) in people with these conditions. It works by targeting the CD20 antigen on B-cells, leading to their elimination through immune-mediated mechanisms.
GAZYVA is administered as an intravenous infusion by a healthcare professional, typically in a clinic or hospital setting. For CLL and FL, GAZYVA is typically prescribed in combination with other treatments. As dosing and schedules vary by indication, detailed dosing information is provided on the individual indication pages.
Serious and sometimes fatal adverse reactions can occur with GAZYVA treatment. For detailed information, please refer to the prescribing information, including boxed warnings. Patients are closely monitored for these side effects throughout their treatment course. For more detailed information, it is essential to refer to the prescribing information and consult with a healthcare professional.

[H5]
Important Safety Information and Indications

Back to Top

Indications
GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.

What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA?
Do NOT receive GAZYVA if you have had an allergic reaction (eg, anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past

What are the additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in CLL and NHL patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure, requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN
Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone, are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus standard therapy for LN may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced
Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA for CLL and NHL. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding
The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.
The most common side effects seen with GAZYVA in a study that included patients with relapsed or refractory NHL, including FL patients, were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation, and diarrhea.
The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.

What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines
Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment
Breastfeeding: Because of the potential risk of serious side effects in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information, including Serious Side Effects.

[H1] Indications and Important Safety Information

Indications
GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.

What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA?
Do NOT receive GAZYVA if you have had an allergic reaction (eg, anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past

What are the additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in CLL and NHL patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure, requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN
Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone, are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus standard therapy for LN may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced
Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA for CLL and NHL. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding
The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.
The most common side effects seen with GAZYVA in a study that included patients with relapsed or refractory NHL, including FL patients, were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation, and diarrhea.
The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.

What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines
Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment
Breastfeeding: Because of the potential risk of serious side effects in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information, including Serious Side Effects.

[IMG: YOLO KOLO]

[H4] You only live once, and so do your kidneys
[H2] In lupus nephritis, early and appropriate treatment is critical. Seize the opportunity to ask your doctor about GAZYVA today.

Why GAZYVA

[IMG: Safety and side effects icon for GAZYVA lupus nephritis]

[H2] Safety & side effects

Find out about side effects that may come with GAZYVA.

Learn more

[IMG: IV infusion icon for GAZYVA lupus nephritis]

[H2] How do I receive GAZYVA infusions?
Get information about your GAZYVA infusion schedule, how the treatment is given, and what to expect at each step.

Learn more

[IMG: Co-pay card icon for GAZYVA financial support]

[H2] Financial assistance options
Learn more about how Genentech may be able to help you pay for your medication.*

Learn more

*Genentech provides coverage and reimbursement services to patients to help them understand benefits, coverage, and reimbursement. Genentech provides these services to patients only after a healthcare provider has prescribed a Genentech product.

Lupus nephritis is a severe form of lupus that occurs when the immune system attacks the kidneys, leading to inflammation, swelling, and potential kidney damage. Learn more about lupus nephritis.
GAZYVA® (obinutuzumab) is FDA-approved for the treatment of adults with active lupus nephritis who are receiving standard therapy. GAZYVA is thought to work by targeting the CD20 protein on B-cells, which create harmful antibodies that attack your kidneys. GAZYVA is administered as an intravenous infusion in a medical setting, with a treatment schedule structured specifically for active lupus nephritis. Find the dosing schedule and infusion rates and tips on preparing for treatment. Your healthcare provider will determine the appropriate dosing regimen for you.
Common side effects of GAZYVA include upper respiratory tract infection, COVID-19, and urinary tract infection. Serious and sometimes fatal adverse reactions may occur with GAZYVA treatment. Do not receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA.

[H4]
Important Safety Information and Indication

Back to Top

Indication
GAZYVA® (obinutuzumab) is a prescription medicine used to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.

[H4] What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems
[H4] Who should not receive GAZYVA?
Do NOT receive GAZYVA if you have had an allergic reaction (eg, anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past
[H4] What are additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections can be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced
Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding
The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.
[H4] What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines
Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment
Breastfeeding: Because of the potential risk of serious side effects in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information, including Serious Side Effects.

Lupus nephritis
A type of kidney disease caused by lupus. The immune system attacks the kidneys, causing inflammation and damage.

Mycophenolate mofetil (MMF)
A medicine used to treat lupus nephritis. It is often part of standard or advanced therapy.

Standard therapy
A treatment that uses 2 types of medicine, usually a steroid and an immunosuppressant like MMF (mycophenolate mofetil), to manage lupus nephritis.

Kidney remission
Having low protein in the urine, maintaining kidney function, and showing no active signs of inflammation.

Steroids
Medicines that reduce inflammation but can cause side effects when used in high doses for a long time

[H5] Approved: ~90-minute infusion* click to learn more
[H1] GAZYVA® (obinutuzumab)

for Previously Untreated Advanced† Follicular Lymphoma

†stage II bulky, III, and IV patients

How GAZYVA Is Thought to Work

*Initiate from Cycle 2 onwards for eligible FL patients who do not experience a severe or life-threatening IRR during Cycle 1. Cycle 1 should be administered at standard infusion rate.
Images on this website do not depict actual patients.

[H5] Approved: ~90-minute infusion* click to learn more
[H1] GAZYVA® (obinutuzumab)

for Previously Untreated Advanced† Follicular Lymphoma

†stage II bulky, III, and IV patients

How GAZYVA Is Thought to Work

*Initiate from Cycle 2 onwards for eligible FL patients who do not experience a severe or life-threatening IRR during Cycle 1. Cycle 1 should be administered at standard infusion rate.
Images on this website do not depict actual patients.

[IMG: doctor speaking with patient]

[H2] WHAT IS FOLLICULAR LYMPHOMA (FL)?
Find out about common medical tests and possible symptoms to watch for.

Learn more

[IMG: doctor on the phone]

[H2] HAVE A QUESTION?
Call our Patient Resource Center
This is not meant to replace the advice of your healthcare team.

1 (877) 218-3996

[IMG: patient at computer]

[H2] FINANCIAL ASSISTANCE OPTIONS
Learn more about how Genentech may be able to help you pay for your medication.

Learn more

Follicular lymphoma (FL) is a slow-growing type of blood cancer. Learn more about previously untreated follicular lymphoma.
GAZYVA® (obinutuzumab) is FDA-approved for treating previously untreated advanced follicular lymphoma, also known as first-line follicular lymphoma treatment. GAZYVA works by targeting the CD20 protein on B-cells. It is administered as an intravenous infusion in a medical setting, with a treatment schedule. Common side effects include infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation, and diarrhea.

[H5]
Important Safety Information and Indications

Back to Top

Indication
GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.

What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems
Who should not receive GAZYVA?
Do NOT receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past
What are additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
Hypersensitivity Reactions Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness
Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections can be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection.
Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood; having a low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced
Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor as it can lead to uncontrollable bleeding
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea
What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines
Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment
Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.
You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the accompanying full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information