Having too few red blood cells in the body. This can cause a person to feel tired, weak, and short of breath because the tissues are not getting enough oxygen.
A type of therapy used to find and destroy specific cells within the body (for example, the cells where follicular lymphoma starts). Antibody therapy can also harm healthy cells in the body.
The soft spongy material that fills the inside of bones. Bone marrow is the source of new blood cells, and platelets are made in the bone marrow.
A medical test that uses a computer linked to an x-ray machine to take pictures of the inside of the body.
A drug treatment that destroys growing cells, including cancer cells.
One type of blood cancer or leukemia. With CLL, the blood or bone marrow has too many white blood cells, known as lymphocytes.
The muscle that divides the chest cavity from the abdominal cavity.
This test identifies the type of blood cancer and number of cells involved.
The most common type of indolent (slow growing) Non-Hodgkin lymphoma (NHL). With NHL, abnormal lymphocytes build up in the lymph nodes, bone marrow, and spleen. Follicular lymphoma can be a chronic disease.
Cells that defend the body from infection. These cells are part of the immune system.
The group of organs and cells that defends the body from infections.
A treatment (such as antibodies) that uses your body’s immune system to help fight cancer. Immunotherapy can also harm healthy cells in the body.
A cancer of white blood cells.
A small bean-shaped organ that stores white blood cells.
A type of white blood cell that plays an important role in fighting infection.
A medical test that uses a form of radioactive sugar that can be traced by a special camera. This can help tell if an area contains lymphoma and if that lymphoma is responding to treatment.
A medical test that combines the PET scan with a CT scan. This lets the doctor compare areas with lymphoma on the PET scan with the more detailed appearance of that area on the CT scan.
A type of cell found in the blood and spleen. Platelets help prevent bleeding by forming blood clots.
A term used to describe disease that has not responded to previous treatment.
The return of a disease, or the signs and symptoms of a disease after a period of improvement.
A term used to describe disease that has returned after responding to previous treatment.
A term used to describe a response to treatment. Partial remission means the cancer is significantly improved, but evidence of the cancer remains. Complete remission means all evidence of the cancer is gone for a period of time.
An organ that is part of the lymphatic system. The spleen makes lymphocytes, filters blood, stores blood cells, and destroys old blood cells. It is located on the left side of the abdomen near the stomach.
A period of time when patients, along with their doctor, watch the disease and do not start treatment unless needed.
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 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 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
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 bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP
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 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
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