Gazyva (obinutuzumab) is a type of targeted anticancer treatment for chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). It’s usually used in combination with other anticancer medications. Gazyva (obinutuzumab) is given as an infusion through the vein by a healthcare provider. It’s a recommended treatment option for certain adults, but can commonly cause infusion-related reactions, which can be severe.
Chronic lymphocytic leukemia (CLL)
Follicular lymphoma (FL)
Gazyva (obinutuzumab) is a monoclonal antibody that attaches to specific proteins called CD20 on B cells. B cells are a type of white blood cell. They are a part of your immune system and help your body make antibodies. Cancer cells usually have more CD20 proteins than normal, healthy cells.
When Gazyva (obinutuzumab) attaches to CD20, an immune response gets triggered. Signals get sent out to attack and kill the cells that the medication is attached to. Gazyva (obinutuzumab) can also signal the cancer cells to die directly.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
black, tarry stools
bleeding gums
blood in the urine or stools
chest tightness
chills
flushing
headache
hoarseness
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
trouble breathing
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Incidence not known
Blurred vision
confusion
dark urine
dizziness
drowsiness
general tiredness and weakness
light-colored stools
seizures
upper right abdominal or stomach pain
yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Recommended treatment option for chronic lymphocytic leukemia and follicular lymphoma, in combination with other anticancer medications
More precise in the way it targets cancer cells, compared to traditional chemotherapy
Long-lasting, so it doesn't have to be administered that often after the first 3 infusions
Requires visits to the clinic or infusion center to receive your dose
Can take several hours for each infusion
High risk for infusion-related reactions
You might experience an infusion or allergic reaction during or shortly after your Gazyva (obinutuzumab) infusion, some of which can be life-threatening. Let your provider know or get help right away if you experience any trouble breathing, hives, flushing, chest pain, fast heartbeats, dizziness, or chills.
You’ll be given an antihistamine, corticosteroid, and acetaminophen (Tylenol) 30 to 60 minutes before your very first dose(s) of Gazyva (obinutuzumab) in your first cycle. This is called premedication and helps lower the risk of infusion reactions. These medications can also be given before the infusions of your following cycles if necessary.
You might need to take preventative medication, such as allopurinol (Zyloprim), to lower uric acid levels and receive extra hydration with fluids while receiving Gazyva (obinutuzumab) treatment.
Gazyva (obinutuzumab) can raise your risk of infection. You might need to take antibiotics, antivirals, or antifungals to prevent infections during treatment with Gazyva (obinutuzumab) .
Make sure to get your lab work done on time. Since Gazyva (obinutuzumab) can lower your blood cell counts, your provider will monitor your blood counts often while you receive the medication.
Avoid getting live vaccines, such as Varicella (chickenpox vaccine) and MMR (measles, mumps, and rubella vaccine), while receiving Gazyva (obinutuzumab). It’s not known if the medication can change the way your body responds to this type of vaccine. Before getting any vaccines, let your provider or pharmacist know you're receiving Gazyva (obinutuzumab), and talk to them if you're not sure if you can receive the vaccine.
If you’re a female who can get pregnant, you should use birth control while receiving Gazyva (obinutuzumab) and for 6 months after the last dose. This medication might cause harm to an unborn baby.
Gazyva (obinutuzumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Current or previous hepatitis B infection
Gazyva (obinutuzumab) can cause serious liver problems that can lead to liver failure or death. This is due to infection with the hepatitis B virus. If you’ve had hepatitis B in the past, the virus can become active in your body again while you receive Gazyva (obinutuzumab), since the medication can weaken your immune system, allowing the virus to reappear.
Before starting Gazyva (obinutuzumab), your provider will check to see if you’ve been exposed to the hepatitis B virus. If your provider detects you’re infected with hepatitis B at any time, you might need to take medications to treat the infection.
During treatment with Gazyva (obinutuzumab), you might need to get regular blood tests done to make sure your liver is working properly. Seek medical attention right away if you notice swelling of your stomach, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), coughing or vomiting up blood, dark urine, fatigue, or stomach pain. You might need to stop Gazyva (obinutuzumab) to prevent further liver damage.
Though rare, some people receiving Gazyva (obinutuzumab) have developed a serious brain condition called progressive multifocal leukoencephalopathy (PML). This is caused by a viral infection and can happen when your immune system has been weakened from Gazyva (obinutuzumab) or chemotherapy treatment. Tell your provider immediately if you experience any changes in mood or behavior, problems thinking or concentrating, vision loss, facial drooping, weakness, or issues with balance or walking.
Risk factors: Heart problems | Lung or breathing problems
Gazyva (obinutuzumab) can cause infusion-related and allergic reactions, which can be serious. Infusion reactions can happen at any time, but most commonly occur with the first infusion that’s split over 2 days. These reactions can happen during or within 24 hours after the infusions. Delayed allergic reactions (serum sickness) can also happen if you’ve received Gazyva (obinutuzumab) before. Your risk for severe infusion-related reactions might be higher if you have heart or lung problems. Let your provider know if you have any of these problems before starting treatment so they can monitor you more closely.
Alert your provider or get medical help right away if you experience any throat tightness, trouble breathing, fast heartbeat, fever, chills, hives, flushing, dizziness, chest pain, or nausea.
Risk factors: High number of cancer cells or having large tumors | Kidney problems
Treatment with Gazyva (obinutuzumab) can cause a serious reaction called tumor lysis syndrome (TLS). TLS is when many cancer cells die quickly and break down in your body. This causes a rapid release of the cells’ contents, like uric acid, potassium, and phosphorus, into your blood. High levels of uric acid and electrolytes in your body can cause serious kidney damage and abnormal heart rhythms.
You’re at higher risk if you have a large number of cancer cells in your body, larger tumors, or kidney problems. Your provider will monitor you more closely if you have a higher risk for TLS. You also might need to take preventative medication to lower uric acid levels and receive extra hydration with fluids. Tell your provider right away if you’re urinating less than usual or have dark urine, muscle cramps, or a racing heartbeat.
Gazyva (obinutuzumab) can cause your white blood cell and platelet counts to drop. White blood cells are important to help your body fight infections, and platelets help stop any bleeding. When the number of these cells are lower than normal, you’re at risk of developing infections and bleeding or bruising, which can both be life-threatening.
Don’t start Gazyva (obinutuzumab) until you’ve recovered from any current infections. Once you start the medication, your provider will check your blood counts often. During treatment, you might need to take medications to prevent infections. Your provider might pause your treatment or adjust the doses of your other chemotherapy medications if you develop or have worsening platelet problems.
Let your provider know if you have any signs or symptoms of an infection, like fever or chills, or any serious bleeding that doesn’t stop. You can still be at a higher risk for infections for a month or more after stopping this medication, so continue to look out for symptoms of infection even after your treatment ends.
Based on animal studies, Gazyva (obinutuzumab) can possibly harm an unborn baby. Because of this risk, if you’re a female who can get pregnant, you should use birth control while receiving Gazyva (obinutuzumab) and for 6 months after the last dose. Let your provider know right away if you become pregnant during this time.
This medication is an injection into a vein (intravenously or IV) that’s given by a healthcare provider.
The typical dose is 1,000 mg per infusion. Gazyva (obinutuzumab) is given weekly for the first 3 weeks in your first cycle. Then, it’s given every 3 to 4 weeks for future cycles, depending on your treatment regimen.
Due to the risk for infusion reactions, your very first infusion will be split over 2 days, with 100 mg on the first day, then 900 mg on the second day.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain types of CD20-positive non-Hodgkin’s lymphoma (NHL) in adults and children ages 6 months and older
CD20-positive chronic lymphocytic leukemia (CLL) in adults
Moderate to severe rheumatoid arthritis (RA) in adults
Granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA) in adults and children ages 2 years and older
Moderate to severe pemphigus vulgaris in adults
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