Gazyva
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.
What is Gazyva (obinutuzumab)?
What is Gazyva (obinutuzumab) used for?
- Chronic lymphocytic leukemia (CLL)
- Follicular lymphoma (FL)
How Gazyva (obinutuzumab) works
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.
Drug facts
Side effects of Gazyva (obinutuzumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Infusion-related reactions (66-72%)
- Infections of the nose, throat, or lungs (up to 50%)
- Cough (31-35%)
- Muscle, bone, or joint pain (12-28%)
- Fever (up to 19%)
*Side effects listed above might not be from Gazyva (obinutuzumab) alone, since studies included people receiving Gazyva (obinutuzumab) with other anticancer medications.
Less Common Side Effects
- Diarrhea
- Constipation
- Lack of appetite
- Fatigue
- Headache
- Trouble sleeping
- Urinary tract infections (UTIs)
- Herpes or shingles infection
- Rash
- Itching
Gazyva (obinutuzumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infusion-related or allergic reactions: throat tightness, trouble breathing, itching or hives, swelling, chest pain, fast heartbeat, dizziness, flushing, chills, fever
- Infections (general): repeated fevers, chills, cough, trouble breathing, severe diarrhea, vomiting, painful urination, urinating more often than usual
- Brain infection: changes in mood or behavior, difficulty concentrating, vision loss, weakness, facial drooping, issues with balance or walking
- Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
The following Gazyva (obinutuzumab) side effects have also been reported
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.
Pros and cons of Gazyva (obinutuzumab)
Pros
- 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
Cons
- 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
Pharmacist tips for Gazyva (obinutuzumab)
- 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.
Common questions about Gazyva (obinutuzumab)
There are several chemotherapy regimens that can be used as recommended options for treating CLL and FL. Gazyva (obinutuzumab) is used in some of these treatments in combination with other anticancer medications. Your provider will choose the most appropriate option for you depending on many factors, including your age, health, other conditions, and how well you’ll tolerate treatment. Talk with your provider if you have any questions about the benefits and risks with any of the treatment options.
Gazyva (obinutuzumab) and Rituxan (rituximab) are both monoclonal antibodies that target the CD20 protein on B cells. Gazyva (obinutuzumab) attaches to CD20 more strongly than Rituxan (rituximab) and can trigger more cancer cell death. However, people receiving Gazyva (obinutuzumab) might be more likely to experience infusion-related reactions and serious side effects compared to those receiving rituximab (Rituxan). They might also have a higher infection and bleeding risk than those with chemotherapy regimens with rituximab (Rituxan). Talk with your provider if you have any questions about the benefits and risks with either treatment option.
You should receive Gazyva (obinutuzumab) treatment as instructed by your provider. This medication is usually given weekly or every 3 to 4 weeks during each chemotherapy cycle, so it’s important to follow the schedule your provider gives you. How long you receive Gazyva (obinutuzumab) therapy depends on several factors, including how well the medication is working to treat your cancer, your treatment regimen, and how well you tolerate it. Don’t stop receiving Gazyva (obinutuzumab) without first discussing with your provider.
Gazyva (obinutuzumab) might cause harm to your unborn baby and isn’t recommended for use in pregnancy, unless your provider thinks the benefit is greater than the risk for both you and your unborn baby. If you’re a female of childbearing age, 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 at any time during treatment.
Gazyva (obinutuzumab) isn’t recommended while breastfeeding. We don’t know if it can pass into breast milk, but there’s a risk of serious harm to nursing infants if it in fact does. Because of this risk, you shouldn’t breastfeed during Gazyva (obinutuzumab) treatment and for 6 months after your last dose. Talk with your provider if you have any questions about alternative options to breastfeeding while receiving Gazyva (obinutuzumab).
Gazyva (obinutuzumab) is a type of protein called a monoclonal antibody. It’s made in a lab using genetic material from hamsters, then modified, or “humanized”, to be more similar to human genetic material. Monoclonal antibodies work similarly to your body’s natural antibodies. They can recognize and target specific proteins on cancer cells to act like or boost an immune response. In particular, Gazyva (obinutuzumab) targets CD20 proteins on B cells and triggers an immune response to fight and kill cancer cells.
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Risks and warnings for Gazyva (obinutuzumab)
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.
Hepatitis B reactivation
- 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.
Viral brain infection
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.
Infusion-related and allergic reactions
- 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.
High uric acid and electrolyte imbalances
- 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.
Low blood counts
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.
Harm to unborn baby
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.
Gazyva (obinutuzumab) dosage
Typical dosage for Gazyva (obinutuzumab)
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.
Interactions between Gazyva (obinutuzumab) and other drugs
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.
