Gazyva (obinutuzumab) is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) for use in adults to treat:
- chronic lymphocytic leukemia that hasn’t been treated before
- certain forms of follicular lymphoma (FL) that haven’t been treated before
- FL that’s been treated with Rituxan (rituximab), but the cancer was refractory (didn’t get better) or has relapsed (came back or worsened)
For all these conditions, you’ll likely receive Gazyva in combination with chemotherapy for about 6 months. Some people with FL may receive Gazyva alone for up to 2 additional years.
Here are some fast facts about Gazyva:
- Active ingredient: obinutuzumab, which is a
- Drug class: monoclonal antibody
- Drug form: solution for IV infusion given by a healthcare professional
Like other drugs, Gazyva can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Gazyva, including details about its uses, see this article.
Gazyva can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Gazyva in clinical trials:
- upper respiratory infection, such as the common cold
- infusion reaction*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Gazyva. This list doesn’t include all possible mild side effects of the drug. For more details, you can refer to Gazyva’s prescribing information.
Mild side effects that have been reported with Gazyva include:
- upper respiratory infection, such as the common cold
- sinusitis (inflammation of the sinuses)
- urinary tract infection
- herpes infection, such as cold sores
- pain in your muscles, bones, joints, back, or neck
- skin rash
- reduced appetite
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect with Gazyva and want to tell the FDA about it, visit MedWatch.
Gazyva may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more details, you can refer to Gazyva’s prescribing information.
If you develop serious side effects with Gazyva, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects of Gazyva that have been reported and their symptoms include:
- Serious infections, such as pneumonia. Symptoms can include:
- trouble breathing
- rapid breathing
- Thrombocytopenia (low level of blood cells called platelets). Symptoms can include:
- bruising easily
- bleeding gums
- bleeding that takes longer than usual to stop
- Reactions to infusions.†
- Tumor lysis syndrome.†
- Hepatitis B reactivation.*
- Progressive multifocal leukoencephalopathy.*
- Allergic reaction.†
* Gazyva has a
† For more information about this side effect, see “Side effect specifics” below.
Gazyva may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Does Gazyva cause hair loss?
No, Gazyva is not known to cause hair loss. People who took the drug in clinical trials did not report losing their hair. However, you’ll likely receive Gazyva in combination with chemotherapy to treat your condition. Chemotherapy commonly causes hair loss.
If you lose hair while receiving Gazyva with chemotherapy, your hair will usually grow back after you finish the chemotherapy. If you’re concerned about this side effect, talk with your doctor. They can recommend ways to help you manage hair loss.
Are there long-term side effects of Gazyva?
There might be. Most of Gazyva’s side effects ease within a few days to weeks. However, this drug can also cause some side effects that may last for a long time.
For example, Gazyva commonly causes neutropenia* (low level of certain white blood cells). This side effect can increase your risk of infection. If you have neutropenia, it may take a few months before your white blood cell level returns to normal. And if you develop an infection while receiving Gazyva, it can sometimes take a long time to clear up, even with treatment.
Keep in mind that receiving Gazyva for a long period of time does not seem to increase your risk of developing side effects. And some side effects, such as infusion reactions,* become less likely with each dose you receive.
If you’re concerned about long-term side effects with Gazyva, talk with your doctor.
* For more information about these side effects, see “Side effect specifics” below.
What are Gazyva’s rare side effects?
Rare side effects of Gazyva include hepatitis B reactivation and a disease called progressive multifocal leukoencephalopathy. Gazyva has
Before you have treatment with Gazyva, talk with your doctor about your health history. Certain factors may increase your risk of developing rare side effects. Your doctor can give you more information about your risk. They can also advise you on symptoms to watch for.
Learn more about some of the side effects that Gazyva may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Gazyva.
Reactions to infusions
Reactions to infusions may occur with Gazyva.
A healthcare professional will administer Gazyva as an IV infusion. This is an injection into a vein that’s given over a period of time. An infusion reaction refers to side effects that happen during the infusion or up to 24 hours after.
In clinical trials, Gazyva commonly caused an infusion reaction with the first dose. Most of these reactions were mild. However, some were more severe and in certain cases, life threatening. Infusion reactions were less common and less severe with subsequent doses.
Symptoms of mild infusion reactions may include:
Symptoms of severe infusion reactions may include throat irritation or swelling, shortness of breath, and trouble breathing. Other symptoms may include increased or decreased blood pressure and increased heart rate.
You may be more likely to have a severe infusion reaction with Gazyva if you have a heart or lung condition.
What you can do
To help prevent infusion reactions, you may receive certain drugs before Gazyva infusions. These drugs are called premedications. Before your first infusion, you’ll likely receive:
- Tylenol (acetaminophen)
- an antihistamine, such as Benadryl (diphenhydramine)
- a corticosteroid, such as Decadron (dexamethasone)
If you don’t have a severe reaction to your first infusion, you may not need an antihistamine or corticosteroid before upcoming infusions.
Also, if you take blood pressure medication, your doctor may recommend pausing it before Gazyva infusions. This can help prevent your blood pressure from dropping too low during the infusion. Your doctor may advise you to not take your blood pressure medication in the 12 hours before a Gazyva infusion. They’ll tell you when to start taking it again after you receive Gazyva.
A healthcare professional will monitor you for infusion reactions during and after each Gazyva infusion. If you have symptoms of a reaction, be sure to tell them right away. They may slow down or pause the infusion until your symptoms ease. They may also give you medication to treat the reaction.
If you have a severe infusion reaction, your doctor may determine that you should not continue treatment with Gazyva.
Neutropenia was a common side effect of Gazyva in clinical trials. Neutropenia refers to low levels of white blood cells called neutrophils.
It’s important to note that Gazyva is typically used with chemotherapy, which also commonly causes neutropenia.
Neutrophils help your body fight germs, especially bacteria, which can cause infections. If you have a lower level of neutrophils than usual, your risk of infection can increase. Most infections reported in people who received Gazyva were mild. However, serious infections, such as pneumonia, have also been reported.
Neutropenia often has no symptoms until an infection develops. Symptoms of an infection may include:
- feeling unwell
- sore throat
- mouth ulcers (sores)
What you can do
While you have treatment with Gazyva, your doctor will order frequent blood tests to check your white blood cell levels. Be sure to keep all your appointments for blood tests. Tell your doctor right away if you have any symptoms of neutropenia.
If blood tests show that you have neutropenia, your doctor may delay your next Gazyva infusion until your blood cell levels have recovered. They may also prescribe:
- antibiotic, antiviral, or antifungal medication to treat or help prevent infection
- a medication called a granulocyte colony stimulating factor, such as Neulasta (pegfilgrastim), to help increase your white blood cell levels
Your doctor will usually recommend that you take extra care to avoid infections during treatment with Gazyva. For example, they may advise you to wash your hands often and avoid crowds and people who are sick. You should also talk with your doctor about getting up to date on your vaccines before you start treatment. (For more about vaccines, see “Immunizations” in “Precautions for Gazyva” below.)
Tumor lysis syndrome
Gazyva treatment can sometimes cause a serious side effect called tumor lysis syndrome (TLS). This syndrome can develop if cancer treatments kill large numbers of cancer cells in a short time. With TLS, contents released from the killed cancer cells build up in your bloodstream. These contents include uric acid and potassium.
It’s not known how often TLS happens with Gazyva. You’re more likely to develop this side effect if you have a lot of cancer cells in your body when you start treatment. TLS is also more likely to occur if you have a kidney problem.
Symptoms of TLS may include:
- nausea and vomiting
- loss of appetite
- muscle spasms
- heart palpitations
If TLS isn’t treated, it can lead to problems such as arrhythmia (irregular heart rate or rhythm) or kidney failure. TLS may also, on rare occasions, lead to death.
What you can do
To help prevent TLS, it’s important to drink plenty of fluids during treatment with Gazyva. If your doctor thinks you have an increased risk of TLS , they may recommend medication to help prevent it. For example, they may prescribe Zyloprim (allopurinol) to help lower the level of uric acid in your blood.
After your first Gazyva infusion, your doctor will order tests to monitor levels of uric acid and other cell contents, such as potassium, in your blood. They’ll also order tests to monitor your kidneys. These tests can show if you’re developing TLS. If needed, your doctor can prescribe medication to treat this side effect.
Be sure to tell your doctor right away if you have symptoms of TLS during treatment with Gazyva.
Hepatitis B reactivation
Gazyva has a
Hepatitis B is a type of infection that’s caused by a virus. Low levels of the virus can lie dormant (inactive) in your body for a long time. The virus can remain in your body even if you took medication to treat hepatitis B in the past.
Gazyva makes it harder for your body to keep the virus in check, so it’s possible the virus could reactivate (become active again). Hepatitis B reactivation may occur while receiving Gazyva or for several months after you finish Gazyva treatment.
Hepatitis B reactivation can cause symptoms of hepatitis B, which may include:
- abdominal pain
- dark-colored urine
Hepatitis B reactivation can lead to liver failure and, in some cases, death.
What you can do
If you’ve ever had hepatitis B, be sure to tell your doctor before you have treatment with Gazyva. They’ll order a hepatitis B virus test before you receive Gazyva. If you have the virus, your doctor may prescribe medication to treat it. Be sure to take this as prescribed.
During and after Gazyva treatment, your doctor may also order blood tests to monitor for hepatitis B reactivation.
If you have symptoms of hepatitis B during or after Gazyva treatment, see your doctor right away. If you’re still receiving the drug, they’ll likely recommend that you stop treatment. Your doctor will also usually prescribe medication to treat hepatitis B.
Progressive multifocal leukoencephalopathy
Gazyva has a boxed warning about a risk of progressive multifocal leukoencephalopathy (PML). A boxed warning is a serious warning from the FDA.
Gazyva can increase your risk of developing PML. This is a serious condition caused by a rare viral infection of the brain. It can, in some cases, lead to death.
Symptoms of PML may include:
- balance problems
- trouble walking
- trouble speaking
- problems with vision
What you can do
If you have any symptoms of PML during Gazyva treatment, see your doctor right away. They may order tests such as brain scans to check you for this side effect. If you have PML, your doctor will likely recommend that you stop receiving Gazyva.
As with most drugs, Gazyva can cause an allergic reaction in some people.
Symptoms can be mild or serious and can include:
- skin rash
- swelling under your skin, typically in your lips, eyelids, feet, or hands
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep receiving Gazyva. If your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
There are several precautions to consider before having treatment with Gazyva. This includes
This drug has boxed warnings about risks of hepatitis B reactivation and progressive multifocal leukoencephalopathy. These are serious warnings from the Food and Drug Administration (FDA). For details, see “Side effect specifics” above.
Be sure to talk with your doctor about your health history before receiving Gazyva. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Allergic reaction. If you’ve had an allergic reaction to Gazyva or any of its ingredients, your doctor will likely not prescribe Gazyva. Ask them what other medications may be better options for you.
Infections. Gazyva treatment can make it harder than usual for your body to fight germs that can cause infections. If you currently have an infection, your doctor will likely need to treat it before you start receiving Gazyva. If you have a history of long-term infections or infections that keep coming back, you may have an increased risk of infection with Gazyva. Be sure to talk with your doctor about any infections you have now or have had in the past.
Immunizations. You should not get immunized with live vaccines during Gazyva treatment and for a few months after.Gazyva can weaken your immune system. If your immune system isn’t as strong as usual, receiving a live vaccine may cause serious infection. (A live vaccine contains a small, weakened amount of the bacterium or virus it’s meant to ward off.) Examples of live vaccines include those for typhoid, yellow fever, rotavirus, and chickenpox.
In addition, if you receive non-live (inactivated) vaccines when your immune system is weakened, the vaccines may be less effective than usual. (A non-live vaccine doesn’t contain a live bacterium or virus.) Examples of non-live vaccines include the flu shot, pneumonia vaccine, and COVID-19 vaccines.
Your doctor will likely advise you to get up to date with all recommended vaccines before starting Gazyva treatment.
Alcohol use with Gazyva
Alcohol does not interact with Gazyva. However, drinking alcohol during Gazyva treatment may worsen side effects such as diarrhea, headache, dizziness, or fatigue.
If you drink alcohol, talk with your doctor about how much, if any, is safe to consume with Gazyva.
Pregnancy and breastfeeding while receiving Gazyva
Here’s some information about pregnancy, breastfeeding, and Gazyva.
Pregnancy. If Gazyva is given during pregnancy, it may have harmful effects on a developing fetus. The drug could cause the infant to be born with a weakened immune system.
If you’re pregnant or planning to become pregnant, talk with your doctor about the risks and benefits of Gazyva. If you receive Gazyva during pregnancy, your doctor should not give your child live vaccines until their immune system is strong enough. See “Other precautions” above to read more about immunizations and Gazyva.
If you could become pregnant, you should use birth control during Gazyva treatment and for 6 months after your last dose. If you’re a male* and your sexual partner can become pregnant, ask your doctor about your birth control needs with Gazyva. The manufacturer of Gazyva has not provided birth control recommendations for males who receive the drug.
Breastfeeding. You should not breastfeed while you receive Gazyva and for 6 months after your last dose. This is because the drug may pass into breast milk. If you’re breastfeeding or plan to breastfeed, talk with your doctor. They can advise you on healthy ways to feed your child and other cancer treatment options.
* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.
As with many cancer treatments, side effects are common with Gazyva. Most side effects are mild and easily managed. However, some can be serious and, in certain cases, life threatening. Be sure to talk with your doctor if you develop any serious side effects. Keep in mind that the drug is typically used with chemotherapy, which can also cause side effects.
If you’d like to learn more about Gazyva, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Gazyva. For details about other aspects of Gazyva, refer to this article.
- Drug comparison. Learn how Gazyva compares with Rituxan and Imbruvica.
- A look at your condition. For more information about cancer, see our cancer hub. Our lists of leukemia and lymphoma articles might also be helpful.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.