Gazyva (obinutuzumab)

What is Gazyva?

Gazyva is a brand-name prescription medication that’s used for certain forms of cancer. Gazyva is FDA-approved to treat the following:

• Chronic lymphocytic leukemia that hasn’t been treated. In this case, you’ll use Gazyva along with a drug called chlorambucil (Leukeran) for chronic lymphocytic leukemia.
• Follicular lymphoma that’s relapsed or refractory. You must have tried rituximab (Rituxan) for follicular lymphoma (FL), but the cancer relapsed (came back) or was refractory (didn’t get better with treatment). You’ll use Gazyva along with bendamustine (Treanda), and then just Gazyva alone.
• FL that hasn’t been treated. Gazyva is used for these forms of FL: stage II bulky, III, or IV.* You’ll use Gazyva along with chemotherapy, and then just Gazyva alone if your cancer goes into at least partial remission. This is when the cancer is still present, but there are fewer cancer cells in your body.

* For details about these stages, see the “Gazyva uses” section below.

Gazyva drug class and form

Gazyva contains the active drug obinutuzumab and belongs to a class of medications called monoclonal antibodies. (A class of medications is a group of drugs that work in a similar way.)

Gazyva is a liquid solution that comes in a vial. It’s available in one strength: 1,000 mg/40 mL.

A healthcare provider will give you Gazyva as an intravenous (IV) infusion at your doctor’s office or in a hospital. An infusion is an injection into a vein that’s given over a set time. Gazyva infusions last 4 hours at first, but later doses may take less time. (See the “Gazyva dosage” section to learn more.)

Effectiveness

To learn about the effectiveness of Gazyva, please see the “Gazyva uses” section below.

Gazyva generic or biosimilar

Gazyva is available only as a brand-name medication. It’s not currently available in biosimilar form.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug.

Biosimilars are based on biologic drugs, which are made from parts of living organisms. Generics are based on regular medications made from chemicals. Biosimilars and generics also tend to cost less than brand-name drugs.

Gazyva contains the active drug obinutuzumab. This means obinutuzumab is the ingredient that makes Gazyva work.

Gazyva side effects

Gazyva can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Gazyva. These lists don’t include all possible side effects. Your side effects may vary depending on what condition you’re using Gazyva to treat.

For more information on the possible side effects of Gazyva, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they’ve approved. If you would like to report to the FDA a side effect you’ve had with Gazyva, you can do so through MedWatch.

Mild side effects

Mild side effects of Gazyva can include*:

• diarrhea
• cough
• constipation
• fever
• upper respiratory infection, such as the common cold
• joint pain
• sinus infection
• feeling weak
• urinary tract infection
• herpes infections, such as cold sores
• insomnia (trouble sleeping)
• decreased appetite
• rash

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Gazyva. To learn about other mild side effects, talk with your doctor or pharmacist or visit Gazyva’s prescribing information.

Serious side effects

Serious side effects from Gazyva aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Severe infections such as pneumonia (a type of lung infection). Symptoms can include:
  • fever
  • trouble breathing
  • cough
• Decreased level of white blood cells. Symptoms can include:
  • infections that keep coming back or won’t go away
  • feeling tired
  • mouth sores
• Decreased level of platelets (blood cells that help your blood clot). Symptoms can include:
  • bruising or bleeding easily
  • nosebleeds
  • bleeding gums

Other serious side effects, explained in more detail below in “Side effect details,” include:

• allergic reaction
• infusion reactions
• tumor lysis syndrome (a condition in which the contents of cancer cells pass into your blood)
• hepatitis B virus reactivation (flare-up of the hepatitis B virus if you’ve had it in the past)*
• a type of brain infection called progressive multifocal leukoencephalopathy (PML)*

* Gazyva has boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug.Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Gazyva. It’s not known how many people in clinical trials had allergic reactions.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Gazyva is given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a set time. Allergic reactions may happen while you’re receiving your infusion or right after. However, sometimes, allergic reactions may occur after your infusion is complete. In this case, your symptoms may include chest pain, joint pain, or fever.

It’s very rare to have an allergic reaction with your first dose of Gazyva. Usually, allergic reactions occur after you’ve already had at least one dose of the drug.

Call your doctor right away if you’re having a severe allergic reaction to Gazyva. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Hair loss

Hair loss isn’t currently noted as a possible side effect that can occur with Gazyva. However, in a past study, hair loss was reported only in people who received Gazyva for follicular lymphoma (FL) that hadn’t yet been treated with any medication.

This may be because with untreated FL, you’ll receive Gazyva along with chemotherapy drugs. And because chemotherapy can cause you to lose hair, the hair loss may be due to the chemotherapy drugs and not Gazyva.

In the study, researchers found the following:

• 13% of people who received Gazyva along with chemotherapy had hair loss. No one had hair loss that was considered severe.
• In comparison, 11% of people who received rituximab (Rituxan) and chemotherapy had hair loss. Less than 1% had hair loss that was considered severe.

If you have hair loss that’s serious or bothersome to you while using Gazyva, talk with your doctor. They may be able to recommend ways to ease this side effect.

Infusion reactions

Infusion reactions are a common side effect when receiving a dose of Gazyva.

Study results

In clinical trials of people who took Gazyva for any form of cancer that the drug treats:

• Between 66% and 72% of people had an infusion reaction. Of those people, between 11% and 20% had infusion reactions that were severe.
• In comparison, between 38% and 63% of people who took other medications (rituximab and chlorambucil, bendamustine, or chemotherapy) had an infusion reaction. Between 4% and 8% had a reaction that was considered severe.

Symptoms of infusion reactions

Infusion reaction reactions often occur during or within 24 hours of your first dose of Gazyva. However, they can still happen in people who have already received their first dose.

Your doctor will monitor you for infusion reactions while you receive Gazyva. Common symptoms include:

• nausea or vomiting
• diarrhea
• rash
• feeling tired
• fever and chills

You may also develop more serious infusion reactions such as decreased blood pressure, trouble breathing, and increased heart rate.

If you have an infusion reaction that’s considered severe, your doctor may decrease the rate of your infusion or stop your dose completely. They may also have you stop taking Gazyva if you have a serious reaction.

Decreased blood pressure as an infusion reaction

Because of the risk of decreased blood pressure, your doctor may have you pause the use of any blood pressure medications you’re taking. They may have you stop using the blood pressure drug at certain times.

These are: 12 hours before each dose of Gazyva, during infusions, and for the first hour after your dose is complete. This is done to make sure that your blood pressure doesn’t go too low, which can cause you to pass out.

Prevention of infusion reactions

To help prevent infusion reactions, your doctor will give you certain medications before your dose of Gazyva. With your first infusion of Gazyva, you’ll likely receive:

• a steroid medication, such as dexamethasone (Decadron)
• a medication to treat fever, such as acetaminophen (Tylenol)
• an antihistamine medication, such as diphenhydramine (Benadryl)

If you tolerate your first dose of Gazyva well and don’t have an infusion reaction, your doctor may give you only acetaminophen for future doses.

If you have any infusion reactions after receiving Gazyva, tell your doctor. Depending on the reaction, they may be able to help ease the side effects or switch you to a different medication instead.

Tumor lysis syndrome

Tumor lysis syndrome may occur with Gazyva. Depending on the condition being treated, in clinical trials, between 0.5% and 2% of people who took Gazyva developed severe tumor lysis syndrome. It wasn’t reported how many people in comparison groups also developed this side effect.

Tumor lysis syndrome occurs when many cancer cells are killed in a short period of time, and the cell contents pass into your blood. This can cause high levels of uric acid and electrolytes in your blood, which can be dangerous, and in some cases, may cause death. (Uric acid is a type of chemical that your body makes, and electrolytes are electrically charged minerals.)

Increased risk of tumor lysis syndrome

Certain people may be at a higher risk of developing tumor lysis syndrome. This includes people who have a lot of cancer cells or those with kidney problems, such as decreased kidney function.

If you have an increased risk for tumor lysis syndrome, your doctor may give you medication to decrease your level of uric acid. An example of this medication is allopurinol.

Your doctor will also help make sure that you’re well-hydrated before you receive your dose of Gazyva. And after your first dose of Gazyva, they’ll monitor your blood for the first few days to make sure you’re not developing tumor lysis syndrome.

Symptoms of tumor lysis syndrome

Symptoms of tumor lysis syndrome can include:

• nausea or vomiting
• diarrhea
• feeling tired or weak

If you develop any of these symptoms while using Gazyva, talk with your doctor right away. They’ll give you blood tests to determine if you have tumor lysis syndrome and treat it if needed.

Hepatitis B virus reactivation

Gazyva can cause the hepatitis B virus (HBV)* to become active again in people who had hepatitis B in the past. It wasn’t reported how often HBV reactivated in people who took Gazyva in clinical trials.

HBV reactivation means that even if you’ve been treated for hepatitis B, the infection could come back. This can cause very serious conditions such as liver failure, and in some cases, death.

Your doctor will test your blood for HBV before you start using Gazyva. If you test positive, they may treat the HBV or monitor you more during and after your Gazyva use. If you have a history of HBV, talk with your doctor before using Gazyva.

Symptoms of HBV reactivation include belly pain and yellowing of the skin and white of the eyes. If you develop any of these symptoms while using Gazyva, tell your doctor right away. They can recommend the appropriate treatment.

* Gazyva has a boxed warning for HBV reactivation. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Progressive multifocal leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML)* is a rare infection of the brain that can occur while taking Gazyva. It wasn’t reported how many people developed PML in clinical trials.

PML is caused by a virus, and it can result in serious effects, such as trouble walking or speaking. In some cases, PML can lead to death.

Symptoms of PML can include:

• confusion
• feeling dizzy
• not able to walk or talk
• changes in vision

If you notice any symptoms of PML while taking Gazyva, tell your doctor right away. They’ll perform testing, such as brain scans, to determine if you have PML.

* Gazyva has a boxed warning for PML. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Gazyva uses

The Food and Drug Administration (FDA) approves prescription drugs such as Gazyva to treat certain conditions. Gazyva may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Gazyva for untreated chronic lymphocytic leukemia (CLL)

Gazyva is FDA-approved to treat chronic lymphocytic leukemia (CLL) that hasn’t yet been treated. In this case, the drug is used along with another medication called chlorambucil (Leukeran).

CLL is a type of cancer that affects your white blood cells, causing them to become abnormal. This can be dangerous because the abnormal cells crowd out the normal blood cells. CLL grows very slowly.

Effectiveness

In clinical trials, Gazyva was shown to be an effective medication to treat CLL. Trials compared people who received Gazyva along with chlorambucil and people who received chlorambucil by itself.

• People who received both medications survived for 27.2 months without their cancer getting worse.
• In comparison, people who received chlorambucil alone survived for 11.2 months before their cancer began to get worse.

In another clinical trial, researchers compared people who took Gazyva along with chlorambucil and people who took rituximab along with chlorambucil.

• In this trial, people who received both Gazyva and chlorambucil survived for 26.7 months without their cancer getting worse.
• In comparison, people who received rituximab along with chlorambucil had about 14.9 months before their cancer began to get worse.

Gazyva for follicular lymphoma that’s relapsed or refractory

Gazyva is also FDA-approved to treat follicular lymphoma (FL) that’s relapsed or refractory. You must have tried rituximab (Rituxan) for FL, but the cancer relapsed (came back) or was refractory (didn’t get better with treatment).

You’ll fist use Gazyva along with bendamustine (Treanda). After treatment is complete, you may keep taking Gazyva by itself.

FL is a type of non-Hodgkin lymphoma (NHL). This is a type of cancer that affects white blood cells called lymphocytes. These blood cells usually help you fight infections. With FL, your lymphocytes grow abnormally, which can cause them to not work properly.

Effectiveness

In a clinical trial, Gazyva was shown to be an effective treatment for FL that’s relapsed or refractory. The trial lasted for 21.1 months and compared people who took Gazyva with bendamustine and people who took only bendamustine.

• By the end of the 21.1 months, FL didn’t get worse for people who received Gazyva with bendamustine.
• FL did get worse after about 13.8 months for people who received just bendamustine.

Gazyva for untreated follicular lymphoma

Gazyva is also FDA-approved to treat FL that hasn’t yet been treated. In this case, Gazyva is used for these forms of FL:

• Stage II bulky: Stage II means the cancer is in two or more groups of lymph nodes that are either both above, or both below, your diaphragm. (Your diaphragm is the muscle that’s beneath your lungs and helps them work.) So if you have stage II FL, you can have cancer in your neck and armpit area because these are both above the diaphragm. But you can’t have cancer in your neck and your abdomen (belly). That’s because one of these areas is above the diaphragm and the other is below it. The disease is considered bulky if you have a large mass in your chest. If your cancer is stage II bulky, you may need stronger treatments.
• Stage III: The cancer is on both sides of the diaphragm and may even spread into the spleen.
• Stage IV: The cancer has spread throughout your body. It may be in bone marrow or in other organs in your body.

You’ll use Gazyva along with chemotherapy, and then just Gazyva alone if your cancer goes into at least partial remission. This is when the cancer is still present, but there are fewer cancer cells in your body.

FL is a type of NHL. FL affects white blood cells called lymphocytes, which usually help you fight infections. With FL, your lymphocytes will grow abnormally, which can cause them to not work properly.

Effectiveness

In a clinical trial, researchers compared people with FL who received Gazyva and chemotherapy or rituximab along with chemotherapy. During the 38-month study:

• FL worsened for about 18% of people who received Gazyva and chemotherapy.
• FL worsened for 23% of people who received rituximab and chemotherapy.

Off-label uses for Gazyva

In addition to the uses listed above, Gazyva may be used off-label for other purposes. Off-label drug use is when a drug that’s approved for one or more uses is prescribed for a different one that’s not approved. Below are examples of off-label uses for Gazyva.

Gazyva for lupus nephritis

Gazyva isn’t currently FDA-approved to treat lupus nephritis. However, the drug may be prescribed off-label for this use.

Lupus nephritis may occur when someone with lupus develops kidney swelling or damage. (Lupus is an autoimmune disorder in which your immune system mistakenly attacks your own body.)

With lupus nephritis, your immune system attacks your kidneys and can cause serious kidney problems, such as kidney failure.

Breakthrough therapy designation

The FDA has given Gazyva a breakthrough therapy designation. This means that Gazyva may be better than current treatments for lupus nephritis, but the drug needs to be studied more before it can be approved. Currently, the FDA and the manufacturer of Gazyva are working together to complete Gazyva trials and get the medication approved as quickly as possible.

Clinical trial

An ongoing clinical trial is testing how many people with lupus nephritis regain normal kidney function after treatment. People are taking standard medications for lupus nephritis along with either Gazyva or a placebo (treatment with no active drug). So far, the Gazyva group is having better results than the placebo group.

If you’re interested in taking Gazyva for lupus nephritis, talk with your doctor.

Gazyva for DLBCL and other forms of lymphoma

Diffuse large B-cell lymphoma (DLBCL) is a type of cancer that affects your white blood cells. Currently, Gazyva isn’t FDA-approved to treat DLBCL or any other types of lymphoma besides FL and CLL. However, in some cases, Gazyva may be prescribed off-label for these uses.

There are some studies that have been done to test Gazyva in people with DLBCL. In one study, Gazyva was compared with rituximab. The results showed that the 3-year survival rates for people who took Gazyva or rituximab were similar.

In another study, Gazyva and the medications cyclophosphamide, doxorubicin, vincristine, and prednisone were given to people with DLBCL. The results showed that Gazyva can be added to other medications to be a possibly effective treatment for DLBCL.

If you have questions about using Gazyva for DLBCL or other types of lymphoma, check with your doctor.

Gazyva vs. Rituxan

You may wonder how Gazyva compares with other medications that are prescribed for similar uses. Here we look at how Gazyva and Rituxan are alike and different.

Ingredients

The active drug ingredient in Gazyva is obinutuzumab. The active drug ingredient in Rituxan is rituximab.

Uses

Gazyva is used for certain forms of cancer. The Food and Drug Administration (FDA) has approved Gazyva to treat the following:

• Chronic lymphocytic leukemia that hasn’t been treated. In this case, you’ll use Gazyva along with a drug called chlorambucil (Leukeran) for chronic lymphocytic leukemia.
• Follicular lymphoma that’s relapsed or refractory. You must’ve tried rituximab (Rituxan) for follicular lymphoma (FL), but the cancer relapsed (came back) or was refractory (didn’t get better with treatment). You’ll use Gazyva along with bendamustine (Treanda), and then just Gazyva alone.
• FL that hasn’t been treated. Gazyva is used for these forms of FL: stage II bulky, III, or IV.* You’ll use Gazyva along with chemotherapy, and then just Gazyva alone if your cancer goes into at least partial remission. This is when the cancer is still present, but there are fewer cancer cells in your body.

* For details about these stages, see the “Gazyva uses” section above.

Rituxan is approved to treat the following forms of CLL and FL:

• CLL that hasn’t been treated before. In this case, you’ll use Rituxan along with fludarabine and cyclophosphamide.
• CLL that’s CD20-positive and has been treated before. In this case, you’ll use Rituxan along with fludarabine and cyclophosphamide.
• FL that’s CD20-positive and relapsed or refractory.
• FL that’s CD20-positive and hasn’t been treated before. In this case, you’ll use Rituxan with chemotherapy. After treatment, you may possibly use just Rituxan.

In addition to the above uses, Rituxan is approved to treat other forms of non-Hodgkin lymphoma (NHL): diffuse large B-cell NHL and non-progressing (including stable disease) B-cell NHL. FL is a type of NHL.

Rituxan is also approved to treat certain forms of:

• rheumatoid arthritis
• granulomatosis with polyangiitis
• microscopic polyangiitis
• pemphigus vulgaris

Drug forms and administration

Both Gazyva and Rituxan are liquid solutions that come in a vial. And both drugs are given by a healthcare provider as an intravenous (IV) infusion. This is an injection into a vein that’s given over a set time. You’ll receive the infusions at your doctor’s office or in a hospital.

Side effects and risks

Gazyva and Rituxan both contain drugs used to treat certain types of CLL and FL. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Gazyva and Rituxan (when taken individually).

• Can occur with Gazyva:
  • diarrhea or constipation
  • insomnia (trouble sleeping)
  • decreased appetite
• Can occur with Rituxan:
  • chills
  • nausea
• Can occur with both Gazyva and Rituxan:
  • fever
  • feeling weak
  • infections such as sinus infection, urinary tract infection, upper respiratory infection (including the common cold), herpes infection (including cold sores)
  • rash
  • joint pain
  • cough

Serious side effects

These lists contain examples of serious side effects that can occur with Gazyva, with Rituxan, or with both drugs (when taken individually).

• Can occur with Gazyva:
  • decreased level of platelets (cells that help clot your blood)
• Can occur with Rituxan:
  • heart problems, such as heart attack
  • blockage or tear in your intestines
  • severe reactions of the skin or mucous membranes¹
  • kidney problems
• Can occur with both Gazyva and Rituxan:
  • tumor lysis syndrome (a condition in which the contents of cancer cells pass into your blood)
  • infusion reactions, such as low blood pressure¹
  • decreased level of white blood cells
  • severe infections, such as pneumonia
  • allergic reaction
  • progressive multifocal leukoencephalopathy (a type of brain infection)^1,2
  • hepatitis B virus reactivation (flare-up of the hepatitis B virus if you’ve had it in the past)^1,2

1 Rituxan has boxed warnings for these side effects. A boxed warning is the most serious warning from FDA.

2 Gazyva has boxed warnings for these side effects. For more information, see “FDA warnings” at the beginning of this article.

Effectiveness

Gazyva and Rituxan have different FDA-approved uses, but they’re both used to treat certain types of CLL and FL.

CLL

The use of Gazyva and Rituxan in treating CLL has been directly compared in a clinical study. People took Gazyva and chlorambucil or Rituxan and chlorambucil to treat their CLL.

• For people who received Gazyva and chlorambucil, their CLL worsened after 26.7 months.
• For people who received Rituxan and chlorambucil, their CLL worsened after an average of 14.9 months.

Untreated FL

Gazyva and Rituxan were also compared in a clinical trial of people with FL that hadn’t been treated before. People received chemotherapy and either Gazyva or rituximab during the 38-month study.

• FL worsened for about 18% of people who received Gazyva and chemotherapy.
• FL worsened for 23% of people who received rituximab and chemotherapy.

FL that has been treated

Gazyva is approved for use in people with FL that has come back or not gotten better after Rituxan treatment. In this case, it wouldn’t make sense to compare Gazyva with Rituxan because people who received Gazyva already tried Rituxan, which didn’t help their cancer.

Costs

Costs of Gazyva and Rituxan will vary depending on your treatment plan. The actual price you’ll pay for either drug will depend on your insurance plan and your location.

Generics or biosimilars

Many typical drugs that are made from chemicals have generic versions. A generic medication is an exact copy of the active ingredient in a brand-name drug. It often costs less than the brand-name version.

However, Gazyva and Rituxan are both brand-name biologic medications, which are made from parts of living organisms. Instead of generics, biologic drugs have biosimilars. A biosimilar is a drug that’s similar to a biologic drug.

Like generics, biosimilars often cost less than the brand-name biologic they’re based on.

Gazyva doesn’t have a biosimilar version. Rituxan has two biosimilar versions: Truxima and Ruxience.

Gazyva vs. Imbruvica

Like Rituxan (above), the drug Imbruvica has uses similar to those of Gazyva. Here’s a comparison of how Gazyva and Imbruvica are alike and different.

Ingredients

The active drug ingredient in Gazyva is obinutuzumab. The active drug ingredient in Imbruvica is ibrutinib.

Uses

Gazyva is used for certain forms of cancer. The Food and Drug Administration (FDA) approved Gazyva to treat the following:

• Chronic lymphocytic leukemia that hasn’t been treated. In this case, you’ll use Gazyva along with a drug called chlorambucil (Leukeran) for chronic lymphocytic leukemia.
• Follicular lymphoma that’s relapsed or refractory. You must’ve tried rituximab (Rituxan) for follicular lymphoma (FL), but the cancer relapsed (came back) or was refractory (didn’t get better with treatment). You’ll use Gazyva along with bendamustine (Treanda), and then just Gazyva alone.
• FL that hasn’t been treated. Gazyva is used for these forms of FL: stage II bulky, III, or IV.* You’ll use Gazyva along with chemotherapy, and then just Gazyva alone if your cancer goes into at least partial remission. This is when the cancer is still present, but there are fewer cancer cells in your body.

* For details about these stages, see the “Gazyva uses” section above.

Imbruvica is approved to treat CLL as well as CLL with a change in your genes called 17p deletion. Imbruvica isn’t approved to treat FL.

In addition to the above uses, Imbruvica is approved to treat certain forms of:

• small lymphocytic lymphoma
• mantle cell lymphoma
• Waldenstrom’s macroglobulinemia
• marginal zone lymphoma
• chronic graft-versus-host disease

Drug forms and administration

Gazyva comes as a liquid solution that comes in a vial. A healthcare provider will give you Gazyva as an intravenous (IV) infusion. This is an injection into a vein that’s given over a set time. You’ll receive the infusions at your doctor’s office or in a hospital.

Imbruvica comes as a capsule or tablet that you swallow.

Side effects and risks

Gazyva and Imbruvica both contain medications to treat certain forms of CLL. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Gazyva and Imbruvica (when taken individually).

• Can occur with Gazyva:
  • joint pain
  • feeling weak
  • mild infections such as sinus infection, urinary tract infection, upper respiratory infection (including the common cold), herpes infections (including cold sores)
  • insomnia (trouble sleeping)
  • decreased appetite
• Can occur with Imbruvica:
  • bruising
  • nausea
  • feeling tired
• Can occur with both Gazyva and Imbruvica:
  • cough
  • diarrhea
  • rash
  • fever
  • muscle pain

Serious side effects

These lists contain examples of serious side effects that can occur with Gazyva, with Imbruvica, or with both drugs (when taken individually).

• Can occur with Gazyva:
  • infusion reactions, such as low blood pressure
  • progressive multifocal leukoencephalopathy (a type of brain infection)*
  • hepatitis B virus reactivation (flare-up of the hepatitis B virus if you’ve had it in the past)*
• Can occur with Imbruvica:
  • anemia (low level of red blood cells)
  • serious bleeding
  • heart problems, such as changes in heart rhythm
  • increased blood pressure other types of cancer such as skin cancer
• Can occur with both Gazyva and Imbruvica:
  • decreased level of white blood cells
  • decreased level of platelets (blood cells that help your blood clot)
  • severe infections, such as pneumonia
  • tumor lysis syndrome (a condition in which the contents of cancer cells pass into your blood)
  • allergic reaction

* Gazyva has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Effectiveness

Gazyva and Imbruvica have different FDA-approved uses, but they’re both used to treat certain forms of CLL.

Gazyva can be used with Imbruvica to treat CLL that hasn’t been treated before. The FDA approved this combination after a clinical trial showed that the combination of drugs was an effective treatment. The study lasted 31.3 months, and people received Gazyva and Imbruvica or Gazyva and chlorambucil.

• For people who received Gazyva and Imbruvica, their CLL didn’t get worse over the course of the study.
• For people who received Gazyva along with chlorambucil, their CLL worsened after an average of 19 months.

Gazyva and Imbruvica haven’t been directly compared in clinical studies, but studies have found both Gazyva and Imbruvica to be effective for treating CLL.

Costs

Gazyva costs significantly less than Imbruvica. The actual price you’ll pay for either drug will depend on your insurance plan and your location.

Generics or biosimilars

Many typical drugs that are made from chemicals have generic versions. A generic medication is an exact copy of the active ingredient in a brand-name drug. It often costs less than the brand-name version.

However, Gazyva is a brand-name biologic medication, which is made from parts of living organisms. Instead of generics, biologic drugs have biosimilars. A biosimilar is a drug that’s similar to a biologic drug.

Like generics, biosimilars often cost less than the brand-name biologic they’re based on.

Gazyva doesn’t have a biosimilar version. Imbruvica doesn’t have a generic version.

Gazyva dosage

The Gazyva dosage your doctor prescribes will depend on several factors. These include:

• the type of the condition you’re using Gazyva to treat
• other medical conditions you may have
• if you’ve received Gazyva in the past and how your body responded to the drug

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Gazyva is a liquid solution that comes in a vial. It’s available in one strength: 1,000 mg/40 mL.

A healthcare provider will give you Gazyva as an intravenous (IV) infusion. This is an injection into a vein that’s given over a set time. You’ll receive the infusions at your doctor’s office or in a hospital.

Dosage for untreated chronic lymphocytic leukemia (CLL)

Gazyva is approved to treat chronic lymphocytic leukemia (CLL) that hasn’t yet been treated. In this case, you’ll receive Gazyva with another medication called chlorambucil (Leukeran).

The dosage for CLL is different for cycle 1 of treatment than for the rest of your treatment. You’ll first receive a loading dose. This helps you get enough medication in your body quickly so that it can start working as quickly as possible. Your treatment for CLL will be given in six cycles, with 28 days in each cycle. Here’s the schedule:

• cycle 1, day 1: You’ll receive a 100-mg infusion of Gazyva over a 4-hour period.
• cycle 1, day 2: You’ll receive a 900-mg infusion of Gazyva. How long this and other doses take will depend on how your body reacts to the first dose. For example, if you have a mild reaction during the first dose, other doses may be given more slowly. This lets your body have more time to adjust to the drug. (For more about infusion reactions, see “Infusion reactions” in the “Gazyva side effects” section above.)
• cycle 1, days 8 and 15: You’ll receive a 1,000-mg infusion of Gazyva.
• cycles 2 through 6, day 1: You’ll receive a 1,000-mg infusion of Gazyva.

Dosage for follicular lymphoma that’s relapsed or refractory

Gazyva is also FDA-approved to treat follicular lymphoma (FL) that’s relapsed or refractory. You must’ve tried rituximab (Rituxan) for FL, but the cancer relapsed (came back) or was refractory (didn’t get better with treatment). You’ll first use Gazyva along with bendamustine (Treanda). After treatment is complete, you may keep taking Gazyva by itself.

For these types of FL, your treatment will be given in six cycles, with 28 days in each cycle. You’ll take Gazyva along with bendamustine for all six cycles.

You’ll receive a 1,000-mg infusion of Gazyva on these days:

• cycle 1, day 1
• cycle 1, days 8 and 15
• cycles 2 through 6, day 1

After your six cycles of Gazyva and bendamustine treatment, you’ll receive just Gazyva if your cancer has gone away, improved, or hasn’t gotten worse. You’ll have a 1,000-mg infusion of Gazyva every 2 months for up to 2 years.

Dosage for untreated follicular lymphoma

Gazyva can also be used for FL that has not yet been treated. Gazyva is used for these forms of FL: stage II bulky, III, or IV.* You’ll use Gazyva along with chemotherapy, and then just Gazyva alone if your cancer goes into at least partial remission. This is when the cancer is still present, but there are fewer cancer cells in your body.

* For details about these stages, see the “Gazyva uses” section above.

Your treatment will be given in six to eight cycles, with 21 to 28 days in each cycle. Your dosage schedule will depend on what type of chemotherapy you’re receiving along with Gazyva:

• Gazyva with bendamustine: You’ll have six cycles of treatment. Each cycle is 28 days long.
• Gazyva with doxorubicin, cyclophosphamide, vincristine, and prednisone: You’ll have six cycles of treatment. Each cycle is 21 days long. After you finish the six cycles, you’ll have two additional cycles during which you’ll receive only Gazyva. These cycles are 21 days long.
• Gazyva with rituximab, cyclophosphamide, vincristine, and prednisone: You’ll have eight cycles of treatment. Each cycle is 21 days long.

You’ll receive a 1,000-mg infusion of Gazyva on these days:

• cycle 1, on day 1
• cycle 1, days 8 and 15
• cycles 2 through 6, day 1

After your six or eight cycles of Gazyva treatment, you’ll receive just Gazyva if your cancer has gone away or improved. You’ll have a 1,000-mg infusion of Gazyva every 2 months for up to 2 years.

What if I miss an infusion appointment?

If you miss an appointment for an infusion, reschedule it as soon as possible. The doctor’s office staff may have to adjust the timing of your future visits.

To help make sure that you don’t miss an appointment, try setting a reminder on your phone. You can also write your treatment schedule on a calendar.

Will I need to use this drug long term?

Gazyva is meant to be used as a long-term treatment. Usually, you’ll keep receiving Gazyva for up to a maximum of 2 years. But if your cancer worsens during this time, your doctor may stop your treatment.

If you and your doctor determine that Gazyva is safe and effective for you, you’ll likely take it long term.

Common questions about Gazyva

Here are answers to some frequently asked questions about Gazyva.

How long does Gazyva stay in your system?

Gazyva stays in your body for about 25 to 31 days. That’s why you usually receive it once every 21 to 28 days. By having the doses spread out, you’ll have the correct amount of medication in your body.

Will I need to take medication to prevent infections while I use Gazyva?

Usually, you won’t need to take medication to help prevent infections while you’re receiving Gazyva.

But your doctor will be checking your blood levels during your treatment. It’s possible that your level of neutrophils (a type of white blood cell) may drop too low and stay low for more than 1 week. If this happens, your doctor may have you take medication to prevent viral or fungal infections. (These are infections caused by viruses or fungi.)

In some cases, your doctor may have you take a granulocyte-colony stimulating factor (G-CSF). This is a medication that helps increase the number of neutrophils in your body. If your neutrophil count gets too low, you’re at a higher risk for developing an infection. So by taking a GCSF, you can stimulate your immune system to help prevent you from developing an infection while you receive Gazyva.

Talk with your doctor if you have any questions about medications you should take to help prevent infections during Gazyva treatment. They can also recommend other ways to avoid getting an infection.

Is Gazyva chemotherapy?

No. Gazyva isn’t chemotherapy. Gazyva belongs to a class of medications called monoclonal antibodies. (A class of medications is a group of drugs that work in a similar way.) Monoclonal antibodies are a kind of targeted treatment. And targeted treatments work by acting on a specific area of your body. They also affect just that one area.

In comparison, chemotherapy affects all of the cells in your body, but especially fast-growing cells such as those that make up hair and line your stomach. Because chemotherapy affects many cells in your body, it can also cause many more side effects than targeted treatments.

Should I avoid getting any vaccines during my Gazyva treatment?

Yes. You should avoid getting live vaccines while you’re receiving Gazyva and for a time after you finish your treatment.

Live vaccines have a weakened form of a virus or bacterium in them. Gazyva may weaken your immune system, so your body may not be able to fight the virus or bacterium in the live vaccine. This may cause you to develop an infection.

For more information and examples of live vaccines, see the “Gazyva and live vaccines” section below.

The manufacturer of Gazyva doesn’t mention whether it’s safe to get non-live (inactive) vaccines while using Gazyva. These vaccines don’t contain a live virus or bacterium.

Before you receive Gazyva, ask your doctor if you’re due for any vaccines. If you do need any vaccines, they may recommend getting them before you start treatment with Gazyva.

Can I drive myself home after a Gazyva infusion?

No. You shouldn’t drive yourself home after an infusion because you may be dizzy or very tired after your appointment.

Plan for someone to drop you off and pick you up after your infusion is complete. You can also have someone come with you to your infusion appointment and drive you home.

Gazyva use with other drugs

Usually, you’ll receive Gazyva along with other medications to treat your cancer. However, the type of cancer you have will determine what other drugs you need.

• For chronic lymphocytic leukemia (CLL), you’ll receive Gazyva along with chlorambucil (Leukeran).
• For follicular lymphoma (FL) that got worse after taking a treatment that included rituximab, you’ll receive Gazyva along with bendamustine (Treanda), and then just Gazyva alone.
• For stage II bulky, III, or IV* FL that you haven’t tried any medications for, you’ll receive Gazyva along with chemotherapy. If your cancer improves, you’ll receive just Gazyva.

* For details about these stages, see the “Gazyva uses” section above.

Premedications

You may also need to take premedications. These are drugs that you receive before your Gazyva doses to help prevent certain side effects, such as infusion reactions. (See the “Infusion reactions” section above to learn more.)

You’ll be given the premedications about 30 minutes to 1 hour before your dose of Gazyva. Which drugs you’re given depends on the type of cancer you have and if you had a reaction to Gazyva in the past.

With your first dose of Gazyva, you’ll likely take:

• a steroid medication, such as dexamethasone (Decadron)
• a medication to treat fever, such as acetaminophen (Tylenol)
• an antihistamine medication, such as diphenhydramine (Benadryl)

If you tolerate your first dose of Gazyva well and don’t have an infusion reaction, your doctor may give you only acetaminophen for future doses.

Premedications for tumor lysis syndrome

You may also be given premedications if you have a history of or are at high risk for tumor lysis syndrome (TLS). This syndrome occurs when many cancer cells are killed in a short period of time, and the cell contents pass into your blood.

TLS can cause a high level of uric acid and electrolytes in your blood. (Uric acid is a type of chemical that your body makes, and electrolytes are electrically charged minerals.)

Your doctor may recommend that you take premedications, such as allopurinol (Lopurin), to decrease your uric acid level. They may also give you fluids so that you stay hydrated.

Gazyva and alcohol

There’s no known interaction between Gazyva and alcohol. However, sometimes Gazyva can cause you to have low blood pressure. Alcohol may also cause your blood pressure to decrease. So taking Gazyva and drinking alcohol may cause your blood pressure to become too low, which can be dangerous.

If you drink alcohol, talk with your doctor about what amount is safe to drink during your Gazyva treatment.

Gazyva interactions

Gazyva can interact with certain medications and vaccines. But the drug isn’t known to interact with supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Gazyva and other medications

Below is a list of medications that can interact with Gazyva. This list doesn’t contain all drugs that may interact with Gazyva.

Before taking Gazyva, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Gazyva and blood pressure medications

Gazyva may decrease your blood pressure while you’re getting an infusion (an injection into a vein that’s given over a set time). So if you’re taking any medications to lower your blood pressure, your doctor may have you pause your use of them. Your blood pressure could drop too low if you take those drugs around the time of your infusions.

Examples of blood pressure medications include:

• amlodipine (Norvasc)
• diltiazem (Cartia XT)
• lisinopril (Prinivil)
• metoprolol (Toprol XL, Lopressor)

Your doctor may recommend that you stop taking your blood pressure medications during these times:

• 12 hours before infusions
• during infusions
• for 1 hour after infusions

If you take any blood pressure drugs, talk with your doctor before you start treatment with Gazyva. They can advise you if and when to pause your use of the medications.

Gazyva and live vaccines

You should avoid getting live vaccines while you’re receiving Gazyva. Live vaccines have a weakened form of a virus or bacterium in them. Gazyva may weaken your immune system, so your body may not be able to fight the virus or bacterium in the live vaccine. This may cause you to develop an infection.

You also shouldn’t get live vaccines for a period of a time after you stop Gazyva treatment. You’ll likely need to wait until immune system is strong enough. Your doctor can check your blood levels to see how quickly your immune system recovers after you stop taking Gazyva. Then they can determine when you can get live vaccines after stopping this medication.

Examples of live vaccines include:

• measles, mumps, rubella (MMR)
• nasal spray version of the flu shot
• smallpox
• chickenpox
• rotavirus
• yellow fever
• typhoid

The manufacturer of Gazyva doesn’t mention whether it’s safe to get non-live (inactive) vaccines while using Gazyva. These vaccines don’t contain a live virus or bacterium.

Before you receive Gazyva, ask your doctor if you’re due for any vaccines. If you do need any vaccines, they may recommend getting them before you start treatment with Gazyva.

Gazyva and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Gazyva. However, you should still check with your doctor or pharmacist before using any of these products while taking Gazyva.

Gazyva and foods

There aren’t any foods that have been specifically reported to interact with Gazyva. If you have any questions about eating certain foods with Gazyva, talk with your doctor.

Gazyva cost

As with all medications, the cost of Gazyva can vary. The actual price you’ll pay will depend on your insurance plan and your location.

Before approving coverage for Gazyva, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Gazyva, contact your insurance plan.

Financial assistance

If you need financial support to pay for Gazyva, help is available. Genentech Inc., the manufacturer of Gazyva, offers a number of programs, including the Genentech BioOncology Co-pay Assistance Program. For more information and to find out if you’re eligible for support, call 866-422-2377 or visit the program website.

Generic version

Gazyva is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Alternatives to Gazyva

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Gazyva, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for chronic lymphocytic leukemia (CLL)

Examples of other drugs that may be used to treat chronic lymphocytic leukemia (CLL) include:

• ibrutinib (Imbruvica)
• idelalisib (Zydelig)
• duvelisib (Copiktra)
• venetoclax (Venclexta)
• rituximab (Rituxan, Truxima)
• bendamustine (Treanda)
• chlorambucil (Leukeran)

Alternatives for follicular lymphoma

The medication that you take to treat your follicular lymphoma (FL) will depend on whether you’ve ever been treated for FL before or if your FL has been treated and came back. It may also depend on your health history. Your doctor can recommend the best medications to treat your FL.

Examples of other drugs that may be used to treat FL include:

• rituximab (Rituxan, Truxima)
• bendamustine (Treanda)
• cyclophosphamide
• doxorubicin
• vincristine
• chlorambucil (Leukeran)

How Gazyva is given

You should take Gazyva according to your doctor or healthcare provider’s instructions.

Gazyva is a liquid solution that comes in a vial. A healthcare provider will give you Gazyva as an intravenous (IV) infusion at your doctor’s office or in a hospital. An infusion is an injection into a vein that’s given over a set time. Gazyva infusions last 4 hours at first, but later doses may take less time. (See the “Gazyva dosage” section to learn more.)

Premedications

Before the infusion, you may be given premedications. These are drugs that you receive before your Gazyva doses to help prevent certain side effects, such as infusion reactions. (See the “Infusion reactions” section above to learn more.)

With your first infusion of Gazyva, you’ll likely receive:

• a steroid medication, such as dexamethasone (Decadron)
• a medication to treat fever, such as acetaminophen (Tylenol)
• an antihistamine medication, such as diphenhydramine (Benadryl)

If you tolerate your first dose of Gazyva well and don’t have an infusion reaction, your doctor may give you only acetaminophen for future doses.

How often Gazyva is given

How often you receive Gazyva depends on what type of cancer you have and which treatment cycle you’re in. See the “Gazyva dosage” section above for details.

Taking Gazyva with food

You don’t need to eat while you’re getting your Gazyva infusion. However, your infusion may last many hours. So if you want to bring food or drinks with you, first talk with your doctor. They’ll be able to recommend what you can consume during your infusion appointment.

How Gazyva works

Gazyva is a targeted treatment. This means it works on specific cells, called B cells, in your body.

Chronic lymphocytic leukemia explained

Chronic lymphocytic leukemia (CLL) is a type of cancer that affects your white blood cells. The majority of CLL cases affect white blood cells called B-cells. When you have CLL, you have a lot of abnormal white blood cells. They crowd out the normal cells in your blood and bone marrow (the tissue inside bones that makes blood cells).

Gazyva works to treat CLL by binding specifically to B-cells and destroying them. This decreases the number of abnormal B-cells that you have in your blood and bone marrow and allows new cells to grow.

Follicular lymphoma explained

Follicular lymphoma (FL) is a kind of cancer that begins in white blood cells called B-cells. FL is a type of non-Hodgkin lymphoma.

Gazyva works to treat FL by binding specifically to B-cells and destroying them. This decreases the number of abnormal B-cells that you have in your blood and bone marrow and allows new, healthy cells to grow.

If you have questions about how Gazyva works to treat your cancer, talk with your doctor or pharmacist.

How long does it take to work?

Gazyva will start working after your first dose of the medication.

Gazyva and pregnancy

It’s not known if Gazyva is safe to use during pregnancy.

In animal studies where mothers were given Gazyva during pregnancy, their babies had an increased risk of infection and certain allergic reactions. However, animal studies don’t always show exactly what will happen in humans.

Live vaccines

It’s believed that Gazyva weakens the immune system of babies whose mothers receive Gazyva. Because of this, babies shouldn’t be given live vaccines until their immune system regains strength. Live vaccines have a weakened form of a virus or bacterium in them, and they can cause infections in people with weak immune systems. (See the “Gazyva and live vaccines” section above to learn more.)

Your baby’s doctor will give your baby a blood test to make sure their immune system is strong enough for live vaccines.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting Gazyva treatment. They can review the pros and cons of the drug with you.

Gazyva and birth control

It’s not known if Gazyva is safe to take during pregnancy.

For women using Gazyva

If you’re a woman who can become pregnant, you should use birth control during your Gazyva treatment. And you should keep using it for 6 months after you have your last dose of Gazyva.

For men using Gazyva

The maker of Gazyva hasn’t supplied any birth control recommendations for men who take the medication. However, if you’re a man who’s using Gazyva and your sexual partner can become pregnant, talk with your doctor. They can review your birth control needs during and after your treatment.

For more information about taking Gazyva during pregnancy, see the “Gazyva and pregnancy” section above.

Gazyva and breastfeeding

It’s not known if Gazyva is safe to take while you’re breastfeeding.

In studies of animals that were given Gazyva while pregnant, low levels of the drug were found in breast milk. However, this doesn’t mean that Gazyva will be present in human breast milk.

It’s believed that breastfed children won’t be exposed to enough Gazyva to cause problems. However, it’s important to talk with your doctor about the risks of breastfeeding while you’re using Gazyva.

Gazyva precautions

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

• Reactivation of hepatitis B virus. If you’ve had hepatitis B in the past, taking Gazyva can cause the hepatitis B virus (HBV) to become active again. This means that even if you’ve been treated for hepatitis B, the infection could come back. HBV reactivation can cause very serious conditions such as liver failure, and in some cases, death. Your doctor will test your blood for HBV before you start using Gazyva. If you test positive, they may treat the HBV or monitor you more during and after your Gazyva use. If you have a history of HBV, talk with your doctor before using Gazyva.
• Progressive multifocal leukoencephalopathy. A rare brain infection called progressive multifocal leukoencephalopathy (PML) can occur during Gazyva treatment. PML can cause problems such as trouble walking and speaking. And in certain cases, PML can lead to death. If you notice any symptoms of PML while using Gazyva, tell your doctor right away. (For symptoms, see the “Side effect details” section above.)

Other precautions

Before taking Gazyva, talk with your doctor about your health history. Gazyva may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Current infections. Your doctor will treat you for any infections you have before you start using Gazyva. This is because the drug may weaken your immune system. So if you already have an infection, your body may not be able to fight it as well after you start Gazyva treatment. Talk with your doctor about any infections that you may have before you start using Gazyva.
• Vaccines. You shouldn’t get any live vaccines while you’re using Gazyva. (See the “Gazyva and live vaccines” section above to learn more.) Talk with your doctor about any vaccines that you may need to get before starting Gazyva treatment.
• Pregnancy. It’s not known if Gazyva is safe to use while pregnant. For more information, please see the “Gazyva and pregnancy” section above.
• Breastfeeding. It’s not known if Gazyva is safe to take while you’re breastfeeding. For more information, please see the “Gazyva and breastfeeding” section above.
• Allergic reaction. If you’re allergic to Gazyva or any of its ingredients, you shouldn’t use the medication. Ask your doctor what other treatment options are better choices for you.

Note: For more information about the potential negative effects of Gazyva, see the “Gazyva side effects” section above.