Gazyva is a prescription injection medicine used for people with certain cancers, such as chronic lymphocytic leukemia (CLL) and certain types of follicular lymphoma. It is a type of medicine known as a monoclonal antibody.
Gazyva is given as an infusion into a vein (IV) by a health care provider in a hospital setting. It can be given along with other chemotherapy or by itself.
How Does Gazyva Work?
Gazyva helps your immune system fight cancer cells. It sticks to a portion of B cells, which are immune cells. Once it is attached, it sends signals to the cancer cells that cause them to die.
How often will I receive Gazyva?
You will get Gazyva in a health care setting. The dose, schedule, and duration that you will get depend on the type of cancer that you have. Follow all instructions from your health care provider on when to return for your next IV infusion.
What should I expect when I receive Gazyva?
You may get some of the following medicines before your infusion to lower your risk of having an infusion-related reaction.
- Acetaminophen
- Antihistamines, such as diphenhydramine
- Steroids such as dexamethasone or methylprednisolone
You may also receive fluids and other medicines, such as allopurinol or rasburicase, before your infusion to lower your risk of certain side effects of infections.
You may receive antibiotics, antivirals, or antifungal medicines even if you do not have an active infection to help prevent you from getting an infection while you are being treated with Gazyva.
While you are getting your infusion, your health care provider will watch you for signs of infusion reactions. Let your health care provider know right away if you get any of the following symptoms during or within one day of receiving your infusion.
- Low blood pressure
- Fast heart rate
- Trouble breathing
- Throat irritation
- Wheezing
- Throat swelling
Your health care provider may slow down the rate of the infusion, pause the infusion, or stop the infusion if you have any infusion reactions.
Talk to your health care provider before getting any vaccines while you are having your Gazyva treatments. Certain vaccines should be avoided while you are receiving this medicine.
Is Gazyva Right for Me?
Gazyva should not be used in people who have had a serious allergic reaction to it in the past. It should also not be used in people who have had a history of serum sickness with this agent in the past.
How Was Gazyva Studied for Chronic Lymphocytic Leukemia?
How was the study designed?
Gazyva was studied in 781 people with CLL who had not been treated with other medicines in the past. People in this study had other health conditions or had kidneys that were not working as well as they should. People in this study got one of three treatment options:
- Chlorambucil
- Gazyva plus chlorambucil
- Rituximab plus chlorambucil
The treatments were given as part of a 28-day cycle. A total of six cycles were given to the people in this study. People in the Gazyva group received pre-medication with allopurinol, acetaminophen, antihistamines, and steroids to help prevent infusion reactions and other potential side effects.
To find out if Gazyva worked, the researchers looked at progression-free survival (PFS). PFS is the length of time between when the person was randomized (randomly put in a study group) and when their CLL got worse (progressed) or when the person died.
To find out if Gazyva was safe, the researchers collected information on what types of side effects people had during the study.
What types of people were included in the study?
The median age of people in this study was 73 years. About 62% were male and 95% were White. About 83% had more than three other medical conditions and about 27% had at least one medical condition that was not controlled at the start of the study.
What are the main findings based on this study?
Progression-free survival was highest in the people who received the Gazyva plus chlorambucil combination. Results are in the table below.
| Group | Progression-Free Survival |
| Gazyva plus chlorambucil | 26.7 months |
| Rituximab plus chlorambucil | 16.3 months |
| Chlorambucil alone | 11.1 months |
Infusion-related reactions were reported in about 66% of people who got Gazyva. Other serious side effects reported by people who got Gazyva include a decrease in white blood cells, anemia, a decrease in platelets, and infections.
Your results may differ from what was seen in clinical studies.
How Was Gazyva Studied for Follicular Lymphoma?
Two studies established the efficacy of Gazyva for follicular lymphoma.
- The GALLIUM Study
- The GADOLIN study
How was the GALLIUM study designed?
Gazyva was studied in 1,202 adults with certain types of follicular lymphoma. People in this study had to have advanced disease (stage II bulky, stage III, or stage IV follicular lymphoma) that had not been treated with other medicines before.
People in this study got one of two treatment options:
- Gazyva plus other chemotherapy
- Rituximab plus other chemotherapy
The treatments were given as part of six to eight cycles of chemotherapy. People in the Gazyva group received pre-medication with allopurinol, acetaminophen, antihistamines, and steroids to help prevent infusion reactions and other potential side effects.
To find out if Gazyva worked, the researchers looked at PFS.
To find out if Gazyva was safe, the researchers collected information on what types of side effects people had during the study.
What types of people were included in the GALLIUM study?
The median age of people in this study who had follicular lymphoma was 59 years. About 81% were White and about 53% were female. The median time since diagnosis of follicular lymphoma was about 1½ months. About 7% of people in this study had stage II disease, about 35% had stage III, and about 56% had stage IV.
What are the main findings based on the GALLIUM study?
After about 34.5 months, about 17% of people in the Gazyva group had progression of cancer, relapse, or death. About 24% had progression of cancer, relapse, or death in the rituximab group. The researchers estimated that 80% of the people in the Gazyva group would be progression-free at three years. They estimated that about 73% of people who received rituximab would be progression-free at three years.
The most common side effects reported by people taking Gazyva in the GALLIUM study were infusion-related reactions, a decrease in white blood cells, infections, constipation, and diarrhea.
Your results may differ from what was seen in clinical studies.
How was the GADOLIN study designed?
Gazyva was studied in 321 adults with certain types of follicular lymphoma. People in this study had to have received rituximab in the past, but it did not work.
People in this study got one of two treatment options:
- Gazyva plus bendamustine
- Bendamustine alone
The treatments were given as part of a 28-day cycle. A total of six cycles were given to the people in this study. People in the Gazyva group received pre-medication with allopurinol, acetaminophen, antihistamines, and steroids to help prevent infusion reactions and other potential side effects.
To find out if Gazyva worked, the researchers looked at PFS.
To find out if Gazyva was safe, the researchers collected information on what types of side effects people had during the study.
What types of people were included in the GADOLIN study?
The median age of people in this study who had follicular lymphoma was 63 years. About 88% were White and 56% were male. The median time since diagnosis of follicular lymphoma was about three years. About 46% of people had been treated with one other chemotherapy treatment plan in the past, and about 33% had been treated with two other chemotherapy treatment plans.
What are the main findings based on the GADOLIN study?
After about 21 months, people who were in the bendamustine alone group had a median PFS of 13.8 months. People who were in the Gazyva plus bendamustine group did not have a PFS value. This happens when more than 50% of the people did not have any new cancer growth.
The most common side effects reported by people taking Gazyva included infusion-related reactions, fatigue, a decrease in white blood cells, coughing, infections, and muscle pain.
Your results may differ from what was seen in clinical studies.
How Do I Know if Gazyva Is Working?
You may not see changes right away. It may take weeks to months before your health care provider can tell if Gazyva is working for you. Your health care provider will look at blood tests, biopsies, and scans to find out if it is working for you.
What Else Do I Need to Know About Gazyva?
If you have had the hepatitis B virus (HBV), treatment with Gazyva may cause your HBV to come back. Your health care provider will check to see if you have been exposed to HBV before you start Gazyva. You will need to stop Gazyva if you get HBV during treatment.
Is There Any Cost Assistance Available for Gazyva?
There may be cost assistance to help you afford Gazyva. You may have options even if you do not have health insurance. Your health care provider can help you get started, or you can call Gazyva Access Solutions at 877-436-3683.
