• Gazyva is a brand (trade) name for obinutuzumab which may be used to treat or delay the progression of chronic lymphocytic leukemia and follicular lymphoma.
• Gazyva works by targeting a specific antigen called CD20 which is a type of protein found on normal and cancerous B-lymphocytes. Gazyva binds to this protein which signals cells in our immune system to attack and destroy these B-cells. This happens via several different mechanisms, such as the activation of signaling pathways that trigger cell death. Although Gazyva causes cell death in both normal and malignant B-cells, stem cells, which are young cells in the bone marrow that develop into various types of cells, do not have the CD20 antigen and will not be attacked.
• Gazyva belongs to the class of medicines known as CD20 monoclonal antibodies. Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system.

• Gazyva (obinutuzumab) is an intravenous medication that is used to treat or delay the progression of certain types of cancer, usually in combination with other treatments.
• Approved to treat people with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.
• May be given in combination with bendamustine followed by Gazyva monotherapy to people with follicular lymphoma who relapsed after or are refractory to, a rituximab-containing regimen.
• Approved to treat adults with previously untreated stage II bulky, III, or IV follicular lymphoma in combination with chemotherapy followed by Gazyva monotherapy in those who achieve at least partial remission.
• Available as single-dose vials containing 1000mg/40mL (25 mg/mL) for intravenous infusion.
• Apart from the initial loading dose where Gazyva is given multiple times over a series of days during cycle 1, Gazyva is administered once during a 21-day or 28-day cycle
• Gazyva is not chemotherapy, it is a targeted treatment that works by binding to a protein called CD20 that is present on the surface of B-lymphocytes, which are a type of white blood cell. When Gazyva binds to this protein, it causes B-cells to self-destruct or disintegrate.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Infusion-related reactions, fever, diarrhea, neutropenia, thrombocytopenia, diarrhea, constipation, nasopharyngitis, and urinary tract infections are the most common side effects reported. Monitor patients with grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution, and consider dose delays or administration of granulocyte colony-stimulating factor if necessary. Cough, muscle aches and pains, rash, and itch have also been reported.
• Regular monitoring for neutropenia, thrombocytopenia, and hemorrhagic events, particularly during the first cycle is important. Hepatic enzyme elevations have occurred in patients with CLL within 24 to 48 hours of Gazyva administration.
• Patients need to be premedicated with a glucocorticoid (either dexamethasone 20mg or methylprednisolone 80mg) at least 1 hour before the first infusion. At least 30 minutes before every infusion, acetaminophen 650-1000mg and an antihistamine (diphenhydramine 50mg) should be administered as well. These premedications lower the risk of infusion-related reactions. Patients with an infusion-related reaction (IRR grade 3) in the prior infusion require a glucocorticoid as well.
• 65% of patients with CLL, 60% with previously untreated NHL, and 37% with relapsed or refractory NHL experienced an infusion reaction to the first 1000mg dose of Gazyva. Infusion-related reactions can be fatal. These usually occur during the first infusion with a time to onset of 30–120 minutes, but within 24 hours, and symptoms include nausea, urticaria, low blood pressure, tachycardia, or respiratory symptoms. Some have been fatal. Patients with preexisting cardiac or pulmonary conditions are at the greatest risk. Antihypertensives may need to be withheld for 12 hours before each infusion. Follow the manufacturer's recommendations with regard to how to manage IRR.
• Must be administered via an intravenous infusion by a healthcare professional with facilities to manage severe infusion-related reactions. Cannot be administered via an IV push or bolus. The dosage and rate of infusion vary depending on the condition being treated and how well tolerated the infusion is. Do not mix with any other drugs.
• Not suitable for people with a previous reaction (ie, anaphylaxis) or serum sickness to obinutuzumab. Do not administer during an active infection.
• Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving Gazyva. Perform cardiac monitoring during and after all infusions of Gazyva for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina and discontinue infusions for serious or life-threatening cardiac arrhythmias.
• Reactivation of hepatitis B has been reported in people with a current or prior hepatitis B virus (HBV) infection who have been treated with anti-CD20 antibodies such as Gazyva. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. All patients should be screened for current or prior hepatitis B virus (HBV) infection by measuring HBsAg and anti-HBc before initiating treatment with Gazyva.
• Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients with hematologic malignancies or with autoimmune diseases who have received Gazyva. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability. Posterior reversible encephalopathy syndrome (PRES), tumor lysis syndrome (TLS), and respiratory effects have also been reported.
• Gazyva will suppress the immune system and will reduce a person's ability to fight infection. This ability will be further compromised if the person is also taking other drugs that suppress the immune system, such as chemotherapy agents, immune-modulating therapies, or other immunosuppressants. This immune-suppressing effect will persist for a few months after stopping Gazyva treatment. Review all other immune-suppressing medications before initiating Gazyva, and be aware of those with a long half-life whose effects may persist for weeks after discontinuation. Grade 3 to 5 infections have been reported in up to 8% of patients during combination therapy, up to 13% of patients during monotherapy, and up to 8% of patients after treatment.
• Gazyva will also reduce the immune response to live vaccines, such as MMR and varicella vaccines. All vaccines should be up to date before Gazyva is started. Administer all live or live-attenuated vaccines at least 4 weeks before initiating Gazyva, and non-live vaccines at least 2 weeks before. Do not administer live virus vaccines during Gazyva treatment.
• Needs to be kept in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not shake or freeze. Once diluted, use immediately. If not used, it may be stored for up to 24 hours in the refrigerator, but discarded after 24 hours.
• May cause B-cell depletion and fetal harm if administered to pregnant women and those of childbearing potential should use effective contraception while receiving Gazyva and for 6 months after the last dose. If a woman becomes inadvertently pregnant she should advise her doctor immediately. Women should not breastfeed during treatment with Gazyva and for 6 months after the last dose.
• Not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before starting treatment with Gazyva, and during treatment with Gazyva, tell your health care provider if you think you have an infection or have symptoms of an infection such as a fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. Also, let them know if you have infections that keep coming back.
• Some vaccinations may need to be avoided during treatment with Gazyva and for a few months after stopping it. Take care to avoid people who are unwell and protect yourself from injury.
• Your doctor will also obtain a complete blood count including platelets and screen you for hepatitis B virus (HBV) infection before starting Gazyva. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Gazyva is started. You will need regular blood counts while you are being administered Gazyva.
• Your first infusion of Gazyva will be given slowly to see how well you tolerate it. Your actual appointment time will be longer because premedication with a glucocorticoid, acetaminophen, and an antihistamine, needs to be administered 30 to 60 minutes before giving Gazyva, to lessen the risk of an infusion reaction happening.
• Infusion reactions, some serious, may occur while you are having a Gazyva infusion. Symptoms may include itchy skin, a rash, hives, skin redness, bronchospasm, throat irritation, oropharyngeal pain, shortness of breath, throat edema, flushing, low blood pressure, fever, fatigue, headache, dizziness, nausea, a fast heartbeat, and anaphylaxis. Tell your doctor if you feel unwell or have any of these symptoms during an infusion.
• Also report any other symptoms of concern, such as nausea, vomiting, diarrhea, yellow discoloration of the skin or eyes, confusion, dizziness, loss of balance, and fatigue.
• Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding before being administered Gazyva as it is not suitable during pregnancy and breastfeeding. Use effective contraception while receiving Gazyva and for 12 months after the last infusion. If you inadvertently become pregnant, see your doctor immediately.

• Research has shown that treatment with Gazyva and chlorambucil for CLL increased the average progression-free survival to 27.2 months compared to 11.2 months for those treated with chlorambucil alone. The overall response rate with Gazyva treatment was 78.2% compared to 33.1% with chlorambucil. The average duration of response was 22.4 months with Gazyva compared with 4.7 months with chlorambucil. A good response has also been seen with Gazyva and chlorambucil (median progression-free survival of 26.7 months) compared with rituximab plus chlorambucil (PFS of 14.9 months).
• For patients with follicular lymphoma (FL), the median PFS time was not reached after an average observation time of 21.1 months, compared to a PFS of 13.8 months for Bendamustine. The best overall response was 78.7% with Gazyva plus bendamustine compared with 74.7% with bendamustine alone. In the final analysis, after 52.2 months, there were 66 deaths (40.2%) in the Gazyva arm compared with 85 deaths (51.3%) in the bendamustine alone arm. In those with previously untreated FL, overall response rates and remission rates were similar between Gazyva plus chemotherapy followed by Gazyva monotherapy compared to rituximab plus chemotherapy followed by rituximab monotherapy (91% vs 88% respectively, with complete remission rates of 28% and 27% respectively).

Medicines that interact with Gazyva may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Gazyva. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Gazyva include:

• antipsychotics, such as clozapine
• biologics, such as adalimumab, etanercept, golimumab, or infliximab
• fingolimod or golimumab
• HIV medications, such as zidovudine
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, Covid-19 vaccines, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Gazyva reduces the immune response to vaccination. Administer live or live-attenuated vaccines at least 4 weeks before Gazyva initiation, and non-live vaccines at least 2 weeks before)
• probiotics, such as bifidobacterium or lactobacillus
• zinc.

Gazyva may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Take this into account when switching from drugs with prolonged immune effects.

Note that this list is not all-inclusive and includes only common medications that may interact with Gazyva. You should refer to the prescribing information for Gazyva for a complete list of interactions.