Gazyva: Uses, Side Effects and Dosage

Serious warnings and precautions box

What GAZYVA is used for:

GAZYVA contains obinutuzumab, which belongs to a group of medicines called monoclonal antibodies. This medicine is used to treat several different conditions. These include:

• Chronic Lymphocytic Leukaemia (CLL)

  • GAZYVA is used in adults who have not had any treatment before. It is used together with another medicine for cancer called chlorambucil.

• Follicular Lymphoma (FL) - a type of Non-Hodgkin Lymphoma. GAZYVA is used:

  • in combination with other cancer medications to treat patients with stage II bulky, III or IV follicular lymphoma (FL) who have not been treated for FL before.
  • with another medicine for cancer, called bendamustine, in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse after this treatment.

• Patients who respond to treatment with GAZYVA in combination with other cancer medications can continue to be treated with GAZYVA on its own (monotherapy) for up to 2 years.
• Lupus nephritis (LN)
• GAZYVA is used for the treatment of adult patients with LN (inflammation of the kidney caused by lupus) who are being treated with standard therapy.

How GAZYVA works:

GAZYVA binds to the surface of the “B lymphocyte” cells and causes them to die.

CLL and FL are types of cancers of the blood which affect a type of white blood cell called “B lymphocytes”. The affected B lymphocytes multiply too quickly and live too long. This means that there are too many of them circulating in your blood. CLL can also make your lymph nodes get larger; they are part of a network of vessels running round your body that is filled with clear watery fluid called “lymph”.

LN is a type of kidney disease where the body’s own immune system attacks the kidneys by mistake. GAZYVA reduces the amount of B-lymphocytes, a kind of immune system cell that is involved in the cause of some of the LN symptoms. GAZYVA is given to patients with LN together with other medicines to decrease lupus-related kidney inflammation.

The ingredients in GAZYVA are:

Medicinal ingredients: obinutuzumab

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride, poloxamer 188, trehalose, water for injection.

GAZYVA comes in the following dosage form:

Each 50 mL single-use glass vial contains a single 1000 mg dose of obinutuzumab in 40 mL of liquid concentrate (25 mg/mL), to be diluted in 0.9% aqueous sodium chloride solution, for intravenous administration. GAZYVA is available in a pack containing 1 vial.

Do not use GAZYVA if:

• If you are allergic to obinutuzumab, any of the other ingredients of this medicine, or the container it is in.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GAZYVA. Talk about any health conditions or problems you may have, including:

• Infusion related reactions: GAZYVA is an infusion (“drip”) which is given intravenously (into your veins). Very commonly patients being given GAZYVA have some side effects while the infusion is being given. Most patients are also given medication such as acetaminophen, antihistamines, and steroids (such as prednisone) for allergic reactions before the infusion to prevent these reactions. If you notice any trouble breathing, feel hot or shivery, have hives or an itchy rash, tell the person giving you the infusion immediately; these side effects are more common with the first infusions of GAZYVA, and decreased with subsequent infusions of GAZYVA. Let your doctor know if you have ever had breathing problems or lung problems. If

  • you develop any of these symptoms, the infusion will be slowed down or stopped for a while. Once these symptoms go away, or improve, the infusion can be continued.
• Heart Disease: If you have ever had heart disease, or are taking medicines for high blood pressure, your doctor will take special care of you during therapy with GAZYVA.
• Hepatitis B infection: Tell the doctor if you had or think you had hepatitis; you will be carefully checked for signs of active hepatitis B virus.
• Infection: While you are taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection or if you have ever taken medicines which affect your immune system (such as chemotherapy or immunosuppressants). The symptoms of infection can include one or more of the following: fever of 38ºC or greater, chills, cough, sore throat, or pain on urination. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP.
• Progressive multifocal leukoencephalopathy (PML): Cases of PML have been observed in patients treated with GAZYVA. PML is a condition that causes nerve damage within the brain. Tell your doctor immediately if you have memory loss, trouble thinking, and difficulty with walking, clumsiness, falls or weakness on one side of the body, changes in mood or loss of vision. Your doctor will check if you need to see a neurologist.
• Tumour Lysis Syndrome (TLS): Cases of TLS have been reported during the use of GAZYVA. TLS is a condition that causes sudden kidney failure and abnormal heart rhythms due to changes in blood chemistry, which may be fatal. Tell your doctor immediately if you have palpitations/irregular heartbeats; vomiting; fatigue/weakness; difficulty concentrating/trouble thinking; swelling, numbness or tingling in hands, face or feet; back pain; muscle cramps; fainting or trouble breathing. Some patients with TLS in its early stages have no symptoms, and your doctor will be performing blood tests for this and other side effects.
• Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections.

• Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. Let your doctor know if you are taking medicines which may increase bleeding risk (platelet inhibitors, anticoagulants). While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have

  • occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced.
• Gastrointestinal perforation (a hole in the stomach or intestines): Gastrointestinal perforation has been reported in patients treated with GAZYVA. Most cases occurred in patients with Non- Hodgkin Lymphoma. One patient died of gastrointestinal perforation. Some patients experienced serious events.
• Allergic reactions: Immediate (e.g. anaphylaxis) and delayed (e.g. serum sickness) allergic reactions have been reported in patients treated with GAZYVA. If an allergic reaction is suspected during or after an infusion (e.g. symptoms typically occurring after previous exposure and very rarely with the first infusion), your doctor will permanently take you off treatment.
• Vaccination: Certain vaccine may not be recommended during treatment with GAZYVA and the safety of certain vaccines following treatment with GAZYVA has not been studied. Talk to your doctor if you are due to have a vaccine or may need one in the near future.

Other warnings you should know about:

GAZYVA has not been studied in pregnant or breastfeeding women. If you are pregnant, could become pregnant or are breastfeeding, be sure to discuss with your doctor whether GAZYVA is right for you. Women should avoid pregnancy and use effective birth control methods during treatment with GAZYVA and for 18 months after the last dose GAZYVA. Women should avoid breastfeeding during treatment and for 18 months after the last dose of GAZYVA. If you have given birth while on GAZYVA treatment, your newborn will be monitored for reduced immunity. Postponing your child’s vaccinations, that use live virus vaccines, may be considered until your child’s immunity levels are acceptable.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take GAZYVA:

• A health professional in a healthcare facility will give you GAZYVA as prescribed by your doctor. It is given into a vein (intravenously) as a drip (infusion) over several hours.

Usual dose:

Chronic Lymphocytic Leukaemia

You will be given 6 treatment cycles of GAZYVA. Each cycle lasts 28 days. A typical schedule is shown below.

Your first cycle:

• Day 1 – 100 mg
• Day 1 (continued) or Day 2 – 900 mg
• Day 8 – 1000 mg
• Day 15 – 1000 mg

If you are able to tolerate the first 100 mg of the infusion on Day 1 without any changes to the infusion rate or interruptions to the infusion, the second 900 mg infusion may be given on Day 1 as well.

Your next cycles 2, 3, 4, 5, and 6:

• Day 1 – 1000 mg.

Follicular Lymphoma (that has returned)

You will be given 6 treatment cycles of GAZYVA with bendamustine (each cycle lasts 28 days) followed by GAZYVA only treatment (infusion every 2 months) for up to 2 years. A typical schedule is shown below.

Your first cycle:

• Day 1 – 1000 mg
• Day 8 – 1000 mg
• Day 15 – 1000 mg

Your next cycles 2, 3, 4, 5, and 6, as well as monotherapy:

• Day 1 – 1000 mg.

Follicular Lymphoma (previously untreated)

You will be given 6 treatment cycles of GAZYVA with bendamustine (each cycle lasts 28 days) or 6 treatment cycles of GAZYVA with CHOP (each cycle lasts 21 days) followed by 2 additional cycles of GAZYVA alone, or 8 treatment cycles of GAZYVA with CVP (each cycle lasts 21 days). If your lymphoma responds to the treatment, you will be given GAZYVA-only treatment (infusion every 2 months) for up to 2 years or until your cancer returns. A typical schedule is shown below.

Your first cycle:

• Day 1 – 1000 mg
• Day 8 – 1000 mg
• Day 15 – 1000 mg

Your next cycles 2-6 or 2-8, as well as monotherapy:

• Day 1 – 1000 mg.

Lupus Nephritis

You will be given GAZYVA as an intravenous infusion as shown in the schedule below:

• Dose 1 (initial infusion): 1000 mg
• Dose 2 (Week 2, two weeks after Dose 1): 1000 mg
• Dose 3 (Week 24): 1000 mg
• Dose 4: (Week 26, two weeks after Dose 3): 1000 mg
• Dose 5 (six months after Dose 4, and every six months thereafter): 1000 mg

Before each infusion of GAZYVA, you will be given medicines which help to reduce possible infusion related reactions or tumour lysis syndrome. These may include:

• Fluids
• Medicines to reduce an allergic reaction (anti-histamines)
• Medicines to reduce inflammation (corticosteroids)
• Painkillers (analgesics)
• Medicines to reduce a fever
• Medicines to prevent “tumour lysis syndrome”

Overdose:

It is unlikely that you will receive too much GAZYVA as you will be closely monitored by health professionals during your infusion. However, if you suspect you received too much GAZYVA, contact your doctor and poison control centre immediately.

Missed Dose:

If you miss a dose of GAZYVA, contact your doctor immediately. Your doctor will decide when you should receive your next dose.

Possible side effects from using GAZYVA:

These are not all the possible side effects you may feel when taking GAZYVA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects with using GAZYVA

Very common: may affect 1 in 10 or more people

• Nausea
• Decreased number of red blood cells in the blood that carry oxygen (symptoms include feeling of weakness or fatigue in general or during exercise, poor concentration)
• Diarrhoea
• Constipation
• Hair loss
• Headache
• Vomiting
• Inflammation of the lungs (bronchitis)

Common: may affect up to 1 in 10 people

• Lung infection (pneumonia)
• Herpes simplex viral infection of the mouth (such as cold sores) or the genitals

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

GAZYVA will be stored by the health professionals at the hospital or clinic. The storage details are as follows:

• Store in a refrigerator (2 to 8 ^oC)
• Do not use this medicine after the expiry date shown on the vial and carton
• Keep vial in outer carton to protect from light.
• Do not freeze or shake.

Do not throw away any medicines via wastewater or household waste. Your health professional will properly discard any medicines that are no longer being used.

Keep out of reach and sight of children.

If you want more information about GAZYVA:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-

  • products/drug-product-database.html; the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388.

Date of Authorization: 2026-10-13

^©Copyright 2026, Hoffmann-La Roche Limited

GAZYVA^® is a registered trademark of F. Hoffmann-La Roche AG, used under license

Hoffmann-La Roche Limited

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