(oh bi nue TOOZ ue mab)

Trade Names: Gazyva™

Obinutuzumab is the generic name for the trade chemotherapy drug Gazyva™. In some cases, health care professionals may use the trade name Gazyva™ when referring to the generic drug name obinutuzumab.

Drug Type:

Obinutuzumab is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Obinutuzumab is classified as a "monoclonal antibody" (For more detail, see "How Obinutuzumab Works" section below).

What Obinutuzumab Is Used For:

• Obinutuzumab is a CD20-directed cytolytic antibody and is indicated in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)
• In combination with bendamustine for the treatment of patients with follicular lymphoma (FL) who have had prior therapy with rituximab-containing regimen.

Note: If a drug has been approved for one use, physicians sometimes elect to use this same drug for other problems if they believe it might be helpful.

How Obinutuzumab Is Given:

• Obinutuzumab is given as an infusion into the vein (intravenous, IV). The time of the infusion may be shortened, depending on whether or not you have received obinutuzumab in the past, or how well you tolerate obinutuzumab
• Medications (such as steroids, acetaminophen (Tylenol™) and an anti-histamine) are usually given just before the infusion to reduce the occurrence of infusion-related symptoms.
• There is no pill form of obinutuzumab.
• The amount of obinutuzumab you will receive and the schedule it is given will depend on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects of Obinutuzumab:

Important things to remember about the side effects of obinutuzumab:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of obinutuzumab.

The following are common (occurring in greater than 30%) side effects for patients taking obinutuzumab:

• Lymphocytopenia
• Leukopenia
• Neutropenia
• Infusion reaction-initial infusion
• Thrombocytopenia
• Infection
• Hypoglycemia
• Hyperkalemia

These are less common side effects (occurring in 10-29%) for patients receiving obinutuzumab:

• Hyponatremia
• Increased serum AST
• Increased serum creatinine
• Increased serum ALT
• Hypoalbuminemia
• Musculoskeletal signs and symptoms
• Increased serum alkaline phosphataseLiver Problems - Managing Side Effects - Chemocare
• Antibody development
• Hypokalemia
• Anemia

Serious, but uncommon side effects of obinutuzumab include:

• Hepatitis B Virus (HBV) reactivation. This occurs only in those who were previously infected with the Hepatitis B virus. Blood tests for Hepatitis B will be drawn prior to initiation of obinutuzumab.
• Progressive Multifocal Leukoencephalopathy (PML) is a rare disorder that damages the material (myelin) that covers and protects nerves in the brain.
• Patients with cancer who take this drug may be at a greater risk of tumor lysis syndrome (TLS) within 12-24 hours of the first dose. It is caused by massive tumor cell destruction with the release of large amounts of potassium, phosphate, and nucleic acids into the circulation.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C), chills
• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, chest tightness, hoarseness, swelling of facial features, hives, red, swollen, blistered or peeling skin (possible allergic reaction)
• Confusion

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain (possible signs of infection)
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Signs of liver problems, such as dark urine, fatigue, not feeling hungry, upset stomach or stomach pain, light colored stools, or yellow skin or eyes
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools or urine
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)
• Fast heartbeat
• Bad headache

Always inform your health care provider if you experience any unusual symptoms.

Obinutuzumab Precautions:

• Before starting obinutuzumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking obinutuzumab.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking obinutuzumab. Barrier methods of contraception, such as condoms, are recommended during therapy and for 12 months after therapy is completed. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking obinutuzumab.

Obinutuzumab Self-Care Tips:

• You will be closely monitored during the infusion, report immediately any pain, burning or swelling at the infusion site, chest pain or palpitations; difficulty breathing or swallowing; chills. These may be signs of an infusion reaction. If signs of reaction occur, the infusion is stopped. In most cases, the infusion can be restarted at a slower rate once symptoms subside.
• Drink 2 to 3 quarts of fluid for the first 48 hours after each infusion, unless you were told to restrict your fluid intake.
• This medication infrequently causes nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals. Sucking on lozenges and chewing gum may also help.
• You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
• In general, drinking alcoholic beverages should be avoided. You should discuss this with your doctor.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Obinutuzumab:

You will be checked regularly by your health care professional while you are taking obinutuzumab, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor. Hepatitis B screening will be completed as well.

How Obinutuzumab Works:

Obinutuzumab is classified as a monoclonal antibody. Monoclonal antibodies are a type of "targeted" cancer therapy.

Antibodies are an integral part of the body's immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually given only for cancers in which antigens (and the respective antibodies) have been identified already.

Obinutuzumab works by targeting the CD20 antigen on normal and malignant (cancerous) B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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