Trade name: Obinutuzumab
Gazyva is the trade name for the generic chemotherapy
drug obinutuzumab. In some cases, health care professionals may use the
generic name obinutuzumab when referring to the trade name Gazyva.
Drug Type :
Gazyva is an anti-cancer ("antineoplastic" or "cytotoxic")
chemotherapy drug. Gazyva is classified as a "monoclonal
antibody" (For more detail, see "How Gazyva Works"
What Gazyva Is Used For:
Gazyva 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)
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
How Gazyva Is Given:
Side Effects of Gazyva:
- Gazyva 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 Gazyva in the past, or how well you
- 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 Gazyva.
- The amount of Gazyva 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.
Important things to remember about the side effects of Gazyva:
The following are common (occurring in greater than 30%) side
effects for patients taking Gazyva:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and
- 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 Gazyva.
These are less common side effects (occurring in 10-29%) for
patients receiving Gazyva:
- Infusion reaction-initial infusion
Serious, but uncommon side effects of Gazyva include:
- Increased serum AST
- Increased serum creatinine
- Increased serum ALT
- Musculoskeletal signs and symptoms
- Increased serum alkaline phosphatase
- Liver Problems - Managing Side Effects - Chemocare
- Antibody development
- 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 Gazyva.
- 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 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
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
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:
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:
- 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
- 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
- Nausea (interferes with ability to eat and unrelieved with
- 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
Gazyva Self Care Tips:
- Before starting Gazyva 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 Gazyva.
- 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
- For both men and women: Do not conceive a child (get pregnant)
while taking Gazyva. 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 Gazyva.
Monitoring and Testing While Taking Gazyva:
- 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
You will be checked regularly by your health care professional while you
are taking Gazyva 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 Gazyva Works:
Gazyva 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.
Gazyva 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