Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using Gazyva?
Gazyva contains the active ingredient obinutuzumab. Gazyva is used to:
- treat chronic lymphocytic leukaemia (CLL)
- treat follicular lymphoma (FL) either in patients who have not been treated before
or in patients who are no longer responding to treatment with another medicine called
rituximab
- reduce the severity of cytokine release syndrome (CRS), a possible serious side
effect of glofitamab treatment
2. What should I know before I use Gazyva?
Do not use if you have ever had an allergic reaction to Gazyva or any of the ingredients
listed at the end of the CMI. Talk to your doctor if you have any other medical conditions,
take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding
. For more information, see Section
2. What should I know before I use Gazyva? in the full CMI.
3. What if I am taking other medicines?
4. How is Gazyva given?
Gazyva must be prepared by a healthcare professional and will be given in a hospital
or clinic by a doctor or nurse. You will be given Gazyva by infusion into a vein (intravenous
(IV) infusion). The number of infusions you will be given depends on why you are being
given Gazyva and how you respond to the treatment. Before you receive Gazyva you will
be given other medicines to help reduce the severity of possible infusion reactions.
More instructions can be found in Section
4. How is Gazyva given? in the full CMI.
5. What should I know while using Gazyva?
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Things you should do
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Remind any doctor, dentist, nurse or pharmacist you visit that you are using Gazyva.
Tell your doctor or nurse immediately if you have any signs or symptoms of an infusion
reaction or allergic reaction, or heart problems.
Tell your partner or caregiver you are receiving Gazyva and ask them to tell you if
they notice any changes in your movement or behaviour. If they notice any changes
you should tell your doctor about them immediately.
Tell your doctor if you become pregnant or intend to start a family while receiving
Gazyva, if you intend to breast feed whilst receiving Gazyva, or if you intend to
vaccinate your baby and were pregnant with your baby whilst receiving Gazyva.
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Things you should not do
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Do not stop your Gazyva treatment without talking to your doctor first.
Do not take any other medicines, whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist
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Driving or using machines
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Be careful driving or operating machinery until you know how Gazyva affects you.
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6. Are there any side effects?
Serious side effects include reactions such as swelling of the face, lips, tongue,
throat or other parts of the body, trouble breathing, wheezing or coughing. For more
information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING: Progressive Multifocal Leukoencephalopathy
Progressive Multifocal Leukoencephalopathy (PML) is a rare, serious brain infection
that can cause severe disability or even death. PML is a rare side effect that can
occur whilst receiving Gazyva. Tell your partner or caregiver you are receiving Gazyva
and ask them to tell you if they notice any changes in your movement or behaviour.
If they notice any changes you should tell your doctor about them immediately
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Active ingredient(s): obinutuzumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Gazyva. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Gazyva.
Where to find information in this leaflet:
1. Why am I using Gazyva?
Gazyva contains the active ingredient obinutuzumab. Gazyva belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents.
There are many different classes of anti-neoplastic agents. Gazyva belongs to a class
called monoclonal antibodies.
Monoclonal antibodies are proteins which specifically recognise and bind to other
unique proteins in the body.
Gazyva is used to:
treat chronic lymphocytic leukaemia (CLL)
treat follicular lymphoma (FL) either in patients who have not been treated before
or in patients who are no longer responding to treatment with another medicine called
rituximab
reduce the severity of cytokine release syndrome (CRS), a possible serious side effect
of glofitamab treatment
Gazyva recognises and attaches to a protein called CD20 which is found on the surface
of white blood cells known as B lymphocytes. During the process of binding to the
protein, the abnormal growth of the B lymphocytes is stopped. It is the abnormally
growing B lymphocytes that are responsible for CLL and FL.
For CLL Gazyva is used with the chemotherapy medicine chlorambucil. For FL Gazyva
is first given with chemotherapy medicines and then on its own.
Gazyva reduces the number of B lymphocytes before treatment with glofitamab, a medicine
given to treat diffuse large b-cell lymphoma (DLBCL).
For further information about any other medicines used with Gazyva please ask your
doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) for these
medicines.
2. What should I know before I use Gazyva?
Warnings
Do not use Gazyva if:
you are allergic to obinutuzumab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
if you have had an allergic reaction to any other proteins that are of mouse origin
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Check with your doctor if:
you have an infection, or a history of a recurring or long-term infection such as
hepatitis B
you are taking or have previously taken medicines which may affect your immune system,
such as chemotherapy or immunosuppressive medicines
you are taking or have taken medicines which affect your immune system, you may have
an increased risk of infections. There have been reports of a rare, serious brain
infection called PML (progressive multifocal leukoencephalopathy) usually affecting
people with a weakened immune system. Your chance of getting PML may be higher if
you are treated with medicines that weaken the immune system, including Gazyva. PML
can cause severe disability or even death.
you have a history of heart disease with:
cardiac arrhythmias (abnormal beating of the heart)
angina (chest pain)
heart failure or a recent heart attack
you are taking medicine to control blood pressure
you are taking medicine to prevent blood clots
you have pre-existing lung disease
you have kidney disease
you have liver disease
you intend to have or have had immunisation with any vaccine
you are allergic to any other medicines or any other substances such as foods, preservatives
or dyes
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
Check with your doctor if you are pregnant or intend to become pregnant.
It is not known whether Gazyva is harmful to an unborn baby. It is not recommended
that you are given Gazyva while you are pregnant.
If you are of child bearing potential, it is recommended that you do not become pregnant
for 18 months following the end of treatment with Gazyva.
If you are of child bearing potential, it is recommended that you use effective contraceptive
methods during treatment and for up to 18 months following the end of treatment with
Gazyva.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if Gazyva passes into breast milk. It is recommended that you discontinue
breast feeding while you are treated with Gazyva and for 18 months after your final
infusion of Gazyva.
Use in children
The safety and efficacy of Gazyva in children and adolescents under 18 years of age
have not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
As Gazyva may cause a temporary drop in your blood pressure, your doctor may advise
you to temporarily stop taking your blood pressure medicine before you are given Gazyva.
Gazyva can reduce the number of platelets in your blood. Taking medicine to prevent
blood clots while you are receiving Gazyva may further reduce the number of platelets.
This may cause life-threatening bleeding. Your doctor will supervise you closely during
treatment with Gazyva.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Gazyva.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Gazyva.
4. How is Gazyva given?
Follow all directions given to you by your doctor or nurse carefully.
They may differ from the information contained in this leaflet.
Gazyva must be prepared by a healthcare professional and will be given in a hospital
or clinic by a doctor or nurse. Gazyva is given by infusion into a vein (intravenous
(IV) infusion).
How much and when to take Gazyva
Your doctor will decide how many infusions you need and the duration of the infusions.
Your doctor may adjust your infusion depending on how well each one is tolerated.
You will be closely monitored during each infusion.
Before you receive Gazyva you will be given other medicines to help reduce the severity
of possible infusion reactions.
For chronic lymphocytic leukaemia (CLL)
The first infusion: you will be given 100 mg of Gazyva by IV infusion over 4 hours.
The second infusion: if the first infusion was well tolerated, you will be given 900
mg of Gazyva by IV infusion, either on the same day as the first infusion or a day
later.
Subsequent infusions: if the previous infusion was well tolerated, you will be given
1000 mg of Gazyva by IV infusion.
For follicular lymphoma (FL)
The first infusion: you will be given 1000 mg of Gazyva by IV infusion.
Subsequent infusions: if the first infusion was well tolerated, you will be given
1000 mg of Gazyva by IV infusion.
Maintenance treatment: if you respond to initial treatment your doctor may decide
to continue your treatment with Gazyva.
You may receive Gazyva once every 2 months for up to 2 years.
For pre-treatment to reduce the severity of Cytokine Release Syndrome (CRS) induced
by glofitamab
You will be given a single 1000 mg dose of Gazyva by IV infusion 7 days before your
glofitamab treatment begins.
If you miss a dose
As Gazyva is given under the supervision of your doctor, you are unlikely to miss
a dose. However, if you forget or miss your appointment to receive Gazyva, you should
not wait until the next planned dose but make another appointment as soon as possible.
If you use too much Gazyva
As Gazyva is given under the supervision of your doctor, it is very unlikely that
you will be given too much. However, if you experience any side effects after being
given Gazyva, tell your doctor immediately.
5. What should I know while using Gazyva?
Things you should do
Tell your doctor or nurse immediately if you have any signs or symptoms of an infusion
reaction or allergic reaction, or heart problems.
Some signs and symptoms can include:
swelling of your face, lips, tongue or throat with difficulty breathing
swelling of other parts of your body
shortness of breath, wheezing or trouble breathing
rash, itching or hives on the skin
feeling sick (nausea)
fever, chills
feeling tired
headache
chest pain
abnormal or irregular heartbeat
Tell your partner or caregiver you are receiving Gazyva and ask them to tell you if
they notice any changes in your movement or behaviour. If they notice any changes
you should tell your doctor about them immediately.
Your doctor may need to perform some tests and alter your treatment.
Tell all doctors, dentists, nurses and pharmacists who are treating you that you are
receiving Gazyva.
Tell your doctor if you become pregnant or intend to start a family while receiving
Gazyva, if you intend to breast feed whilst receiving Gazyva, or if you intend to
vaccinate your baby and were pregnant with your baby whilst receiving Gazyva.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Your doctor will perform regular blood tests.
Things you should not do
Do not stop your Gazyva treatment without talking to your doctor first.
Tell your doctor if you feel that Gazyva is not helping your condition.
Do not take any other medicines, whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Gazyva
affects you.
Gazyva is unlikely to cause any problems with your ability to drive or operate machinery.
However if you get any signs or symptoms of an infusion reaction or allergic reaction,
or heart problems, you should refrain from driving or operating machinery until the
reaction stops.
Looking after your medicine
Gazyva will be stored in the pharmacy or on the hospital ward in a refrigerator at
a temperature between 2°C and 8°C.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or nurse as soon as possible if you do not feel well while you are
receiving Gazyva.
If you are 65 years of age or older or suffer problems with your kidneys you may have
an increased chance of getting side effects.
You may experience side effects during an infusion or after an infusion, these can
be serious or less serious.
Serious side effects
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Serious side effects
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What to do
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During an infusion:
swelling of your face, lips, tongue or throat with difficulty breathing
swelling of other parts of your body
shortness of breath, wheezing or trouble breathing
rash, itching or hives on the skin
vomiting or feeling sick (nausea)
fever, flushing or chills
diarrhoea
cough or throat irritation
feeling tired
headache
chest pain
dizziness or light headedness
abnormal or irregular heartbeat
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Tell your doctor or nurse immediately if you notice any of these while receiving an
infusion. These may be serious side effects. You may need medical attention.
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After an infusion:
swelling of your face, lips, tongue or throat with difficulty breathing
swelling of other parts of your body
shortness of breath, wheezing or trouble breathing
skin problems including rash, itchiness or hives, hardened or discoloured skin lesions
which may increase in size
stomach cramps or pains
severe or bloody diarrhoea
nausea and vomiting including vomiting blood or material that looks like coffee grounds
fever, chills
severe coughing
abnormal or irregular heartbeat
chest pain
bleeding or bruising more than normal
blood clots
feeling dizzy or lightheaded
one or a combination of the following: confusion, disorientation or memory loss, changes
in the way you move, walk or talk, decreased strength or progressive weakness in your
body, blurred or loss of vision.
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Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of these signs after an infusion. These may be serious side effects. You may need medical attention.
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Less serious side effects
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Less serious side effects
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What to do
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After an infusion:
frequent infections such as fever, severe chills, respiratory infections (including
pneumonia), shingles, mouth ulcers or urinary infections
pain in mouth or throat
runny or stuffy nose or stuffy chest
joint, bone or muscle pain
arm, leg or back pain
headache
diarrhoea, constipation, abdominal discomfort or pain, or haemorrhoids
urinary incontinence or pain
increased weight
persistent cough
hair loss
night sweats
itchy skin
red eye
sleeplessness and/or feeling tired
feeling depressed or anxious
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Gazyva contains
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Active ingredient
(main ingredient)
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obinutuzumab.
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Other ingredients
(inactive ingredients)
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histidine
histidine hydrochloride monohydrate
trehalose dehydrate
poloxamer 188
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Potential allergens
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Refer to your healthcare professional for further advice
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Do not take this medicine if you are allergic to any of these ingredients.
What Gazyva looks like
Gazyva is a clear, colourless to slightly brownish liquid. Gazyva is supplied as a
single-dose glass vial containing 40 mL of solution for intravenous infusion (25 mg/mL).
It is diluted before infusion into a vein. (AUST R 210562).
Who distributes Gazyva
Gazyva is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney, NSW 2000
AUSTRALIA
Medical enquiries: 1800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information (CMI).
This leaflet was prepared in May 2023.