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. This CMI is for the subcutaneous dosage form of
Tecentriq. For information about the intravenous dosage form of Tecentriq, please
refer to the intravenous Tecentriq CMI.
1. Why am I using Tecentriq SC?
Tecentriq SC contains the active ingredient atezolizumab. Tecentriq SC is used to
treat different types of cancers.
2. What should I know before I use Tecentriq SC?
Do not use if you have ever had an allergic reaction to atezolizumab 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.
3. What if I am taking other medicines?
Some medicines may interfere with Tecentriq SC and affect how it works.
4. How do I use Tecentriq SC?
Tecentriq solution for subcutaneous (SC) injection is given as an injection under
your skin by a doctor or nurse every three weeks. The injection will be given in the
thigh over approximately 7 minutes. More instructions can be found in Section
4. How do I use Tecentriq SC? in the full CMI.
5. What should I know while using Tecentriq SC?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Tecentriq SC.
Tell your doctor if you are pregnant, think you might be pregnant or are planning
to become pregnant.
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Driving or using machines
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Be careful driving or operating machinery until you know how Tecentriq SC affects
you.
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6. Are there any side effects?
Like all medicines, Tecentriq SC can cause side effects, although not everybody gets
them. Your doctor will discuss these with you and will explain the risks and benefits
of your treatment.
When you are using Tecentriq SC, you can have some serious side effects. Serious side
effects associated with Tecentriq SC may include lung problems, liver problems, intestinal
problems, heart problems, muscle problems, kidney problems, problems in hormone glands
(for example thyroid, pituitary, adrenal problems or diabetes), the nervous system,
the skin, the immune system and other organs. The most common side effects when atezolizumab
is used on its own include diarrhoea, nausea, vomiting, urinary tract infection, decreased
appetite, feeling tired or weak, fever, cough, shortness of breath, rash, itchy skin
and headache. The most common side effects when atezolizumab was given in combination
with other anti-cancer medicines include feeling tired or weak, constipation, swelling
of legs or arms, lung infections, hair loss, high blood pressure and common cold.
Active ingredient(s):
atezolizumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Tecentriq SC. 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 Tecentriq SC.
Where to find information in this leaflet:
1. Why am I using Tecentriq SC?
Tecentriq SC contains the active ingredient atezolizumab. Tecentriq SC works by attaching to a specific protein in your body called ‘PD-L1’.
This protein makes the immune system in the body work less well. By attaching to the
protein, Tecentriq SC works by helping your immune system fight your cancer.
Tecentriq SC may be given in combination with other medicines. It is important you
read the Consumer Medicine Information for those medicines. Please ask your doctor
if you have any questions about Tecentriq SC or any other medicines used with Tecentriq
SC.
Tecentriq SC is used to treat:
non-small cell lung cancer, when the lung cancer has not spread to other parts of
the body. Treatment will be given after surgery takes place and after chemotherapy
has been given.
non-small cell lung cancer, when the lung cancer has spread to other parts of the
body. Tecentriq SC is used together with other medicines (bevacizumab, paclitaxel
and carboplatin; or nab-paclitaxel and carboplatin). Tecentriq SC can also be used
as a single treatment (monotherapy) if the cancer has come back after previous treatment.
a type of cancer that affects the bladder and the urinary system, called “urothelial
carcinoma”.
a type of cancer that affects the lungs, called small cell lung cancer (SCLC). Tecentriq
SC is used together with the chemotherapy medicines etoposide and carboplatin.
a type of cancer that affects the liver called hepatocellular carcinoma. Tecentriq
SC is used together with a medicine called bevacizumab when the liver cancer is unable
to be removed by surgery or has spread to other parts of the body
2. What should I know before I use Tecentriq SC?
Warnings
Do not use Tecentriq SC if:
you are allergic to atezolizumab, or any of the ingredients listed at the end of this
leaflet.
Check with your doctor if you:
have any immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have inflammation of the lungs (called ‘pneumonitis’)
have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome
have liver problems, such as hepatitis
have thyroid problems
have been given a live, attenuated vaccine recently
have been told your cancer has spread to your brain
take any medicines for any other condition
have any allergies to any other medicines, foods, preservatives or dyes
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 and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Tecentriq SC can
harm your unborn baby.
If you are a woman who is able to become pregnant, you should use an effective method
of birth control during your treatment with Tecentriq SC and for at least 5 months
after your last dose of Tecentriq SC. Talk to your healthcare provider about birth
control methods that you can use during this time.
Tell your doctor right away if you become pregnant during treatment with Tecentriq
SC.
Tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed
during treatment with Tecentriq SC.
It is not known if Tecentriq SC passes into your breastmilk. A risk to the breastfed
infant cannot be excluded.
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. Tell your doctor or pharmacist if you are taking
other medicines that make your immune system weak, such as immunosuppressants and/or
steroids
Some medicines may interfere with Tecentriq SC and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tecentriq SC.
4. How do I use Tecentriq SC?
How to use Tecentriq solution for subcutaneous (SC) injection
Tecentriq SC is given as an injection under your skin (subcutaneous injection) by
a doctor or a nurse. Injections will be given in the thigh over approximately 7 minutes.
Your doctor or nurse will make sure each injection is given in a new place (at least
2.5 cm away from any previous injection), and where the skin is not red, bruised,
tender or hard. Different places for injection should be used for other medicines.
When to use Tecentriq SC
Tecentriq SC is given every three weeks.
Your doctor will decide how long you should receive Tecentriq SC, this will depend
on your response to the medicine and the state of your disease. If you are receiving
Tecentriq SC for lung cancer after surgery, you may receive Tecentriq SC for up to
1 year.
If you forget to use Tecentriq SC
As Tecentriq SC 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 Tecentriq
SC, make another appointment as soon as possible.
If you use too much Tecentriq SC
As Tecentriq SC is given under the supervision of your doctor, it is unlikely that
you will be given too much. However, if you experience any side effects after being
given Tecentriq SC, tell your doctor immediately.
5. What should I know while using Tecentriq SC?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are receiving Tecentriq SC.
Tell any other doctors, dentists, and pharmacists who treat you that you are receiving
this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
If you are a woman who is able to become pregnant, you must use effective contraception
while you are being treated with Tecentriq SC and for at least 5 months after the
last dose.
If you become pregnant while you are being treated with Tecentriq SC tell your doctor.
Ask your doctor if you should stop breastfeeding or if you should stop treatment with
Tecentriq SC.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Tecentriq
SC affects you. It is not known whether Tecentriq SC may impair your ability to drive
or operate machinery.
6. Are there any side effects?
Like all medicines, Tecentriq SC can cause side effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of the
side effects.
Tecentriq SC may cause side effects that appear weeks or months after your last dose.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
These side effects can sometimes become life-threatening and can lead to death. These
side effects may happen anytime during treatment or even after your treatment has
ended. You may experience more than one side effect at the same time. Some side effects
can only be found when your doctor does blood tests from time to time to check your
progress.
If you have any of the following symptoms, call or see your doctor right away.
Serious side effects
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Serious side effects
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What to do
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Signs and symptoms of lung problems:
new or worsening cough
chest pain
Signs and symptoms of liver problems:
yellowing of skin and/or eyes
nausea and/or vomiting
bleeding or bruising
dark urine
stomach pain
Signs and symptoms of intestinal problems:
diarrhoea (watery, loose or soft stools)
blood in stools
stomach pain
Signs and symptoms of thyroid problems:
tiredness
weight loss or weight gain
changes in mood or behaviour
visual disturbances
increased sensitivity to cold or heat
slow or rapid heart rate
hair loss
constipation
headache and/or dizziness
Signs and symptoms of blood sugar problems (type 1 diabetes mellitus) and acid in
the blood caused by diabetes (diabetic ketoacidosis):
feeling more hungry or thirsty than usual
need to urinate more often
weight loss
feeling tired
Signs and symptom of problems with the brain and the membrane around the spinal cord
and brain:
neck stiffness
headache
fever
chills
vomiting
eye sensitivity to light
confusion and sleepiness
muscle weakness in the legs and arms
problems with mobility, the bladder and bowel
Signs and symptoms of problems with the nerves:
muscle weakness, numbness or tingling in hands and feet
difficulty with facial movements
pins and needles sensation in your fingers and toes
inability to walk or climb stairs
paralysis of the facial muscles
Signs and symptoms of problems with the pancreas:
abdominal pain
nausea and/or vomiting
Signs and symptoms of problems with the heart:
shortness of breath
difficulty breathing and speaking
feeling tired
irregular heart beat and/or pounding/racing heart beat (palpitations)
chest pain
fainting and/or light-headedness
swelling of legs or abdomen
pale and/or clammy skin
Signs and symptoms of problems with the muscles:
muscle pain or stiffness
skin rash
Signs and symptoms of problems with the kidneys:
change in urine output and/or colour
pain in pelvis
swelling of the body (oedema)
Signs and symptoms of infusion reactions:
fever
chills
flushing
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Signs and symptoms of severe skin reactions:
rash
itching
skin blistering, peeling or sores
ulcers in the mouth or in lining of the nose, throat or genital area
Signs and symptoms of excessive activation of the immune system:
fever
swollen lymph nodes
skin rash
yellow colour of the skin and eyes (jaundice)
lung (coughing, difficulty breathing), stomach (vomiting, diarrhoea) and nervous system
(headache, changes in vision, weakness) symptoms
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest
hospital if you notice any of these serious side effects.
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The following side effects have also been reported, in addition to the serious side
effects above:
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Side effects
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What to do
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The following side effects were reported when atezolizumab was given alone (monotherapy)
Signs and symptoms of lung problems
feeling tired with no energy (fatigue)
cough
Signs and symptoms of problems with your heart
dizziness or light-headedness
Signs and symptoms of problems with your kidneys
strong and frequent urge to urinate
cloudy, bloody, or strong-smelling urine
pain or a burning sensation when urinating
Signs and symptom of problems with your blood pressure
dizziness or light headedness
fainting
lack of concentration
Signs and symptoms of low oxygen levels in your blood (hypoxia):
changes of the colour of your skin
sweating
Signs and symptoms of systemic inflammatory disorder (sarcoidosis):
shortness of breath
cough
chest discomfort and/or pain
tender, painful, reddish bumps or patches on the skin
swollen and painful joints
swollen lymph nodes
eye pain
blurry vision and/or light sensitivity
Signs and symptoms of problems in other organs:
bleeding, bruising or blood in the urine or stool
red, itchy scaly patches of skin, including dry and cracked skin
dry skin
local reaction at injection site
sore throat
difficulty swallowing
common cold
flu-like symptoms
nasal congestion
back, muscle, bone, tendon, joint or nerve pain
generalised weakness, tiredness and droopy eyelids
loss of appetite
pain and redness of the eye, including light sensitivity, dark floating spots in vision
and blurred vision
The following side effects were reported in clinical trials when atezolizumab was
given in combination with other medicines (in addition to those above).
Signs and symptoms of low iron in your blood (anaemia)
tiredness
headaches
being short of breath when exercising
dizziness
looking pale
Signs and symptoms of problems with your lungs
bronchitis
infections such as pneumonia
Signs and symptom of problems with your kidneys (proteinuria)
foamy or bubbly urine
swelling in the face, feet or ankles
muscle cramps at night
Signs and symptom of problems with your blood pressure
severe headaches
nose bleeds
irregular heartbeat
Signs and symptoms of problems in other organs:
a change in the way things taste
low white blood cell count, which can increase the risk of infection
inflamed and sore mouth, mouth ulcers and/or cold sores
dry mouth
constipation
changes in your voice or hoarseness
hair loss
swelling to the arms and legs (peripheral oedema)
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Speak to your doctor straight away if you have any of these side effects.
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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 Tecentriq SC contains
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Active ingredient
(main ingredient)
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atezolizumab
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Other ingredients
(inactive ingredients)
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Vorhyaluronidase alfa
histidine
acetic acid
methionine
sucrose
polysorbate 20
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Tecentriq SC looks like
Tecentriq SC is a colourless to slightly yellow solution. Tecentriq SC is supplied
as a single use glass vial and is available in one presentation:
1875 mg of atezolizumab in 15 mL solution (AUST R 400555)
Who distributes Tecentriq
Tecentriq is distributed in Australia by:
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30 – 34 Hickson Road
Sydney NSW 2000
AUSTRALIA
This leaflet was prepared in February 2024.