BAVENCIO®
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 medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
BAVENCIO contains the active ingredient, avelumab. BAVENCIO is used to treat certain
types of cancer.
For more information, see Section 1. Why am I using BAVENCIO? in the full CMI.
Do not use if you have ever had an allergic reaction to BAVENCIO 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 BAVENCIO? in the full CMI.
Some medicines may interfere with BAVENCIO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Prior to the first four infusions of BAVENCIO, you will be given paracetamol and an
antihistamine. For subsequent infusions, these medicines will only be given if your
doctor believe this is necessary.
You will receive BAVENCIO as an infusion (a drip) into a vein (intravenously) over
a period of 60 minutes, once every 2 weeks.
More instructions can be found in Section 4. How do I use BAVENCIO? in the full CMI.
Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are using BAVENCIO.
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Driving or using machines
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Treatment-related symptoms can affect your concentration and ability to react.
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For more information, see Section 5. What should I know while using BAVENCIO? in the full CMI.
Common side effects include feeling tired or weak; muscle, back, stomach area or joint
pain; loose stools, vomiting, nausea, constipation; swelling in the arms, feet or
legs; feeling less hungry, weight loss; cough; rash, itching, redness of the skin;
fever, chills; shortness of breath; dizziness, headache; high blood pressure; low
blood pressure; flushing; difficulty in speaking or breathing, hoarseness; urinary
tract infection such as burning sensation when urinating, strong or frequent urge
to urinate.
Serious side effects include infusion-related reactions; problems due to inflammation
of your lungs (pneumonitis); problems with your liver (hepatitis or liver toxicity
when used in combination with axitinib); problems with your intestines (colitis) or
diarrhoea; problems with your hormone producing glands (including the thyroid, pituitary,
and adrenal glands); problems with your pancreas (pancreatitis); Type 1 diabetes,
including a serious, sometimes life-threatening problem due to increased acid in the
blood produced from diabetes (diabetic ketoacidosis); problems with your kidneys;
problems with your muscles (myositis, myasthenia gravis/myasthenic syndrome, polymyalgia
rheumatica); problems with your bile ducts (sclerosing cholangitis), problems with
your joints (arthritis), problems with your glands that make moisture for the body
(Sjögren’s syndrome), problems with your heart (myocarditis or major adverse cardiovascular
events when used in combination with axitinib); problems with your eyes (uveitis);
an immune system disorder that can cause nerve inflammation (Guillain-Barré Syndrome).
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.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
BAVENCIO®
Active ingredient:
avelumab (rch)
Consumer Medicine Information (CMI)
This leaflet provides important information about using BAVENCIO. 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 BAVENCIO.
Where to find information in this leaflet:
BAVENCIO contains the active ingredient, avelumab. BAVENCIO is a monoclonal antibody, which is a protein designed to recognise and attach
to a specific target in the body to help the immune system attack and destroy cancer
cells.
BAVENCIO is used to treat a rare type of skin cancer called metastatic Merkel cell
carcinoma (mMCC) where the disease has spread; a type of cancer in the bladder or
urinary tract called urothelial carcinoma, when the disease is advanced or metastatic
but has not progressed with platinum-based chemotherapy; or a type of kidney cancer
called renal cell carcinoma (RCC), when it is advanced, in combination with another
medicine, axitinib. It is important that you also read the Consumer Medicine Information
for axitinib. If you have any questions about axitinib, ask your doctor.
Do not use BAVENCIO if:
you are allergic to avelumab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions, including an autoimmune disease (a condition where
the body attacks its own cells) like Crohn's, Guillain- Barré, ulcerative colitis
or lupus. If you already have an autoimmune disease, your risk of immune-mediated
side effects may be higher as BAVENCIO may cause inflammation in parts of your body.
You may also experience frequent flares of your autoimmune disease, which in the majority
of cases are mild; human immunodeficiency virus (HIV) infection or acquired immune
deficiency syndrome (AIDS); hepatitis B or hepatitis C; have had an organ transplant
take any medicines for any other condition, including medicines that suppress your
immune system
Once you are treated with BAVENCIO, your doctor may give you corticosteroids to reduce
any possible side effects that you may have during your treatment.
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?
Talk to your doctor or nurse before receiving BAVENCIO as it may cause:
problems due to inflammation of your lungs (pneumonitis)
problems with your liver (hepatitis or liver toxicity when used in combination with
axitinib)
problems with your intestines (colitis) or diarrhoea
problems with your hormone producing glands (including the thyroid, pituitary, and
adrenal glands)
problems with your pancreas (pancreatitis)
Type 1 diabetes, including a serious, sometimes life-threatening problem due to increased
acid in the blood produced from diabetes (diabetic ketoacidosis).
problems with your kidneys
problems with your muscles (myositis, myasthenia gravis/myasthenic syndrome, polymyalgia
rheumatica)
problems with your bile ducts (sclerosing cholangitis)
problems with your joints (arthritis)
problems with your glands that make moisture for the body such as tears and saliva
(Sjögren’s syndrome)
problems with your heart (myocarditis or major adverse cardiovascular events such
as trouble breathing, chest discomfort, or swelling of lower legs or hands when used
in combination with axitinib)
problems with your eyes (uveitis)
an immune system disorder that can cause nerve inflammation (Guillain-Barré Syndrome)
infusion-related reactions
In addition, autoimmune haemolytic anaemia (headaches, short of breath, looking pale,
and yellowing of the skin and/or eyes) and systemic inflammatory response syndrome
(redness and swelling in the affected parts of your body, pain, loss of function of
parts of your body, fatigue, fast heart rate, abnormal breathing, fever or low body
temperature, shaking or chills, warm or clammy/sweaty skin, rash, confusion, agitation
or other mental changes, loss of consciousness) have been reported with BAVENCIO or
other products in this class (PD-1/PD-L1 blocking antibodies).
Should any of the above occur, your doctor may give you other medicines in order to
prevent complications and reduce your symptoms; withhold the next dose of BAVENCIO;
or stop your treatment with BAVENCIO altogether.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
BAVENCIO must not be used during pregnancy as it may cause harm to your unborn baby.
Make sure you maintain adequate contraception during treatment and for at least one
month after your last dose.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is unknown if BAVENCIO is passed into your breast milk. A risk to the breast-fed
infant cannot be excluded.
You should not breastfeed during treatment and for at least one month after your last
dose.
Use in children
For mMCC, the effectiveness of BAVENCIO in children under the age of 12 years has
not been established.
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.
Some medicines may interfere with BAVENCIO and affect how it works.
These include medicines that make your immune system weak, such as steroids.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BAVENCIO.
Prior to the first four infusions of BAVENCIO, you will be given paracetamol and an
antihistamine. For subsequent infusions, these medicines will only be given if your
doctor believe this is necessary. These premedications are given to help minimise
potential reactions to the BAVENCIO infusion.
How much to use
A doctor experienced in the use of medicines for cancer will supervise your treatment
with BAVENCIO.
Depending on your cancer, the recommended dose is either 10 mg per kg of your body
weight or 800 mg of BAVENCIO.
BAVENCIO has to be diluted with 0.9% or 0.45% saline solution before use.
Your doctor will calculate the correct dose and dilution for you.
When to use BAVENCIO
You will receive BAVENCIO as an infusion (a drip) into a vein (intravenously) over
a period of 60 minutes, once every 2 weeks.
Your doctor will decide how long you will receive BAVENCIO based on your response
to the medicine and the type of cancer you have.
If you use too much BAVENCIO
As BAVENCIO is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much.
However, if you think that you have used too much BAVENCIO, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Keep all appointments with your doctor so that your progress can be checked. Your
doctor may do blood tests or other laboratory tests from time to time to prevent unwanted
side effects during your treatment with BAVENCIO.
If you miss an appointment, talk to your doctor or nurse and arrange another visit
as soon as possible.
Call your doctor straight away if you:
Become pregnant while you are being treated with BAVENCIO
Remind any doctor, nurse, dentist or pharmacist you visit that you are using BAVENCIO.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BAVENCIO
affects you.
Treatment-related symptoms can affect your concentration and ability to react.
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.
Be aware of important symptoms of inflammation. BAVENCIO acts on your immune system
and may cause inflammation in parts of your body. Inflammation may cause serious damage
to your body and some inflammatory conditions may be life-threatening and need treatment
or withdrawal of BAVENCIO.
Less serious side effects
Less serious side effects
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What to do
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feeling tired or weak
muscle or back pain, stomach area pain, joint pain
loose stools, vomiting, nausea, constipation
swelling in the arms, feet or legs
feeling less hungry, weight loss
cough
rash, itching, redness of the skin
fever, chills
shortness of breath
dizziness, headache
high blood pressure
low blood pressure
flushing
difficulty in speaking or breathing, hoarseness
urinary tract infection (UTI) such as burning sensation when urinating, strong or
frequent or urge to urinate
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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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Serious side effects
Serious side effects
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What to do
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Signs of problems with your liver:
yellowing of the whites of the eyes or skin (jaundice), severe nausea or vomiting,
pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea
coloured), bleeding or bruising more easily than normal, feeling less hungry than
usual, tiredness or abnormal liver function tests
Signs of problems with your thyroid, adrenal or pituitary glands (hormone producing
glands):
extreme tiredness, rapid heartbeat, increased sweating, weight changes, changes in
mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood
pressure (fainting, dizziness, fatigue, nausea), headache
Signs of problem with your intestines:
diarrhoea (loose stools), more bowel movements than usual, blood in your stools or
dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
Signs of problems with your lungs:
breathing difficulties, coughing
Type 1 diabetes including a serious, sometimes life-threatening problem due to increase
acid in the blood produced from diabetes (diabetic ketoacidosis)):
feeling more hungry or thirsty than usual, needing to urinate more often, weight loss,
and feeling tired, having difficulty thinking clearly, breath that smells sweet or
fruity, feeling sick or being sick, stomach pain, deep or fast breathing
Signs of problems with your kidneys:
abnormal kidney function tests, needing to urinate less than usual, blood in your
urine, or swelling in your ankles
Signs of problems with your heart:
trouble breathing, dizziness or fainting, fever, chest pain, chest tightness, swelling
in lower legs or hands, or flu-like symptoms
Signs of problems with your muscles:
muscle pain, stiffness, or weakness
Signs of problems with your pancreas:
abdominal pain, nausea, vomiting
Signs of problems with your eyes:
eye pain, eye redness, sensitivity to light, blurred or cloudy vision, small shapes
moving across your field of vision (floaters), loss of peripheral vision (the ability
to see objects at the side of your field of vision)
Signs of problems with your bile ducts:
pain in the upper right part of the stomach
swelling of the liver or spleen
fatigue
itching
yellowing of the skin or the whites of the eyes
Signs of problems with your joints:
joint pain, stiffness or swelling
Signs of problems with your glands that make moisture for the body:
dry eyes
dry mouth
Guillain-Barré Syndrome (an immune system disorder that can cause nerve inflammation):
pain, numbness, muscle weakness, difficulty walking
Signs of an allergic reaction (anaphylactic reaction and/or hypersensitivity):
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
Infusion-related:
fever
back and/or abdominal pain
chills or shaking
shortness of breath or wheezing
bumpy rash or skin wheals (hives)
flushing
low blood pressure (dizziness, fatigue, nausea)
Sometimes these symptoms may occur up to several hours later. To recognise early signs
of these side effects, you will be monitored closely while you are receiving each
infusion.
Your doctor may consider reducing the infusion rate, stop the infusion temporarily
or permanently in order to manage these 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.
Please note that these signs and symptoms are sometimes delayed, and may develop weeks
or months after your last dose.
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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.
This medicine is only available with a doctor's prescription.
What BAVENCIO contains
Active ingredient
(main ingredient)
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avelumab (rch)
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Other ingredients
(inactive ingredients)
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Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections
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Potential allergens
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N/A
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Do not take this medicine if you are allergic to any of these ingredients.