2. What should I know before I am given MVASI?
Read this leaflet carefully before you use MVASI and keep it with the medicine. Check
the list of ingredients at the end of the CMI. Do not use MVASI if you have ever had
an allergic reaction to any of the ingredients.
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 MVASI and affect how it works.
4. How I be given MVASI?
You will be given MVASI as an infusion (slow injection or "drip") into a vein every
2 to 3 weeks, for as long as you need it.
The infusion usually takes between 30-90 minutes.
5. What should I know while being treated with MVASI?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are being treated with
MVASI
Be sure to keep all of your appointments with your doctor so that your progress can
be checked
Tell your doctor immediately if you become pregnant or are breastfeeding during treatment
Tell your doctor if you:
are planning to have surgery or have a wound that is not healing properly or
need to undergo an invasive dental treatment or dental surgery or
feel MVASI is not helping your condition
|
|
Things you should not do
|
Do not take any other prescription medicines without first checking with your doctor
or pharmacist
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how MVASI affects you
|
6. Are there any side effects?
Common side effects include weakness, pain, headache, bleeding, nose bleeds, nausea,
vomiting, diarrhoea, loss of appetite, and mouth sores, rectal bleeding, bleeding
or bruising more easily than normal, urinary tract infection, foamy urine, fainting.
Serious side effects include serious bleeding, severe high blood pressure, holes in
the stomach or intestine, stroke, severe heart failure or other heart problems, nervous
system or vision problems, shortness of breath, difficulty breathing, or fistula (abnormal
connection between two body parts). 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.
Active ingredient(s):
bevacizumab (pronounced bev-a-SIZZ-u-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MVASI. 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 MVASI.
Where to find information in this leaflet:
1. Why am I receiving MVASI?
MVASI contains the active ingredient bevacizumab. MVASI is a biosimilar medicine to AVASTIN®. It has been assessed to be as safe and effective as the reference product and provides
the same health outcomes. Avastin® is not available in Australia.
MVASI is used to treat:
Brain tumours that are resistant to previous treatments.
Metastatic cancers of the large bowel (i.e., in the colon or rectum), breast or cervix
in combination with chemotherapy agents. Metastatic means the cancer has spread to
other parts of the body from where it started.
Lung cancer and cancer of the ovaries and fallopian tubes (which can extend to the
lining of surrounding organs such as stomach, liver) in combination with chemotherapy
agents.
Kidney cancer in combination with interferon therapy (Roferon-A®).
All cancers need a blood supply to be able to survive and grow. Bevacizumab targets
a protein called vascular endothelial growth factor (VEGF). This protein helps cancer
cells to grow blood vessels, so they can get nutrients and oxygen from the blood.
When MVASI binds to VEGF it disrupts the blood supply to the tumour, stopping or slowing
down its growth.
2. What should I know before I am given MVASI?
Warnings
MVASI is not approved for use in the eye.
Based on your age, especially if you are 65 years or older, or on your general health,
your doctor will discuss your ability to tolerate MVASI.
MVASI can increase the risk of blood clots which can lead to strokes or heart attacks
in patients older than 65 years of age compared with younger patients.
MVASI can also increase the risk of side effects in patients older than 65 years of
age compared with younger patients.
You must not be given MVASI if you:
are allergic to bevacizumab, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use it. 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 or rash, itching or hives on
the skin.
have had an allergic reaction to any proteins that are of Chinese hamster origin or
to other recombinant human or humanised antibodies.
are a child or adolescent. The safety and effectiveness in children and adolescents
have not been established.
Check with your doctor if you:
have or previously have had any of the following:
radiation therapy or radiotherapy (treatment with high energy x-rays)
inflammation of the
bowel (symptoms may include fever, vomiting, diarrhoea and stomach pain) or stomach ulcers,
hypertension (high blood pressure) - it is important to follow all your doctor's instructions to control your blood
pressure
blood clots or stroke, or if you are taking medicine to prevent blood clots (e.g. warfarin) or if anyone
in your family suffers from bleeding problems
heart
disease
diabetes
major surgery within the last 28 days or have a wound that has not healed properly. MVASI can cause an increased risk of post-operative bleeding or problems with wound
healing.
blocked lung artery (pulmonary embolism). MVASI may increase the risk of recurrence
received anthracyclines (e.g., doxorubicin) or have had radiotherapy to your chest. Anthracyclines are a
specific type of chemotherapy used to treat some cancers. MVASI can increase the risk
of developing a weak heart.
pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. Tell your
doctor immediately. You may be advised to have a dental check-up before you start
treatment with MVASI
allergies to any other medicines, foods, dyes or preservatives
other health problems.
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
Do not use MVASI if you are pregnant. MVASI may cause damage to your unborn baby.
Check with your doctor if you are pregnant or intend to become pregnant. MVASI may interfere with your ability to become pregnant. Your doctor will advise
you of your options prior to starting treatment.
If you are a woman of childbearing potential, use suitable methods of contraception
during treatment with MVASI and for at least 6 months after your last dose. Your doctor
can advise about using contraception during treatment with MVASI.
Immediately inform your doctor if you become pregnant while you are being treated
with MVASI.
Breastfeeding
Do not breastfeed while being treated with MVASI and for at least 6 months after the
last dose. MVASI may interfere with the growth and development of your baby. Talk to your doctor
if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with MVASI and affect how it works.
Tell your healthcare professional if you:
have recently received, or are receiving a bisphosphonate (medicine used in preventing
or treating bones that are weak and likely to break), such as ibandronate sodium,
zoledronic acid or disodium pamidronate.
are taking other medicines, including any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy, supermarket or health food shop.
Read the CMI leaflets of all medicines you take in combination with MVASI. This will help you understand the information related to those medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MVASI.
4. How will I be given MVASI?
When you will be given MVASI
MVASI will be given either once every 2 weeks or once every 3 weeks depending on the
type of cancer to be treated.
How much MVASI you will be given
Your doctor will prescribe your dose. The dose depends on your body weight, general
health and the type of cancer to be treated.
How MVASI is given
Your healthcare provider will give you MVASI as an infusion into a vein ("drip"),
through a tube, using an infusion pump. The first dose is usually given over 90 minutes.
If it is well tolerated, the later infusion times may be shortened to between 30 to
60 minutes.
How long MVASI is given
The number of infusions you will receive depends on how you are responding to treatment.
Your doctor will discuss this with you.
If you miss a dose
Your doctor will decide when you should be given your next dose of MVASI.
If you have been given too much MVASI
As MVASI is given to you under the supervision of your doctor, it is unlikely that
you will receive too much. However, if you experience severe side effects, like a
severe migraine, after being given this medicine, tell your doctor or nurse immediately.
You may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
5. What should I know while being treated with MVASI?
Things you should do
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Call your doctor straight away if you:
become pregnant during treatment with MVASI, or plan to start a family in the near
future.
are breastfeeding while being treated with MVASI.
are planning to have surgery.
You have a wound that is not healing properly.
need to undergo an invasive dental treatment or dental surgery, in particular when
you are also receiving or have received a bisphosphonate (for example medicines containing
ibandronate sodium, zoledronic acid or disodium pamidronate)
feel MVASI is not helping your condition.
Remind any doctor, dentist or pharmacist you visit that you are using MVASI.
Things you should not do
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MVASI
affects you.
MVASI has not been shown to impair your ability to drive or operate machinery.
Looking after your medicine
MVASI will be stored in the pharmacy or on the hospital ward in a refrigerator at
a temperature between 2-8°C.
Disposal
MVASI is for single use only.
The vials should be used once only, and any remaining contents should be discarded.
MVASI must not be used after the expiry date.
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.
Because MVASI is used with other medicines that treat cancer (including chemotherapy),
it may be difficult for your doctor to tell whether the side effects are due to MVASI
or due to other medicines.
MVASI may exacerbate some chemotherapy side effects when used in combination with
chemotherapy agents including hair loss, nail disorders, pain, redness and/or swelling
of your hands and/or soles of your feet, and a feeling of numbness or tingling in
the hands or feet.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Lungs and upper airways
changes in your voice or hoarseness
nose bleed; blocked or runny nose
difficulty speaking
Ears, eyes and mouth
inflammation of the mouth
sore mouth; mouth ulcers; cold sores
blurred vision or other problems with the eye (including increased production of tears)
Metabolism and nutrition
loss of appetite
Muscles and joints
swollen/stiff neck
muscle and joint pain
Brain and nervous system
change in sense of taste
dizziness
numbness or weakness of the arms and legs
Gut and digestion
diarrhoea; constipation or rectal bleeding
Skin and nails
dry skin; rash; flaking, swelling or redness of the skin or change in skin colour
pain, redness and/or swelling of your hands and/or the soles of your feet that has
affected your normal activities (hand-foot syndrome)
Blood
high blood pressure
bleeding or bruising more easily than normal
Body as a whole
headache
general body pain
lack of energy or tiredness
fever; chills; shivering
loss of body weight
Stomach and abdominal region
abdominal, pelvic, anal or back pain
|
Speak to your doctor if you have any of these less serious side effects and they worry
you
|
|
Infections and infestations
signs of infection such as swelling, redness and increased temperature, fever, chills,
sore throat or mouth ulcers
Body as a whole
sudden headache and nausea (may include stiff/swollen neck, vision trouble)
hypersensitivity and/or infusion reactions (reactions related to your injection of
the medicine)
Stomach and abdominal region
sudden pain in the stomach or back (may include fainting, hiccups, hearing loss, problems
with balance)
Ears, eyes and mouth
pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, loosening
of a tooth, or numbness or a feeling of heaviness in the jaw. These could be signs
and symptoms of bone damage in the jaw (osteonecrosis).
nose bleeds, nasal congestion or infection, or whistling sounds when breathing. You
may have developed a very rare side effect of a hole in the septum of the nose, the
structure that separates the nostrils.
Kidney and urinary related:
Urinary tract infection
Foamy urine
|
Tell your doctor if you experience any of these side effects.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Lungs and upper airways
bleeding in the lungs, including coughing or spitting blood
Heart
problems with the heart with breathing difficulties
increase in heart rate (pulse)
Ears, eyes and mouth
dry mouth in combination with thirst and/or reduced or darkened urine
Brain and nervous system
confusion
seizures (fits)
falling asleep or fainting
sudden, extremely severe headache, nausea and vomiting
Gut and digestion
severe or bloody diarrhoea
bleeding from stomach or intestines which may look like coffee grounds or black sticky
bowel motions (stools)
nausea and vomiting; including vomiting blood or material that looks like coffee grounds
loss of control of your bladder or bowels; passage of wind or bowel motions through
the vagina
Blood
pain, redness, swelling and warmth over a vein which may suggest deep vein thrombosis
(blood clots in the veins of legs)
severe bleeding
Signs of a blood clot, such as sudden severe headache, loss of vision, loss of coordination,
slurred speech, shortness of breath, chest pain, numbness heat or swelling in the
arms and legs
Body as a whole
severe body pain including headaches
problems with your wounds healing after surgery
feeling of numbness or tingling in hands or feet
abscesses (pus-filled sores)
sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness,
fast heartbeat, sweating and loss of consciousness (anaphylactic shock)
Stomach and abdominal region
stomach cramps or pains
a sudden pain in the back or stomach or feeling weak, numb or tingly down one side,
like a stroke.
|
Tell your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Some side effects are more common in elderly patients. These include blood clots in
the arteries, which can lead to a stroke or a heart attack. In addition, elderly patients
have a higher risk of a reduction in the number of white cells in the blood and cells
that help the blood clot, which can lead to infections and bleeding or bruising more
easily than normal. Other side effects reported with a higher frequency in elderly
patients were diarrhoea, nausea or sickness, headache, hair loss, inflammation of
the mouth and throat, a feeling of numbness or tingling in the hands or feet and fatigue.
There have been reports of abnormal tube-like connections (fistulae) between internal
organs and skin or other tissues that are not normally connected. You may have an
increased risk of fistulae forming between the vagina and any part of the gastro-intestinal
system if you are being treated with MVASI for cancer of the cervix.
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 MVASI contains
|
Active ingredient
(main ingredient)
|
bevacizumab
|
|
Other ingredients
(inactive ingredients)
|
trehalose dihydrate
monobasic sodium phosphate monohydrate
dibasic sodium phosphate
polysorbate 20
water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What MVASI looks like
MVASI is a clear to slightly opaque, colourless to pale yellow solution.
MVASI is supplied in a glass vial. Each pack contains one vial.
MVASI bevacizumab 100 mg/4 mL injection concentrated injection vial (AUST R 297455)
MVASI bevacizumab 400 mg/16 mL injection concentrated injection vial (AUST R 297456)
Who distributes MVASI
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
This leaflet was prepared in February 2024.