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.
1. Why am I using Vyndamax?
Vyndamax contains the active ingredient tafamidis. Vyndamax is used to treat a disease
called transthyretin amyloid cardiomyopathy, also known as ATTR-CM.
2. What should I know before I use Vyndamax?
Do not use if you have ever had an allergic reaction to Vyndamax 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 Vyndamax and affect how it works.
4. How do I use Vyndamax?
Take one 61 mg capsule once a day.
5. What should I know while using Vyndamax?
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Things you should do
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Remind any doctor or dentist you visit that you are using Vyndamax.
If you become pregnant while taking this medicine, tell your doctor immediately.
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Things you should not do
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Do not stop using this medicine or lower the dosage without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know Vyndamax affects you.
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Looking after your medicine
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Keep your capsules in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Common side effects include diarrhoea, feeling weak or a lack of energy, feeling unbalanced
when standing or walking, fall, sinusitis, cataract (clouding of the lens in your
eye), flatulence, muscle or joint pain, skin ulcer, bladder infections and excessive
sweating.
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 .
Active ingredient(s): tafamidis (ter-fam-e-dis)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Vyndamax. 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 Vyndamax.
Where to find information in this leaflet:
1. Why am I using Vyndamax?
Vyndamax contains the active ingredient tafamidis.
Vyndamax is used to treat a disease called transthyretin amyloid cardiomyopathy, also
known as ATTR-CM.
In patients with ATTR-CM, a protein called transthyretin (TTR) breaks up and may form
fibrils called amyloid. Amyloid can build up between cells in your heart and in other
places in your body, preventing your heart from working normally and causing symptoms.
Vyndamax is used to prevent TTR from breaking up and forming amyloid.
This medicine belongs to a group of medicines called transthyretin stabilisers.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I use Vyndamax?
Do not use Vyndamax if:
1. You are allergic to tafamidis, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
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 and/or rash, itching or hives on the skin.
3. You are breast feeding.
4. You are aged under 18 years.
Check with your doctor if you:
Have any other medical conditions including:
An illness requiring an organ transplant
A medical condition affected by excessive sorbitol
Severe liver problems
Severe kidney problems.
Have allergies to any other medicines, 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 and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you are able to become pregnant, you must use birth control while you are taking
Vyndamax and should continue using birth control for one month after stopping treatment
with Vyndamax.
There are no data on the use of Vyndamax in pregnant women.
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.
Some medicines may interfere with Vyndamax and affect how it works. These include:
Methotrexate, a medicine used to treat rheumatoid arthritis or some cancers
Rosuvastatin, a medicine used to treat high cholesterol
Imatinib, a medicine used for some cancer treatment.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Vyndamax.
4. How do I use Vyndamax?
How much to take
Take one 61 mg capsule once a day.
Follow the instructions provided and use Vyndamax until your doctor tells you to stop.
One 61 mg Vyndamax capsule will produce the same level of active ingredient in your
blood and give the same effect as four 20 mg capsules of Vyndaqel (total dose = 80
mg), even though one milligram of Vyndamax is not the same as one milligram of Vyndaqel.
Do not take Vyndamax and Vyndaqel at the same time.
When to take Vyndamax
Take your medicine at about the same time each day.
It does not matter if you take this medicine with or without food.
How to take Vyndamax
Swallow the capsule whole with a full glass of water.
The capsule should not be crushed or cut.
If you forget to take Vyndamax
Vyndamax should be used regularly at the same time each day. If you miss your dose
at the usual time, and if it is within 6 hours before your next dose, skip the dose
you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you take too much Vyndamax
If you think that you have taken too much Vyndamax, 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.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Vyndamax?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Vyndamax.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Things you should not do
Do not take Vyndamax to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Vyndamax
affects you.
Looking after your medicine
Keep your capsules in the pack until it is time to take them.
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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.
Side effects
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Side effects
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What to do
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diarrhoea
feeling weak or a lack of energy
feeling unbalanced when standing or walking
fall
sinusitis
cataract (clouding of the lens in your eye)
flatulence
muscle or joint pain
skin ulcer
bladder infection
excessive sweating
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Speak to your doctor if you have any of these 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 Vyndamax contains
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Active ingredient
(main ingredient)
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61 mg tafamidis
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Other ingredients
(inactive ingredients)
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Butylated hydroxytoluene
Ethanol
Gelatin
Glycerol
Iron oxide red
Isopropyl alcohol
Polysorbate 20
Polyvinyl acetate phthalate
Povidone
Propylene glycol
Macrogol 400
Mannitol
Sorbitol
Strong ammonium solution
Titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine contains sulfites.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
What Vyndamax looks like
Vyndamax 61 mg is a reddish brown, opaque, oblong capsule printed with "VYN 61" in
white.
They are supplied in blister packs of 30 capsules.
AUST R 314813
Who distributes Vyndamax
Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in August 2023.
® Registered Trademark
© Pfizer Australia Pty Ltd 2023