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VYALEV®
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.
VYALEV contains two ingredients foslevodopa and foscarbidopa. VYALEV is used to treat
advanced Parkinson’s disease.
For more information, see Section 1. Why am I using VYALEV? in the full CMI.
Check the list of ingredients at the end of the CMI. Do not use VYALEV if you have
ever had an allergic reaction to any of them.
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 VYALEV? in the full CMI.
Some medicines may interfere with VYALEV and affect how it works, or VYALEV may interfere
with other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
VYALEV is a solution (liquid) that goes through an infusion pump and a tube under
your skin (subcutaneously).
VYALEV dose is calculated by your doctor based on your individual needs.
More instructions can be found in Section 4. How do I use VYALEV? in the full CMI.
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Things you should do
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Tell your doctor if you notice any skin changes at the infusion site. You should
always follow aseptic (sterile) techniques while using this medicine.
Regularly change the infusion site (at least every third day), using a new infusion
set.
Tell your doctor if your Parkinson’s symptoms get worse.
If you are pregnant or breast-feeding, ask your doctor for advice before using this
medicine.
Remind any doctor, dentist or pharmacist you visit that you are using VYALEV.
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Things you should not do
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Do not stop using this medicine suddenly or reduce the dose without checking with
your doctor. Always follow the directions provided from your doctor.
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Driving or using machines
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Use caution when driving or operating machines.
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Drinking alcohol
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There is no information on the effects of using VYALEV with alcohol.
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Looking after your medicine
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Store VYALEV in the refrigerator at 2°C to 8°C. Do not freeze.
However, vials may be kept at room temperature up to a maximum of 30°C for a single
period of up to 28 days. Once a vial has been stored at room temperature, do not return
the product to the refrigerator.
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For more information, see Section 5. What should I know while using VYALEV? in the full CMI.
The most common side effects are pain and redness at the infusion site, uncontrollable
twitching, jerking movements, hallucination, fall, anxiety, and dizziness. 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 .
VYALEV®
Active ingredient(s): foslevodopa (fos-lee-voe-'doe-pah) and foscarbidopa (fos-'kah-bee-'doe-pah)
Consumer Medicine Information (CMI)
This leaflet provides important information about using VYALEV. 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 VYALEV.
Where to find information in this leaflet:
VYALEV contains two ingredients foslevodopa and foscarbidopa. In the body, foslevodopa and foscarbidopa are made into levodopa and carbidopa, respectively.
Levodopa is then made into 'dopamine'. This adds to the dopamine already in your brain
and spinal cord. Dopamine helps transfer signals between nerve cells. Too little dopamine
causes Parkinson’s disease signs like tremor, feeling stiff, slow movement, and problems
keeping your balance. Treatment with foslevodopa increases the amount of dopamine
in your body. This means it reduces these signs.
Foscarbidopa improves the effect of foslevodopa. It also reduces the side effects
of foslevodopa.
VYALEV is used to treat advanced Parkinson’s disease, helping you to gain control
over your movements and posture.
Do not use VYALEV if:
you are allergic to foslevodopa, foscarbidopa, levodopa, carbidopa or any of the ingredients
listed at the end of this leaflet.
you have a sudden fluid build-up inside the eye causing very high pressure (narrow
angle glaucoma).
you have had severe heart conditions (including stroke or heart attack, blocked blood
vessels in your heart or an uneven heartbeat (arrhythmia).
you have any condition that affects the adrenal glands, the glands responsible for
releasing hormones that control heart rate, metabolism, and blood pressure, e.g. a
tumour on the adrenal gland called pheochromocytoma, or a condition called Cushing’s
syndrome.
you have an over-active thyroid (hyper-thyroidism).
you are taking antidepressants called monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine.
you have or have had melanoma, or if you have skin marks or sores that have not been
checked by a doctor.
Check with your doctor if you:
have had any heart conditions.
you have problems with your liver or kidneys.
have a lung problem – such as asthma.
have an eye problem called 'wide-angle glaucoma'
have or have had depression (low mood, a feeling of
worthlessness) or you have had thoughts about suicide.
have or have had other mental health issues.
have ever had a stomach ulcer.
have a condition affecting the endocrine glands (including the thyroid, adrenal glands
or pancreas).
have ever had fits (convulsions)
are on a controlled sodium diet as VYALEV contains 42.4 mg sodium per mL.
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
Make sure your doctor is aware that you are pregnant or plan to become pregnant or
are breastfeeding or plan to do so. Do not use VYALEV if you are breast-feeding.
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 VYALEV and affect how it works.
Check with your doctor before you use VYALEV if you are taking or have recently taken
(in the last 2 weeks), any medicine to treat depression. There are certain types of
antidepressants that cannot be taken with VYALEV. These can include some MAO inhibitors.
Examples include moclobemide, phenelzine, tranylcypromine.
Medicines that may
increase
the effect of VYALEV include:
entacapone, tolcapone, opicapone (sometimes added to therapy to reduce Parkinson’s
symptoms for a longer time).
other medicines used to treat Parkinson’s disease (e.g. pramipexole, ropinirole and
rotigotine).
amantadine (used to treat certain viral infections)
Medicines that may
reduce
the effect of VYALEV include:
some medicine used to treat certain mental and emotional conditions (e.g. chlorpromazine,
thioridazine, haloperidol, risperidone).
some medicines used to treat nausea or vomiting (e.g. metoclopramide).
some medicines that work in the brain used to treat anxiety, and to relax muscles
(e.g. diazepam, clonazepam).
isoniazid (used to treat tuberculosis)
phenytoin (used to treat convulsions or fits)
papaverine (used to increase blood flow, and to treat problems with the stomach and
gall bladder).
Medicines where VYALEV may increase their effect include:
certain medicines used to treat high blood pressure (such as anti-hypertensives) which
may make you feel dizzy when you get up from a chair or bed (orthostatic hypertension).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VYALEV.
How much to use
The VYALEV dose is calculated by your doctor based on your individual needs.
Follow all the instructions given to you and continue to use VYALEV until your doctor
tells you to stop.
How to use
Your doctor or pharmacist will train you on proper use of VYALEV and the delivery
system (pump, solution vial, vial adapter, syringe, infusion set, carrying accessory,
rechargeable battery, and charger) prior to initiating treatment with VYALEV and as
needed.
VYALEV is a solution that is administered under your skin (called ‘subcutaneous infusion’)
most frequently on the abdomen (choose an area at least 5 cm from the belly button)
using an infusion pump.
Rotate the infusion site and use a new infusion set (tubing and cannula) at least
every 3 days. If the infusion is interrupted for less than 1 hour, then the infusion
set can remain in place for up to 3 days.
The solution comes in a glass vial. The solution from the vial is transferred to a
sterile syringe and the syringe is then placed within the pump.
The entire contents of the vial should be transferred all at one time into a syringe
for administration.
The pump is connected via a tube for subcutaneous infusion to a cannula that is applied
onto your skin.
Administer VYALEV only with the Vyafuser Pump and infusion components (syringe, infusion
set, and vial adapter) qualified for use. Follow the steps as indicated in your Patient
Instructions for Use of Vyafuser Pump.
When to use VYALEV
Usually a steady dose of hourly infusion is given. If needed, you may have extra doses
or your hourly infusion rate may need to be adjusted, this will be decided by your
doctor. You should contact your doctor if 5 or more extra doses are required in
a 24-hour period. Your doctor will decide if your medication dose needs to be adjusted.
The pump continuously gives you the medicine for 24 hours daily. You may need to reload
the pump with a new syringe within a 24-hour period to make sure you have enough medicine
in your blood to control your symptoms.
VYALEV can be interrupted for brief periods of time, such as when taking a shower.
Make sure to change your infusion set (tubing and cannula) and rotate to a different
infusion site if you interrupt the infusion for longer than 1 hour. For interruptions
longer than 3 hours, you may need to also self-administer a loading dose to quickly
re-establish your symptom control. Do not stop using VYALEV unless a doctor tells
you to.
Click on the link for the instructions on how to use VYALEV: https://www.medsinfo.com.au/media/veivyale
Please look for the QR code on the medicine pack. Scan this code with your smart phone
for more information on VYALEV.
If you forget to use VYALEV
The vial(s) should be changed at the same time each day.
If you forget to resume VYALEV, start your pump as soon as possible. For interruptions
longer than 1 hour, make sure to change your infusion set (tubing and cannula) and
rotate to a different infusion site before resuming infusion. For interruptions longer
than 3 hours, you may need to also administer a loading dose to quickly re-establish
your symptom control. Do not suddenly stop using VYALEV without discussing with your
doctor.
If you use too much VYALEV
If you think that you have used too much VYALEV, 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. Take the medicine pack with
you.
You should do this even if there are no signs of discomfort or poisoning.
Call your doctor straight away if you:
notice any skin changes at the infusion site, such as redness, warmth, swelling, pain,
and discolouration when you apply pressure to it. You should always follow aseptic
(sterile) techniques while using this medicine and regularly change the infusion site
(at least every third day), using a new infusion set. Make sure the new infusion site
is at least 2.5 cm from a site used in the last 12 days. You may need to change the
infusion site more often than every third day, if you notice any of the above-mentioned
skin changes.
you have any problems with the pump including if you are finding it difficult to manage
it.
you, your family or carer notices you are developing urges or cravings to behave in
ways that are unusual for you, or you cannot resist the impulse, drive or temptation
to carry out certain activities that could harm yourself or others. These behaviours
are called 'impulse control disorders' and can include addictive gambling, excessive
eating or spending and abnormally high sex drive or an increase in sexual thoughts
or feelings.
you, your family or carer notice you are developing addiction-like symptoms leading
to craving for large doses of Vyalev and other medicines used to treat Parkinson’s
disease.
your Parkinson's disease symptoms get worse or it is harder to move than usual.
you become pregnant while using VYALEV.
Remind any doctor, dentist or pharmacist you visit that you are using VYALEV.
Things you should not do
Do not stop using VYALEV or lower your dose suddenly unless your doctor tells you
to. In such a case your doctor may need to adjust your other medicines to control
your Parkinson’s symptoms, especially levodopa, to avoid Neuroleptic Malignant Syndrome
(a rare condition with symptoms including muscle stiffness, agitation and confusion,
coma, increases and decreases in your blood pressure, sweating, palpitations, and
fever).
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VYALEV
affects you.
VYALEV may cause you to feel dizzy, lightheaded, or sleepy and may cause your vision
to be blurred.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep VYALEV in the refrigerator (at 2°C to 8°C). Do not freeze.
Vials that are for use beyond 28 days should be stored and transported refrigerated
(at 2°C to 8°C).
The vials may be kept at room temperature up to a maximum of 30°C for a single period
of up to 28 days (record the date when you remove the medicine from the refrigerator
on the carton).
Keep it where young children cannot reach it.
When to discard your medicine
Once the medicine has been stored at room temperature, do not return the medicine
to the refrigerator. Discard medicine if not used within the 28 days stored at room
temperature.
Discard the syringe and any unused medicine in the syringe after the medicine has
been in the syringe for 24 hours.
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.
Do not use this medicine after the expiry date.
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.
Bear in mind that with Parkinson’s disease and its treatment, your carer may observe
some symptoms more easily than you.
Less serious side effects
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Less serious side effects
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What to do
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Skin:
Infusion site redness
infusion site swelling (oedema)
infusion site nodule, pain
rashes and itching
Brain and nerves:
headache
anxiety
falling
feeling dizzy when you stand up quickly or change positions
uncontrollable twitching, jerking movements or a worsening of your Parkinson’s symptoms
reduced sense of touch, tingling or numbness, burning or prickling feeling in your
hands, arms, legs or feet
unable to control urine (incontinence) or have difficulty passing urine
feeling tired, weak (fatigue), faint
swelling in your lower legs or hands caused by too much fluid
feeling short of breath
feeling suddenly very tired
difficulty sleeping (insomnia)
false beliefs (delusion)
difficulty thinking, learning and remembering
Gut:
pain in your belly
decreased appetite
constipation
dry mouth
nausea, vomiting
weight loss
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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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More serious side effects
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Serious side effects
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What to do
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Skin:
Infusion site infection, abscess, cellulitis
- There may be a potential for germs to enter the blood and spread all over the body
from infusion site infection, this is called sepsis (symptoms such as fever, rapid
heart rate and rapid breathing).
Brain and nerves:
low mood or feeling a sense of worthlessness (depression)
thoughts of suicide
feeling confused or especially nervous
seeing or hearing things that aren’t real (hallucinations)
sudden uncontrolled urges.
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Call your doctor straight away if you notice any of these serious side effects.
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Very serious side effects
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Serious side effects
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What to do
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Allergic reaction:
swelling of the face, lips, tongue or throat which may cause difficulty in swallowing
or breathing,
rash (hives).
Neuroleptic Malignant Syndrome:
agitation, confusion
fast heartbeat, blood pressure changes
sweating, and fever,
fast breathing,
muscle stiffness,
losing consciousness
General:
Acute pain in eyes, headache, blurred vision, nausea and vomiting. These may be signs
of narrow angle glaucoma.
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Go straight to the Emergency Department at your nearest hospital if you notice any
of these serious 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.
This medicine is only available with a doctor's prescription.
What VYALEV contains
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Active ingredient
(main ingredient)
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Foslevodopa (converted in the body to levodopa), and foscarbidopa (converted in the
body to carbidopa).
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Other ingredients
(inactive ingredients)
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sodium hydroxide, hydrochloric acid and water
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Do not take this medicine if you are allergic to any of these ingredients.
What VYALEV looks like
VYALEV is a sterile, preservative-free, colourless to yellow to brown, clear to slightly
opalescent solution in a glass vial. The solution should be free from particles and
may have a purple or red tint. Variations in colour are expected and have no impact
on medicine quality. The solution may become darker in colour after piercing of the
vial stopper or while in the syringe.
1 mL of solution contains 240 mg foslevodopa and 12 mg foscarbidopa.
Each carton contains 7 vials of 10 mL each.
The carton includes the Australian registration number AUST R 372902.
