Important safety information

VYALEV (foslevodopa/foscarbidopa), like all medicines, has both benefits and risks. This page provides some information on the possible side effects and other safety information to keep in mind while using VYALEV.

It’s important that you also review the Consumer Medicine Information (CMI) for a complete list of safety information. If you have any concerns or are unsure about your treatment, speak to your prescribing specialist.

What you should know before starting VYALEV

Do not use VYALEV if you:

Are allergic to foslevodopa, foscarbidopa, levodopa, carbidopa, or any of the ingredients listed in section 7 of the CMI.
Have a sudden fluid build-up inside the eye causing very high pressure.
Have had severe heart conditions (including stroke or heart attack, blocked blood vessels in your heart or an uneven heartbeat).
Are taking antidepressants such as moclobemide, phenelzine, tranylcypromine.
Have or have had melanoma, or if you have unexamined skin marks or sores.
Have any condition that affects the adrenal glands, such as a tumour on the adrenal gland called pheochromocytoma, or a condition called Cushing’s syndrome.
Have an over-active thyroid (hyperthyroidism).

Speak with your prescribing specialist if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to do so. Do not use VYALEV if you are breastfeeding.

Tell your prescribing specialist if you:

Have had any heart conditions.
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 thoughts about self-harm.
Have, or have had, other mental health issues.
Have ever had a stomach ulcer.
Have ever had fits (convulsions).
Have a condition affecting the thyroid, adrenal glands or pancreas.
Are on a controlled sodium diet, as VYALEV contains 42.4 mg sodium/mL.
Take any medicines for any other condition, as some medicines may interfere with VYALEV 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 VYALEV.

Possible side effects to be aware of

Like all medicines, VYALEV may cause side effects. However, everyone is different. Some people may experience side effects and others may not.

If you do experience any side effects, most are minor and temporary. However, some side effects may need medical attention. Make sure to tell your prescribing specialist, GP, nurse or pharmacist as soon as possible if you start to feel unwell while using VYALEV.

Speak to your prescribing specialist or GP if you have any of these less serious side effects and they are worrying you

Skin:

Infusion site redness
Infusion site swelling
Infusion site nodule or pain
Rashes and itching

Brain and nerves:

Headache, blurred vision
Anxiety
Falling
Feeling dizzy when you stand up quickly or change positions
Uncontrollable twitching, jerking movements or a worsening of your PD symptoms
Feeling less sensitive to touch, tingling or numbness, burning or prickling in the hands, arms, legs or feet
Poor bladder control or difficulty passing urine
Feeling tired (can be sudden), weak, faint and short of breath
Swelling in your lower legs or hands
Difficulty sleeping or insomnia
False beliefs (delusion)
Difficulty thinking, learning and remembering

Gut:

Pain in your belly
Decreased appetite
Constipation
Dry mouth
Nausea and vomiting
Weight loss

Call your prescribing specialist or GP straight away if you notice any of these serious side effects

Skin:

Infusion site infection, abscess or cellulitis

Infusion site infection can lead to 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 self-harm
Feeling confused or especially nervous
Seeing or hearing things that aren’t real (hallucinations)
Sudden uncontrolled urges

Go straight to the Emergency Department at your nearest hospital if you have any signs of these very serious side effects

Allergic reaction:

Swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
Rash or hives

Neuroleptic malignant syndrome:

Fast heartbeat and blood pressure changes
Fast breathing
Sweating and fever
Muscle stiffness
Losing consciousness
Agitation and confusion

General:

Acute pain in eyes, headache, blurred vision, nausea and vomiting

Tell your prescribing specialist, GP, nurse 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.

Watch this video to learn why it’s important to be aware of your medicine’s safety information and who to contact if side effects occur.

Infusion site care

It’s important to actively monitor and care for your skin to avoid any adverse infusion reactions and infections. When using VYALEV, it’s important to:

Follow aseptic techniques

This means using clean practices when administering VYALEV to reduce the risk of infection. You can do this by washing your hands with soap, using alcohol pads to clean the vial and keeping the preparation surfaces clean.

Maintain general hygiene

Prepare your skin where you plan to insert your cannula by cleaning it thoroughly with an alcohol pad prior to infusion.

Monitor for skin changes

Look out for any skin changes at the infusion site that could indicate infection, such as redness, warmth, swelling, pain and discolouration when you apply pressure to it.

Rotate infusion site regularly

Rotate your infusion site at least every 3 days, using a new infusion set (tubing, insertion device and cannula). You may need to change the infusion site more often than every 3 days if you notice any skin changes or advised by your prescribing specialist or Parkinson’s disease nurse.

You can use the Infusion Site Tracker to help you monitor your infusion site and determine when to switch to a new location.

Keep distance between infusion sites

Ensure your new infusion sites are at least 2.5 cm away from your previous sites within the last 12 days.

If you notice some redness and swelling on your skin around the injection site, you can massage the area with your hand or a spike ball. Applying a cold compress to the infusion site may also help. If the skin changes continue or if you are worried, follow up with your prescribing specialist or GP.

Watch this video to learn more about caring for your skin while using VYALEV

For a full list of important safety information and details on possible side effects, please review the CMI.

AU-ABBV-230287. AC-004199-01. July 2025.