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 VYEPTI®?
VYEPTI® contains the active ingredient eptinezumab. VYEPTI® is used for the preventive treatment of migraine in adults.
2. What should I know before I use VYEPTI®?
Do not use if you have ever had an allergic reaction to eptinezumab 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 VYEPTI® and affect how it works.
4. How do I receive VYEPTI®?
VYEPTI® is given to you in the hospital or clinic. VYEPTI® should be administered under the guidance and supervision of a doctor or healthcare
professional. The recommended dosage is 100 mg administered by intravenous infusion.
VYEPTI® should be administered once every 3 months (12 weeks).
5. What should I know while using VYEPTI®?
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Things you should do
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Remind any doctor or dentist you visit that you are using VYEPTI®. If you become pregnant while being given this medicine, tell your doctor immediately.
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Things you should not do
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This medicine is prescribed to you by your doctor. Do not stop your VYEPTI® treatment without talking to your doctor first.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how VYEPTI® affects you.
This medicine is not expected to affect your ability to drive a car or operate machinery.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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It should be stored in a refrigerator (2°C to 8°C).
Do not freeze or shake.
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6. Are there any side effects?
Some of the less serious side effects include: Allergic reactions (e.g. hives, rash,
itching and flushing/hot flush). Infection of the nose and throat.
Some of the serious side effects include: Serious allergic reactions, which may have
symptoms of difficulty breathing, a fast or weak pulse or a sudden drop in blood pressure
(making you feel dizzy or lightheaded), swelling of the face, lips, tongue or other
parts of the body.
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):
EPTINEZUMAB
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VYEPTI®. 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 VYEPTI®.
Where to find information in this leaflet:
1. Why am I using VYEPTI®?
VYEPTI® contains the active ingredient eptinezumab. VYEPTI® belongs to a group of medicines which are comprised of antibodies that inhibit the
activity of calcitonin-gene-related peptide (CGRP). VYPETI® works by blocking the activity of CGRP. Increased levels of CGRP are associated with
migraines.
VYEPTI® is a prescription medicine used for the preventive treatment of migraine in adults.
2. What should I know before I use VYEPTI®?
Warnings
Do not use VYEPTI® if:
1. You are allergic to eptinezumab, or any of the ingredients listed at the end of this
leaflet.
2. Always check the ingredients to make sure you can use this medicine.
3. Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
a fast or weak pulse or a sudden drop in blood pressure (making you feel dizzy or
lightheaded)
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
redness in your face
Check with your doctor if you:
have any other medical conditions including
cardiovascular disease (e.g. hypertension or ischemic heart disease). VYEPTI® has not been studied in patients with a history of cardiovascular disease, there
is limited safety information on these patients.
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.
There is a very limited amount of information regarding the use of VYEPTI® in pregnant women. Your doctor will discuss with you the benefits of using VYEPTI® against the potential the risk to the foetus.
It is not known if VYEPTI® is passed into breast milk, nor what the potential effects on the breast-fed infant
may be. Your doctor will help you decide if you should stop breast-feeding or stop
using VYEPTI®. Talk to your doctor about the best way to feed your baby while using Vyepti®.
Use in children
VYEPTI® has not been studied in patients under 18 years of age.
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 VYEPTI® 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 VYEPTI®.
4. How do I receive VYEPTI®?
How much is given to you
VYEPTI® is given to you in the hospital or clinic.
VYEPTI® should be administered under the guidance and supervision of a doctor or healthcare
professional.
The recommended dosage is 100 mg administered by intravenous infusion. Some patients
may benefit from a dosage of 300 mg administered by intravenous infusion.
When VYEPTI® is given
VYEPTI® should be administered every 12 weeks in a hospital or clinical setting.
How VYEPTI® is given
VYEPTI® will be given by a healthcare professional in a healthcare setting
VYEPTI® is given by intravenous infusion in your vein
VYEPTI® should be administered once every 3 months (12 weeks)
Once prepared, VYEPTI® is administered by intravenous infusion over approximately 30 minutes.
Ask your doctor or healthcare professional if you have questions about your infusion
schedule.
If you miss a dose of VYEPTI®
VYEPTI® is given every 3 months, under the supervision of a doctor or healthcare professional.
If you miss or forget your appointment for VYEPTI®, contact your doctor and make another appointment as soon as possible. Do not wait
for the next scheduled dose.
If you use too much VYEPTI®
As this medicine is being given by your doctor or healthcare professional in a hospital
or clinical setting, it is unlikely that you will be given the wrong dose. In the
unlikely event of an overdose, your doctor will monitor you for side effects and treat
any of your symptoms as required.
5. What should I know while using VYEPTI®?
Things you should do
If you become pregnant while being given this medicine, tell your doctor immediately.
Tell your doctor or healthcare professional straight away if you:
feel unwell during infusion. Typical symptoms associated with allergic reactions are
redness of the face or chest, itching, coughing, shortness of breath, chest discomfort,
etc. Serious allergic reactions may have symptoms of difficulty breathing, a fast
or weak pulse or a sudden drop in blood pressure (making you feel dizzy or lightheaded),
swelling of the face, lips, tongue or other parts of the body.
These side effects mostly occur during infusion. Steps should be taken by healthcare
professionals to monitor any changes to your condition during the treatment with VYEPTI®.
Depending on the seriousness of the side effect, the infusion may be discontinued,
and appropriate treatment for the side effect may be given.
Remind any doctor or dentist you visit that you are using VYEPTI®.
Things you should not do
This medicine is prescribed to you by your doctor. Do not stop your VYEPTI® treatment without talking to your doctor first.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how
VYEPTI®
affects you.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
It should be stored in a refrigerator (2°C to 8°C).
Do not freeze or shake.
It should be stored in original packaging in order to protect it from light.
If removed from the refrigerator, VYEPTI® must be kept at room temperature (≤25°C) in the original carton and used within 2
days. VYEPTI® must not be returned to the refrigerator.
If VYEPTI® is allowed to remain out of the refrigerator at ≤25°C for more than 2 days, it must
not be used and should be returned to the pharmacy for destruction.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
When to discard your medicine
VYEPTI® is for single use in one patient only. Any residue must be discarded.
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.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Less serious side effects
Serious side effects
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 VYEPTI® contains
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Active ingredient
(main ingredient)
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Eptinezumab
VYEPTI® 100 mg/mL contains 100 mg of eptinezumab in 1.0 mL
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Other ingredients
(inactive ingredients)
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Histidine
Histidine hydrochloride monohydrate
Polysorbate 80
Sorbitol
Water for Injections
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Do not take this medicine if you are allergic to any of these ingredients.
The vial stopper is not made with natural rubber latex.
What VYEPTI® looks like
VYEPTI® is a concentrated injection for dilution for infusion.
Each carton contains one vial.
Aust R 335256
Who distributes VYEPTI®
Lundbeck Australia Pty Ltd
1 Innovation Road
North Ryde NSW 2113
Ph: 02 8669 1000
This leaflet was prepared in June 2022.