Vyepti – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Vyepti, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yo urs.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What VYEPTI is and what it is used for
VYEPTI contains the active substance eptinezumab, which blocks the activity of calcitonin gene – related peptide (CGRP), a naturally occurring substance in the body. People with migraine may have increased levels of this substance.
VYEPTI is used to prevent migraine in adults who have migraine at least 4 days per month.
VYEPTI can reduce the number of days with migraine and improve your quality of life. You may feel the preventive effect starting the day after receiving this medicine.
⚠️ 2. What you need to know before you are given VYEPTI
Do not use VYEPTI
- if you are allergic to eptinezumab or any of the other ingredients of this medicine (listed in section 6) .
Warnings and precautions
Talk to your doctor or nurse before being given VYEPTI if you have disease affecting the heart and blood circulation .
VYEPTI can cause serious allergic reactions. These reactions can develop quickly even while the medicine is being given . Tell your doctor immediately if you get any symptoms of an allergic reaction, such as:
- breathing difficulty
- a fast or weak pulse or a sudden drop in blood pressure which makes you feel dizzy or lightheaded 29 • swelling of the lips or tongue
- severe itching of the skin or rash while you receive VYEPTI , or afterwards
Children and adolescents
VYEPTI is not recommended for children or adolescents under 18 years because it has not been studied in this age group.
Other medicines and VYEPTI
Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy, breast -feeding and fertility If you a re pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
It is preferable to avoid the use of VYEPTI during pregnanc y as the effec ts of this medicine in pregnant women are not known.
It is not known if VYEPTI passes into breast milk. Your doctor will help you decide if you should stop breast -feeding or stop VYEPTI treatment . If you are breast -feeding or are planning to breast -feed, talk to your doctor before being treated with V YEPTI . You and your doctor should decide if you should breast -feed and be treated with V YEPTI .
Driving and using machines
VYEPTI has no or negli gible effect on the ability to drive or use machines.
VYEPTI contains sorbitol
Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you have HFI.
VYEPTI contains polysorbate
VYEPTI contains 0,15 mg of polysorbate 80 in each mL. Polysorbate may cause allergic reactions.
Tell you r doctor if you have any known allergies.
💊 3. How to use VYEPTI
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
VYEPTI is given a s a drip (infusion) into a vein. The infusion lasts about 30 minutes. VYEPTI will be given to you by a healthcare professional , who prepares the infusion before giv ing it to you. During and after the infusion the healthcare professional will observe you in accordance with normal clinical practice for signs of an allergic reaction .
The recommended dose is 100 mg given every 12 weeks. Some patients may benefit from a dose of 300 mg given every 12 weeks. Your doctor will decide the right dose for you and how long you should continue to be treated .
If you use more VYEPTI than you should
Because the medicine will be given to you by a healthcare professional, it is unlikely you will receive too much VYEPTI. Inform your doctor if you think this has happened .
If you forget to use VYEPTI
If a dose is missed, your doctor will decide when the next dose should be given.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you notice any of the following side effects – you may need urgent medical treatment:
Common: may affect up to 1 in 10 people
- allergic reactions and other reactions due to the infusion Reactions can develop quickly during infusion. Symptoms of allergic reactions are:
- breathing difficulties
- fast or weak pulse
- sudden drop in blood pressure making you feel dizzy or lightheaded
- swelling of the lips or tongue
- severe skin itching , rash Serious allergic reactions are uncommon (may affect up to 1 in 100 people) .
Other symptoms that may occur due to the infusion include respiratory symptoms (such as blocked or runny nose, throat irritation, cough, sneezing, shortness of breath) and feeling tired. These symptoms are usually non-serious and of short duration.
Other side effects can occur with following frequency
Common: may affect up to 1 in 10 people
- stuffy nose
- sore throat
- fatigue
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store VYEPTI
Keep this medicine out of the sight a nd reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerat or (2°C – 8°C).
Do not freeze or shake.
Keep the vial in the outer carton in order to protect from light.
If removed from the refrigerator, VYEPTI must be kept at room temperature ( below 25°C) in the original carton and used within 7 days, or else discarded . Do not put VYEPTI back in the refrigerator once it h as been removed.
After dilution, the solution may be stored at room temperature (below 25°C ) or in a refrigerat or at 2°C – 8°C. The diluted solution for infusion must be given within 8 hours.
31 Do not use this medicine if you notice that the solution contains visible particles or is cloudy or discolored.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What VYEPTI contains
- The active substance is eptinezumab.
- Each vial of 100 mg concentrate contains 100 mg of eptinezumab per m L.
- Each vial of 300 mg concentrate contains 300 mg of eptinezumab per 3 m L.
- The other ingredients are s orbitol (E420) , L-histidine, L-histidine hydrochloride monohydrate , polysorbate 80 and w ater for i njection s.
What VYEPTI looks like and contents of the pac k VYEPTI concentrate for solution for infusion is clear to slightly milky , colourless to brownish-yellow.
Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminium seal and plastic flip-off cap.
VYEPTI 100 mg concentrate is available in pack sizes of 1 and 3 vial(s) for single-use.
VYEPTI 300 mg concentrate is available in pack size of 1 vial for single -use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 7979 Lietuva H. Lundbeck A/S Tel: +45 36301311( Danija) [email protected] България Lundbeck Export A/S Representative Office Tel: +359 2 962 4696 Luxembourg/Luxemburg Lundbeck S.A.
Tél: +32 2 535 7979 Česká republika Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600 Magyarország Lundbeck Hungaria Kft.
Tel: +36 1 4369980 Danmark Lundbeck Pharma A/S Tlf.: +45 4371 4270 Malta H. Lundbeck A/S Tel: + 45 36301311 Deutschland Lundbeck GmbH Tel: +49 40 23649 0 Nederland Lundbeck B.V.
Tel: +31 20 697 1901 32 Eesti Lundbeck Eesti AS Tel: + 372 605 9350 Norge H. Lundbeck AS Tlf: +47 91 300 800 Ελλάδα Lundbeck Hellas S.A.
Τηλ: +30 210 610 5036 Österreich Lundbeck Austria GmbH Tel: +43 1 253 621 6033 España Lundbeck España S.A.
Tel: +34 93 494 9620 Polska Lundbeck Poland Sp. z o. o.
Tel.: + 48 22 626 93 00 France Lundbeck SAS Tél: + 33 1 79 41 29 00 Portugal Lundbeck Portugal – Produtos Farmacêuticos, Unipessoal Lda Tel: +351 21 00 45 900 Hrvatska Lundbeck Croatia d.o.o.
Tel.: + 385 1 6448263 România Lundbeck Romania SRL Tel: +40 21319 88 26 Ireland Lundbeck (Ireland) L imited Tel: +353 1 468 9800 Slovenija Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500 Ísland Vistor hf.
Tel: +354 535 7000 Slovenská republika Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18 Italia Lundbeck Italia S.p.A.
Tel: +39 02 677 4171 Suomi/Finland Oy H. Lundbeck Ab Puh/Tel: +358 2 276 5000 Κύπρος Lundbeck Hellas A.E Τηλ.: +357 22490305 Sverige H. Lundbeck AB Tel: +46 40 699 8200 Latvija H. Lundbeck A/S Tel: +45 36301311(Dānija) [email protected]
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
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🩺 Information intended for healthcare professionals only
Instructions for dilution and administration The medicinal product requires dilution prior to administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution for infusion.
The medicinal product contains no preservative and is i ntended for single use only and any unused medicinal product should be disposed.
Prior to dilution, the medicinal product ( concentrate in the vials) should be inspected visually; do not use if the concentrate contains visible particulate matter or is clou dy or discoloured (other than clear to slightly opalescent, colourless to brownish -yellow).
For both the 100 mg and the 300 mg dose, a 100 mL bag of sodium chloride 9 mg/mL ( 0.9%) solution for injection should be used to prepare the VYEPTI solution for infusion as described below. No other intrav enous diluents or volume may be used to prepare the VYEPTI solution for infusion.
Gently invert the VYEPTI solution for infusion to mix completely. Do not shake.
Following dilution, VYEPTI solution for infusion must be infused within 8 hours. During this time, VYEPTI solution for infusion may be stored at room temperature (below 25°C ) or refrigerated at 2°C – 8°C. If stored at 2 °C – 8°C, allow the VYEPTI solution for infusion to warm to room temperature prior to infusion. DO NOT FREEZE.
- VYEPT I 100 mg dose To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from one single -use 100 mg vial using a sterile needle and syringe. Inject the 1.0 mL (100 mg) content into a 100 mL bag of 0.9% s odium chloride for i njection
- VYEPT I 300 mg dose To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from 3 single -use 100 mg vials or 3.0 mL of VYEPTI from one single -use 300 mg vial using a sterile needle and syringe. Inject the resulting 3.0 mL (300 mg) content into a 100 mL bag of 0.9% s odium chloride for injection.
Infusion administration instructions Parenteral medicinal produ cts should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the liquid contains visible particulate matter or is cloudy or discolored.
Infuse VYEPTI 100 mg dose or VYEPT I 300 mg dose as prescribed, following dilution of the vial content in a 100 mL bag of 0.9% s odium chloride for i njection, over approximately 30 minutes. Use an intravenous infusion set with a 0.2 or 0.22 μm in -line or add-on filter. After the infusion is complete, flu sh the line with 20 mL of 0.9% sodium chloride for i njection.
Do not administer VYEPTI as a bolus injection.
No other medications should be administered through the infusion set or mixed with VYEPTI.
34 Any unused medicinal product or waste material should be disposed in accordance with local requirements.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Vyepti (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1599).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.