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About the medicine

How to use VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION

Contents of the leaflet

  1. Introduction
  2. What is VYEPTI and what is it used for
  3. What you need to know before you are given VYEPTI
  4. How to use VYEPTI
  5. Possible side effects
  6. Storage of VYEPTI
  7. Contents of the pack and other information

Introduction

Package Leaflet: Information for the Patient

VYEPTI 100 mg concentrate for solution for infusion

VYEPTI 300mg concentrate for solution for infusion

eptinezumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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 yours.
  • 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.

Contents of the pack

  1. What is VYEPTI and what is it used for
  2. What you need to know before you are given VYEPTI
  3. How to use VYEPTI
  4. Possible side effects
  5. Storage of VYEPTI
  6. Contents of the pack and other information

1. What is VYEPTI and what is it used for

VYEPTI contains the active substance eptinezumab, which blocks the activity of calcitonin gene-related peptide (CGRP), a substance that occurs naturally in the body. People with migraine may have elevated levels of this substance.

VYEPTI is used to prevent migrainein adults who have migraine on at least 4 days per month.

VYEPTI may reduce the number of migraine days and improve your quality of life. You may feel the preventive effect from the day after you receive this medicine.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

Tell your doctor or nurse before you are given VYEPTI if you have any disease that affects your heart and blood circulation.

VYEPTI may cause serious allergic reactions. These reactions can occur quickly, even while the medicine is being administered. Tell your doctor immediately if you experience any symptoms of an allergic reaction, such as:

  • difficulty breathing
  • fast or weak pulse or a sudden drop in blood pressure that makes you feel dizzy or faint
  • swelling of the lips or tongue
  • severe itching of the skin or rash

Children and adolescents

VYEPTI is not recommended for children or adolescents under 18 years of age 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, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

It is preferable to avoid the use of VYEPTI during pregnancy, as the effects of this medicine on pregnant women are not known.

It is not known whether VYEPTI passes into breast milk. Your doctor will help you decide whether to stop breastfeeding or stop VYEPTI treatment. If you are breastfeeding or plan to breastfeed, consult your doctor before receiving VYEPTI treatment. You and your doctor must decide whether to breastfeed while receiving VYEPTI treatment.

Driving and using machines

The effect of VYEPTI on the ability to drive and use machines is negligible or non-existent.

VYEPTI contains sorbitol

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you should not receive this medicine. Patients with HFI cannot break down fructose, which can cause serious side effects.

Consult your doctor before receiving this medicine if you have HFI.

VYEPTI contains polysorbate

VYEPTI contains 0.15 mg of polysorbate 80 per ml. Polysorbate can cause allergic reactions. Consult your doctor if you have any known allergies.

3. How to use VYEPTI

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

VYEPTI is given as an infusion (drip) into a vein. The infusion takes about 30 minutes. A healthcare professional, who will prepare the infusion beforehand, will give you VYEPTI. During and after the infusion, the healthcare professional will monitor you according to standard clinical practice to detect signs of an allergic reaction.

The recommended dose is 100 mg administered every 12 weeks. Some patients may benefit from a dose of 300 mg administered every 12 weeks. Your doctor will decide the right dose for you and how long you should continue treatment.

If you use more VYEPTI than you should

Since the medicine will be given to you by a healthcare professional, it is unlikely that you will receive too much VYEPTI. Tell your doctor if you think this is the case.

If you miss a dose of VYEPTI

If a dose is missed, your doctor will decide when the next dose should be given.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediatelyif 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 infusion-related reactions

Reactions can occur quickly during the infusion. The symptoms of an allergic reaction are:

  • difficulty breathing
  • fast or weak pulse
  • sudden drop in blood pressure that makes you feel dizzy or faint
  • swelling of the lips or tongue
  • severe itching of the skin or 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 nasal congestion or runny nose, throat irritation, cough, sneezing, difficulty breathing) and feeling tired. These symptoms are usually not serious and do not last long.

Other side effects may occur with the following frequency:

Common: may affect up to 1 in 10 people:

  • nasal congestion
  • sore throat
  • fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are 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. Storage of VYEPTI

Keep this medicine out of the sight and 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 the month shown.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze or shake.

Keep the vial in the outer packaging to protect it from light.

Once removed from the refrigerator, VYEPTI should be stored at room temperature (below 25°C) in the original package and used within 7 days, or discarded. Do not put VYEPTI back in the refrigerator once it has been removed.

After dilution, the solution can be stored at room temperature (below 25°C) or in a refrigerator between 2°C and 8°C. The diluted infusion solution must be administered within 8 hours.

Do not use this medicine if you notice that the solution has visible particles or is cloudy or discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in VYEPTI

  • The active substance is eptinezumab.
  • Each 100 mg vial contains 100 mg of eptinezumab per ml.
  • Each 300 mg vial contains 300 mg of eptinezumab per 3 ml.
  • The other ingredients are sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and water for injections.

Appearance and packaging

VYEPTI concentrate for solution for infusion is a clear or slightly cloudy, colorless or pale yellow-brown solution. Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminum seal, and a manual extraction cap.

VYEPTI 100 mg concentrate is available in packs of 1 and 3 single-use vials.

VYEPTI 300 mg concentrate is available in a pack of 1 single-use vial.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

  • Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information about this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien

Lundbeck S.A./N.V.

Tél/Tel: +32 2 535 7979

Lietuva

  • Lundbeck A/S

Tel: +45 36301311 (Denmark)

[email protected]

Text in Bulgarian and English with contact information for a Lundbeck Export A/S office and a phone number

Luxembourg/Luxemburg

Lundbeck S.A.

Tél: +32 2 535 7979

Ceská republika

Lundbeck Ceská 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

  • Lundbeck A/S

Tel: + 45 36301311

Deutschland

Lundbeck GmbH

Tel: +49 40 23649 0

Nederland

Lundbeck B.V.

Tel: +31 20 697 1901

Eesti

Lundbeck Eesti AS

Tel: + 372 605 9350

Norge

  • Lundbeck AS

Tlf: +47 91 300 800

Ελλáδα

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) Limited

Tel: +353 1 468 9800

Slovenija

Lundbeck Pharma d.o.o.

Tel.: +386 2 229 4500

Ísland

Vistor hf.

Tel: +354 535 7000

Slovenská republikaa

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

Κúπρος

Lundbeck Hellas A.E

Τηλ: +357 22 48 38 58

Sverige

  • Lundbeck AB

Tel: +46 40 699 8200

Latvija

  • Lundbeck A/S

Tel: +45 36301311 (Denmark)

[email protected]

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions for dilution and administration.

This medicine must be diluted before administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared infusion solution.

The medicine does not contain preservatives and is for single use; unused medicine should be discarded.

Before dilution, the medicine (concentrate in the vials) should be inspected visually; do not use if the concentrate has visible particles or is cloudy or discolored (except clear or slightly cloudy, colorless or pale yellow-brown).

For both the 100 mg and 300 mg doses, a 100 ml bag of sodium chloride 9 mg/ml (0.9%) injection solution should be used to prepare the VYEPTI infusion solution as described below. No other diluents or volumes other than those stated should be used to prepare the VYEPTI infusion solution.

Invert the VYEPTI infusion solution gently to mix completely. Do not shake.

After dilution, the VYEPTI infusion solution should be administered within 8 hours.

During this time, the VYEPTI infusion solution can be stored at room temperature (below 25°C) or refrigerated between 2°C and 8°C. If refrigerated, allow the VYEPTI infusion solution to reach room temperature before administration. DO NOT FREEZE.

  • VYEPTI dose of 100 mg

To prepare the VYEPTI infusion solution, withdraw 1.0 ml of VYEPTI from a single-use vial of 100 mg with a sterile needle and syringe. Inject the contents of 1.0 ml (100 mg) into a 100 ml bag of 0.9% sodium chloride injection solution.

  • VYEPTI dose of 300 mg

To prepare the VYEPTI infusion solution, withdraw 1.0 ml of VYEPTI from 3 single-use vials of 100 mg or 3.0 ml of VYEPTI from a single-use vial of 300 mg with a sterile needle and syringe. Inject the resulting 3.0 ml (300 mg) into a 100 ml bag of 0.9% sodium chloride injection solution.

Instructions for infusion administration

Parenteral medicines should be inspected visually for particles and discoloration before administration. If the liquid contains visible particles or is cloudy or discolored, it should not be used.

Administer the VYEPTI dose of 100 mg or 300 mg as prescribed, after diluting the contents of the vial in a 100 ml bag of 0.9% sodium chloride injection solution, over approximately 30 minutes. Use an infusion set with an in-line or additional filter of 0.2 or 0.22 μm. After the infusion is complete, flush the line with 20 ml of 0.9% sodium chloride injection solution.

Do not administer VYEPTI as a bolus injection.

No other medicines should be administered through the same infusion set or mixed with VYEPTI.

Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.

Online doctors for VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION

Discuss questions about VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

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Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment

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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal

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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Throughout his career, he has participated in various medical and academic projects, including a research fellowship in Spain, where he contributed to evidence-based studies in the field of family medicine. This experience allowed him to broaden his global perspective on healthcare and comprehensive patient care.

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Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
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  • renewal of prescriptions when clinically appropriate

Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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With a strong interest in a comprehensive approach to skin health, she also treats scars, post-procedural skin changes, and conditions related to hormonal factors and aging, including those associated with pregnancy, menopause, and age-related skin changes.

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Hocine Lokchiri

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Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Frequently Asked Questions

VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION is eptinezumab. This information helps identify medicines with the same composition but different brand names.

VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION is manufactured by H. Lundbeck A/S. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Psychiatrists, Neurologists, General medicine doctors, Pain medicine doctors, Anaesthesiologists may assess whether VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (eptinezumab) include AIMOVIG 140 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AIMOVIG 70 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AJOVY 225 mg PRE-FILLED SYRINGE SOLUTION FOR INJECTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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