Vyepti 100 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

VYEPTI 100 mg concentrate for solution for infusion

VYEPTI 300 mg concentrate for solution for infusion

eptinezumab

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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 substance that occurs naturally in the body. People with migraine may have elevated levels of this substance.

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

VYEPTI can reduce the number of migraine days and improve your quality of life. You may notice the preventive effect 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given VYEPTI if you have any disease affecting the heart or blood circulation.

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

• difficulty breathing
• rapid or weak pulse or a sudden drop in blood pressure causing dizziness or fainting
• swelling of the lips or tongue
• severe skin itching or rash while receiving VYEPTI or afterwards

Children and adolescents

VYEPTI is not recommended for children or adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and VYEPTI

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before you are given this medicine.

It is preferable to avoid the use of VYEPTI during pregnancy, as the effects of this medicine in pregnant women are unknown.

It is not known whether VYEPTI passes into breast milk. Your doctor will help you decide whether to stop breast-feeding or to stop treatment with VYEPTI. If you are breast-feeding or plan to breast-feed, talk to your doctor before receiving treatment with VYEPTI. You and your doctor should decide whether to breast-feed while receiving treatment with VYEPTI.

Driving and using machines

The effect of VYEPTI on the ability to drive and use machines is none or negligible.

VYEPTI contains sorbitol

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not be given this medicine. Patients with HFI cannot break down fructose, which may lead to serious adverse effects.

Consult 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. Consult your doctor if you have any known allergy.

3. How to use VYEPTI

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

VYEPTI is administered as a drip (infusion) into a vein. The infusion lasts about 30 minutes. A healthcare professional, who will prepare the infusion beforehand, will administer VYEPTI to you. 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 appropriate dose for you and how long treatment should continue.

If you use more VYEPTI than you should

Since a healthcare professional will administer the medicine to you, it is unlikely that 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 administered.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor or nurse immediately if you notice any of the following adverse effects; you may require urgent medical treatment:

Common: may affect up to 1 in 10 people:

• allergic reactions and other reactions due to the infusion

Reactions may occur rapidly during the infusion. Symptoms of an allergic reaction include:

• difficulty breathing
• rapid or weak pulse
• sudden drop in blood pressure causing dizziness or fainting
• swelling of the lips or tongue
• intense skin itching, rash

Severe 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 adverse effects may occur with the following frequency:

Common: may affect up to 1 in 10 people:

• nasal congestion
• sore throat
• fatigue

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

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.

After removal from the refrigerator, VYEPTI must be stored at room temperature (below 25 °C) in the original container and used within 7 days, otherwise it must be discarded. Do not return VYEPTI to the refrigerator once removed.

After dilution, the solution may 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 contains visible particles, or if it is cloudy or discolored.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of VYEPTI

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

Nature of the product and contents of the container

VYEPTI concentrate for solution for infusion is a transparent or slightly milky, colourless or brownish-yellow liquid. Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminium seal, and tamper-evident cap.

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

This information is intended for healthcare professionals only:

Instructions for dilution and administration.

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

The medicine contains no preservatives and is for single use only; any unused medicine must be discarded.

Before dilution, the medicine (concentrate in vials) should be visually inspected; do not use if the concentrate contains visible particles or appears cloudy or discolored (except for clear or slightly opalescent, colorless to pale brownish-yellow solution).

For both the 100 mg and 300 mg doses, a 100 ml bag of 9 mg/ml (0.9%) sodium chloride injectable solution must be used to prepare the VYEPTI infusion solution as described below. Other diluents or volumes must not be used to prepare the VYEPTI infusion solution.

Gently invert the VYEPTI infusion solution to ensure complete mixing. Do not shake.

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

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

• VYEPTI 100 mg dose

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

• VYEPTI 300 mg dose

To prepare the VYEPTI infusion solution, withdraw 1.0 ml of VYEPTI from three 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) into a 100 ml bag of 0.9% injectable sodium chloride solution.

Instructions for infusion administration

Parenteral medicines should be inspected visually for particulate matter and discoloration prior to administration. If the solution contains visible particles or appears cloudy or discolored, it must not be used.

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

Do not administer VYEPTI as an intravenous bolus injection.

Other medicinal products must not be administered through the same infusion equipment or mixed with VYEPTI.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.