Vyepti 100 mg concentrado para solucion para perfusion

Prospect: 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 expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before this medicine is administered to you, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

VYEPTI contains the active ingredient eptinezumab, which blocks the activity of the calcitonin gene-related peptide (CGRP) peptide, a naturally occurring substance in the body. Individuals with migraines may have elevated levels of this substance.

VYEPTI is used toprevent migrainesin adults who experience migraines at least 4 days per month.

VYEPTI may reduce the number of days with migraines and improve quality of life. You may feel the preventive effect starting from the day after receiving this medication.

Do not use VYEPTI

• if you are allergic to eptinezumab or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor or nurse before receiving VYEPTI if you have any heart or blood circulation disease.

VYEPTI may cause severe allergic reactions. These reactions can occur quickly, even while the medication 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 that causes dizziness or lightheadedness
• swelling of the lips or tongue
• intense skin itching or rash while receiving VYEPTI or after

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 medications and VYEPTI

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

It is preferable to avoid using VYEPTI during pregnancy, as the effects of this medication on pregnant women are unknown.

The passage of VYEPTI into breast milk is unknown. Your doctor will help you decide whether to stop breastfeeding or interrupt treatment with VYEPTI. If you are breastfeeding or plan to do so, speak with your doctor before receiving treatment with VYEPTI. You and your doctor must decide whether to breastfeed while receiving treatment with VYEPTI.

Driving and operating machines

The effect of VYEPTI on the ability to drive and operate machines is negligible.

VYEPTI contains sorbitol

Sorbitol is a source of fructose. If you suffer from hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication. Patients with HFI cannot break down fructose, which can cause severe adverse effects.

Consult your doctor before receiving this medication if you suffer from HFI.

VYEPTI contains polysorbate

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

VYEPTI is administered as an infusion (drip) 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 on the appropriate dose for you and for how long you should continue treatment.

If you use more VYEPTI than you should

Since a healthcare professional will administer the medication, it is unlikely that you will receive an excessive amount of VYEPTI. Inform your doctor if you think this is the case.

If you forgot to use VYEPTI

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

If you have any other questions about using this medication, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Contact your doctor or nurse immediatelyif you notice any of the following adverse effects; you may need urgent medical treatment:

Frequent:may affect up to 1 in 10 people:

• Allergic reactions and other reactions due to perfusion

These reactions may occur rapidly during perfusion. The symptoms of an allergic reaction are as follows:

• Difficulty breathing
• Fast or weak pulse
• Sudden drop in blood pressure that causes dizziness or lightheadedness
• Swelling of the lips or tongue
• Intense itching of the skin, rash

Severe allergic reactions are rare (may affect up to 1 in 100 people).

Other symptoms that may occur due to perfusion include respiratory symptoms (such as nasal congestion or runny nose, throat irritation, cough, sneezing, difficulty breathing) and a feeling of fatigue. These symptoms are usually not severe and do not last long.

Other adverse effects may occur with the following frequency:

Frequent: may affect up to 1 in 10 people:

• Nasal congestion
• Sore throat
• Fatigue

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

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

Do not freeze or shake.

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

Once removed from the refrigerator, VYEPTI must be stored at room temperature (below 25 °C) in the original container and used within 7 days, or discard. Do not reintroduce VYEPTI into the refrigerator once removed.

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

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

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of VYEPTI

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

Appearance of the product and contents of the pack

VYEPTI concentrate for solution for infusion is transparent or slightly milky, colorless or light yellowish. Each vial contains concentrate in a transparent glass vial with a rubber stopper, aluminum seal, and manual closure 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.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Dilution and administration instructions.

This medicinal product must be diluted before administration. A healthcare professional should prepare the dilution using aseptic technique to ensure the sterility of the infusion solution prepared.

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

Before dilution, the medicinal product (concentrate in vials) should be visually inspected; do not use if the concentrate contains visible particles or is turbid or discolored (except transparent or slightly opalescent, colorless or light yellowish).

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

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

After dilution, the VYEPTI infusion solution should be infused 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 infusion. DO NOT FREEZE.

• 100 mg VYEPTI dose

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

• 300 mg VYEPTI dose

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 using a sterile needle and syringe. Inject the resulting 3.0 ml (300 mg) into a 100 ml bag of 0.9% sodium chloride injection.

Infusion administration instructions

Parenteral drugs should be visually inspected for particulate matter and color before administration. If the liquid contains visible particles or is turbid or discolored, it should not be used.

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

Do not administer VYEPTI as a bolus injection.

Do not administer other medicinal products through the perfusion set or mix them with VYEPTI.

The disposal of unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations.