Vyepti

Package leaflet: Information for the patient

VYEPTI 100 mg concentrate for solution for infusion, 300 mg concentrate for solution for infusion

eptinezumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

1. What VYEPTI is and what it is used for
2. What you need to know before receiving 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 naturally present in the body. People who suffer from migraine may have increased levels of this substance.
VYEPTI is used to prevent migraine in adults with at least 4 migraine days per month.
VYEPTI can reduce the number of days with migraine and improve quality of life. You may notice an improvement as early as the day after receiving the medicine.

2. What you need to know before receiving 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
If you have diseases affecting the heart or blood circulation, consult your doctor or
nurse before receiving VYEPTI.
VYEPTI may cause severe allergic reactions. These reactions can develop rapidly, even
during administration of the medicine. Seek immediate medical advice if you experience symptoms
of an allergic reaction, such as:

• difficulty breathing
• rapid or weak pulse or sudden drop in blood pressure causing dizziness or feeling faint
• swelling of the lips or tongue
• intense skin itching or skin rash during or after administration of VYEPTI

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
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before receiving this medicine.
It is preferable to avoid using 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 breastfeeding or discontinue treatment with VYEPTI. If you are breastfeeding or planning to
breastfeed, talk to your doctor before starting treatment with VYEPTI. You and your
doctor must decide whether to avoid breastfeeding or treatment with VYEPTI.
Driving and using machines
VYEPTI has no or negligible influence on the ability to drive vehicles and use machinery.
VYEPTI contains sorbitol
Sorbitol is a source of fructose. If your doctor has diagnosed you with hereditary fructose intolerance (HFI), a rare genetic disorder, you must not take this medicine. Patients with
hereditary fructose intolerance are unable to metabolize fructose, and its accumulation may lead to
serious adverse effects.
Before taking this medicine, inform your doctor if you suffer from hereditary
fructose intolerance.
VYEPTI contains polysorbate
VYEPTI contains 0.15 mg of polysorbate 80 per mL. Polysorbate may cause allergic reactions.
Inform your doctor if you have known allergies.

3. How to use VYEPTI

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
VYEPTI is administered through an intravenous infusion (IV infusion). The infusion lasts approximately 30 minutes. You will receive VYEPTI from a doctor or nurse who prepares the infusion prior to administration. During and after the infusion, the healthcare professional will monitor you, following standard clinical practice, for any signs of an allergic reaction.
The recommended dose is 100 mg every 12 weeks. Some patients may benefit from a dose of 300 mg, administered every 12 weeks. Your doctor will determine the correct dose for you and how long you should continue treatment.
If you use more VYEPTI than you should
Since this medicine will be administered by a doctor or nurse, it is unlikely that you will receive too much VYEPTI. If you think this has happened, inform your doctor.
If you forget to use VYEPTI
If a dose is missed, your doctor will decide when to administer your next dose.
If you have any questions about the use of this medicine, consult 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 experience any of the following side effects, as you may require urgent medical treatment:
Common: may affect up to 1 in 10 people:

• Allergic reactions and other infusion-related reactions
  Reactions may occur rapidly during infusion. Signs of allergic reactions include:
  • difficulty breathing
  • rapid or weak pulse
  • sudden drop in blood pressure making you feel dizzy or faint
  • swelling of the lips or tongue
  • intense skin itching, skin 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, shortness of breath) and feeling tired.
These symptoms are generally not serious and are short-lived.
Other side effects may occur with the following frequency:
Common: may affect up to 1 in 10 people:

• nasal congestion
• sore throat
• tiredness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or nurse.
You can also report side effects directly through the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze or shake.
Keep the vial in the outer packaging to protect the medicine from light.
If removed from the refrigerator, VYEPTI must be stored at room temperature (below 25 °C) in the
original packaging and used within 7 days, otherwise it must be discarded. Do not return VYEPTI to the
refrigerator once it has been removed.
After dilution, the solution can be stored at room temperature (below 25 °C) or in a refrigerator at 2 °C –
8 °C. The diluted infusion solution must be administered within 8 hours.
Do not use this medicine if you notice visible particles in the solution or if the solution is cloudy or discoloured.
Do not dispose of medicines via wastewater. 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 VYEPTI contains

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

Description of the appearance of VYEPTI and contents of the pack
VYEPTI concentrate for solution for infusion is clear or slightly opalescent, colourless to yellowish-brown. Each vial containing the concentrate is made of clear glass with a rubber stopper, aluminium seal, and plastic flip-off cap.
VYEPTI 100 mg concentrate is available in packs of 1 and 3 single-use vials.
VYEPTI 300 mg concentrate is available in packs of 1 single-use vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and 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 Authorisation Holder:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S
Tél/Tel: +32 2 535 7979 Tel: +45 36301311 (Denmark)
[email protected]

България Luxembourg/Luxemburg
Lundbeck Export A/S Representative Office Lundbeck S.A.
Tel: +359 2 962 4696 Tél: +32 2 535 7979

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980

Danmark Malta
Lundbeck Pharma A/S H. Lundbeck A/S
Tlf: +45 4371 4270 Tel: +45 36301311

Deutschland Nederland
Lundbeck GmbH Lundbeck B.V.
Tel: +49 40 23649 0 Tel: +31 20 697 1901

Eesti Norge
Lundbeck Eesti AS H. Lundbeck AS
Tel: +372 605 9350 Tlf: +47 91 300 800

Ελλάδα Österreich
Lundbeck Hellas S.A. Lundbeck Austria GmbH
Τηλ: +30 210 610 5036 Tel: +43 1 253 621 6033

España Polska
Lundbeck España S.A. Lundbeck Poland Sp. z o.o.
Tel: +34 93 494 9620 Tel.: +48 22 626 93 00

France Portugal
Lundbeck SAS Lundbeck Portugal – Produtos Farmacêuticos, Unipessoal Lda
Tél: +33 1 79 41 29 00 Tel: +351 21 00 45 900

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Romania SRL
Tel.: +385 1 6448263 Tel: +40 21319 88 26

Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Vistor hf. Lundbeck Slovensko s.r.o.
Tel: +354 535 7000 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Lundbeck Italia S.p.A. Oy H. Lundbeck Ab
Tel: +39 02 677 4171 Puh/Tel: +358 2 276 5000

Κύπρος Sverige
Lundbeck Hellas A.E. H. Lundbeck AB
Τηλ.: +357 22490305 Tel: +46 40 699 8200

Latvija
H. Lundbeck A/S
Tel: +45 36301311 (Denmark)
[email protected]

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

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The following information is intended for healthcare professionals only:

Instructions for dilution and administration

The medicine must be diluted before administration. Dilution must be prepared by a healthcare professional using aseptic technique to ensure sterility of the prepared infusion solution.
The medicine does not contain preservatives, is for single use only, and any unused residue must be discarded.

Before dilution, visually inspect the medicine (concentrate in vials); do not use if the concentrate contains visible particulate matter or is cloudy or discoloured (other than being clear or slightly opalescent, colourless to yellowish-brown).

For both the 100 mg and 300 mg doses, use a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection to prepare the VYEPTI infusion solution, as described below. Other diluents or volumes for intravenous administration 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 period, the solution may be stored at room temperature (below 25 °C) or refrigerated at 2 °C – 8 °C. If refrigerated, allow the VYEPTI infusion solution to reach room temperature before infusion.
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 each of 3 single-use 100 mg vials or 3 mL of VYEPTI from a single-use 300 mg vial using a sterile needle and syringe. Inject the total volume of 3.0 mL (300 mg) into a 100 mL bag of 0.9% injectable sodium chloride solution.

Instructions for infusion administration

Before administration, visually inspect parenteral medicines for particulate matter and discoloration. Do not use if the solution contains visible particulate matter or is cloudy or discoloured.

After diluting the vial contents into a 100 mL bag of 0.9% sodium chloride for injection, administer VYEPTI 100 mg or VYEPTI 300 mg as prescribed over approximately 30 minutes. Use an intravenous infusion set with an in-line or add-on filter of 0.2 or 0.22 μm. At the end of the infusion, flush the line with 20 mL of 0.9% sodium chloride for injection.

Do not administer VYEPTI as a bolus injection.
Do not administer other medications through the same infusion set or mix with VYEPTI.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.