VYEPTI 100 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. VYEPTI 100 mg concentrate for solution for infusion, 300 mg concentrate for solution for infusion
   1. What is VYEPTI and what is it used for
   2. What you need to know before you receive VYEPTI
   3. How to use VYEPTI
   4. Possible side effects
   5. How to store VYEPTI
   6. Contents of the pack and other information

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

eptinezumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you receive 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you receive 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 is VYEPTI and what is it used for

VYEPTI contains the active substance eptinezumab, which blocks the activity of the 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 migrainein adults, with at least 4 migraine days
per month.
VYEPTI may reduce the number of migraine days and improve the quality of life. You may
feel an improvement from the day after you received the medicine.

2. What you need to know before you receive 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
If you have heart and blood circulation problems, talk to your doctor or
nurse before receiving VYEPTI
VYEPTI can cause serious allergic reactions. These reactions can develop rapidly even
during the administration of the medicine. Seek immediate medical attention if you experience symptoms
of an allergic reaction, such as:

• difficulty breathing

• rapid or weak pulse or a sudden drop in blood pressure that makes you feel dizzy or lightheaded
• swelling of lips or tongue
• a feeling of intense itching or rash during or after the 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
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor for advice before receiving 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 treatment with VYEPTI. If you are breastfeeding or intend to
breastfeed, talk to your doctor before treatment with VYEPTI. You and your
doctor must decide whether to avoid breastfeeding or treatment with VYEPTI.

Driving and using machines
VYEPTI does not or negligibly alters the ability to drive vehicles and use machines.

VYEPTI contains sorbitol
Sorbitol is a source of fructose. If your doctor has diagnosed you with hereditary fructose intolerance (HFI), a
rare genetic disease, you should not take this medicine. Patients with
hereditary fructose intolerance cannot metabolize fructose, the accumulation of which can cause
serious side effects.
Before taking this medicine, tell your doctor if you suffer from hereditary fructose
intolerance

VYEPTI contains polysorbate
VYEPTI contains 0.15 mg of polysorbate 80 in each mL. Polysorbate can cause allergic reactions.
Inform your doctor in case of known allergies.

3. How to use VYEPTI

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
VYEPTI is administered through an intravenous infusion. The infusion lasts approximately
30 minutes. You will receive VYEPTI from a doctor or nurse who prepares the infusion before
administration. During and after the infusion, the healthcare professional will monitor you,
following normal 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 right dose for you and
for how long you should continue treatment.

If you use more VYEPTI than you should
Since the medicine will be administered by a doctor or nurse, it is unlikely that you will receive
an excessive amount of VYEPTI. If you think this may have happened, inform your doctor.

If you forget to use VYEPTI
If a dose is missed, the doctor will decide when to administer the next dose.
If you have any doubts about 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 immediatelyif you notice any of the following side
effects, as you may need urgent medical attention:

Common:may affect up to 1 in 10 people:

• allergic reactions and other infusion-related reactionsReactions can occur quickly during the infusion. Symptoms of allergic reactions are:
• difficulty breathing
• fast or weak pulse
• sudden drop in blood pressure making you feel dizzy or faint
• swelling of lips or tongue
• feeling of intense itching, rash Severe allergic reactions are uncommon (may affect up to 1 in 100).

Other symptoms that may occur due to the infusion include respiratory symptoms (such as stuffy or
runny nose, sore throat, 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:

• stuffy nose
• sore throat
• fatigue

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
to 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 the packaging 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 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 that the solution contains visible particles or is cloudy or
discolored.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. 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 vial of sterile concentrate contains 100 mg of eptinezumab/mL.
• Each 300 mg vial of sterile concentrate contains 300 mg of eptinezumab/3 mL.
• The other components are sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 and water for injections.

Description of VYEPTI and contents of the pack
VYEPTI concentrate for solution for infusion is transparent or slightly milky, from colourless to
yellowish-brown. Each vial containing the concentrate is made of clear glass with a rubber stopper,
aluminium seal and a plastic tear-off cap.
VYEPTI 100 mg concentrate is available in packs of 1 and 3 single-use vial/s.
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 on this medicinal product, 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(Denmark) [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

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

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

România
Lundbeck Romania SRL
Tel: +40 21319 88 26

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(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 .
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended for healthcare professionals only:
Instructions for dilution and administration
The medicinal product must be diluted before administration. The dilution must be prepared by
a healthcare professional using aseptic technique to ensure the sterility of the solution
prepared for infusion.
The medicinal product does not contain preservatives, is for single use and any unused residue must be
discarded.
Before dilution, the medicinal product (concentrate in vials) must be visually inspected; do not use if the
concentrate contains visible particulate matter or is turbid or discoloured (other than being clear or
slightly opalescent, from 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 solution for infusion, as described below. Other diluents or volumes
for intravenous administration cannot be used for the preparation of the VYEPTI solution for infusion.
Gently invert the VYEPTI solution for infusion to mix it thoroughly. Do not shake.
After dilution, the VYEPTI solution for infusion must be infused within 8 hours. During this time
interval, the VYEPTI solution for infusion may be stored at room temperature (below 25 °C) or in a
refrigerator at 2 °C – 8 °C. If stored at 2 °C – 8 °C, allow the VYEPTI solution for infusion to reach
room temperature before infusion.
DO NOT FREEZE.

• VYEPTI 100 mg dose

To prepare the VYEPTI solution for infusion, draw up 1.0 mL of VYEPTI from
a single-use 100 mg vial, using 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.

• VYEPTI 300 mg dose

To prepare the VYEPTI solution for infusion, draw up 1.0 mL of VYEPTI from 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 resulting contents of 3.0 mL (300 mg) into a 100 mL bag of
0.9% sodium chloride injection.

Instructions for administering the infusion
Before administration, parenteral medicines must be visually inspected to exclude the presence of
particulate matter and discolouration. Do not use if the liquid contains visible particulate matter or is
turbid or discoloured.
After dilution of the vial contents in a 100 mL bag of 0.9% sodium chloride injection,
infuse 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 0.2 or 0.22 μm filter. At the end of the infusion, flush the
line with 20 mL of 0.9% sodium chloride injection.
Do not administer VYEPTI as a bolus injection.
Do not administer other medicines using the infusion set, or mix them with VYEPTI.
Unused medicinal product and waste material should be disposed of in accordance with local
regulations.