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VYEPTI 100 mg concentrate for solution for infusion {equilateral_black_triangle}

Active Ingredient:
eptinezumab
Company:  
Lundbeck Limited See contact details
ATC code: 
N02CD05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 22 Nov 2024

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 00458/0314.

{printer} Print patient leaflet as text only

VYEPTI 100 mg concentrate for solution for infusion (300mg not marketed)

Package leaflet: Information for the patient

VYEPTI 100 mg concentrate for solution for infusion

VYEPTI 300 mg concentrate for solution for infusion

eptinezumab

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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.

What is in this 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 naturally occurring substance in the body. People with migraine may have increased levels of this substance.

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

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

Warnings and precautions

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

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

  • breathing difficulty
  • a fast or weak pulse or a sudden drop in blood pressure which makes you feel dizzy or lightheaded
  • swelling of the lips or tongue
  • severe itching of the skin or rash while you receive VYEPTI, or afterwards

Children and adolescents

VYEPTI is not recommended for children or adolescents under 18 years 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, breast-feeding and fertility

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

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

It is not known if VYEPTI passes into breast milk. Your doctor will help you decide if you should stop breast-feeding or stop VYEPTI treatment. If you are breast-feeding or are planning to breast-feed, talk to your doctor before being treated with VYEPTI. You and your doctor should decide if you should breast-feed and be treated with VYEPTI.

Driving and using machines

VYEPTI has no or negligible effect on the ability to drive or use machines.

VYEPTI contains sorbitol

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

You must tell 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. Tell your doctor if you have any known allergies.

3. How to use VYEPTI

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

VYEPTI is given as a drip (infusion) into a vein. The infusion lasts about 30 minutes. VYEPTI will be given to you by a healthcare professional, who prepares the infusion before giving it to you. During and after the infusion the healthcare professional will observe you in accordance with normal clinical practice for signs of an allergic reaction.

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

If you use more VYEPTI than you should

Because the medicine will be given to you by a healthcare professional, it is unlikely 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 given.

If you have any further questions on 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 immediately if 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 reactions due to the infusion
    Reactions can develop quickly during infusion. Symptoms of allergic reactions are:
    • breathing difficulties
    • fast or weak pulse
    • sudden drop in blood pressure making you feel dizzy or lightheaded
    • swelling of the lips or tongue
    • severe skin itching, 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 blocked or runny nose, throat irritation, cough, sneezing, shortness of breath) and feeling tired. These symptoms are usually non-serious and of short duration.

Other side effects can occur with 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you 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 carton in order to protect from light.

If removed from the refrigerator, VYEPTI must be kept at room temperature (below 25°C) in the original carton and used within 7 days, or else discarded. Do not put VYEPTI back in the refrigerator once it has been removed.

After dilution, the solution may be stored at room temperature (below 25°C) or in a refrigerator at 2°C - 8°C. The diluted solution for infusion must be given within 8 hours.

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

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What VYEPTI contains
  • The active substance 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 ingredients are sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 and water for injections.

What VYEPTI looks like and contents of the pack

VYEPTI concentrate for solution for infusion is clear to slightly milky, colourless to brownish-yellow.

Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminium seal and plastic flip-off cap.

VYEPTI 100 mg concentrate is available in pack size of 1 vial for single-use.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Lundbeck Limited
Iveco House
Station Road
Watford
Hertfordshire
WD17 1ET
United Kingdom

Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Lundbeck Limited
Tel: +44 1908 64 9966

This leaflet was last revised in 11/2024.

Lundbeck Limited
Company image
Address
Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK
Telephone
+44 (0)1908 649 966
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)1908 649966
WWW
http://www.lundbeck.co.uk
Medical Information Direct Line
+44 (0)1908 638 972