Vyepti - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

VYEPTI 100 mg concentrate for solution for infusion

eptinezumab

This medicine is subject to additional monitoring. This will allow quick identification of new afety information. You canhelp by reporting anyside effects you may get. See the end ofsection 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

alk 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 neglible 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.

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

These 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 rare (may affect up to 1 in 1,000 people).

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 the national reporting system listed in * 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 refrigerater (2°C – 8°C).

Do not freeze or shake.

Keep the vial in the outer carton in order to protect from light.

After dilution, the solution may be stored at room temperature (below 25°C) or in a refrigerater 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 concentrate contains 100 mg of eptinezumab per 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 one mL concentrate in a clear glass vial with a rubber stopper, aluminium seal and plastic flip-off cap.

Each pack contains one vial for single use.

Marketing Authorisation Holder and Manufacturer

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http : //.

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The following information is intended for healthcare professionals only:

Instructions for dilution and administration

The medicinal product requires dilution prior to administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution for infusion.

The medicinal product contains no preservative and is intended for single use only and any unused medicinal product should be disposed.

Prior to dilution, the medicinal product (concentrate in the vials) should be inspected visually; do not use if the concentrate contains visible particulate matter or is cloudy or discoloured (other than clear to slightly opalescent, colourless to brownish-yellow).

For both the 100 mg and the 300 mg dose, a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prepare the VYEPTI solution for infusion as described below. No other intravenous diluents or volume may be used to prepare the VYEPTI solution for infusion.

Gently invert the VYEPTI solution for infusion to mix completely. Do not shake.

Following dilution, VYEPTI solution for infusion must be infused within 8 hours. During this time, VYEPTI solution for infusion may be stored at room temperature (below 25°C) or refrigerated at 2°C – 8°C. If stored at 2°C – 8°C, allow the VYEPTI solution for infusion to warm to room temperature prior to infusion. DO NOT FREEZE.

• VYEPTI 100 mg dose

To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from one 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 for injection

• VYEPTI 300 mg dose