VYEPTI 100 MG CONCENTRATE FOR INFUSION SOLUTION

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

Tell your doctor or nurse before you are given VYEPTI if you have any disease that affects your heart and blood circulation.

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

• difficulty breathing
• fast or weak pulse or a sudden drop in blood pressure that makes you feel dizzy or faint
• swelling of the lips or tongue
• severe itching of the skin or rash

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 medicines and VYEPTI

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given 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 VYEPTI treatment. If you are breastfeeding or plan to breastfeed, consult your doctor before receiving VYEPTI treatment. You and your doctor must decide whether to breastfeed while receiving VYEPTI treatment.

Driving and using machines

The effect of VYEPTI on the ability to drive and use machines is negligible or non-existent.

VYEPTI contains sorbitol

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

Consult your doctor before receiving this medicine if you have HFI.

VYEPTI contains polysorbate

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

3. How to use VYEPTI

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

VYEPTI is given as an infusion (drip) into a vein. The infusion takes about 30 minutes. A healthcare professional, who will prepare the infusion beforehand, will give you VYEPTI. 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 the right dose for you and how long you should continue treatment.

If you use more VYEPTI than you should

Since the medicine will be given to you by a healthcare professional, it is unlikely that you will receive too much VYEPTI. Tell your doctor if you think this is the case.

If you miss a dose of VYEPTI

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

If you have any other questions 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.

Tell your doctor or nurse immediatelyif 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 infusion-related reactions

Reactions can occur quickly during the infusion. The symptoms of an allergic reaction are:

• difficulty breathing
• fast or weak pulse
• sudden drop in blood pressure that makes you feel dizzy or faint
• swelling of the lips or tongue
• severe itching of the skin or 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 nasal congestion or runny nose, throat irritation, cough, sneezing, difficulty breathing) and feeling tired. These symptoms are usually not serious and do not last long.

Other side effects may occur with the following frequency:

Common: may affect up to 1 in 10 people:

• nasal congestion
• sore throat
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month shown.

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

Do not freeze or shake.

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

Once removed from the refrigerator, VYEPTI should be stored at room temperature (below 25°C) in the original package and used within 7 days, or discarded. Do not put VYEPTI back in the refrigerator once it has been removed.

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

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

Medicines should not be disposed of via wastewater or household waste. 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 is in VYEPTI

• The active substance is eptinezumab.
• Each 100 mg vial contains 100 mg of eptinezumab per ml.
• Each 300 mg vial 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.

Appearance and packaging

VYEPTI concentrate for solution for infusion is a clear or slightly cloudy, colorless or pale yellow-brown solution. Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminum seal, and a manual extraction 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions for dilution and administration.

This medicine must be diluted before administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared infusion solution.

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

Before dilution, the medicine (concentrate in the vials) should be inspected visually; do not use if the concentrate has visible particles or is cloudy or discolored (except clear or slightly cloudy, colorless or pale yellow-brown).

For both the 100 mg and 300 mg doses, a 100 ml bag of sodium chloride 9 mg/ml (0.9%) injection solution should be used to prepare the VYEPTI infusion solution as described below. No other diluents or volumes other than those stated should be used to prepare the VYEPTI infusion solution.

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

After dilution, the VYEPTI infusion solution should be administered within 8 hours.

During this time, the VYEPTI infusion solution can be stored at room temperature (below 25°C) or refrigerated between 2°C and 8°C. If refrigerated, allow the VYEPTI infusion solution to reach room temperature before administration. DO NOT FREEZE.

• VYEPTI dose of 100 mg

To prepare the VYEPTI infusion solution, withdraw 1.0 ml of VYEPTI from a single-use vial of 100 mg with 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 solution.

• VYEPTI dose of 300 mg

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

Instructions for infusion administration

Parenteral medicines should be inspected visually for particles and discoloration before administration. If the liquid contains visible particles or is cloudy or discolored, it should not be used.

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

Do not administer VYEPTI as a bolus injection.

No other medicines should be administered through the same infusion set or mixed with VYEPTI.

Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.