Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
VYEPTI 100 mg concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Eptinezumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
VYEPTI contains the active substance eptinezumab, which blocks the activity of calcitonin generelated 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 take it
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 1
• •
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 take it
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. 2
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 it
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. 3
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.
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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 100 mg 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 To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from 3 single-use 100 mg vials or 3.0 mL of VYEPTI from one single-use 300 mg vial using a sterile needle and syringe. Inject the resulting 3.0 mL (300 mg) content into a 100 mL bag of 0.9% sodium chloride for injection.
Infusion administration instructions Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the liquid contains visible particulate matter or is cloudy or discolored. Infuse VYEPTI 100 mg dose or VYEPTI 300 mg dose as prescribed, following dilution of the vial content in a 100 mL bag of 0.9% sodium chloride for injection, over approximately 30 minutes. Use an intravenous infusion set with a 0.2 or 0.22 μm in-line or add-on filter. After the infusion is complete, flush the line with 20 mL of 0.9% sodium chloride for injection. Do not administer VYEPTI as a bolus injection. No other medications should be administered through the infusion set or mixed with VYEPTI. 5
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
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Frequently asked questions about VYEPTI 100 mg concentrate for solution for infusion
How do I take VYEPTI 100 mg concentrate for solution for infusion?
VYEPTI 100 mg concentrate for solution for infusion comes as infusion containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in VYEPTI 100 mg concentrate for solution for infusion?
The active substance in VYEPTI 100 mg concentrate for solution for infusion is eptinezumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for VYEPTI 100 mg concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get VYEPTI 100 mg concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: eptinezumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
4.2. Posology and method of administration
The treatment should be initiated by a healthcare professional experienced in the diagnosis and treatment of migraine. The infusion of VYEPTI should be initiated and supervised by a healthcare professional.
Posology
The recommended dose is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks (see section 5.1).
The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. When switching dosage, the first dose of the new regimen should be given on the next scheduled dosing date.
Overall benefit and continuation of treatment should be assessed 6 months after initiation of the treatment. Any further decision to continue the treatment should be made on an individual patient basis.
Special Populations
Elderly (aged 65 years and over)
There is limited data available for the use of VYEPTI in patients ≥65 years of age. No dose adjustment is required in the elderly patients as the pharmacokinetics of eptinezumab were not affected by age.
Renal impairment/hepatic impairment
No dose adjustment is required in patients with renal impairment or hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of VYEPTI in children aged 6 to 18 years has not yet been established. Currently no data are available.
There is no relevant use of VYEPTI in children below the age of 6 years for the prophylaxis of migraine.
Method of administration
VYEPTI is for intravenous use only after dilution.
For instructions on dilution of the medicinal product prior to administration, see section 6.6.
Following dilution, infuse VYEPTI over approximately 30 minutes.
The treating healthcare professional should observe or monitor patients during and after the infusion in accordance with normal clinical practice.
Do not administer VYEPTI as a bolus injection.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.
Patients with cardiovascular, neurological or psychiatric diseases
Patients with a history of cardiovascular disease (e.g. hypertension, ischemic heart disease) were excluded from clinical studies (see section 5.1). No safety data are available in these patients. Limited safety data are available in patients with cardiovascular risk factors such as diabetes, circulatory diseases and hyperlipidaemia.
Patients with a history of neurological diseases or patients with psychiatric conditions that were uncontrolled and/or untreated were excluded from the clinical studies. Limited safety data are available in these patients.
Serious hypersensitivity
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Most hypersensitivity reactions occurred during infusion and were not serious (see section 4.8). If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated. If the hypersensitivity reaction is not serious, continuation of further treatment with VYEPTI is up to the discretion of the treating physician, taking into account the benefit-risk for the individual patient.
Excipients
VYEPTI contains sorbitol (E420). Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
4.5. Interaction with other medicinal products and other forms of interaction
Eptinezumab is not metabolized by cytochrome P450 enzymes. Therefore, interactions by eptinezumab with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are considered unlikely.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is limited data from the use of eptinezumab in pregnant women. Animal studies with eptinezumab do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human IgG is known to cross the placental barrier; therefore, eptinezumab may be transmitted from the mother to the developing fetus.
As a precautionary measure, it is preferable to avoid the use of VYEPTI during pregnancy.
Breast-feeding
There are no data on the presence of eptinezumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterward; consequently, a risk to the breastfed infant cannot be excluded during this short period. Afterwards, use of eptinezumab could be considered during breast-feeding only if clinically needed.
Fertility
The effect of eptinezumab on human fertility has not been evaluated. Animal studies with eptinezumab showed no impact on female and male fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
VYEPTI has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Over 2 000 patients have been treated with VYEPTI in clinical studies. Of these, approximately 1 000 patients were exposed for 48 weeks (four doses).
The most common adverse reactions were nasopharyngitis and hypersensitivity. Most hypersensitivity reactions occurred during infusion and were not serious. Infusion site related adverse events occurred infrequently and in similar proportions of VYEPTI and placebo patients (< 2%) with no apparent relationship to VYEPTI dose. The most frequently occurring infusion-site related adverse event was infusion site extravasation, which occurred in < 1% of VYEPTI and placebo patients.
Tabulated list of adverse reactions
Adverse reactions from clinical trials and post-marketing experience (table 1) are classified by MedDRA system organ classification and frequency. Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000).
Table 1: List of Adverse Reactions
System organ class
Adverse reaction preferred term
Frequency category
Infections and infestations
Nasopharyngitis
Common
Immune system disorders
Hypersensitivity reactions
Common
Anaphylactic reaction1
Uncommon
General disorders and administration site conditions
Infusion-related reaction
Common
Fatigue
Common
1 Not reported in PROMISE 1 and PROMISE 2, but reported in other studies and in the post-marketing setting.
Description of selected adverse reactions
Nasopharyngitis
Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE 1 and PROMISE 2 experienced nasopharyngitis. Nasopharyngitis was most frequent after the first dose of VYEPTI at any dose. The incidence decreased notably with subsequent doses and remained fairly steady thereafter.
Hypersensitivity and infusion-related reactions
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion (see section 4.4). The reported anaphylactic reactions have included symptoms of hypotension and respiratory difficulties, and have led to discontinuation of VYEPTI. Other hypersensitivity reactions, including angioedema, urticaria, flushing, rash and pruritus, were reported in approximately 4% of patients on 300 mg, 3% of patients on 100 mg and 1% of patients on placebo in PROMISE 1 and PROMISE 2.
Other symptoms reported in association with eptinezumab infusion include respiratory symptoms (nasal congestion, rhinorrhea, throat irritation, cough, sneezing, dyspnea) and fatigue (see below). Most of these events were non-serious and transient in nature.
Fatigue
Approximately 3% of patients on eptinezumab and 2% of patients on placebo in the placebo-controlled clinical trials experienced fatigue. Fatigue was most frequent on the day of the first infusion. Following the first week and with subsequent infusions, fatigue was reported in lower incidences and the incidences were comparable to placebo.
Immunogenicity
In the clinical studies, PROMISE 1 (up to 56 weeks) and PROMISE 2 (up to 32 weeks), the incidence of anti-eptinezumab antibodies across both studies was 18% (105/579) and 20% (115/574) in patients receiving 100 mg and 300 mg every 12 weeks, respectively. In both studies, the incidence of anti-eptinezumab antibodies peaked at week 24 and thereafter showed a steady decline even after subsequent dosing every 12 weeks. The incidence of neutralizing antibodies across both studies was 8.3% (48/579) and 6.1% (35/574) for the 100 mg and 300 mg treatment groups, respectively.
In an open-label study, PREVAIL (up to 96 weeks of treatment with 300 mg VYEPTI every 12 weeks), 18% (23/128) of patients developed anti-eptinezumab antibodies with an overall incidence of neutralizing antibodies of 7% (9/128). 5.3% patients were ADA positive at week 48, 4% were ADA positive at week 72, and all patients, except one patient lost to follow up, were ADA negative at week 104 (the last assessment in the study).
In the clinical studies, eptinezumab trough plasma concentrations appeared lower in patients who developed anti-eptinezumab antibodies. There was no evidence of impact of anti-eptinezumab antibody development on efficacy or safety in the clinical studies.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Doses up to 1 000 mg have been administered intravenously to humans without tolerability issues or clinically significant adverse reactions.
In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VYEPTI 100 mg prescriptionEPTINEZUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VyeptiEptinezumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about VYEPTI 100 mg concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.