TM Owner Lundbeck
Vyepti 100mg/ml Injection
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Indications & Clinical Uses
- Vyepti 100mg/ml injection contains eptinezumab (eptinezumab-jjmr in the US), a monoclonal antibody that blocks calcitonin gene-related peptide (CGRP) and is used to prevent migraine in adults.
- In the EU it is approved for adults with at least 4 migraine days a month.
- The usual dose is 100 mg given as an intravenous infusion over about 30 minutes every 3 months (every 12 weeks), and some patients benefit from 300 mg.
- Vyepti is supplied as a 100 mg/mL single-dose vial that must be diluted in 100 mL of 0.9% sodium chloride before use.
- It is given only by a healthcare provider in a clinic or hospital setting, not at home, and it is not used to treat an attack that has already started.
- The EU marketing authorisation holder is H.
- Lundbeck A/S, Denmark.
Side Effects
- Nasopharyngitis (a cold-like illness) was the most common reaction in trials, reported in 6% of people on 100 mg and 8% on 300 mg, compared with 6% on placebo.
- Hypersensitivity reactions, including angioedema, hives and difficulty breathing, occurred in 1% to 2% of people and can be serious; anaphylaxis has been reported after approval, and fatigue has also been reported.
- The US label warns of new or worsening high blood pressure, usually within 7 days of a dose, Raynaud's phenomenon, and constipation that can be serious.
- Vyepti has no boxed warning.
- Tell the infusion team right away if you feel itchy, flushed, breathless or unwell during the infusion, and report any new symptoms afterwards.
Precautions & Warnings
- Vyepti must not be given to anyone with a serious allergy to eptinezumab or any ingredient.
- The infusion team should watch for hypersensitivity during and after the infusion and stop it if a reaction occurs.
- Blood pressure should be checked, and fingers or toes that turn pale or blue in the cold should be reported.
- Constipation that does not settle should be reported early.
- Safety and effectiveness in children have not been established.
- There are no adequate human pregnancy data; animal studies showed no harm at 30 times the human dose, and a US pregnancy registry exists.
- Vyepti is diluted and infused intravenously only, is stored in the vial at 2°C to 8°C away from light, and must not be frozen or shaken.
Avoid Interactions
- Vyepti is not broken down by cytochrome P450 enzymes, so interactions with other medicines through these enzymes are not expected.
- Taking sumatriptan with Vyepti did not cause a meaningful interaction in studies.
- No medicines are listed that increase or reduce its effect, but blood pressure medicines and other treatments should still be reviewed by your healthcare provider because high blood pressure has been reported.
- Vyepti must not be mixed with other medicines in the infusion bag; it is diluted only in 0.9% sodium chloride.
- Tell your healthcare provider about all prescription and non-prescription medicines and supplements you take.
References
Frequently Asked Questions
Vyepti (eptinezumab) is a monoclonal antibody infusion that prevents migraine in adults. In the EU it is for people with at least 4 migraine days a month. It blocks CGRP, a protein involved in migraine. It does not treat an attack that has already started.
Vyepti (eptinezumab) is given by a healthcare provider as a 30-minute intravenous infusion, once every 3 months (every 12 weeks). The usual dose is 100 mg, and some people benefit from 300 mg. It is given in a clinic or hospital and is not a home injection.
The most common side effect of Vyepti (eptinezumab) is a cold-like nasopharyngitis, seen in 6% to 8% of people. Allergic reactions, including anaphylaxis, can occur. Raised blood pressure, Raynaud's phenomenon and constipation have also been reported. Tell the infusion team at once if you feel unwell during the infusion.
Do not have Vyepti (eptinezumab) if you have had a serious allergic reaction to it or any of its ingredients. It is not broken down by liver P450 enzymes, and sumatriptan showed no meaningful interaction. Tell your healthcare provider about every medicine you take, especially any for blood pressure.
Your healthcare provider dilutes Vyepti (eptinezumab) in a 100 mL bag of 0.9% sodium chloride and gives it into a vein over about 30 minutes through an in-line filter. You are watched for allergic reactions during and after the infusion, and blood pressure may be checked.
Yes, new or worsening high blood pressure has been reported after Vyepti (eptinezumab), usually within 7 days of a dose. The label also warns of Raynaud's phenomenon and constipation that can be serious. Report severe headache, chest pain, cold pale fingers or constipation that does not settle.
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