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VYEPTI is a brand name for Eptinezumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Verbatim from this product's MHRA label. Tap a section to expand.
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.
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.
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. 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.
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 Hypersensitivity reactions CommonImmune system disorders Anaphylactic reaction1 Uncommon Infusion-related reaction CommonGeneral disorders and administration site conditions 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.
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. g. 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. 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.
1.
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The incidence decreased notably with subsequent doses and remained fairly steady thereafter. 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. 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). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.