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VYEPTI is a brand name for Eptinezumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VYEPTI (eptinezumab for injection) is indicated for: • the prevention of migraine in adults who have at least 4 migraine days per month. Vyepti should be prescribed by healthcare professionals experienced in the diagnosis and treatment of migraine. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Vyepti should be administered as an intravenous infusion only. 2 Recommended Dose and Dosage Adjustment • The recommended dose is 100 mg administered by intravenous infusion every 12 weeks. 2 CLINICAL TRIALS, Study results).
• The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. • When switching dosage options, the first dose of the new regimen should be given on the next scheduled dosing date of the prior regimen.
• The treatment benefit should be assessed 3-6 months after initiation of the treatment. • Any further decision to continue the treatment should be made on an individual patient basis and determined prior to each dose (see 14 CLINICAL TRIALS).
1 INDICATIONS, Pediatrics). 3 Reconstitution Parenteral Products: Each vial of Vyepti is intended for single use only.
Preparation instructions:
Use appropriate aseptic technique when preparing Vyepti solution for intravenous infusion. The product contains no preservative and is intended for single use only. Vyepti is a sterile, clear to slightly opalescent, colourless to brownish-yellow solution.
Prior to dilution, the solution in the vial(s) should be inspected visually; do not use if the solution contains visible particulate matter or is cloudy or discoloured (other than clear to slightly opalescent, colourless to brownish-yellow).
9% sodium chloride for injection should be used to prepare the Vyepti infusion solution as described below. No other intravenous diluents or volumes may be used to prepare the Vyepti infusion solution. Gently invert the solution to mix completely.
Do not shake. Following dilution, the infusion solution must be infused within 8 hours. During this time, the infusion solution may be stored at room temperature or refrigerated at 2°C to 8°C. If stored at 2°C to 8°C, allow the solution to warm to room temperature prior to infusion.
DO NOT FREEZE (see 11 STORAGE, STABILITY AND DISPOSAL). 0 mL of Vyepti from one single-use 100 mg vial using a sterile needle and syringe. 9% sodium chloride for injection. 0 mL of Vyepti from one single-use 300 mg vial using a sterile needle and syringe.
1 Adverse Reaction Overview The safety of Vyepti has been evaluated in more than 2,000 patients with migraine who received at least one dose of Vyepti, representing more than 1,600 patient-years of exposure; of these, approximately 1,500 patients were exposed to 100 mg or 300 mg.
Across all doses, 1872 patients were exposed for at least 24 weeks and 991 patients were exposed for 48 weeks. 4 years at study entry. Patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, cerebrovascular disease, morbid obesity and diabetes, alcohol/drug abuse, and severe mental disorders were excluded from clinical studies.
The most common adverse reactions in the placebo-controlled clinical studies (PROMISE 1 and PROMISE 2) for the preventive treatment of migraine were nasopharyngitis and hypersensitivity (see Table 2). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In the placebo-controlled pivotal clinical studies (PROMISE 1 and PROMISE 2) of 1,372 patients, 579 patients received at least one dose of Vyepti 100 mg, 574 patients received at least one dose of Vyepti 300 mg, and 588 patients received placebo during 24 weeks or 48 weeks of double-blind treatment.
In the pivotal studies, the following adverse events in Table 3 were observed to occur at or above 1% and greater than placebo during the double-blind treatment phase. 5) VYEPTI (Eptinezumab) – Product Monograph Page 11 of 25 Nasopharyngitis Nasopharyngitis was most frequent after the first dose of Vyepti at any dose.
, Special Populations, Geriatrics). 2 CONTRAINDICATIONS • In patients who are hypersensitive to eptinezumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 7.
WARNINGS and PRECAUTIONS, Patients with hereditary fructose intolerance). 1 Dosing Considerations • Vyepti should be administered as an intravenous infusion only. 2 Recommended Dose and Dosage Adjustment • The recommended dose is 100 mg administered by intravenous infusion every 12 weeks.
2 CLINICAL TRIALS, Study results). • The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. • When switching dosage options, the first dose of the new regimen should be given on the next scheduled dosing date of the prior regimen.
• The treatment benefit should be assessed 3-6 months after initiation of the treatment. • Any further decision to continue the treatment should be made on an individual patient basis and determined prior to each dose (see 14 CLINICAL TRIALS).
1 INDICATIONS, Pediatrics). 3 Reconstitution Parenteral Products: Each vial of Vyepti is intended for single use only.
Preparation instructions:
Use appropriate aseptic technique when preparing Vyepti solution for intravenous infusion. The product contains no preservative and is intended for single use only. Vyepti is a sterile, clear to slightly opalescent, colourless to brownish-yellow solution.
Prior to dilution, the solution in the vial(s) should be inspected visually; do not use if the solution contains visible particulate matter or is cloudy or discoloured (other than clear to slightly opalescent, colourless to brownish-yellow).
9% sodium chloride for injection should be used to prepare the Vyepti infusion solution as described below. No other intravenous diluents or volumes may be used to prepare the Vyepti infusion solution. Gently invert the solution to mix completely.
• In patients who are hypersensitive to eptinezumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 7.
WARNINGS and PRECAUTIONS, Patients with hereditary fructose intolerance).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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9% sodium chloride for injection. 4 Administration Vyepti is for intravenous infusion only. 3 DOSAGE AND ADMINISTRATION, Reconstitution). Vyepti must be administered by a healthcare professional.
Infusion administration instructions:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored (see
The incidence decreased with subsequent doses and was stable thereafter. Infusion site reactions 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 in pivotal trials. Other infusion site reactions include infusion site rash and infusion site pain.
Hypersensitivity and infusion-related reactions 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 experienced hypersensitivity reactions. The reactions were reported with multiple related adverse event terms, such as hypersensitivity, angioedema, urticaria, flushing/hot flush, rash and pruritus.
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported in other trials and may develop within minutes of the infusion. The reported anaphylactic reactions have included symptoms of hypotension and respiratory difficulties, and have led to discontinuation of Vyepti (See 7 WARNINGS AND PRECAUTIONS, Serious Hypersensitivity).
Other symptoms reported in association with eptinezumab infusion include respiratory symptoms (nasal congestion, rhinorrhea, throat irritation, cough, sneezing, dyspnea) and fatigue. 3 Less Common Clinical Trial Adverse Reactions From all placebo-controlled clinical trials with Vyepti in adult patients with migraine, the following less common adverse events of <1% have been observed.
Causality related to treatment with Vyepti has not been […]
Do not shake. Following dilution, the infusion solution must be infused within 8 hours. During this time, the infusion solution may be stored at room temperature or refrigerated at 2°C to 8°C. If stored at 2°C to 8°C, allow the solution to warm to room temperature prior to infusion.
DO NOT FREEZE (see 11 STORAGE, STABILITY AND DISPOSAL). 0 mL of Vyepti from one single-use 100 mg vial using a sterile needle and syringe. 9% sodium chloride for injection. 0 mL of Vyepti from one single-use 300 mg vial using a sterile needle and syringe.
9% sodium chloride for injection. 4 Administration Vyepti is for intravenous infusion only. 3 DOSAGE AND ADMINISTRATION, Reconstitution). Vyepti must be administered by a healthcare professional.
Infusion administration instructions:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
No other medications should be administered through the infusion set or mixed with Vyepti. Do not administer Vyepti as an intravenous bolus injection. 22 μm in-line or add-on filter. 3 DOSAGE AND VYEPTI (Eptinezumab) – Product Monograph Page 6 of 25 ADMINISTRATION, Reconstitution).
3 DOSAGE AND ADMINISTRATION, Reconstitution), infuse Vyepti 100 mg dose or Vyepti 300 mg dose as prescribed over approximately 30 minutes. 5 Missed Dose In case of a missed dose, resume the regular dosing schedule as soon as possible.
5 OVERDOSAGE There has been no experience of overdose with eptinezumab. Doses up to 1000 mg have been administered intravenously to humans without tolerability issues or clinically significant adverse reactions. In the event of an overdose, it is recommended that the patient should be monitored for any signs or symptoms of adverse reactions and appropriate supportive treatment be available for institution immediately if needed.
For management of a suspected drug overdose, contact your regional poison control centre. 9% sodium chloride for injection prior to infusion. Each single-use glass vial contains either: - 100 mg of eptinezumab in 1 mL solution - 300 mg of eptinezumab in 3 mL solution Each carton contains one vial.
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Route of Administration Dosage Form / Strength/Composition […]