Vyepti

— THERAPEUTIC CATEGORIES —
  • Migraine and headache
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vyepti Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Eptinezumab-jjmr 100mg/mL; per vial; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Calcitonin gene-related peptide (CGRP) receptor antagonist.

    How Supplied

    Single-dose vial—1

    Storage

    Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use; do not freeze or shake.

    Storage and Handling of Diluted Product

    • Diluted product must be infused within 8 hours.
    • Diluted product should be stored at room temperature, 20°C to 25°C (68°F to 77°F).

     

    Manufacturer

    Lundbeck Inc.

    Generic Availability

    NO

    Vyepti Indications

    Indications

    Prophylaxis of migraine.

    Vyepti Dosage and Administration

    Adult

    Give by IV infusion over 30mins. 100mg every 3 months; some patients may benefit from 300mg every 3 months.

    Children

    Not established.

    Vyepti Contraindications

    Not Applicable

    Vyepti Boxed Warnings

    Not Applicable

    Vyepti Warnings/Precautions

    Warnings/Precautions

    Consider discontinuing if a hypersensitivity reaction occurs and treat appropriately. Elderly. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    No adequate data on developmental risks associated with the use of eptinezumab-jjmrin pregnant women.

    Nursing Mother Considerations

    No data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. Consider benefits to the mother vs potential risks to the infant.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    Studies did not include a sufficient number of patients 65 years of age and older.

    Vyepti Pharmacokinetics

    Absorption

    Exposure increases proportionally with doses from 100mg to 300mg after IV administration. Steady-state plasma concentration is attained after the first dose with a once every 3-month dosing schedule.

    Metabolism

    Degraded by proteolytic enzymes into small peptides and amino acids.

    Elimination

    Terminal elimination half-life approximately 27 days.

    Vyepti Interactions

    Not Applicable

    Vyepti Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, hypersensitivity reactions.

    Vyepti Clinical Trials

    Clinical Trials

    Approval was based on data from two phase 3, placebo-controlled trials, PROMISE 1 (N=665; mean migraine frequency at baseline: 8.6 migraines/month) and PROMISE 2 (N=1072; mean migraine frequency at baseline: 16.1 migraines/month), which evaluated the efficacy and safety of Vyepti as a preventive treatment of episodic and chronic migraine, respectively. 

    Both studies randomly assigned  patients 1:1:1 to receive Vyepti 100mg, 300mg, or placebo; patients were allowed to use concurrent acute migraine or headache medications. The primary endpoint was the change from baseline in mean monthly migraine days (MMD) over months 1-3. Secondary end points included the percentage of patients with at least 50% and 75% reductions from baseline in MMD over months 1-3.

    In PROMISE 1 (ClinicalTrials.gov Identifier: NCT02559895), Vyepti was associated with a significantly greater mean change from baseline in MMD compared with placebo over months 1-3: -3.9 days for 100mg (P=.018), -4.3 days for 300mg (P <.001), and -3.2 days for placebo. Moreover, 49.8% (P =.009) and 56.3% (P <.001) of patients treated with Vypeti 100mg and 300mg, respectively, demonstrated at least 50% reduction in MMD compared with 37.4% of placebo patients. The percentage of responders with at least 75% reduction in MMD were: 22.2% for 100mg (P = not statistically significant), 29.7% for 300mg (P <.001), and 16.2% for placebo.

    In PROMISE 2 (ClinicalTrials.gov Identifier: NCT02974153), Vyepti demonstrated a statistically greater mean change from baseline in MMD compared with placebo over months 1-3: -7.7 days for 100mg (P <.001), -8.2 days for 300mg (P <.001) vs -5.6 days for placebo. The percentage of responders with at least 50% reduction and 75% reduction in MMD were: 57.6% (P <.001) and 26.7% (P <.001) for 100mg, 61.4% (P <.001) and 33.1% (P <.001) for 300mg, compared with 39.3% and 15% for placebo.

    In both studies, treatment benefit over placebo was observed for both doses as early as day 1 post infusion; a greater percentage of placebo-treated patients had migraines on individual days during the first 7 days of treatment compared with Vyepti-treated patients.

    Vyepti Note

    Not Applicable

    Vyepti Patient Counseling

    Patient Counseling

    Hypersensitivity reactions: patients should be aware that these reactions can occur with Vyepti and should be reported immediately.

    Pregnant or considering breastfeeding: contact health care provider.

    Cost Savings Program

    Vyepti Connect

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