Vyepti Generic Name & Formulations
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).
Vyepti Dosage and Administration
Vyepti Boxed Warnings
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.
Safety and effectiveness in pediatric patients have not been established.
Studies did not include a sufficient number of patients 65 years of age and older.
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.
Terminal elimination half-life approximately 27 days.
Vyepti Adverse Reactions
Vyepti 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 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.