*Hypersensitivity reactions included multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing.
Overall safety was evaluated in 2076 patients with migraine who received at least 1 dose of VYEPTI, representing 1615 patient-years of exposure.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to eptinezumab-jjmr in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In patients receiving VYEPTI 100 mg or 300 mg every 3 months, the incidence of anti-eptinezumab-jjmr antibody development in PROMISE-1 (up to 56 weeks) was 20.6% (92/447), and 41.3% (38/92) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies. In PROMISE-2 (up to 32 weeks), the incidence of anti-eptinezumab-jjmr antibody development was 18.3% (129/706), and 34.9% (45/129) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies. In an open-label study with 84 weeks of treatment, 18% (23/128) of patients developed anti-eptinezumab-jjmr antibodies, and 39% (9/23) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies.
Although the results from both studies showed no clear evidence of an impact from development of anti-eptinezumab-jjmr antibodies, including neutralizing antibodies, on the safety and efficacy profiles of VYEPTI, the available data are too limited to make definitive conclusions.
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
VYEPTI is indicated for the preventive treatment of migraine in adults.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
For more information, please see the Full Prescribing Information and Patient Information.
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
VYEPTI is indicated for the preventive treatment of migraine in adults.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
For more information, please see the Full Prescribing Information and Patient Information.