Vyepti
- Generic Name: eptinezumab-jjmr injection for intravenous use
- Brand Name: Vyepti
- Drug Class: CGRP Monoclonal Antibodies
Vyepti (Eptinezumab-jjmr Injection for Intravenous Use) side effects drug center
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Vyepti Side Effects Center
What Is Vyepti?
Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
What Are Side Effects of Vyepti?
Side effects of Vyepti include:
- runny or stuffy nose and
- hypersensitivity reactions (itching, flushing)
Dosage for Vyepti
The recommended dosage of Vyepti is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg.
Vyepti In Children
Safety and effectiveness of Vyepti in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Vyepti?
Vyepti may interact with other medicines.
Tell your doctor all medications and supplements you use.
Vyepti During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Vyepti; it is unknown how it could affect a fetus. It is unknown if Vyepti passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Vyepti (eptinezumab-jjmr) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Vyepti Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, rash; sudden warmth or tingling; difficult breathing; redness or swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver if you feel warm, itchy, or light-headed.
Common side effects may include:
- stuffy nose;
- throat irritation; or
- allergic reaction.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Vyepti (Eptinezumab-jjmr Injection for Intravenous Use)
Vyepti Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524 patients were exposed to 100 mg or 300 mg. Across all doses, 1872 patients were exposed for at least 6 months and 991 patients were exposed for 12 months. In the placebo-controlled clinical studies (Study 1 and Study 2) of 1372 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 [see Clinical Studies]. Approximately 86% were female, 89% were white, and the mean age was 40.4 years at study entry.
The most common (incidence at least 2% and at least 2% greater than placebo) adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
Table 1 summarizes the adverse reactions that occurred during Study 1 and Study 2.
Table 1: Adverse Reactions Occurring with an Incidence of at Least 2% for VYEPTI and at Least 2% Greater than Placebo in Studies 1 and 2
| Adverse Reactions | VYEPTI 100 mg N=579 % | VYEPTI 300 mg N=574 % | Placebo N=588 % |
| Nasopharyngitis | 6 | 8 | 6 |
| Hypersensitivity reactions* | 1 | 2 | 0 |
| * Hypersensitivity reactions includes multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing. | |||
In Study 1 and Study 2, 1.9% of patients treated with VYEPTI discontinued treatment because of adverse reactions [see WARNINGS AND PRECAUTIONS].
Immunogenicity
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 Study 1 (up to 56 weeks) was 20.6% (92/447), and 41.3% (38/92) of those patients developed antieptinezumab-jjmr neutralizing antibodies. In Study 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.
Read the entire FDA prescribing information for Vyepti (Eptinezumab-jjmr Injection for Intravenous Use)
&Copy; Vyepti Patient Information is supplied by Cerner Multum, Inc. and Vyepti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.