Eptinezumab-Jjmr
FDA Drug Information • Also known as: Vyepti
- Brand Names
- Vyepti
- Drug Class
- Calcitonin Gene-related Peptide Antagonist [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in Pichia pastoris yeast cells by recombinant DNA technology. VYEPTI (eptinezumab-jjmr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to brownish-yellow solution, for intravenous infusion. VYEPTI is supplied as a 100 mg/mL single-dose vial. Each mL contains 100 mg eptinezumab-jjmr formulated in L-histidine (1 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 80 (0.15 mg), sorbitol (40.5 mg), and Water for Injection, USP, at a pH of 5.8.
What Is Eptinezumab-Jjmr Used For?
1 INDICATIONS AND USAGE VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Must dilute before use. For intravenous infusion only ( 2.1 , 2.2 ) Recommended dosage is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg every 3 months ( 2.1 , 2.3 ) Dilute only in 100 mL of 0.9% Sodium Chloride Injection ( 2.2 ) 2.1 Recommended Dosing The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months. 2.2 Dilution Instructions VYEPTI requires dilution prior to administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing VYEPTI solution for intravenous infusion. VYEPTI single-dose vials contain no preservative; discard unused portion remaining in the vial. Dilution 100 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. 300 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from each of 3 single-dose vials using a sterile needle and syringe. Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. Storage and Handling of Diluted Product Gently invert the VYEPTI solution to mix completely. Do not shake. Following dilution, VYEPTI solution must be infused within 8 hours. During this time, VYEPTI solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze. 2.3 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 Dosage Forms and Strengths (3) ] . No other medications should be administered through the infusion set or mixed with VYEPTI. VYEPTI is for intravenous infusion only; infuse over approximately 30 minutes. Do not administer VYEPTI as an intravenous push or bolus injection. Use an intravenous infusion set with a 0.2 micron or 0.22 micron in-line or add-on sterile filter. After the infusion is complete, flush the line with 20 mL of 0.9% Sodium Chloride Injection, USP.
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] . Hypertension [see Warnings and Precautions (5.2) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 (14) ] . 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 (5.1) ] . In study 3, the safety profile observed in 480 patients who were randomized and treated (238 to VYEPTI 100 mg and 242 to placebo) was consistent with the safety profile observed in the two pivotal placebo-controlled studies with VYEPTI (Study 1 and 2). 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VYEPTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.1) ] General Disorders and Administration Site Conditions: Fatigue Vascular Disorders: Hypertension [see Warnings and Precautions (5.2) ] , Raynaud’s phenomenon [see Warnings and Precautions (5.3) ]
Contraindications
4 CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ] . VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients ( 4)
Pregnancy and Breastfeeding
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-855-810-8549 or by contacting the company at www.vyeptipregnancyregistry.lundbeck.com. Risk Summary There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (MRHD) of 300 mg, on a body weight basis (mg/kg). When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. The higher dose tested (150 mg/kg) is 30 times the MRHD, on a mg/kg basis.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VYEPTI (eptinezumab-jjmr) injection is a clear to slightly opalescent, colorless to brownish-yellow solution supplied as: Carton containing one 100 mg/mL single-dose vial - NDC 67386-130-51. 16.2 Storage and Handling 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. The vial stopper is not made with natural rubber latex.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.