Eptinezumab-jjmr
Generic Name: eptinezumab-jjmr
Brand Names:
Vyepti
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.
Overview
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.
Uses
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
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).
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur ( 5.2 ) Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur ( 5.3 ) 5.1 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. 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
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.
Storage
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.
Frequently Asked Questions
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 )
What are the side effects of Eptinezumab-jjmr?▼
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.
Can I take Eptinezumab-jjmr during pregnancy?▼
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.
What are the important warnings for Eptinezumab-jjmr?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur ( 5.2 ) Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur ( 5.3 ) 5.1 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. 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)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.