VYEPTI

Eptinezumab-jjmr exhibits linear pharmacokinetics and exposure increases proportionally with doses from 100 mg to 300 mg after intravenous administration. Steady-state plasma concentration is attained after the first dose with a once every 3-month dosing schedule.

DistributionThe central volume of distribution (Vc) for eptinezumab-jjmr is approximately 3.7 liters. Metabolism &

EliminationEptinezumab-jjmr is expected to be degraded by proteolytic enzymes into small peptides and amino acids. The...

The efficacy of VYEPTI was evaluated in three randomized, multicenter, placebo-controlled double-blind studies that enrolled patients with episodic and chronic migraine who were eligible for preventive treatment of migraine. In Study 1, which included patients with episodic migraine, and Study 2, which included patients with chronic migraine, either 100 mg or 300 mg VYEPTI was administered by intravenous infusion every 3 months. In Study 3, 100 mg VYEPTI was administered as a single intravenous infusion to patients with episodic or chronic migraine who were eligible for preventive migraine tre...

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....

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)

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 i...