U.S. FDA APPROVED  DRUGS DURING 2020

Sr.No-  6

ADVERSE REACTIONS

The most common adverse reactions (=2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity

CONTRAINDICATIONS

­ VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients (4)

WARNINGS AND PRECAUTIONS

­ Hypersensitivity Reactions: Reactions have included angioedema, urticaria, facial flushing, and rash. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy 

 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions-                                                                                       Inform patients that hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, can occur. 

Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur.

Pregnancy-                                                                                                              Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant 

Lactation-                                                                                                               Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed 

Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc. 11804 North Creek Parkway South Bothell, WA 98011 USA U.S. License No.

XXXX Vyepti is a trademark of Lundbeck Seattle BioPharmaceuticals, Inc.

 CLINICAL PHARMACOLOGY

1. Mechanism of Action-                                                                                     Eptinezumab-jjmr is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

2. Pharmacodynamics-                                                                                             The relationship between the pharmacodynamic activity and the mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown.

3. Pharmacokinetics-                                                                                   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.

Distribution-                                                                                                               The central volume of distribution (Vc) for eptinezumab-jjmr is approximately 3.7 liters.

Metabolism & Elimination-                                                                                   Eptinezumab-jjmr is expected to be degraded by proteolytic enzymes into small peptides and amino acids.

The apparent clearance of eptinezumab-jjmr was 0.006 L/h, and the terminal elimination half-life was approximately 27 days. 

Specific Populations-                                                                                                    A population pharmacokinetic analysis assessing the effects of age, race, sex, and body weight did not suggest any clinically significant impact of these covariates on eptinezumab exposures.

Patients with Renal or Hepatic Impairment-                                                              No dedicated studies were conducted to assess the effects of renal or hepatic impairment on the pharmacokinetics of eptinezumab-jjmr. However, hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumabjjmr.

A population pharmacokinetic analysis of integrated data from eptinezumab-jjmr clinical studies did not reveal clinically significant impact on pharmacokinetics of patients with hepatic or renal impairment.

Drug Interaction Studies-                                                                                          P450 Enzymes Eptinezumab-jjmr is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Sumatriptan-                                                                                                              The co-administration of a single dose of 300 mg eptinezumab-jjmr administered as an intravenous infusion (over a period of 1 hour ± 15 min) with a single dose of 6 mg sumatriptan administered subcutaneously did not significantly influence the pharmacokinetics of eptinezumab-jjmr or sumatriptan.

USE IN SPECIFIC POPULATIONS-

1. Pregnancy 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 

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.

2. Lactation Risk Summary-                                                                                      There are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYEPTI and any potential adverse effects on the breastfed infant from VYEPTI or from the underlying maternal condition.

3.Pediatric Use-                                                                                                      Safety and effectiveness in pediatric patients have not been established.

4.Geriatric Use-                                                                                                     Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.