Galcanezumab-gnlm

Class: Calcitonin Gene-related Peptide (CGRP) Antagonists
- Anti-CGRP Monoclonal Antibodies
- Calcitonin Gene-related Peptide Antagonists
- CGRP Antagonists
Chemical Name: Immunoglobulin G4, anti-(human calcitonin gene-related peptide) (human-Mus musculus clone III heavy chain), disulfide with human-Mus musculus clone III kappa-chain, dimer
Molecular Formula: C₆₃₉₂H₉₈₅₄N₁₆₈₆O₂₀₁₈S₄₆
CAS Number: 1578199-75-3
Brands: Emgality

Medically reviewed by Drugs.com on Oct 25, 2021. Written by ASHP.

Introduction

Antimigraine agent; recombinant humanized IgG₄ monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP) function.

Uses for Galcanezumab-gnlm

Preventive Treatment of Migraine

Preventive treatment of migraine.

Substantially reduces monthly migraine days in patients with episodic or chronic migraine and reduces acute antimigraine agent-use days in patients with episodic migraine compared with placebo.

The American Headache Society (AHS) states that galcanezumab and other CGRP antagonists offer a number of advantages over some oral migraine preventive therapies, including no need for dosage escalation, rapid onset of therapeutic activity, demonstrated efficacy in patients after prior preventive treatments have failed as well as in those concurrently receiving oral preventive treatments, minimal risk of adverse drug interactions, and favorable overall tolerability profiles. However, because of the relatively high cost of CGRP antagonists, AHS recommends that CGRP antagonists be considered for use only in patients who are unable to tolerate oral preventive therapies and/or who have had an inadequate response to a 6-week trial of ≥2 oral preventive therapies (e.g., topiramate, valproate, β-adrenergic blocking agents, tricyclic antidepressants, SNRIs).

Treatment of Episodic Cluster Headache

Treatment of episodic cluster headache.

In the principal efficacy study, substantially reduced weekly cluster headache attack frequency in patients with episodic cluster headache compared with placebo.

Galcanezumab-gnlm Dosage and Administration

Administration

Administer by sub-Q injection only.

Commercially available in single-dose prefilled auto-injectors (i.e., injection pens), which contain 120 mg of the drug, and single-dose prefilled syringes, which contain either 100 or 120 mg of the drug, and are intended for patient self-administration.

Sub-Q Administration

Administer by sub-Q injection into the abdomen, anterior thigh, back of upper arm, or buttocks; avoid injections within 2 inches of the navel, knee, or groin. May use back of the upper arm or buttocks if someone other than the patient is administering the injection (e.g., caregiver, healthcare professional).

May administer multiple injections of the drug (i.e., the initial loading dose for migraine consisting of 2 injections and the dose for treatment of episodic cluster headache consisting of 3 injections) at separate locations at the same body site. Avoid injecti