Overview
11 DESCRIPTION Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. 12.2 Pharmacodynamics There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm. 12.3 Pharmacokinetics Galcanezumab-gnlm exhibits linear pharmacokinetics and exposure increases proportionally with doses between 1 and 600 mg. A loading dose of 240 mg achieved the serum galcanezumab-gnlm steady-state concentration after the first dose. A dose of 300 mg monthly would achieve steady-state concentration after the fourth dose. The time to maximum concentration is 5 days, and the elimination half-life is 27 days.
Indications
- 1 INDICATIONS AND USAGE EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.
Common Doses
- 240 mg
- 120 mg
- 300 mg
- 100 mg
Dosage
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. ( 2.1 , 2.2 , 2.3 ) Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. ( 2.1 ) Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. ( 2.2 ) Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. ( 2.3 ) 2.
Contraindications
- 4 CONTRAINDICATIONS EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients [see Warnings and Precautions ( 5.1 )] . EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4 ) and 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 (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. ( 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.