Galcanezumab

Indications

Galcanezumab is used for: Migraine Prophylaxis, Cluster Headache

Adult Dose

Migraine Prophylaxis Indicated for preventive treatment of migraine Loading dose: 240 mg SC once (ie, 2 consecutive 120-mg SC injections) Maintenance dose: 120 mg SC monthly Cluster Headache Indicated for treatment of episodic cluster headache Loading dose: 300 mg SC once (ie, 3 consecutive 100-mg SC injections) Maintenance dose: 300 mg SC monthly until cluster period ends Hepatic impairment Not expected to affect pharmacokinetics of galcanezumab; dedicated hepatic impairment studies not performed Based on a population pharmacokinetic analysis, bilirubin concentration did not significantly influence the apparent systemic clearance (CL/F)

Child Dose

Renal Dose

Renal impairment Not expected to affect pharmacokinetics of galcanezumab; dedicated renal impairment studies not performed Mild or moderate (CrCl >30 mL/min): Clinical studies revealed that creatinine clearance did not affect the pharmacokinetics Severe (CrCl <30 mL/min): Not studied

Administration

SC Preparation Intended for patient self-administration Provide proper training to patients and/or caregivers on how to prepare and administer, including aseptic technique Protect syringe from direct sunlight Remove from refrigerator and allow to sit at room temperature for 30 minutes; do not warm by using a heat source (eg, hot water, microwave) Do not shake Visually inspect for particulate matter and discoloration Do not use if solution appears cloudy or there are visible particles SC Administration For SC injection only Administer in the abdomen, thigh, back of the upper arm, or buttocks Do not inject into areas where the skin is tender, bruised, red, or hard Both prefilled pen and syringe are single-dose and deliver the entire contents

Contra Indications

History of serious hypersensitivity reactions to drug or excipients

Precautions

Hypersensitivity reactions (eg, rash, urticaria, dyspnea) reported; may occur days after administration and may be prolonged; discontinue administration and initiate appropriate therapy if serious reaction occurs

Pregnancy-Lactation

Pregnancy There are no available data regarding use in pregnant women Animal studies Administration to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development Clinical considerations Published data suggests that women with migraine may be at increased risk of preeclampsia during pregnancy Lactation Unknown if distributed in human milk The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Galcanezumab : >10% Injection site reactions (18%) Frequency Not Defined Hypersensitivity

Mechanism of Action

Human monoclonal antibody; inhibits calcitonin gene-related peptide (CGRP) receptor, which is thought to be causally involved in migraine pathophysiology