Galcanezumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Prophylaxis of migraine Loading dose: 240 mg given as 2 inj of 120 mg. Maintenance: 120 mg once monthly starting 1 month after loading dose. Episodic cluster headache 300 mg given as 3 inj of 100 mg at the onset of cluster period, then once monthly until the end of cluster period.
Dosage Details
Subcutaneous
Migraine
Adult: Prophylaxis: In patients who have at least 4 migraine days/month: Loading dose: 240 mg given as 2 inj of 120 mg. Maintenance: 120 mg once monthly starting 1 month after loading dose.

Subcutaneous
Episodic cluster headache
Adult: 300 mg given as 3 inj of 100 mg at the onset of cluster period, then once monthly until the end of cluster period.
Special Precautions
Patient with CV diseases (e.g. ECG abnormalities, MI, unstable angina, percutaneous coronary intervention, undergone CABG, pulmonary embolism, deep vein thrombosis) or peripheral vascular disease (e.g. recent history [within 6 months] of stroke, intracranial or carotid aneurysm, intracranial haemorrhage, vasospastic angina or Raynaud disease). Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis, angioedema, dyspnoea, rash, urticaria), immunogenicity.
Gastrointestinal disorders: Constipation.
Injury, poisoning and procedural complications: Injection site reactions (e.g. pain, erythema, pruritus).
Patient Counseling Information
This drug may cause vertigo, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor treatment benefit within 3 months after initiation then regularly, thereafter.
Action
Description: Galcanezumab is a human monoclonal antibody which binds to and inhibits the activity of calcitonin gene-related peptide (CGRP), a peptide involved in the pathophysiology of migraine.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 5 days.
Distribution: Crosses placenta. Volume of distribution: 7.3 L.
Metabolism: Degraded into small peptides and amino acids via catabolic pathways.
Excretion: Elimination half-life: 27 days.
Storage
Store between 2-8°C. Do not freeze or shake. Protect from light.
ATC Classification
N02CD02 - galcanezumab ; Belongs to the class of calcitonin gene-related peptide (CGRP) antagonists preparations. Used to relieve migraine.
References
Anon. Galcanezumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/11/2019.

Buckingham R (ed). Galcanezumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/11/2019.

Emgality 120 mg/mL, 100 mg/mL Solution in Pre-filled Syringe (Eli Lily and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 13/11/2019.

Joint Formulary Committee. Galcanezumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/11/2019.

Disclaimer: This information is independently developed by MIMS based on Galcanezumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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