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Galcanezumab

Generic Medicine Info
Indications and Dosage
Subcutaneous
Prophylaxis of migraine
Adult: In patients who have at least 4 migraine days per month: 240 mg (given as 2 SC inj of 120 mg) as a single loading dose, followed by a maintenance dose of 120 mg once monthly starting 1 month after the loading dose. Reassess treatment response 3 months after therapy initiation.

Subcutaneous
Episodic cluster headache
Adult: 300 mg (given as 3 SC inj of 100 mg) at the onset of cluster period, then once monthly until the end of cluster period. Treatment recommendations may vary among individual products or between countries (refer to specific product guidelines).
What are the brands available for Galcanezumab in Malaysia?
Special Precautions
Patient with hypertension or its risk factors, CV disease, history of Raynaud's phenomenon. Pregnancy and lactation.
Adverse Reactions
Significant: Serious hypersensitivity reactions (e.g. anaphylaxis, angioedema, dyspnoea, urticaria); new-onset or exacerbation of pre-existing hypertension; new-onset, recurrence or exacerbation of Raynaud's phenomenon; development of anti-galcanezumab antibodies.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Constipation.
General disorders and administration site conditions: Inj site reactions (e.g. pain, erythema, pruritus, bruising, swelling).
Skin and subcutaneous tissue disorders: Pruritus, rash.
Patient Counseling Information
This drug may cause vertigo, if affected, do not drive or operate machinery.
Monitoring Parameters
Evaluate the need for continued treatment regularly after therapy initiation. Monitor for signs and symptoms of hypersensitivity reactions, new-onset or worsening hypertension, and worsening or recurrence of pre-existing Raynaud's phenomenon.
Action
Description:
Overview: Galcanezumab, a recombinant humanised IgG4 monoclonal antibody, is a calcitonin gene-related peptide (CGRP) antagonist used as an antimigraine agent.
Mechanism of Action: Galcanezumab binds to the CGRP ligand and inhibits its binding with the CGRP receptor. CGRP, a potent vasodilator and pain-signalling neuropeptide, has been associated with migraine attacks.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 5 days.
Distribution: 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. If necessary, may be kept at room temperature (up to 30°C) for up to 7 days; do not store back in the refrigerator once taken out of refrigeration.
MIMS Class
Antimigraine Preparations
ATC Classification
N02CD02 - galcanezumab ; Belongs to the class of calcitonin gene-related peptide (CGRP) antagonists preparations. Used to relieve migraine.
References
Brayfield A, Cadart C (eds). Galcanezumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2025.

Eli Lilly and Company (NZ) Limited. Emgality 120 mg/mL Prefilled Pen or Prefilled Syringe data sheet 03 September 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 09/09/2025.

Emgality 120 mg Solution for Injection in Pre-filled Pen or Pre-filled Syringe (Eli Lilly Nederland B.V.). European Medicines Agency [online]. Accessed 09/09/2025.

Emgality Injection, Solution (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2025.

Galcanezumab-gnlm. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2025.

Galcanezumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2025.

Joint Formulary Committee. Galcanezumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2025.

Pontevia 120 mg Solution for Injection in Pre-filled Pen or Pre-filled Syringe (Zuellig Pharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/09/2025.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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