Galcanezumab
EMGALITY
What it isCGRP ligand antibody; migraine and cluster headache prevention.
Why this oneThe only CGRP agent approved for episodic cluster headache.
What limits itInjection-site reactions; cost and access. Response takes weeks, so it cannot be judged after one dose.
FDA-approved for
- migraine prophylaxis (2018)
- episodic cluster headache (2019)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Migraine prevention | Adults | 240 mg loading, then 120 mg monthly | 120 mg monthly | |
| Episodic cluster headache | Adults | 300 mg monthly (at cluster onset until period ends) | 300 mg monthly |
Renal Undefined
Hepatic Undefined
Instructions
- Subcutaneous only — abdomen, thigh, back of upper arm, or buttocks
- Migraine loading dose given as two consecutive 120 mg injections; cluster dose as three consecutive 100 mg injections
Cautions
- Hypersensitivity reactions (anaphylaxis, angioedema) — can occur days later and be prolonged
- Constipation with serious complications
- Hypertension (new-onset or worsening)
- Raynaud's phenomenon
Adverse reactions
- Injection site reactions
Pregnancy No adequate human data; no adverse developmental effects in animals
Lactation No human data
NO BOXED WARNINGS
Principal riskInjection-site reactions
Cost, est. cash$500–$1,200/month
Generic entry2034 est. (biosimilar)
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityInjection reactions and hypersensitivity; acute overdose toxicity is low.
Mechanism of action: Galcanezumab ballicule
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