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Emgality (galcanezumab-gnlm)
galcanezumab
Adult Dosing .
Dosage forms: INJ (pen): 120 mg per injection; INJ (pre-filled syringe): 100 mg per mL, 120 mg per mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = galcanezumab-gnlm
migraine prophylaxis
- [120 mg SC qmo]
- Start: 240 mg SC x1
cluster headache, episodic
- [300 mg SC qmo]
- Start: 300 mg SC x1 at onset of cluster period; Info: cont. tx until end of cluster period
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
Drug Interactions .
Overview
galcanezumab
CGRP antagonist
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
Common Reactions
- injection site rxn
- hypersensitivity rxn
- rash
- urticaria
- dyspnea
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at 18-64x recommended human dose
Pregnancy Registry
enroll pts or encourage pts to enroll in Migraine Pregnancy Registry at 1-833-464-4724 or www.migrainepregnancyregistry.com
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: none
Excretion: unknown; Half-life: 27 days
Subclass: CGRP Inhibitors ; Headache/Migraine
Mechanism of Action
blocks calcitonin gene-related peptide (CGRP) activity (monoclonal antibody)
Formulary .
No Formulary Selected
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