GALCANEZUMAB-GNLM INJ,SOLN
Clinical Criteria Summary
Indication & Patient Definition
- Episodic Cluster Headache defined as attacks lasting from 7 days to one year, separated by pain-free periods lasting 3 months or more
Exclusion Criteria
- Uncontrolled hypertension
- History of Raynaud’s phenomenon with ischemia (e.g., digital ulcers, tissue necrosis, or other critical ischemia)
- Concurrent preventative therapy with another CGRP targeting agent (including other CGRP-targeting monoclonal antibodies and gepants)
- Diagnosis of hemiplegic migraine or tension headache
Inclusion Criteria
- Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert
- Contraindication, intolerance, or lack of therapeutic response to a therapeutic dose of either verapamil 240-960 mg/day or lithium 600-1500 mg/day
Monitoring & Safety Requirements
- Discontinue galcanezumab if signs or symptoms of Raynaud’s phenomenon develop
- Monitor patients with a history of Raynaud’s phenomenon and inform them about the possibility of recurrence and worsening
- Scheduled blood pressure check 2-4 weeks after initiation of therapy