AJOVY (Fremanezumab) Quarterly vs Monthly Dosing for Migraine Prevention
Both quarterly (675 mg every 3 months) and monthly (225 mg monthly) dosing regimens of AJOVY (fremanezumab) demonstrate similar efficacy for migraine prevention, with no clinically significant differences in outcomes between the two dosing schedules. 1
Comparative Efficacy Data
The FDA-approved label for AJOVY provides direct comparative data between the quarterly and monthly dosing regimens:
In chronic migraine patients:
- Monthly dosing: -4.6 headache days of moderate severity (from baseline)
- Quarterly dosing: -4.3 headache days of moderate severity (from baseline)
- Placebo: -2.5 headache days 1
In episodic migraine patients:
- Monthly dosing: -3.7 migraine days (from baseline)
- Quarterly dosing: -3.4 migraine days (from baseline)
- Placebo: -2.2 migraine days 1
Responder rates (≥50% reduction in migraine days):
- Monthly dosing: 47.7% (episodic migraine)
- Quarterly dosing: 44.4% (episodic migraine)
- Placebo: 27.9% 1
Clinical Implications
Dosing Options
- Monthly dosing: 225 mg administered subcutaneously once per month
- Quarterly dosing: 675 mg administered subcutaneously once every three months 1
Efficacy Onset
Both dosing regimens show significant efficacy within the first month of treatment. The FDA label shows that both quarterly and monthly dosing regimens demonstrated a -4.6 reduction in headache days at 4 weeks after the first dose in chronic migraine patients. 1
Duration of Effect
Research shows sustained efficacy for both dosing regimens throughout the treatment period. In the FOCUS study, which included patients with documented inadequate response to 2-4 prior migraine preventive medications, both dosing regimens maintained efficacy over 6 months of treatment. 2
Additional Benefits
Both dosing regimens significantly reduced:
- Headache severity
- Duration of headache attacks
- Days requiring acute headache medication use
- Associated symptoms (photophobia, phonophobia, nausea, vomiting) 3
Patient Considerations
Convenience Factor
Quarterly dosing may be preferable for patients who:
- Have difficulty with medication adherence
- Prefer fewer injections
- Have limited access to healthcare facilities
Monthly dosing may be preferable for patients who:
- Prefer more consistent drug levels
- Have anxiety about larger injection volumes
Storage Requirements
Both formulations require refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton. If necessary, AJOVY may be kept at room temperature up to 30°C (86°F) for a maximum of 7 days. 1
Special Populations
In patients aged ≥60 years, both quarterly and monthly fremanezumab demonstrated similar efficacy and safety profiles:
- Quarterly fremanezumab: -4.3 migraine days
- Monthly fremanezumab: -4.6 migraine days
- Placebo: -2.3 migraine days 4
Clinical Perspective
While the American College of Physicians guidelines do not specifically address CGRP monoclonal antibodies like fremanezumab in their first-line recommendations for migraine treatment, they do acknowledge that CGRP antagonists may be considered for patients who do not tolerate or have inadequate response to combination therapy of a triptan and an NSAID or acetaminophen. 5
Conclusion
When choosing between quarterly and monthly AJOVY dosing regimens for migraine prevention, clinicians can be confident that both provide similar efficacy outcomes. The decision should be based primarily on patient preference regarding injection frequency, as there is no clinically significant difference in efficacy between the two dosing schedules.