What is Ajovy (fremanezumab) auto‑injector 225 mg/1.5 mL?

AJOVY AUTO-INJ 225mg/1.5mL: Product Overview

AJOVY (fremanezumab) auto-injector 225 mg/1.5 mL is a fully humanized monoclonal antibody administered subcutaneously for the preventive treatment of migraine in adults and pediatric patients aged 6-17 years weighing ≥45 kg. 1, 2

Mechanism of Action and Indication

• Fremanezumab selectively targets and binds both isoforms of calcitonin gene-related peptide (CGRP), a 37-amino acid neuropeptide involved in central and peripheral pathophysiological events in migraine 3, 4
• FDA-approved for migraine prevention in adults (September 2018) and pediatric patients aged 6-17 years weighing ≥45 kg (August 2025) 1, 2
• Indicated for patients with at least four migraine days per month 3

Dosing Regimens and Administration

Available Dosing Options

• Two subcutaneous dosing regimens are available: 225 mg monthly OR 675 mg every 3 months (quarterly, administered as three consecutive 225 mg injections) 1
• When switching between dosing options, administer the first dose of the new regimen on the next scheduled date 1
• If a dose is missed, administer as soon as possible, then resume scheduling from the date of the last dose 1

Administration Technique

• Remove from refrigerator and allow to sit at room temperature for 30 minutes protected from direct sunlight before injection 1
• Do not warm using heat sources (hot water or microwave) 1
• Do not use if stored at room temperature for 7 days or longer 1
• Inject subcutaneously into abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated 1
• For multiple injections (quarterly dosing), use the same body site but not the exact location of the previous injection 1
• Do not co-administer with other injectable drugs at the same injection site 1

Clinical Efficacy

Episodic Migraine

• Fremanezumab reduced mean monthly migraine days by 1.5 days with monthly dosing (from 8.9 to 4.9 days) and 1.3 days with quarterly dosing (from 9.2 to 5.3 days) compared to placebo (from 9.1 to 6.5 days) over 12 weeks (both p < 0.001) 5

Difficult-to-Treat Migraine

• In patients with inadequate response to 2-4 prior preventive medication classes, fremanezumab significantly reduced monthly migraine days and improved quality of life measures over 12 weeks (p < 0.0001) 6, 4
• Fremanezumab reduced days with neurological symptoms by 1.7-1.8 days in patients with migraine-associated neurological dysfunction compared to 0.5 days with placebo (p ≤ 0.01) 6

Position in Treatment Algorithm

• VA/DoD guidelines give fremanezumab a "strong for" recommendation for prevention of episodic or chronic migraine 7
• American College of Physicians classifies fremanezumab as second-line therapy after failure of conventional preventives (beta-blockers, antidepressants, antiseizure medications), driven primarily by ~100-fold cost difference rather than efficacy 8
• European guidelines position fremanezumab as third-line, restricted to patients in whom other preventive drugs have failed or are contraindicated 8
• Efficacy should be assessed after 3-6 months of treatment, as earlier assessment may miss full therapeutic effect 8
• After 6-12 months of successful therapy, consider pausing treatment to determine if preventive therapy can be discontinued 8

Safety Profile

Common Adverse Events

• Most common adverse reaction is injection site reactions (43-45% with fremanezumab vs 38% with placebo), including pain, induration, and erythema 1
• Most reactions were mild to moderate, occurring within hours to one month after administration 1
• Injection site reactions led to discontinuation in 1% of patients 1

Serious Adverse Events

• Hypersensitivity reactions including anaphylaxis and angioedema have been reported in postmarketing surveillance 1
• No serious treatment-related adverse events were reported in Phase III clinical trials 3
• Unlike erenumab, fremanezumab has not been associated with development or worsening of hypertension in postmarketing studies 8

Contraindications

• Contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or any excipients 1
• No contraindications for coronary heart disease, inflammatory bowel disease, COPD, impaired wound healing, or subarachnoid hemorrhage history, though caution is advised 8
• No contraindication for women of childbearing potential (unlike valproate) 8
• No psychiatric contraindications; fremanezumab targets CGRP peptide, not central nervous system pathways that affect anxiety 9

Cost Considerations

• Annual costs range from $7,071 to $22,790, substantially higher than conventional preventives ($67-$393 annually) 8
• This 100-fold cost difference drives guideline recommendations to use conventional preventives first 8

Clinical Pearls

• No tapering required when discontinuing fremanezumab 8
• Can be continued throughout perioperative periods without interruption 8
• May be administered by healthcare professionals, patients, or caregivers after proper training 1
• Inspect solution before use; do not use if cloudy, discolored, or contains particles 1
• Sustained improvements seen with long-term treatment in 12-month studies 4