Profile
General Information
Ixchiq contains live, attenuated chikungunya virus.
Ixchiq is specifically indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
After reconstitution, a single dose of Ixchiq is approximately 0.5 mL. Administer a single dose of Ixchiq by intramuscular injection.
Mechanism of Action
Ixchiq contains live, attenuated chikungunya virus. The exact mechanism of protection has not been determined. Ixchiq elicits CHIKV-specific immune responses.
Side Effects
Adverse effects associated with the use of Ixchiq may include, but are not limited to, the following:
- injection site reaction
- headache
- fatigue
- myalgia
- arthralgia
- fever
- nausea
Clinical Trial Results
The FDA accelerated approval of Ixchiq was based on data from a Phase III for the Ixchiq vaccine in which it demonstrated seroprotection rates of 98.6% in patients aged 18 to 64 years and 100% in patients 65 and older.