IXCHIQ Dosage & Rx Info | Uses, Side Effects

Ixchiq Generic Name & Formulations

Legal Class

General Description

Chikungunya vaccine, live; soln for IM inj after reconstitution; preservative-free.

How Supplied

Single-dose vial—1 (w. diluent)

Storage

Store vial of lyophilized antigen component, live, and syringe of sterile water diluent component in a refrigerator at 2°–8°C (35°–46°F).

Store in the original carton to protect from light. Do not freeze.

Manufacturer

Valneva USA

Generic Availability

Mechanism of Action

The exact mechanism of protection has not been determined. Ixchiq elicits CHIKV-specific immune responses.

Ixchiq Indications

Indications

Prevention of disease caused by chikungunya virus (CHIKV) in adults at increased risk of exposure to CHIKV.

Ixchiq Dosage and Administration

Adult

≥18yrs: a single dose (0.5mL) by IM inj.

Children

<18yrs: not established.

Ixchiq Contraindications

Contraindications

Immunocompromised.

Ixchiq Boxed Warnings

Not Applicable

Ixchiq Warnings/Precautions

Warnings/Precautions

Have appropriate medical treatment readily available. May not protect all individuals. Potential for vertical transmission of vaccine virus to neonates. Pregnancy: monitor neonates for 7 days post-birth for potential disease if born within 14 days of receiving Ixchiq. Nursing mothers.

Ixchiq Pharmacokinetics

See Literature

Ixchiq Interactions

Not Applicable

Ixchiq Adverse Reactions

Adverse Reactions

Tenderness, headache, fatigue, myalgia, arthralgia, fever, nausea; anaphylaxis, syncope, atrial fibrillation, hypovolemic hyponatremia.

Ixchiq Clinical Trials

Clinical Trials

The approval of Ixchiq was based on safety and immunogenicity data from the prospective, double-blind, multicenter, randomized phase 3 trials (ClinicalTrials.gov Identifier: Study 1 [NCT04546724] and Study 2 [NCT04786444]) which was conducted in North America and included a total of 4523 patients 18 years of age and older (median age, 45 years; 54.7% female; 45.3% male; 80.1% White; 14.0% Black or African American). In Study 1, participants were randomly assigned to receive a single intramuscular vaccination of Ixchiq (n=3082) or placebo (n=1033). Study 2 was a non-placebo-controlled study where 408 participants were vaccinated with a single dose of Ixchiq.

The primary endpoint was the proportion of patients with a seroprotective CHIKV antibody level determined by µPRNT (Micro Plaque Reduction Neutralization Test) at 28 days post-vaccination.

Findings showed that 98.9% (n=263/266; 95% CI, 96.7-99.8) of participants who received Ixchiq achieved protective levels of CHIKV neutralizing antibodies at 28 days post vaccination. After 6 months post vaccination, 96.3% (n=233/242; 95% CI, 93.1-98.3) of participants maintained the protective CHIKV antibody titers. The vaccine was also found to be equally effective in participants 65 years of age and older.

Ixchiq Note

Notes

To enroll in the pregnancy exposure registry, call (855) 417-6214.

Ixchiq Patient Counseling