IXCHIQ™ SAFETY INFORMATION1
Clinical use:
Pediatrics (<18 years): The safety and immunogenicity of IXCHIQ™ have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years): Clinical studies of IXCHIQ™ include participants 65 years of age and older and their data contribute to the overall assessment of safety and immunogenicity.
Contraindications:
- In individuals with a history of immunodeficiency (e.g., from hematologic and solid tumours, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
- In patients who are hypersensitive to this vaccine or to any ingredient in the formulation or component of the container.
- Pregnancy. Women of child-bearing potential should be advised to avoid pregnancy for one month following vaccination.
Relevant warnings and precautions:
- IXCHIQ™ is for intramuscular (IM) injection only.
- As with other vaccines, vaccination with IXCHIQ™ should be postponed in individuals suffering from an acute severe febrile illness or infection.
- Syncope (fainting) can occur following, or even before, any vaccination as a vasovagal response to the needle injection in the context of an anxiety-related reaction. It is important that procedures are in place to avoid injury from fainting.
- Vaccination with IXCHIQ™ may not protect all individuals. It is recommended to continue personal protection measures against mosquito bites after vaccination.
- Appropriate medical treatment and supervision must be available to manage immediate allergic reactions in the event an acute anaphylactic reaction occurs following administration of IXCHIQ™.
- No studies on the effects of IXCHIQ™ on the ability to drive and use machines have been performed. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
- As with other vaccines administered intramuscularly, IXCHIQ™ should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an IM administration to these individuals.
- Available data in adults with a history of immune-mediated or clinically relevant arthritis are not sufficient to determine the safety of IXCHIQ™, as this condition was an exclusion criterion for participation in clinical trials.
- Reproductive and developmental toxicology of IXCHIQ™ was conducted in a single pre- and post-natal developmental toxicity study in pregnant rats which did not identify significant adverse effects in female fertility or in fetal examination. No studies in male fertility were conducted.
- Available data in pregnant women are not sufficient to determine the safety of IXCHIQ™ regarding pregnancy, embryofetal development, parturition, and postnatal development.
- Vertical transmission of chikungunya virus (CHIKV) from mothers with viremia at delivery to their infants has been reported and can cause severe, potentially fatal neurological disease in neonates.
- Vaccine viremia can occur 3–7 days after vaccination and is resolved by day 14; the potential for transmission of the vaccine virus from mother to infant is unknown.
- Women who received IXCHIQ™ during pregnancy are encouraged to report any suspected exposure or adverse reactions to Valneva Canada, or ask their healthcare professional to do so.
- Potential for transmission of the vaccine virus from mother to infant through breastmilk is unknown.Precaution should be exercised.
- Any laboratory testing within 2 weeks post-vaccination with IXCHIQ™ may result in transient abnormalities in results, especially among hematology parameters.
For more information:
Please consult the Product Monograph at pdf.hres.ca/dpd_pm/00076049.PDF for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-855-356-0831.
The drug identification number (DIN) for IXCHIQ™ is 02548984.