IXCHIQ® SAFETY INFORMATION1
Clinical use:
Pediatrics (<12 years): The safety and immunogenicity of IXCHIQ® have not been established; therefore, Health Canada has not authorized an indication for individuals under 12 years of age.
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:
- Individuals with current or suspected immunodeficiency or immunosuppression (e.g., from malignancies such as hematologic cancers and solid tumors, recent chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy for chronic conditions such as autoimmune disorders or organ transplants, or poorly managed HIV infection with immunocompromised state).
- 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.
Most serious warnings and precautions:
Risk for individuals ≥65 years of age: Available post-marketing data suggest that individuals 65 years of age and older who are medically frail with multiple chronic medical conditions may have an increased risk for serious and life-threatening adverse reactions following recent vaccination with IXCHIQ®.
Relevant warnings and precautions:
- IXCHIQ® is for intramuscular (IM) injection only.
- IXCHIQ® should only be given when there is a significant risk of acquiring chikungunya infection and after careful consideration of the potential risks and benefits.
- Serious adverse reactions following vaccination with IXCHIQ® were most commonly reported in medically frail individuals with advanced chronic diseases, individuals at older age (i.e., ≥65 years of age, especially ≥75 years of age), and those with a high risk of having an undiagnosed immunocompromised condition (post-market data).
- Severe reactogenicity or chikungunya-like adverse reactions in medically frail individuals with chronic diseases may lead to deterioration of general condition including malaise and decreased appetite, exacerbation of preexisting diseases, confusional state, encephalopathy, or encephalitis, leading to falls, hospitalization and death.
- 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, however, some adverse effects may temporarily affect the ability to drive or use machines. 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 and adolescents 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.
- Additional cases of prolonged chikungunya-like arthralgia reported (range: few weeks – over 5 months) with some requiring follow-up with rheumatology (post-market data).
- Encephalitis and encephalopathy (including with fatal outcome) have been reported in individuals 74 years and older with multiple comorbidities (post-market data).
- Vaccinees should be instructed to promptly seek medical attention if experiencing signs or symptoms suggestive of severe reactogenicity, severe chikungunya-like adverse events, prolonged arthralgia or a neurological disorder, post-vaccination.
- 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.
- There are no data on the safety and immunogenicity following concomitant administration of IXCHIQ® with other vaccines. During post-marketing use, some severe ICSR cases involved co-administration with other vaccines. Administration of immune globulins, blood or plasma transfusions 3 months before or up to 1 month after IXCHIQ® administration may interfere with the expected immune response.
- 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/00083177.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.