Patient Medication Information: uses, side effects, how to take - Ixchiq
What is IXCHIQ used for?
- IXCHIQ is a vaccine for intramuscular injection for use in individuals 12 years of age and older to help protect against chikungunya virus (CHIKV).
How does IXCHIQ work?
IXCHIQ stimulates your immune system to make substances known as antibodies which fight the chikungunya virus. If a vaccinated person comes into contact with chikungunya virus their body can fight off the virus. Following a single intramuscular dose of IXCHIQ, it usually takes two to four weeks to be protected against chikungunya virus. As with all vaccines, 100% protection is not guaranteed.
What are the ingredients in IXCHIQ?
Medicinal ingredients: Purified live-attenuated chikungunya virus (CHIKV)
Non-medicinal ingredients: D-Sorbitol, L-Methionine, Magnesium Chloride, Potassium phosphate, Recombinant Human Albumin (rHA), Sucrose, Trisodium citrate di-hydrate.
IXCHIQ comes in the following dosage forms:
IXCHIQ, chikungunya vaccine, live, attenuated, is a lyophilized powder reconstituted with sterile water to form a sterile solution for intramuscular injection Each 0.5 mL dose of the vaccine contains not less than 3.0 log10 TCID50 of live attenuated chikungunya virus.
Do not use IXCHIQ if:
- you have or if it is suspected that you have an immunodeficiency or immunosuppression (e.g., from malignancies such as cancers arising from abnormal blood or bone marrow cells and solid tumors, recent chemotherapy, immunodeficiency from birth, long-term immunosuppressive therapy for chronic conditions such as autoimmune disorders or organ transplants, or HIV infection with immunocompromised state);
- you are allergic to any of the ingredients in the vaccine (see What are the ingredients in IXCHIQ?)
you are pregnant. Women of child-bearing potential should be advised to avoid pregnancy for one month following vaccination.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IXCHIQ. Talk about any health conditions or problems you may have, including if you:
- have any conditions impacting your overall fitness, and the stability of these conditions.
- have a weakened immune system, for example, due to a genetic defect, HIV infection, or certain medications such as cancer treatment.
- have a bleeding disorder or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) and cannot receive injections in the arm.
- currently have any illness with a fever of more than 38.0 °C.
- have had an allergic reaction to a component of IXCHIQ.
- take any medicines, even those you can buy over the counter.
Serious warnings and Precautions:
- 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 adverse reactions following recent vaccination with IXCHIQ.
- Severe reactogenicity or chikungunya-like adverse reactions may lead to a worsening of the general condition including a general feeling of discomfort and decreased appetite, worsening of preexisting diseases, confusional state, encephalopathy (disturbance of brain function), or encephalitis (inflammation of the brain), leading to falls, hospitalisation and death. Vaccinees should promptly seek medical attention if they experience, after vaccination, symptoms suggestive of severe reactogenicity or severe chikungunya-like adverse reactions.
- For cases received post-marketing indicative of Chikungunya-like adverse reactions, the most frequent symptoms reported in combination with fever were headache (51% of reports), arthralgia (41%), fatigue (38%) and myalgia (35%), pain (19%) and chills (19%). This mostly aligns with findings from clinical trials, with no notable differences observed.
- As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat possible anaphylactic reactions following the administration of the vaccine.
- IXCHIQ must never be injected into a vein or any blood vessel.
- As with any other vaccine, vaccination with IXCHIQ may not result in protection in all people.
- Like other intramuscular injections, this vaccine should not be administered to persons with thrombocytopenia, hemophilia or other bleeding disorders.
- People with a medically-confirmed weak immune system (immunodeficiency) or taking medicines that can undermine the immune system (e.g., high-dose corticosteroids, drugs for rheumatoid arthritis or cancer drugs), IXCHIQ should not be given as it is a live vaccine.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IXCHIQ:
- IXCHIQ is not recommended to be co-administered with other vaccines because there are no data on the safety and immunogenicity following concomitant administration of IXCHIQ with other vaccines.
How to take IXCHIQ:
- IXCHIQ is given by a healthcare professional in a healthcare setting. It is given as an injection in the upper arm muscle in individuals 12 years of age and older.
- You should consult your health care provider on the duration of protection of IXCHIQ prior to potential re-exposure to CHIKV.
- You should still protect yourself from mosquito bites even if you have received the IXCHIQ vaccine.
- IXCHIQ does not protect against other diseases transmitted by mosquitoes.
Usual dose:
IXCHIQ is given as a single injection in the upper arm muscle.
Overdose:
There are no reported cases of overdose with IXCHIQ.
If you think you, or a person you are caring for, have taken too much IXCHIQ, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using IXCHIQ?
The most common side effects of IXCHIQ are headache, fatigue, muscle pain, joint pain, fever and nausea, which are also common symptoms of chikungunya disease. They are usually mild to moderate and go away on their own after a short time. In some individuals, these side effects can interfere with daily activities, may persist for several weeks, might require medical intervention and, in rare cases, could lead to hospitalization.
The most common injection site reactions are tenderness and pain. Redness, hardening, and swelling may also occur. In addition, rare serious side effects shown in the following table may occur.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| X | X | |
Some people who have received IXCHIQ have experienced rare serious side effects similar to complications that can occur with chikungunya virus (similar to section 8.2). Serious side effects that have been reported include:
- Atrial Flutter (abnormal heart rate)
- Rapid heart rate
- Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord that is not due to a bacterial infection)
- Encephalopathy (brain dysfunction with symptoms such as confusion and impaired memory)
- Encephalitis (inflammation of brain tissue) that resulted in death
People 65 years of age and older who are medically frail with multiple chronic (long-term) unstable medical conditions might have an increased risk for these types of serious side effects after receiving IXCHIQ.
These are not all the possible side effects you may have when taking IXCHIQ. If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Suspected Side Effects for Vaccines
For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.
Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Valneva cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit.
Storage:
Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE. Do not use the vaccine after the expiration date shown on the vial label. Store in the original package.
After reconstitution, administer IXCHIQ immediately. If not used immediately, store the reconstituted vaccine at room temperature and administer within 30 minutes. DO NOT FREEZE RECONSTITUTED VACCINE.
Discard reconstituted vaccine, if not used within 30 minutes.
Keep out of reach and sight of children.
If you want more information about IXCHIQ:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.valneva.ca, or by calling Medical Information at Valneva Canada Inc. at 1-855-356-0831. Business hours: 9:00 a.m. to 5:00 p.m. Eastern Time, Monday to Friday.