Version May 2024
Chikungunya virus disease, prevention: IM: ~0.5 mL as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Gastrointestinal: Nausea (11%)
Hematologic & oncologic: Leukopenia (grade 1: 27%; grades 2/3: ≤4%), lymphocytopenia (grade 1: 19%; grades 2/3: ≤4%), neutropenia (grade 1: 28%; grades 2 to 4: ≤11%)
Local: Tenderness at injection site (11%)
Nervous system: Fatigue (29%), headache (32%)
Neuromuscular & skeletal: Arthralgia (17%), myalgia (24%)
Miscellaneous: Fever (14%)
1% to 10%:
Dermatologic: Skin rash (2%)
Gastrointestinal: Diarrhea (1%), vomiting (2%)
Local: Induration at injection site (1%), pain at injection site (6%)
Nervous system: Chills (2%)
Neuromuscular & skeletal: Back pain (1%)
<1%:
Cardiovascular: Atrial fibrillation
Endocrine & metabolic: Hyponatremia
Hematologic & oncologic: Lymphadenopathy
Frequency not defined:
Cardiovascular: Peripheral edema, syncope, tachycardia
Dermatologic: Erythematous rash, hyperhidrosis
Infection: Viremia
Nervous system: Asthenia, ataxia, dizziness, hypoesthesia, paresthesia, peripheral neuropathy, pain
Respiratory: Flu-like symptoms, tachypnea
Severe hypersensitivity reaction (eg, anaphylaxis) to chikungunya vaccine (live) or any component of the formulation; immunodeficiency or immunosuppression due to disease or medical therapy (including persons with hematologic and solid tumors, congenital immunodeficiency, or those severely immunocompromised due to HIV infection; those receiving chemotherapy or long-term immunosuppressive therapy).
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (Ref).
• Chikungunya-like adverse reactions: Severe and/or prolonged chikungunya-like adverse reactions (eg, severe myalgia, hypovolemic hyponatremia atrial fibrillation) have been reported.
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (Ref).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone vaccination in individuals with moderate or severe acute illness (with or without fever). The presence of a mild acute illness (with or without fever) should not delay vaccination (Ref).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (Ref).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (Ref).
• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist (Ref).
Special populations:
• Altered immunocompetence: Use is contraindicated in persons who are immunocompromised (eg, patients receiving chemotherapy); may have a reduced response to vaccination or may have an adverse event secondary to replication. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (Ref). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for at least 3 months after immunosuppressive therapy. Specific recommendations for use of vaccines in immunocompromised patients considering international travel as well as contacts of immunocompromised patients are available from the Infectious Diseases Society of America (Ref).
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (Ref). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Ref).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (Ref).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Ixchiq: (1 ea) [contains albumin human, bovine serum albumin/cross-linking agent]
No
IM: Prior to using, the powder (antigen vial) must be reconstituted with the liquid (diluent). Administer by IM injection into the deltoid muscle (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adults should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, vaccine manufacturer, lot number of vaccine, vaccine information statement edition date and date it was provided, and administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following IM injection, the Advisory Committee on Immunization Practices recommends that the vaccine be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Chikungunya virus disease, prevention: Prevention of disease caused by chikungunya virus (CHIKV) in persons ≥18 years of age who are at increased risk of exposure to CHIKV.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Methotrexate may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy
It is not known if the chikungunya vaccine can cross the placenta.
Maternal-fetal virus transmission has occurred following infection with the chikungunya virus during outbreaks, particularly with maternal viremia at delivery (Ref). Viremia occurs following vaccination; monitor infants closely for 7 days after birth if maternal vaccination occurs within 14 days of delivery.
Data collection to monitor pregnancy and infant outcomes following maternal vaccination is ongoing. Health care providers are encouraged to contact OXON Epidemiology to enroll patients exposed to Ixchiq during pregnancy in the registry (1-855-417-6214); patients may also enroll themselves.
It is not known if the chikungunya vaccine is present in breast milk.
According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother.
Monitor for hypersensitivity and syncope for 15 minutes following administration (Ref). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Induces anti-chikungunya virus neutralizing antibodies. The exact mechanism of protection has not been determined.
Onset: Seroresponse rates were ~99% and ~96% at 28 days and 180 days postvaccination, respectively.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
