Chikungunya Vaccine Live (Monograph)

Brand name: Ixchiq
Drug class: Vaccines

Introduction

Live, attenuated chikungunya virus vaccine.

Uses for Chikungunya Vaccine Live

Prevention of Chikungunya Virus

Prevention of disease caused by chikungunya virus (CHIKV) in individuals ≥18 years of age who are at increased risk of exposure to CHIKV. Indication is approved under accelerated approval. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory studies.

CDC recommends chikungunya vaccine for persons ≥18 years of age traveling to a country or territory where there is a chikungunya outbreak. The vaccine also may be considered for the following persons traveling to a country or territory without an outbreak but with evidence of chikungunya virus transmission among humans within the last 5 years: persons >65 years of age, particularly those with underlying medical conditions, who are likely to have at least moderate exposure to mosquitoes, OR persons staying for a cumulative period of ≥6 months.

CDC also recommends the chikungunya vaccine for laboratory workers with potential exposure to the vaccine.

Chikungunya Vaccine Live Dosage and Administration

General

Patient Monitoring

The decision to administer chikungunya vaccine live during pregnancy should take into consideration the individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to the fetus or neonate from vertical transmission of wild-type virus.
Monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving chikungunya vaccine live.

Dispensing and Administration Precautions

Appropriate treatment must be available during administration to manage immediate allergic reactions.
Because syncope can occur during administration of the vaccine, procedures should be in place to avoid injury from fainting.

Administration

IM Administration

Administer by IM injection only.

Commercially available as a vial of sterile lyophilized antigen component and a syringe of sterile water diluent component. \

Reconstitute the lyophilized antigen component at the time of use with the sterile water diluent.

Reconstitution

Reconstitute the lyophilized antigen by slowly transferring entire contents of the prefilled sterile water diluent syringe into the vial. Gently swirl vial to dissolve powder. Do not shake or invert the vial.

After swirling, wait for at least 1 minute for complete reconstitution of the vaccine. After reconstitution, slightly tilt the vial and withdraw the entire contents into the syringe.

After reconstitution, administer vaccine immediately.

Dosage

Adults

Prevention of Chikungunya Virus

IM

Single dose of 0.5 mL.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Chikungunya Vaccine Live

Contraindications

Individuals who are immunodeficient or immunosuppressed due to disease or medical therapy (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
Individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Warnings/Precautions

Management of Acute Allergic Reactions

Medical treatment to manage immediate allergic reactions must be available if an anaphylactic reaction occurs.

Risk of Severe or Prolonged Chikungunya-like Adverse Reactions

May cause severe or prolonged chikungunya-like adverse reactions.

Potential for Vertical Transmission of Vaccine Virus and Fetal/Neonatal Adverse Reactions

Vertical transmission of wild-type CHIKV to neonates from pregnant individuals with viremia at delivery may occur; can cause severe, potentially fatal chikungunya virus disease in neonates.

Vaccine viremia occurs in the first week after administration of the vaccine, with resolution by 14 days. Unknown if the vaccine virus can be transmitted from a pregnant individual to the fetus or neonate and cause fetal or neonatal adverse reactions.

Consider the pregnant individual's risk of exposure to wild-type CHIKV, gestational age, and risks to the fetus or neonate from vertical transmission of wild-type virus when deciding to administer chikungunya vaccine live during pregnancy.

Monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving chikungunya vaccine live.

Syncope

Syncope (fainting) can occur with administration of vaccines including chikungunya vaccine live. Procedures should be in place to avoid injury from fainting.

Limitations of Vaccine Effectiveness

Vaccination may not protect all individuals.

Specific Populations

Pregnancy

Data are insufficient to determine whether there is a vaccine-associated risk during pregnancy.

Vertical transmission of wild-type CHIKV to neonates from pregnant individuals with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates. Vertical transmission of wild-type CHIKV and fetal death due to the virus during antepartum infection occurs infrequently.

Vaccine viremia occurred in the first week following administration of a vaccine containing the same attenuated CHIKV as in chikungunya vaccine live; viremia resolved by 14 days after vaccination. Unknown if the vaccine virus can be transmitted from a pregnant individual to the fetus or neonate and cause fetal or neonatal adverse reactions.

Manufacturer states to consider a pregnant individual's risk of exposure to wild-type CHIKV, gestational age, and risks to the fetus or neonate from vertical transmission of wild-type CHIKV when deciding to administer chikungunya vaccine live during pregnancy.

CDC recommends that pregnant women avoid the risk for chikungunya virus infection. In general, vaccination should be deferred until after delivery; however, when risk of infection is high and exposure cannot be avoided, consider the potential risks versus benefits of vaccination. If vaccination is necessary, avoid during first trimester (until 14 weeks gestation) and after the 36th week of gestation.

Monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving chikungunya vaccine live.

There is a pregnancy registry for chikungunya vaccine live. Vaccine recipients or their healthcare providers may contact OXON Epidemiology at 1-855-417-6214 to enroll in or obtain information about the registry.

Lactation

Not known if chikungunya vaccine live is present in human milk or if the vaccine has any effects on milk production or on the breastfed child.

Consider developmental and health benefits of breastfeeding along with the mother's need for chikungunya vaccine live and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition.

Vaccine viremia occurs after vaccination. Potential for transmission of the vaccine virus from mother to infant through breastmilk is unknown.

CDC states that breastfeeding women and their infants should avoid the risk of chikungunya virus infection, if possible. The vaccine should be used with caution in breastfeeding women; however, if risk of infection is high (e.g., during an outbreak) and exposure cannot be avoided, consider the risks versus benefits of vaccination.

Pediatric Use

Safety and effectiveness not established.

Geriatric Use

No difference in effectiveness observed based on age. Difference in safety based on age unknown.

CDC is currently investigating cases of hospitalizations for cardiac or neurologic events following vaccination with chikungunya vaccine live among people ≥65 years of age. Consider benefits versus risks of vaccinations for individual travelers.

Hepatic Impairment

Effect of hepatic impairment on pharmacokinetics of chikungunya vaccine live is unknown.

Renal Impairment

Effect of renal impairment on pharmacokinetics of chikungunya vaccine live is unknown.

Common Adverse Effects

Most common solicited injection site reaction (>10%) was tenderness (10.6%). Most common solicited systemic adverse reactions (>10%) were headache (31.6%), fatigue (28.5%), myalgia (23.9%), arthralgia (17.2%), fever (13.5%), and nausea (11.2%).

Drug Interactions

No formal drug interaction studies have been performed to date.

Stability

Storage

Parenteral

Injection solution

Store vial of lyophilized antigen component and sterile water diluent component in refrigerator at 2–8°C. Store in the original carton to protect from light. Do not freeze.

Actions

Live, attenuated chikungunya virus.
Generated by reverse genetics from La Réunion strain LR-CHIKV clone LR2006 OPY1.
Has a deletion in non-structural protein 3, resulting in less efficient viral replications than the wild-type chikungunya virus.
Exact mechanism of protection of the vaccine has not been determined.

Advice to Patients

Advise the vaccine recipient to read the FDA-approved patient labeling (Patient Information).
Question the vaccine recipient about reactions to previous vaccines.
Inform the vaccine recipient of the benefits and risks of chikungunya vaccine live, including the potential for severe or prolonged chikungunya-like adverse reactions and the potential for vertical transmission of vaccine virus from pregnant individuals and potential fetal/neonatal adverse reactions.
Advise the recipient that chikungunya vaccine live may not protect everyone who gets the vaccine and that personal precautions should be taken to reduce exposure to mosquito bites (e.g., adequate clothing, use of repellents, mosquito nets).
There is a pregnancy exposure registry for chikungunya vaccine live. Encourage individuals exposed to the vaccine around the time of conception or during pregnancy to register by calling 1-855-417-6214 or by visiting [Web].
Advise vaccine recipient to report any adverse reactions to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and [Web].
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Chikungunya vaccine live is obtained through designated distributors. Contact manufacturer or consult the chikungunya vaccine live website ([Web]) for specific availability information.

Chikungunya Vaccine Live
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection solution, for IM use	minimum of 3 log₁₀ TCID₅₀ (Tissue Culture Infectious Dose 50%) per 0.5 mL after reconstitution	Ixchiq (supplied in a carton containing one single-dose vial of lyophilized antigen component live and one prefilled syringe of sterile water diluent component)	Valneva