Tick-borne Encephalitis Vaccine (Monograph)

Brand name: TicoVac
Drug class: Vaccines

Introduction

Tick-borne encephalitis vaccine is an inactivated vaccine prepared from tick-borne encephalitis (TBE) virus propagated in chick embryo fibroblast (CEF) cells.

Uses for Tick-borne Encephalitis Vaccine

Tick-borne encephalitis vaccine has the following uses:

Tick-borne encephalitis vaccine is indicated for active immunization to prevent tick-borne encephalitis (TBE). Tick-borne encephalitis vaccine is approved for use in individuals 1 year of age and older.

Tick-borne Encephalitis Vaccine Dosage and Administration

General

Tick-borne encephalitis vaccine is available in the following dosage form(s) and strength(s):

Tick-borne encephalitis vaccine is a suspension for injection supplied as a 0.25 mL or 0.5 mL single dose in pre-filled syringes.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

For intramuscular use only.

• 1 through 15 years of age: 0.25 mL per dose

• 16 years of age and older: 0.5 mL per dose

Complete the primary immunization series at least 1 week prior to potential exposure to TBEV (tick-borne encephalitis virus).

A booster dose (fourth dose) may be given at least 3 years after completion of the primary immunization series if ongoing exposure or re-exposure to TBEV is expected.

Bring the vaccine to room temperature before administration. Shake well prior to administration to thoroughly mix the vaccine suspension. After shaking, the vaccine should be a homogenous off-white, opalescent suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer if particulate matter or discoloration remains after shaking. Administer vaccine by intramuscular injection.

Related/similar drugs

TicoVac

Cautions for Tick-borne Encephalitis Vaccine

Contraindications

Severe allergic reaction (e.g. anaphylaxis) to any component of tick-borne encephalitis vaccine.

Warnings/Precautions

Management of Acute Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of tick-borne encephalitis vaccine.

Altered Immunocompetence

Some individuals with altered immunocompetence may have reduced immune responses to tick-borne encephalitis vaccine.

Human Albumin

Tick-borne encephalitis vaccine contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have been identified for licensed albumin or albumin contained in other licensed products.

Limitation of Vaccine Effectiveness

Vaccination with tick-borne encephalitis vaccine may not protect all individuals.

Specific Populations

Pregnancy

Risk Summary: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of tick-borne encephalitis vaccine in pregnant women. Available human data are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.

Developmental and reproductive toxicity studies in animals have not been conducted with tick-borne encephalitis vaccine.

Lactation

Risk Summary: Human data are not available to assess the impact of tick-borne encephalitis vaccine on milk production, its presence in breast milk, or its effects on the breastfed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tick-borne encephalitis vaccine and any potential adverse effects on the breastfed child from tick-borne encephalitis vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

Safety and effectiveness of tick-borne encephalitis vaccine have not been established in infants below 1 year of age.

Geriatric Use

Clinical studies of tick-borne encephalitis vaccine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. A clinical study (Study 690601, NCT00460486) of tick-borne encephalitis vaccine enrolled 73 subjects 60 years of age and older, including 31 subjects 65 years of age and older.

Common Adverse Effects

Age 1 through 15 years: Local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).

Age 16 through 65 years: Local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Following administration, tick-borne encephalitis vaccine induces TBEV-neutralizing antibodies, which are believed to confer protection. However, a protective antibody level has not been defined.

Advice to Patients

• The potential benefits and risks of immunization with tick-borne encephalitis vaccine

• The importance of completing the approved three dose primary immunization series before potential exposure to TBEV.

• Report any suspected adverse reactions to a healthcare professional.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

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.

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