TICOVAC Highlights

(tick-borne encephalitis vaccine,whole virus, inactivated)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TICOVAC safely and effectively. See full prescribing information for TICOVAC.

TICOVAC (Tick-Borne Encephalitis Vaccine), Suspension for intramuscular injection
Initial U.S. Approval: 2021

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

For intramuscular use only.

•
1 through 15 years of age: each dose 0.25 mL
•
16 years of age and older: each dose 0.5 mL

Primary Vaccination: Three doses (2.1)

Primary Vaccination Schedule

1 through 15 years of age

16 years of age and older

First dose

Day 0

Day 0

Second dose

1 to 3 months after the first vaccination

14 days to 3 months after the first vaccination

Third dose

5 to 12 months after the second vaccination

5 to 12 months after the second vaccination

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 tick-borne encephalitis virus (TBEV) is expected.

DOSAGE FORMS AND STRENGTHS

Suspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes. (3)

CONTRAINDICATIONS

•
Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC. (4)

ADVERSE REACTIONS

The most common adverse reactions are as follows:

•
1 through 15 years of age: Local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%). (6.1)
•
16 through 65 years of age: Local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TICOVAC safely and effectively. See full prescribing information for TICOVAC.

TICOVAC (Tick-Borne Encephalitis Vaccine), Suspension for intramuscular injection
Initial U.S. Approval: 2021

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

For intramuscular use only.

•
1 through 15 years of age: each dose 0.25 mL
•
16 years of age and older: each dose 0.5 mL

Primary Vaccination: Three doses (2.1)

Primary Vaccination Schedule

1 through 15 years of age

16 years of age and older

First dose

Day 0

Day 0

Second dose

1 to 3 months after the first vaccination

14 days to 3 months after the first vaccination

Third dose

5 to 12 months after the second vaccination

5 to 12 months after the second vaccination

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 tick-borne encephalitis virus (TBEV) is expected.

DOSAGE FORMS AND STRENGTHS

Suspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes. (3)

CONTRAINDICATIONS

•
Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC. (4)

ADVERSE REACTIONS

The most common adverse reactions are as follows:

•
1 through 15 years of age: Local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%). (6.1)
•
16 through 65 years of age: Local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2023
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FDA Medwatch

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