Tick-borne Encephalitis Vaccine

Tick-borne encephalitis (TBE) vaccine is indicated for active immunization to prevent tick-borne encephalitis administered as a 3-dose primary immunization series.

• Tick-borne Encephalitis Vaccine is available under the following different brand names: TicoVac, TBE vaccine (whole virus inactivated)

Common side effects of Tick-borne Encephalitis Vaccine include:

• injection site reactions (tenderness, pain, redness, swelling, itching, bruising, hard lump)
• headache
• fever
• restlessness
• fatigue
• muscle pain
• feeling unwell (malaise)

Serious side effects of Tick-borne Encephalitis Vaccine include:

• not available

Rare side effects of Tick-borne Encephalitis Vaccine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, suspension for IM

• 0.25 mL prefilled syringe
• 0.5 mL prefilled syringe

TBE

Adult dosage

• 0.5 mL IM, then repeat 14 days to 3 months after the first dose and 5-12 months after the second dose
• Complete primary immunization series at least 1 week before potential exposure to TBE virus
• Booster (fourth dose): May be administered at least 3 years after completion of primary immunization series if ongoing exposure or reexposure to TBE virus is expected

Pediatric dosage

• Children younger than 1 year: Safety and efficacy not established
• Children aged between 1 to 15 years: 0.25 mL IM, then repeat 1-3 months after the first dose and 5-12 months after the second dose
• Children aged 16 years and older: 0.5 mL IM, then repeat 14 days to 3 months after the first dose and 5-12 months after the second dose
• Complete primary immunization series at least 1 week before potential exposure to TBE virus
• Booster (fourth dose): May be administered at least 3 years after completion of primary immunization series if ongoing exposure or reexposure to TBE virus is expected

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tick-borne Encephalitis Vaccine has no noted severe interactions with any other drugs
• Tick-borne Encephalitis Vaccine has no noted serious interactions with any other drugs
• Tick-borne Encephalitis Vaccine has no noted moderate interactions with any other drugs
• Tick-borne Encephalitis Vaccine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe allergic reaction (eg, anaphylaxis) to any vaccine component

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tick-borne Encephalitis Vaccine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tick-borne Encephalitis Vaccine?”

Cautions

• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration
• Some individuals with altered immunocompetence may have reduced immune response
• Contains human albumin; remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease
• Vaccination may not protect all individuals

Pregnancy and Lactation

• 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
• Lactation
  • Data are not available to assess the effect of the vaccine on milk production, its presence in breast milk, or breastfed infants