Dosing & Uses
Dosage Forms & Strengths
injection, suspension for IM
- 0.25mL prefilled syringe
- 0.5mL prefilled syringe
Tick-Borne Encephalitis
Indicated for active immunization to prevent tick-borne encephalitis (TBE) administered as a 3-dose primary immunization series
0.5 mL IM, then repeat 14 days to 3 months after first dose and 5-12 months after second dose
Complete primary immunization series at least 1 week before potential exposure to TBE virus
Booster (fourth dose): May administer at least 3 years after completion of primary immunization series if ongoing exposure or reexposure to TBE virus is expected
Dosing Considerations
TBE virus is a member of the genus Flavivirus, an RNA virus, in the family Flaviviridae
3 virus subtypes exist: European or Western tick-borne encephalitis virus (transmitted by Ixodes ricinus), Siberian tick borne encephalitis virus (transmitted by I persulcatus), and Far-Eastern tick borne encephalitis virus, formerly known as Russian spring summer encephalitis virus (transmitted by I persulcatus)
Dosage Forms & Strengths
injection, suspension for IM
- 0.25mL prefilled syringe
- 0.5mL prefilled syringe
Tick-Borne Encephalitis
Indicated for active immunization to prevent tick-borne encephalitis (TBE) in individuals aged ≥1 year administered as a 3-dose primary immunization series
<1 year: Safety and efficacy not established
1-15 years: 0.25 mL IM, then repeat 1-3 months after first dose and 5-12 months after second dose
≥16 years: 0.5 mL IM, then repeat 14 days to 3 months after first dose and 5-12 months after second dose
Complete primary immunization series at least 1 week before potential exposure to TBE virus
Booster (fourth dose): May administer at least 3 years after completion of primary immunization series if ongoing exposure or reexposure to TBE virus is expected
Dosing Considerations
TBE virus is a member of the genus Flavivirus, an RNA virus, in the family Flaviviridae
3 virus subtypes exist: European or Western tick-borne encephalitis virus (transmitted by Ixodes ricinus), Siberian tick borne encephalitis virus (transmitted by I persulcatus), and Far-Eastern tick borne encephalitis virus, formerly known as Russian spring summer encephalitis virus (transmitted by I persulcatus)
Adverse Effects
>10%
Aged 16-65 years
- Injection site tenderness (29.9%)
- Local pain (13.2%)
Aged 1-15 years
- Injection site tenderness (18.1%)
- Local pain (11.2%)
- Headache (11.1%)
1-10%
Aged 16-65 years
- Fatigue (6.6%)
- Headache (6.3%)
- Muscle pain (5.1%)
Aged 1-15 years
- Fever (9.6%)
- Restlessness (9.1%)
Postmarketing Reports
Infections and infestations: Herpes zoster (triggered in preexposed individuals)
Immune system disorders: Anaphylactic reaction, hypersensitivity, precipitation or aggravation of autoimmune disorders (eg, multiple sclerosis)
Nervous system disorders: Convulsion, convulsion (including febrile), demyelinating disorders (acute disseminated encephalomyelitis, Guillain-Barré syndrome, myelitis, transverse myelitis), encephalitis, sensory abnormalities and motor dysfunction (hemiparesis, hemiplegia, VIIth nerve paralysis/facial paresis, paralysis, paresis, neuritis, neuralgia, optic neuritis), polyneuropathy, meningism, dizziness, aseptic meningitis
Eye disorders: Visual impairment, photophobia, eye pain
Ear and labyrinth disorders: Tinnitus
Cardiac disorders: Tachycardia
Respiratory, thoracic, and mediastinal disorders: Dyspnea
Skin and subcutaneous tissue disorders: Urticaria, rash (erythematous, maculopapular, vesicular), pruritus, dermatitis, erythema, hyperhidrosis
Musculoskeletal and connective-tissue disorders: Back pain, joint swelling, neck pain, musculoskeletal stiffness (including neck stiffness), pain in extremity
General disorders and administration-site conditions: Injection site joint movement impairment, injection site joint pain, injection site nodule, injection site inflammation, influenzalike illness, chills, gait disturbance, asthenia, edema
Warnings
Contraindications
Severe allergic reaction (eg, anaphylaxis) to any vaccine component
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 & Lactation
Pregnancy
Available human data are insufficient to establish 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 effect on milk production, presence in breast milk, or its effects on breastfed infants
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inactivated whole virus vaccine; induces TBE virus-neutralizing antibodies
Protective antibody level has not been defined
Administration
IM Preparation
Bring vaccine to room temperature before administration
Shake well before administration to thoroughly mix vaccine suspension
After shaking, should appear as a homogenous off-white, opalescent suspension
Inspect visually for particulate matter and discoloration; do not administer if particulate matter or discoloration remains after shaking
IM Administration
For IM administration only
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration
Storage
Refrigerate at 2-8ºC (36-46ºF)
Store syringe in outer carton to protect from light
Do not freeze
Discard if vaccine has been frozen
Images
Formulary
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