tick-borne encephalitis vaccine (Rx)

Brand and Other Names:TicoVac, TBE vaccine (whole virus inactivated)
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension for IM

  • 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 1-3 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 14 days to 3 months after first dose and 5-12 months after second dose

≥16 years: 0.5 mL IM, then repeat 1-3 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)

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Adverse Effects

>10%

Aged 16-65 years

  • Injection site tenderness (29.9%)
  • Local pain (13.2%)
  • Aged 1-15 years H4
  • 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

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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

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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.

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Pharmacology

Mechanism of Action

Inactivated whole virus vaccine; induces TBE virus-neutralizing antibodies

Protective antibody level has not been defined

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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

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.