AdultPediatricDosage 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) >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 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 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 infantsPregnancy 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. Mechanism of Action Inactivated whole virus vaccine; induces TBE virus-neutralizing antibodies Protective antibody level has not been defined 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. 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. View explanations for tiers and restrictions 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 Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. Plans Select State: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Done Non-Medicare Plans Medicare Plans Done CLOSE Additional Offers CLOSE Email to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send CLOSE Email Forms to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send