Rabavert

— THERAPEUTIC CATEGORIES —
  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rabavert Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rabies vaccine, inactivated 2.5IU/mL; pwd for IM inj after reconstitution; may contain trace amounts of bovine gelatin, chicken protein, neomycin, chlortetracycline, and amphotericin B.

    How Supplied

    Single-dose vial—1 (w. diluent)

    Storage

    Store protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution, the vaccine is to be used immediately.

    Manufacturer

    Bavarian Nordic, Inc.

    Mechanism of Action

    Anti-rabies antibody titers after immunization have been shown to reach levels well above the minimum antibody titer accepted as seroconversion (protective titer) within 14 days after initiating the postexposure treatment series.

    Rabavert Indications

    Indications

    Preexposure immunization and post-exposure prophylaxis of rabies.

    Indications

    Preexposure vaccination should be offered to:

    • Persons in high-risk groups (eg, veterinarians, animal handlers, wildlife officers in areas where animal rabies is enzootic, certain laboratory workers, persons spending time in foreign countries where rabies is endemic.)
    • Persons whose activities bring them into contact with potentially rabid dogs, cats, foxes, skunks, bats, or other species at risk of having rabies.
    • International travelers if they are likely to come in contact with animals in areas where dog rabies is enzootic and immediate access to appropriate medical care, including biologics, might be limited.

    According to the CDC’s Advisory Committee on Immunization Practices guidelines, preexposure prophylaxis is not necessary in US populations at large, including persons in rabies-epizootic areas.

    For postexposure treatment in the US, consider the species of the biting animal, the circumstances of the biting incident (ie, unprovoked attack by an unknown animal vs provoked attack by a vaccinated or healthy animal), and whether it was a bite or a non-bite (defined as a contamination of open wounds, abrasions,  or mucous membranes with saliva from a rabid animal) when deciding on treatment.

    Rabavert Dosage and Administration

    Adults and Children

    Adults: inject into deltoid area. Small children: inject into thigh. Preexposure immunization: 3 inj of 1mL IM each on day 0, 7, and either day 21 or 28. Booster: 1 dose as needed to maintain antibody titer (minimum acceptable antibody level is complete virus neutralization at a 1:5 serum dilution by RFFIT; administer booster if titer falls below this level). Post-exposure prophylaxis: a 5-dose regimen of 1mL IM given on days 0, 3, 7, 14, and 28 (give 1st dose with human rabies immunoglobulin at a separate site). If previously immunized: 2 inj of 1mL each on days 0 and 3 (no immune globulin needed).

    Administration

    For intramuscular use only.

    Adults: Deltoid area is the preferred site.

    Small children and infants: Anterolateral zone of the thigh is preferred. 

    Avoid gluteal region: Administration in this area may result in lower neutralizing antibody titers.

    Rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory and antipyretic agents.

    Rabavert Contraindications

    Not Applicable

    Rabavert Boxed Warnings

    Not Applicable

    Rabavert Warnings/Precautions

    Warnings/Precautions

    Immunocompromised: may get suboptimal response (monitor titers). Postpone preexposure immunization during acute febrile illness or infection. Egg allergy. Have epinephrine inj (1:1000) available. Pregnancy.

    Pregnancy Considerations

    Give Rabavert only if clearly needed. It is not known whether the vaccine can cause fetal harm or affect reproduction capacity.

    Nursing Mother Considerations

    Nursing is not considered a contraindication to postexposure prophylaxis because of the consequences of inadequately treated rabies. Preexposure prophylaxis in nursing mothers may also be considered if the risk of exposure to rabies is high.

    Pediatric Considerations

    Preexposure Vaccination in Children

    • Administration to 11 children in Thailand aged 2 years and older resulted in antibody titers >0.5 IU/mL that were present 2 years after immunization in all sera (n=6/6) tested.

    Postexposure Treatment in Children

    • 10-year serosurveillance study.
    • Rabavert was administered to 91 children aged 1 to 5 years and 436 children and adolescents aged 6 to 20 years.
    • Vaccine was effective in both groups; no patients developed rabies.

    Geriatric Considerations

    Clinical studies did not include a sufficient number of individuals 65 years of age and older to determine difference in response.

    Rabavert Pharmacokinetics

    See Literature

    Rabavert Interactions

    Interactions

    Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents: may get suboptimal response. Concomitant immunosuppressive therapy with rabies postexposure prophylaxis: test serum sample on day 14 (the day of the 4th vaccination) to ensure acceptable antibody response has been induced. Do not administer HRIG more than recommended: active immunization to vaccine may be impaired.

    Rabavert Adverse Reactions

    Adverse Reactions

    Injection site reactions (eg, erythema, induration, pain), flu-like symptoms (eg, asthenia, fatigue, fever, headache, myalgia, malaise), arthralgia, dizziness, lymphadenopathy, nausea, rash; neuroparalytic events, anaphylaxis.

    Rabavert Clinical Trials

    Clinical Trials

    Rabies is a viral infection transmitted through the saliva of infected animals. The virus enters the central nervous system of the host, causing an encephalomyelitis that is almost invariably fatal. The incubation period is usually between 20 and 60 days.

    Clinical illness often starts with malaise, anorexia, fatigue, headache, and fever followed by pain and paresthesia at the site of exposure. This is eventually followed by hyperactivity, disorientation, seizures, aerophobia and hydrophobia, hypersalivation, and then finally paralysis, coma, and death.

    Modern day prophylaxis has been proven to be nearly 100% successful, with most fatalities occurring in those who fail to seek treatment. Rabavert for postexposure treatment has been shown to protect patients of all ages from rabies when administered according to the CDC’s ACIP or WHO guidelines soon after rabid animal contact. The minimum antibody titer accepted as seroconversion is ≥0.5 IU/mL.

    Preexposure Vaccination

    • Immunogenicity of Rabavert was demonstrated in clinical trials conducted in different countries, including the US.
    • Administration at the recommended immunization schedule (days 0, 7, and 21 or 0, 7, and 28) led to 100% of patients attaining a protective titer.
    • The ability of Rabavert to boost previously immunized individuals was evaluated in 3 clinical trials.
    • In a US trial, an IM booster dose resulted in a significant increase in titers in patients (n=35/35), regardless of whether they received Rabavert or Human Diploid Cell Vaccine (HDCV).
    • In a UK trial, neutralizing antibody titers >0.5 IU/mL were present 2 years after immunization in all sera tested (n=6/6).

    Preexposure Vaccination in Children

    • Administration to 11 children in Thailand aged 2 years and older resulted in antibody titers >0.5 IU/mL that were present 2 years after immunization in all sera (n=6/6) tested.

    Postexposure Treatment

    • When used in the recommended postexposure WHO program of 5 to 6 IM injections of 1mL (days 0, 3, 7, 14, and 30 and optionally on day 90), Rabavert provided protective titers of neutralizing antibody (>0.5 IU/mL) in 158/160 patients within 14 days and in 215/216 patients by days 28 to 38.
    • 203 cases were followed for 10 months; no cases of rabies observed.
    • No postexposure vaccine failures have occurred in the US since cell culture vaccines have been routinely used.

    Postexposure Treatment in Children

    • 10-year serosurveillance study.
    • Rabavert was administered to 91 children aged 1 to 5 years and 436 children and adolescents aged 6 to 20 years.
    • Vaccine was effective in both groups; no patients developed rabies.

    Rabavert Note

    Not Applicable

    Rabavert Patient Counseling

    See Literature

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