Indications for: RABAVERT

Preexposure immunization and post-exposure prophylaxis of rabies.

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.

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).

RABAVERT 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.

RABAVERT 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.

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.

How Supplied:

Single-dose vial—1 (w. diluent)