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  • RabAvert
    (rabies vaccine)

    THERAPEUTIC CLASS

    Vaccine

    DEA CLASS

    RX

    INDICATIONS

    For preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies.

    ADULT DOSAGE

    Adults: Preexposure: Primary: 3 doses of 1mL IM on Days 0, 7, and on either 21 or 28. Refer to PI for preexposure vaccination criteria. Booster: 1mL IM in high-risk patients to maintain minimum 1:5 serum dilution by rapid fluorescent focus inhibition test (RFFIT). Postexposure: 5 doses of 1mL IM on Days 0, 3, 7, 14, and 28; administer with Human Rabies Immune Globulin (HRIG) 20 IU/kg on Day 0. Postexposure of Previously Immunized: 2 doses of 1mL IM; immediately after exposure and 3 days later. Refer to PI for additional information on pre/postexposure prophylaxis.

    PEDIATRIC DOSAGE

    Pediatrics: Preexposure: Primary: 3 doses of 1mL IM on Days 0, 7, and on either 21 or 28. Refer to PI for preexposure vaccination criteria. Booster: 1mL IM in high-risk patients to maintain minimum 1:5 serum dilution by RFFIT. Postexposure: 5 doses of 1mL IM on Days 0, 3, 7, 14, and 28; administer with HRIG 20 IU/kg on Day 0. Postexposure of Previously Immunized: 2 doses of 1mL IM; immediately after exposure and 3 days later. Refer to PI for additional information on pre/postexposure prophylaxis.

    ADMINISTRATION

    IM route. Inject into the deltoid muscle (adults) and anterolateral zone of thigh (infants and small children). Refer to PI for reconstitution and administration instructions.

    HOW SUPPLIED

    Inj: 1mL

    WARNINGS/PRECAUTIONS

    Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events (eg, encephalitis, transient paralysis, Guillain-Barre syndrome, myelitis, retrobulbar neuritis), and multiple sclerosis reported; carefully consider patient's risk of developing rabies before deciding to d/c immunization. Do not use SQ, intradermally, or intravascularly. Avoid use of the gluteal region. Active immunity development may be impaired in immune-compromised individuals; test serum sample on Day 14 (the day of the 4th vaccination) for rabies antibody when rabies postexposure prophylaxis is administered to persons who are immunosuppressed. Remote risk for transmission of viral diseases; theoretical risk for transmission of Creutzfeldt-Jakob disease. Postpone preexposure vaccination in the sick, convalescent, or during the incubation stage of an infectious disease. May not protect all recipients. Consider potential for allergic reactions in individuals hypersensitive to bovine gelatin, chicken protein, neomycin, chlortetracycline, and amphotericin B. Anaphylactic or other allergic reactions may occur; have epinephrine (1:1000) available.

    ADVERSE REACTIONS

    Inj-site reactions (erythema, induration, pain), flu-like symptoms, arthralgia, dizziness, lymphadenopathy, nausea, rash, myalgia, headache, malaise.

    DRUG INTERACTIONS

    Radiation, antimalarials, corticosteroids, and other immunosuppressive agents may interfere with the development of active immunity and may diminish protective efficacy of vaccination. Test serum sample on Day 14 (the day of the 4th vaccination) for rabies antibody when rabies postexposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy to ensure induction of acceptable antibody response. Do not give immunosuppressive agents during postexposure therapy unless essential. Do not give HRIG at more than the recommended dose; active immunization to the vaccine may be impaired.

    PREGNANCY AND LACTATION

    Category C, safety not known in nursing.

    MECHANISM OF ACTION

    Vaccine; stimulates the immune system to produce antibodies that may protect against rabies.

    ASSESSMENT

    Assess current health status, immunization history, hypersensitivity, presence of immunosuppression, pregnancy/nursing status, possible drug interactions, or any other conditions where treatment is contraindicated or cautioned.

    MONITORING

    Monitor immune status and for allergic reactions, inj-site reactions, and other adverse reactions.

    PATIENT COUNSELING

    Inform of potential benefits/risks of vaccination and possible adverse reactions. Inform that the vaccine may not result in protection in all vaccinees. Instruct to report any adverse reactions to physician.

    STORAGE

    2-8°C (36-46°F). Use immediately after reconstitution. Protect from light.