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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

    Rabies Vaccine

    Preexposure:
    Primary:
    3 doses of 1mL IM on Days 0, 7, and on either 21 or 28
    Booster:
    1mL IM in high-risk patients to maintain a minimum 1:5 serum dilution by the rapid fluorescent focus inhibition test; test serum sample for rabies antibodies every 6 months in patients in the continuous risk category (eg, rabies research lab workers, rabies biologics production workers)

    Postexposure:
    5 doses of 1mL IM on Days 0, 3, 7, 14, and 28; administer w/ human rabies immune globulin (HRIG) 20 IU/kg on Day 0; HRIG is not indicated for >7 days after initiating therapy w/ the vaccine
    Postexposure of Previously Immunized Persons:
    2 doses of 1mL IM, 1 dose immediately after exposure and 1 dose 3 days later; if immune status of a previously vaccinated person is not known, full postexposure antirabies treatment (HRIG + 5 doses of vaccine) is recommended

    Refer to PI for pre/postexposure prophylaxis guides

    PEDIATRIC DOSAGE

    Rabies Vaccine

    Preexposure:
    Primary:
    3 doses of 1mL IM on Days 0, 7, and on either 21 or 28
    Booster:
    1mL IM in high-risk patients to maintain a minimum 1:5 serum dilution by the rapid fluorescent focus inhibition test; test serum sample for rabies antibodies every 6 months in patients in the continuous risk category (eg, rabies research lab workers, rabies biologics production workers)

    Postexposure:
    5 doses of 1mL IM on Days 0, 3, 7, 14, and 28; administer w/ human rabies immune globulin (HRIG) 20 IU/kg on Day 0; HRIG is not indicated for more than 7 days after initiating therapy w/ the vaccine
    Postexposure of Previously Immunized Persons:
    2 doses of 1mL IM, 1 dose immediately after exposure and 1 dose 3 days later; if immune status of a previously vaccinated person is not known, full postexposure antirabies treatment (HRIG + 5 doses of vaccine) is recommended

    Refer to PI for pre/postexposure prophylaxis guides

    ADMINISTRATION

    IM route

    Inject into the deltoid muscle (adults) or anterolateral zone of thigh (infants and small children)
    If anatomically feasible, the full dose of HRIG should be thoroughly infiltrated in the area around and into the wounds; inject any remaining volume of HRIG IM at a site distant from rabies vaccine administration
    Do not administer HRIG in the same syringe or in the same anatomical site as the rabies vaccine

    Reconstitution
    1. Using the longer of the 2 needles supplied, withdraw entire contents of the sterile diluent for the vaccine into the syringe
    2. Insert needle at a 45° angle and slowly inject entire contents of diluent into vaccine vial
    3. Mix gently to avoid foaming
    4. Withdraw total amount of dissolved vaccine into syringe and replace long needle w/ smaller needle for IM inj; use immediately

    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.