INDICATION and IMPORTANT SAFETY INFORMATION
RabAvert® is indicated for pre-exposure vaccination, in both primary series and booster dose, and for post-exposure prophylaxis against rabies in all age groups.
- Patients considered to be at risk of a severe hypersensitivity reaction (e.g. anaphylaxis) to RabAvert® or any of its components should receive an alternative rabies vaccine if a suitable product is available.
- Patients considered to be at risk of a severe hypersensitivity reaction (e.g. anaphylaxis) to RabAvert® or any of its components should receive an alternative rabies vaccine if a suitable product is available. However, in view of the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.
- RabAvert® is contraindicated for pre-exposure vaccination in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to the vaccine or any of its components, which include residues of egg and chicken proteins to which some individuals may be hypersensitive.
- Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions, as well as medical history for emergence of clinical symptoms of anaphylaxis after exposure to egg or chicken proteins, which RabAvert® contains. Reconstituted RabAvert® also contains processed bovine gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B, to which some individuals may be hypersensitive. Appropriate medical treatment—including immediately available epinephrine injection (1:1,000), and readily available volume replacement, corticosteroids, and oxygen—must be close at hand to manage possible anaphylactic reactions following administration of RabAvert®. Development of active immunity after vaccination may be impaired in immune-compromised individuals. Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents, and immunosuppressive illnesses can interfere with the development of active immunity after vaccination and may diminish the protective efficacy of RabAvert®. Pre-exposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. If persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, are vaccinated post-exposure, it is important that a serum sample on Day 14 (the day of the fourth vaccination) be tested for rabies antibody to ensure that an acceptable antibody response has been induced.
- Pre-exposure vaccination should be postponed in the case of sick and convalescent persons and those considered to be in the incubation stage of an infectious disease.
- This product contains albumin, a derivative of human blood. It is present in RabAvert® at concentrations of ≤0.3 mg/dose. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeld-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
- Because animal reproductive studies or studies in pregnant or lactating woman have not been conducted with RabAvert®, it is not known whether RabAvert® can cause fetal harm when administered to a pregnant woman, whether it can affect reproduction capacity, or whether it is excreted in animal or human milk with consequent risk to breastfed infants (but many drugs are excreted in human milk). Use RabAvert® in pregnant or lactating women only if clearly needed.
- Pre-exposure vaccination does not eliminate the need for additional therapy after a known rabies exposure. For intramuscular use only. Unintentional intravascular injection may result in systemic reactions, including shock.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including RabAvert®. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
- No data are available regarding the concurrent administration of RabAvert® with other vaccines.
- Administration of human rabies immune globulin (HRIG), which along with prompt local cleaning of wounds should take place before post-exposure prophylaxis, must not exceed the recommended dose, since active immunization to the vaccine may be impaired. HRIG should not be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-833-365-9596 or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.