Important Safety Information
- People with a history of severe allergic reaction (e.g., anaphylaxis) to RabAvert or any of its ingredients should not receive RabAvert…
Indication
RabAvert is a vaccine approved for all age groups to help prevent rabies infection both before and after a suspected exposure.
…for protection before a potential exposure (PrEP) to the rabies virus. They should receive a different rabies vaccine if a suitable product is available. However, because rabies is almost always fatal if left untreated, the protection provided with RabAvert after a potential exposure (PEP) to the rabies virus outweighs the risks associated with a severe allergic reaction.
- The ingredients of RabAvert, which could in rare cases, cause allergic reactions in some people, include egg and chicken proteins, processed bovine (cow) gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B. Let your healthcare professional know if you have had any issues, including allergic reactions, with any of these ingredients or with vaccines in general.
- Severe, potentially life-threatening allergic reaction, swelling of the brain and spinal cord; loss of movement or sensation due to nerve damage, such as inflammation of the brain or temporary loss of movement; Guillain-Barré Syndrome; inflammation of spinal cord; inflamed nerves of the eye; and multiple sclerosis have in very rare cases been reported.
- RabAvert should be injected into muscle only. RabAvert injected into a vein may cause a reaction throughout the body, including shock.
- Fainting can occur when injectable vaccines are used, including RabAvert. Your healthcare provider should put procedures in place to avoid falling injury and to restore blood flow to the brain after fainting.
- Patients with a weakened immune system due to illness or the use of certain medications or treatments (such as radiation therapy, antimalarials, and corticosteroids) may have issues developing immunity. If such a patient is receiving RabAvert, then the healthcare professional may measure immune response through blood testing. Vaccination with RabAvert for protection before a potential exposure (PrEP) to the rabies virus should be delayed in anyone who is sick or recovering from an illness.
- RabAvert contains albumin which is a protein found in human blood that carries an extremely remote risk for transmission of viral diseases, including Creutzfeldt-Jakob disease (CJD), a rare brain disorder. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
- Persons who have not been previously vaccinated against rabies will receive Human Rabies Immune Globulin (HRIG). HRIG should not be administered to persons who have been previously vaccinated as it may counteract the effect of the rabies vaccine. Let your healthcare provider know if you were previously vaccinated for rabies as you may not need HRIG.
- Only use RabAvert while pregnant or breastfeeding if clearly needed. RabAvert was not studied in pregnant or lactating women so it is not known if RabAvert can cause any harm to the fetus, have any effect on ability to get pregnant, or whether it is passed through breast milk to infants (but many drugs are excreted in human milk).
- There is no information on how RabAvert works when given at the same time as other vaccines.
- The most common side effects in clinical trials were reactions at the injection site, such as reddening, hardening, and pain; flu-like symptoms, such as lack of energy, tiredness, fever, headache, muscle pain, and feeling of discomfort; joint pain; dizziness; swelling of lymph nodes; upset stomach; and rash.
- Vaccination before a potential exposure (PrEP) to the rabies virus does not remove the need for additional therapy after a suspected or known rabies exposure.
- Seek the advice of a healthcare professional to help assess your specific level of risk if you are traveling to areas of high risk of rabies exposure; in frequent contact with the rabies virus or rabid animals, such as on the job; and/or are active outdoors and could encounter animals with rabies in the wild.
- If you are exposed to a potentially rabid animal, seek medical attention right away before you have symptoms. Once symptoms are present, the rabies infection has spread through the body and survival is unlikely.
Uses for RabAvert
RabAvert is a vaccine approved for all age groups to help prevent rabies infection both before and after a suspected exposure.
Patients should always ask their healthcare professionals for medical advice about the appropriate use of vaccines and adverse events. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either
visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
Please see full Prescribing Information