Serious systemic anaphylactic reactions have been reported and neuroparalytic events have been reported in temporal association with RabAvert, rabies vaccine, administration. Against the background of 11.8 million doses distributed worldwide as of June 30, 1995, 10 cases of encephalitis (1 death) or meningitis, 7 cases of transient paralysis (including 2 cases of Guillain-Barre Syndrome), 1 case of myelitis, 1 case of retrobulbar neuritis, and 2 cases of suspected multiple sclerosis have been temporally associated with the use of RabAvert. Also 2 cases of anaphylactic shock have been reported. Such events pose a dilemma for the attending physician. A patient's risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

RABAVERT MUST NOT BE USED SUBCUTANEOUSLY OR INTRADERMALLY!

RabAvert must be injected intramuscularly. For adults, the deltoid area is the preferred site of immunization; for small children, administration into the anterolateral zone of the thigh is preferred. The use of the gluteal region should be avoided, since administration in this area may result in lower neutralizing antibody titers (2).

DO NOT INJECT INTRAVASCULARLY!

Unintentional intravascular injection may result in systemic reactions, including shock. Immediate measures include catecholamines, volume replacement, high doses of corticosteroids, and oxygen.

Development of active immunity after vaccination may be impaired in immune-compromised individuals. Please refer to Drug Interactions, under

General

Care is to be taken by the health care provider for the safe and effective use of the product. The health care provider should also question the patient, parent or guardian about 1) the current health status of the vaccinee; and 2) reactions to a previous dose of RabAvert, or a similar product. Pre-exposure vaccination should be postponed in the case of such and convalescent persons, and those considered to be in the incubation stage of an infectious disease. A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis and other infectious agents from person to person. Needles should not be recapped and should be properly disposed of. As with any vaccine, vaccination with RabAvert may not protect 100% of susceptible individuals.

Hypersensitivity

RabAvert is produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion should not be immunized with this vaccine. At present there is no evidence that persons are at increased risk if they have egg hypersensitivities that are not anaphylactic or anaphylactoid in nature; however, in this case, HDCV rabies vaccines or RVA should be administered. There is no evidence to indicate that persons with allergies to chickens or feathers are at increased risk of reaction to vaccines produced in chick embryo cell culture.

Since reconstituted RabAvert contains traces of processed bovine gelatin, chicken protein, neomycin, chlortetracycline and amphotericin B, the possibility of allergic reactions in individuals sensitive to these substances should be considered when administering the vaccine. Epinephrine injection (1:1000) must be immediately available should anaphylactic or other allergic reactions occur. When a person with a history of hypersensitivity must be given RabAvert, antihistamines may be given; epinephrine (1:1000), volume replacement, corticosteroids and oxygen should be readily available to counteract anaphylactic reactions.

Drug Interactions

Corticosteroids, other immunosuppressive agents, antimalarials and immunosuppressive illnesses can interfere with the development of active immunity after vaccination, and may diminish the protective efficacy of the vaccine. Pre-exposure prophylaxis should be administered to such persons with the awareness that the immune response may be inadequate. Immunosuppressive agents should not be administered during post-exposure therapy unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, it is important that a serum sample be tested for rabies antibody to ensure that an acceptable antibody response has been induced (23).

Rabies Immuno Globulin must not be administered at more than the recommended dose, since response to active immunization may be impaired.

Use in Pregnancy

Category C. Animal reproductive studies have not been conducted with RabAvert. It is also not known whether RabAvert can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RabAvert should be given to a pregnant woman only if clearly needed. However, because of the potential consequences of inadequately treated rabies exposure, and limited data which indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to post-exposure prophylaxis. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy. However, i n such instances, consideration should be given to removing the pregnant woman from the high risk environment.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies with RabAvert have not been conducted to assess the potential for carcinogenesis, mutagenesis, or impairment of fertility.

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