Vaccine Information: RabAvert (Page 2 of 4)

The sooner treatment is begun after exposure, the better. However, there have been instances in which the decision to begin treatment was made as late as 6 months or longer after exposure due to delay in recognition that an exposure had occurred. Postexposure antirabies treatment should always include administration of both passive antibody (HRIG) and immunization, with the exception of persons who have previously received complete immunization regimens (preexposure or postexposure) with a cell culture vaccine, or persons who have been immunized with other types of vaccines and have had documented rabies antibody titers. Persons who have previously received rabies immunization should receive 2 IM doses of RabAvert: one on Day 0 and another on Day 3. They should not be given HRIG as this may blunt their rapid memory response to rabies antigen.

Postexposure Prophylaxis Outside the United States: If postexposure treatment is begun outside the US with regimens or biologics that are not used in the US, it may be prudent to provide additional treatment when the patient reaches the US. State or local health departments should be contacted for specific advice in such cases.1

CONTRAINDICATIONS

Preexposure Prophylaxis:

Hypersensitivity: History of anaphylaxis to the vaccine or any of the vaccine components constitutes a contraindication to preexposure vaccination with this vaccine.

Postexposure Prophylaxis: In view of the almost invariably fatal outcome of rabies, there is no contraindication to postexposure prophylaxis, including pregnancy.1

WARNINGS

Patients considered to be at risk of a severe hypersensitivity reaction to the vaccine or any of the vaccine components should receive an alternative rabies vaccine if a suitable product is available.

Anaphylaxis, meningitis; neuroparalytic events such as encephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RabAvert. See PRECAUTIONS and ADVERSE REACTIONS. A patient’s risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

For intramuscular use only. For adults, the deltoid area is the preferred site of immunization; for small children and infants, 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.1

Unintentional intravascular injection may result in systemic reactions, including shock.

Syncope (fainting) can occur in association with administration of injectable vaccines, including RabAvert. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. See PRECAUTIONS and ADVERSE REACTIONS.

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

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.

PRECAUTIONS

General: The healthcare provider should 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. Preexposure 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. A separate, sterile syringe and needle should be used for each patient. Needles must not be recapped and should be properly disposed of. As with any rabies vaccine, vaccination with RabAvert may not protect 100% of susceptible individuals.

Hypersensitivity: RabAvert contains residues of egg and chicken proteins, such as ovalbumin. In instances where individuals have developed clinical symptoms of anaphylaxis such as generalized urticaria, upper airway (lip, tongue, throat, laryngeal, or epiglottal) edema, laryngeal spasm or bronchospasm, hypotension, or shock, following exposure to egg or chicken protein, the vaccine should only be administered by personnel with the capability and facilities to manage anaphylaxis post vaccination.

Since reconstituted RabAvert contains processed bovine gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B, the possibility of allergic reactions in individuals hypersensitive to these substances should be considered when administering the vaccine.

Epinephrine injection (1:1,000) 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 (1:1,000), volume replacement, corticosteroids, and oxygen should be readily available to counteract anaphylactic reactions.

Drug Interactions: 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 the vaccine. Preexposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. Immunosuppressive agents should not be administered during postexposure therapy unless essential for the treatment of other conditions. When rabies postexposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, 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.1

HRIG must not be administered at more than the recommended dose, since active immunization to the vaccine may be impaired.

No data are available regarding the concurrent administration of RabAvert with other vaccines.

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.

Use in Pregnancy: 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. The ACIP has issued recommendations for use of rabies vaccine in pregnant women.1

Use in Nursing Mothers: It is not known whether RabAvert is excreted in animal or human milk, but many drugs are excreted in human milk. Although there are no data, because of the potential consequences of inadequately treated rabies exposure, nursing is not considered a contraindication to postexposure prophylaxis. If the risk of exposure to rabies is substantial, preexposure vaccination might also be indicated during nursing.

Pediatric Use: Children and infants receive the same dose of 1 mL, given intramuscularly, as do adults.

Only limited data on the safety and efficacy of RabAvert in the pediatric age group are available. However, in 3 studies some preexposure and postexposure experience has been gained12,19,26 (see CLINICAL PHARMACOLOGY: Clinical Studies).

Geriatric Use: Clinical studies of RabAvert did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

ADVERSE REACTIONS

In very rare cases, neurological and neuroparalytical events have been reported in temporal association with administration of RabAvert (see WARNINGS). These include cases of hypersensitivity (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration, and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia, and malaise; arthralgia; dizziness; lymphadenopathy; nausea; and rash.

A patient’s risk of acquiring rabies must be carefully considered before deciding to discontinue vaccination. Advice and assistance on the management of serious adverse reactions for persons receiving rabies vaccines may be sought from the state health department or CDC (see CONTRAINDICATIONS).

Local reactions such as induration, swelling, and reddening have been reported more often than systemic reactions. In a comparative trial in normal volunteers, Dreesen et al.. 4 described their experience with RabAvert compared with an HDCV rabies vaccine. Nineteen subjects received RabAvert and 20 received HDCV. The most commonly reported adverse reaction was pain at the injection site, reported in 45% of the HDCV group and 34% of the group receiving RabAvert. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15% RabAvert vs. 25% HDCV), headache (10% RabAvert vs. 20% HDCV), and dizziness (15% RabAvert vs. 10% HDCV). In a recent study in the US5 , 83 subjects received RabAvert and 82 received HDCV. Again, the most common adverse reaction was pain at the injection site in 80% in the HDCV group and 84% in the group receiving RabAvert. The most common systemic reactions were headache (52% RabAvert vs. 45% HDCV), myalgia (53% RabAvert vs. 38% HDCV), and malaise (20% RabAvert vs. 17% HDCV). None of the adverse events were serious; almost all adverse events were of mild or moderate intensity. Statistically significant differences between vaccination groups were not found. Both vaccines were generally well tolerated.

Uncommonly observed adverse events include temperatures above 38°C (100°F), swollen lymph nodes, pain in limbs, and gastrointestinal complaints. In rare cases, patients have experienced severe headache, fatigue, circulatory reactions, sweating, chills, monoarthritis, and allergic reactions; transient paresthesias and 1 case of suspected urticaria pigmentosa have also been reported.

Observed During Clinical Practice (See WARNINGS and PRECAUTIONS): The following adverse reactions have been identified during post approval use of RabAvert. Because these reactions are reported voluntarily from a population of uncertain size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to RabAvert, or a combination of these factors:

Allergic: Anaphylaxis, Type III hypersensitivity-like reactions, bronchospasm, urticaria, pruritus, edema.

Central Nervous System: Neuroparalysis, encephalitis, meningitis, transient paralysis, Guillain-Barré Syndrome, myelitis, retrobulbar neuritis, multiple sclerosis, presyncope, syncope, vertigo, visual disturbance.

Cardiac: Palpitations, hot flush.

Local: Extensive limb swelling.

Skin and Subcutaneous Tissue Disorders: Angioedema.

The use of corticosteroids to treat life-threatening neuroparalytic reactions may inhibit the development of immunity to rabies (see PRECAUTIONS, Drug Interactions).

Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory and antipyretic agents.

Reporting of Adverse Events: Adverse events should be reported by the healthcare provider or patient to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Report forms and information about reporting requirements or completion of the form can be obtained from VAERS by calling the toll-free number 1-800-822-7967.1 In the US, such events can be reported to Bavarian Nordic: phone: 1-800-675-9596.

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