Vaccine Information: IMOVAX RABIES (Page 2 of 4)

B. Post-exposure

The essential components of rabies post-exposure prophylaxis are wound treatment and, for previously unvaccinated persons, the administration of both human rabies immune globulin (RIG) and vaccine. (11)

1. Local treatment of wounds

Thorough washing and flushing (for about 15 minutes, if possible) with soap or a cleansing agent and copious amounts of water of all bite wounds and scratches should be done immediately or as early as possible. Where available, an iodine-containing, or similarly viricidal, topical preparation should be applied to the wound. (12)

Tetanus prophylaxis and measures to control bacterial infection should be given as indicated.

2. Specific treatment

The sooner treatment is begun after exposure, the better. Post-exposure antirabies vaccination should always include administration of both passive antibody and vaccine, with the exception of persons who have ever previously received complete vaccination regimens (pre-exposure or post-exposure) with a cell culture vaccine or persons who have been vaccinated with other types of vaccines and have previously had a documented rabies virus neutralizing antibody titer. These persons should receive only vaccine (ie, post-exposure for a person previously vaccinated). The combination of RIG and vaccine is recommended for both bite and nonbite exposures reported by persons who have never been previously vaccinated for rabies, regardless of the interval between exposure and initiation of prophylaxis. If post-exposure prophylaxis has been initiated and appropriate laboratory diagnostic testing (ie, the direct fluorescent antibody test) indicates that the exposing animal was not rabid, post-exposure prophylaxis can be discontinued. (11)

3. Treatment outside the United States

If post-exposure is begun outside the United States with locally produced biologics, it may be desirable to provide additional treatment when the patient reaches the US. State or local health departments should be contacted for specific advice in such cases. (11)

POST-EXPOSURE RABIES PROPHYLAXIS GUIDE

The following recommendations are only a guide. In applying them, take into account the animal species involved, the circumstances of the bite or other exposure, the vaccination status of the animal, the availability of the exposing animal for observation or rabies testing, and the presence of rabies in the region (see Table 2). Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis. (11)

Table 2: Post-exposure Treatments Guide (11)
Animal type Evaluation and disposition of animal Post-exposure prophylaxis recommendations
*
During the 10-day observation period, begin post-exposure prophylaxis at the first sign of rabies in a dog, cat, or ferret that has bitten someone. If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
Post-exposure prophylaxis should be initiated as soon as possible following exposure to such wildlife unless the animal is available for testing and public health authorities are facilitating expeditous laboratory testing or it is already known that brain material from the animal has tested negative. Other factors that might influence the urgency of decision-making regarding initiation of post-exposure prophylaxis before diagnostic results are known include the species of the animal, the general appearance and behavior of the animal, whether the encounter was provoked by the presence of a human, and the severity and location of bites. Discontinue vaccine if appropriate laboratory diagnostic test (ie, the direct fluorescent antibody test) is negative.
The animal should be euthanized and tested as soon as possible. Holding for observation is not recommended.
Dogs, cats, and ferrets Healthy and available for 10 days observation. Persons should not begin prophylaxis unless animal develops clinical signs of rabies.*
Rabid or suspected rabid. Immediately begin prophylaxis.
Unknown (eg, escaped). Consult public health officials.
Skunks, raccoons, foxes, and most other carnivores; bats Regard as rabid unless animal proven negative by laboratory tests. Consider immediate prophylaxis.
Livestock, small rodents (rabbits and hares), large rodents (woodchucks and beavers), and other mammals Consider individually. Consult public health officials. Bites from squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other small rodents, rabbits, and hares almost never require anti-rabies post-exposure prophylaxis.

CONTRAINDICATIONS

Pre-exposure Prophylaxis

Do not administer to anyone with a known life-threatening systemic hypersensitivity reaction to any component of the vaccine (see WARNINGS, PRECAUTIONS, and DESCRIPTION sections).

Post-exposure Prophylaxis

None.

WARNINGS

  • Do not inject the vaccine into the gluteal area as administration in this area may result in lower neutralizing antibody titers. (11)
  • The product is provided in a single dose vial. Because the single dose vial contains no preservative, it is not to be used as a multidose vial for intradermal injection.
  • In both pre-exposure and post-exposure immunization, the full 1.0 mL dose should be given intramuscularly.
  • Serum sickness type reactions have been reported in persons receiving booster doses of rabies vaccine for pre-exposure prophylaxis. The reaction is characterized by onset approximately 2 to 21 days post-booster, presents with a generalized urticaria, and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise. None of the reported reactions were life-threatening. This has been reported in up to 7% of persons receiving booster vaccination. (13)
  • Rare cases of neurologic illness resembling Guillain-Barré syndrome, (14) (15) a transient neuroparalytic illness, that resolved without sequelae in 12 weeks and a focal subacute central nervous system disorder temporally associated with HDCV, have been reported. (16)
  • This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

All serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine should be immediately reported to VAERS at 1-800-822-7967 (http://vaers.hhs.gov) or Sanofi Pasteur Inc., 1-800-VACCINE (1-800-822-2463).

  • Vaccination with Imovax Rabies vaccine may not protect 100% of vaccinated individuals.

PRECAUTIONS

  • IN ADULTS AND CHILDREN THE VACCINE SHOULD BE INJECTED INTO THE DELTOID MUSCLE. IN INFANTS AND SMALL CHILDREN, THE ANTEROLATERAL ASPECT OF THE THIGH MAY BE PREFERABLE.
  • When a person with a history of hypersensitivity must be given rabies vaccine, antihistamines may be given. Epinephrine (1:1000) and other appropriate agents should be readily available to counteract anaphylactic reactions, and the person should be carefully observed after immunization.
  • While the concentration of antibiotics in each dose of vaccine is extremely small, persons with known hypersensitivity to any of these agents, or any other component of the vaccine, could manifest an allergic reaction. While the risk is small, it should be weighed in light of the potential risk of contracting rabies.

DRUG INTERACTIONS

Corticosteroids, other immunosuppressive agents or treatments, and immunosuppressive illnesses can interfere with the development of active immunity and predispose the patient to developing rabies. 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 steroids or other immunosuppressive therapy, it is especially important that serum be tested for rabies antibody to ensure that an adequate response has developed. (11)

USAGE IN PREGNANCY

Pre-exposure

Animal reproduction studies have not been conducted with Imovax Rabies vaccine. It is also not known whether Imovax Rabies vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Imovax Rabies vaccine should be given to a pregnant woman only if potential benefits outweigh potential risks. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy. (11)

Post-exposure

Because of the potential consequences of inadequately treated rabies exposure and limited data that indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to post-exposure prophylaxis. (11) (17)

USAGE IN NURSING MOTHERS

It is not known whether Imovax Rabies vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Imovax Rabies vaccine is administered to a nursing woman.

PEDIATRIC USE

Both safety and efficacy in children have been established.

Adverse Reactions to IMOVAX RABIES

  • 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, antihistaminic, and antipyretic agents. (11)
  • Reactions after vaccination with HDCV have been observed. (13) In a study using five doses of HDCV, local reactions such as pain, erythema, swelling or itching at the injection site were reported in about 25% of recipients of HDCV, and mild systemic reactions such as headache, nausea, abdominal pain, muscle aches, and dizziness were reported in about 20% of recipients. (8)
  • Serious systemic anaphylactic or neuroparalytic reactions occurring during the administration of rabies vaccines pose a dilemma for the attending physician. A patient’s risk of developing rabies must be carefully considered before deciding to discontinue vaccination. Moreover, the use of corticosteroids to treat life-threatening neuroparalytic reactions carries the risk of inhibiting the development of active immunity to rabies. It is especially important in these cases that the serum of the patient be tested for rabies antibodies. Advice and assistance on the management of serious adverse reactions in persons receiving rabies vaccines may be sought from the local or state health department. (8)
  • SEE WARNINGS AND CONTRAINDICATIONS SECTIONS FOR ADDITIONAL STATEMENTS.

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