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BayRab

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BayRab

Indications
Dosage
How Supplied

INDICATIONS

Rabies vaccine and BayRab (rabies immune globulin (human) solvent/detergent treated) should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. BayRab (rabies immune globulin (human) solvent/detergent treated) should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.

Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP).19

Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated:

Species of Biting Animal

Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies in the United States since 1960.20 Unless the animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or nonbite exposure to these animals (see item 3 below). If treatment has been initiated and subsequent testing in a competent laboratory shows the exposing animal is not rabid, treatment can be discontinued.

In the United States, the likelihood that a domestic dog or cat is infected with rabies varies from region to region; hence, the need for postexposure prophylaxis also varies. However, in most of Asia and all of Africa and Latin America, the dog remains the major source of human exposure; exposures to dogs in such countries represent a special threat. Travelers to those coun-tries should be aware that .50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.

Rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are rarely found to be infected with rabies and have not been known to cause human rabies in the United States. However, from 1971 through 1988, woodchucks accounted for 70% of the 179 cases of rabies among rodents reported to CDC.21 In these cases, the state or local health department should be consulted before a decision is made to initiate post-exposure antirabies prophylaxis.

Circumstances of Biting Incident

An unprovoked attack is more likely to mean that the animal is rabid. (Bites during attempts to feed or handle an apparently healthy animal may generally be regarded as provoked.)

Type of Exposure

Rabies is transmitted only when the virus is introduced into open cuts or wounds in skin or mucous membranes. If there has been no exposure (as described in this section), postexposure treatment is not necessary. Thus, the likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure. Two categories of exposure should be considered:

Bite: any penetration of the skin by teeth. Bites to the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment.22

Bat-associated strains of rabies can be transmitted to humans either directly through a bat's bite or indirectly through the bite of an animal previously infected by a bat. Because some bat bites may be less severe, and can go completely undetected, unlike bites inflicted by larger animals, especially mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded.23

Nonbite: scratches, abrasions, open wounds or mucous membranes contaminated with saliva or any potentially infectious material, such as brain tissue, from a rabid animal constitute nonbite exposures. If the material containing the virus is dry, the virus can be considered noninfectious. Casual contact, such as petting a rabid animal and contact with the blood, urine, or feces (e.g., guano) of a rabid animal, does not constitute an exposure and is not an indication for prophylaxis. Instances of air-borne rabies have been reported rarely. Adherence to respiratory precautions will minimize the risk of airborne exposure.24

The only documented cases of rabies from human-to-human transmission have occurred in patients who received corneas transplanted from persons who died of rabies undiagnosed at the time of death. Stringent guidelines for acceptance of donor corneas have reduced this risk.

Bite and nonbite exposures from humans with rabies theoretically could transmit rabies, although no cases of rabies acquired this way have been documented.

Vaccination Status of Biting Animal

A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.

Presence of Rabies in Region

If adequate laboratory and field records indicate that there is no rabies infection in a domestic species within a given region, local health officials are justified in considering this in making recommendations on antirabies treatment following a bite by that particular species. Such officials should be consulted for current interpretations.

Rabies Postexposure Prophylaxis

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, and presence of rabies in the region. Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.

Local Treatment of Wounds: Immediate and thorough washing of all bite wounds and scratches with soap and water is perhaps the most effective measure for preventing rabies. In experimental animals, simple local wound cleansing has been shown to reduce markedly the likelihood of rabies.

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

Active Immunization: Active immunization should be initiated as soon as possible after exposure (within 24 hours). Many dosage schedules have been evaluated for the currently available rabies vaccines and their respective manufacturers' literature should be consulted.

Passive Immunization: A combination of active and passive immunization (vaccine and immune globulin) is considered the acceptable postexposure prophylaxis except for those persons who have been previously immunized with rabies vaccine and who have documented adequate rabies antibody titer. These individuals should receive vaccine only. For passive immunization, Rabies Immune Globulin (Human) is preferred over antirabies serum, equine.16,19 It is recommended both for treatment of all bites by animals suspected of having rabies and for nonbite exposure inflicted by animals suspected of being rabid. Rabies Immune Globulin (Human) should be used in conjunction with rabies vaccine and can be administered through the seventh day after the first dose of vaccine is given. Beyond the seventh day, Rabies Immune Globulin (Human) is not indicated since an antibody response to cell culture vaccine is presumed to have occurred.

Rabies Postexposure Prophylaxis Guide19

Animal species Condition of animal at time of exposure/attack Treatment of exposed person [1]
Dog and cat Healthy and available for 10 days of observation
Rabid or suspected rabid Unknown (escaped)
None, unless animal develops rabies [2]
RIGH [3] and HDCV Consult public health officials
Skunk, bat, fox, coyote, raccoon, bobcat, and other carnivores; woodchuck Regard as rabid unless animal proven negative by laboratory tests [4] RIGH [3] and HDCV
Livestock, rodents, and lagomorphs (rabbits and hares) Consider individually. Local and state public health officials should be consulted on questions about the need for rabies prophylaxis. In most geo graphical areas bites of squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other rodents, rabbits, and hares almost never require antirabies postexposure prophylaxis
[1] ALL POSTEXPOSURE PROPHYLAXIS SHOULD BEGIN WITH IMMEDIATE THOROUGH CLEANSING OF THE WOUND (IF ONE CAN BE DETECTED) WITH SOAP AND WATER. If antirabies treatment is indicated, both Rabies Immune Globulin (Human) [RIGH] and human diploid cell rabies vaccine (HDCV) should be given as soon as possible, REGARDLESS of the interval from exposure.
[2] During the usual holding period of 10 days, begin postexposure prophylaxis at first sign of rabies in a dog or cat that has bitten someone. If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
[3] If RIGH is not available, use antirabies serum, equine (ARS). Do not use more than the recommended dosage.
[4] The animal should be euthanized and tested as soon as possible. Holding for observation is not recommended. Discontinue vaccine if immunofluorescence test results of the animal are negative.

DOSAGE AND ADMINISTRATION

The recommended dose for BayRab (rabies immune globulin (human) solvent/detergent treated) is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose.8,9 It may also be given through the seventh day after the first dose of vaccine is given. If anatomically feasible, up to the full dose of BayRab (rabies immune globulin (human) solvent/detergent treated) should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the gluteal area or lateral thigh muscle. Because of risk of injury to the sciatic nerve, the central region of the gluteal area MUST be avoided; only the upper, outer quadrant should be used.26 BayRab (rabies immune globulin (human) solvent/detergent treated) should never be administered in the same syringe or needle or in the same anatomical site as vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Rabies postexposure prophylaxis schedule—United States, 199919

Vaccination status Treatment Regimen*
Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
RIG Administer 20 IU/kg body weight. If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration. Also, RIG should not be administered in the same syringe as vaccine. Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given.
Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area), one each on days 0 § , 3, 7, 14, and 28.
Previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
  RIG RIG should not be administered.
  Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area), one each on days 0 § and 3.
HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin;
RVA=rabies vaccine adsorbed; IM, intramuscular
* These regimens are applicable for all age groups, including children.
The deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used. Vaccine should never be administered in the gluteal area.
§ Day 0 is the day the first dose of vaccine is administered.
Any person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination.

HOW SUPPLIED

BayRab (rabies immune globulin (human) solvent/detergent treated) is packaged in 2 mL and 10 mL single dose vials with an average potency value of 150 international units per mL (IU/mL). The 2 mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg. The 10 mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg.

NDC Number Size
0026-0618-02 2 mL vial
0026-0618-10 10 mL vial

Storage

BayRab (rabies immune globulin (human) solvent/detergent treated) should be stored under refrigeration (2-8°C, 36-46°F). Solution that has been frozen should not be used.

Caution

U.S. federal law prohibits dispensing without prescription.

Limited Warranty

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness is made. Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert for this product, except by printed notice from the Company's headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

8. Cabasso VJ, Loofbourow JC, Roby RE, et al: Rabies immune globulin of human origin: preparation and dosage determination in non-exposed vol-unteer subjects. Bull WHO 45:303-15, 1971.

9. Loofbourow JC, Cabasso VJ, Roby RE, et al: Rabies immune globulin (human): clinical trials and dose determination. JAMA 217(13): 1825-31, 1971.

16. Bahmanyar M, Fayaz A, Nour-Salehi S, et al: Successful protection of humans exposed to rabies infection: postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum. JAMA 236(24):2751-4, 1976.

19. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Rabies prevention—United States, 1999. MMWR 48 (RR-1):1-21, 1999.

20. Reid-Sanden FL, Dobbins JG, Smith JS, et al: Rabies surveillance in the United States during 1989. J Am Vet Med Assoc 197(12):1571-83, 1990.

21. Fishbein DB, Belotto AJ, Pacer RE, et al: Rabies in rodents and lagomorphs in the United States, 1971-1984: increased cases in the woodchuck (Marmota monax) in mid-Atlantic states. J Wildl Dis 22(2):151-5, 1986.

22. Hattwick MAW: Human rabies. Public Health Rev 3(3):229-74, 1974.

23. Epidemiologic Notes and Reports: Human Rabies—California, 1994. MMWR 43(25):455-457, 1994.

24. Garner JS, Simmons BP: Guideline for isolation precautions in hospitals. Infect Control 4(4 Suppl):245-325, 1983.

26. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13):205-14; 219-27, 1989.

Bayer Corporation, Pharmaceutical Division, Elkhart, IN 46515 USA. Revision: April 1999.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
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