Postexposure prophylaxis of rabies in previously unvaccinated children, adolescents, and adults following exposure to rabies disease or virus.
Used in a combined regimen that includes activeimmunization with rabies vaccine and passive immunization with RIG. RIG provides immediate, temporary antibodies until the patient has an immunologic response to active immunization with rabies vaccine.
RIG is not included in rabies postexposure prophylaxis regimens used in individuals who previously received preexposure or postexposure regimens that included rabies vaccine. Passive immunization is not necessary in such individuals and may interfere with the desired anamnestic response to booster doses of rabies vaccine used for postexposure prophylaxis in such individuals.
Rabies is a viral infection transmitted by saliva of infected mammals, most commonly wild, terrestrial carnivores (e.g., skunks, raccoons, foxes, coyotes) or bats. In the US, the greatest risk for naturally-acquired rabies is from contact with and bites from insectivorous bats. Following exposure and infection, rabies virus usually moves along a neural pathway and enters the CNS. After entrance into the CNS, the virus is unlikely to be affected by antirabies antibodies and encephalomyelitis usually develops and almost always is fatal. In the US, approximately 16,000–39,000 individuals receive rabies postexposure prophylaxis each year. Between 1990 and 2004, there were 47 rabies-related deaths in the US. Worldwide, rabies is much more common and about 40,000–100,000 rabies-related deaths occur each year.
Following possible exposure to rabies, base decisions regarding use of postexposure prophylaxis on vaccination status of the exposed individual, type of exposure (bite, nonbite), information about the animal involved (type, vaccination status, condition at time of attack), and rabies epidemiology in the specific geographic region. Whenever possible, consult local or state public health officials regarding the need for postexposure prophylaxis.
Bite exposures include any skin penetration by teeth; all bite exposures from an animal known or suspected to be rabid, regardless of bite location, pose a potential risk of rabies transmission and require postexposure prophylaxis. Risk of transmission varies in part based on the species of biting animal, anatomic site of bite, and severity of wound. Rabies transmission can occur from bites of some animals (e.g., bats) that inflict rather minor injury and wounds that are difficult to detect.
Any potential exposure to a bat requires thorough evaluation. If possible, the bat should be submitted for rabies diagnosis. Postexposure prophylaxis is not necessary if the individual can be reasonably certain a bite, scratch, or mucous membrane exposure did not occur or if the bat is available for testing and is negative for rabies virus. Situations that might qualify as exposures include finding a bat in the same room as a person who might be unaware that a bite or direct contact has occurred (e.g., a deeply sleeping individual awakened to find a bat in the room; an adult observes a bat in the room with a previously unattended child, mentally disabled person, or intoxicated person). Other household members who do not have direct contact with the bat or were awake and aware when in the room with the bat should not be considered as having exposure to rabies.
Nonbite exposures include contamination of preexisting open wounds, abrasions, mucous membranes, or scratches with saliva or other potentially infectious material (e.g., neural tissue) from an animal known or suspected to be rabid. Although nonbite exposures only rarely cause rabies, such exposures require assessment to determine if sufficient reasons exist to consider postexposure prophylaxis. Nonbite exposures of highest risk occur in surgical recipients of corneas, solid organs, and vascular tissue transplanted from patients who died of rabies and individuals exposed to large amounts of aerosolized rabies virus.
Other forms of contact in the absence of a bite or nonbite exposure (e.g., petting a rabid animal; contact with blood, urine, or feces of a rabid animal; contact of saliva with intact skin) are not considered exposure, and postexposure prophylaxis is not necessary.
In health-care personnel, routine delivery of health care to a patient with rabies is not an indication for postexposure rabies prophylaxis, unless there was exposure of mucous membranes or nonintact skin to potentially infectious body fluids.
Regardless of immunization status, ACIP and AAP recommend local wound treatment as an essential initial step in rabies postexposure prophylaxis in all individuals. (See General under Dosage and Administration.)
For ACIP recommendations regarding rabies postexposure prophylaxis in the US based on the type and status of the animal involved, see the table.
Recommendations for Rabies Postexposure Prophylaxis
Animal Type
Evaluation and Disposition of Animal
Postexposure Prophylaxis Recommendations
Dogs, cats, ferrets
Healthy and available; confine for 10 days of observation
Do not begin prophylaxis unless animal develops clinical signs of rabies
Rabid or suspected rabid
Immediately begin postexposure prophylaxis
Unknown (e.g., 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 postexposure prophylaxis
Livestock, small rodents, lagomorphs (rabbits, hares), large rodents (woodchucks, beavers), 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 rabies postexposure prophylaxis
During the 10-day observation period, begin postexposure prophylaxis in the exposed individual at the first sign of rabies in the dog, cat, or ferret that has bitten them. If the animal exhibits clinical signs of rabies, euthanize it immediately and perform appropriate testing.
Initiate postexposure prophylaxis as soon as possible following exposure to such wildlife, unless animal is available for testing and public health authorities are facilitating expeditious laboratory testing or it is already known that brain material from the animal has tested negative. Other factors that might influence urgency of decision-making regarding initiation of postexposure prophylaxis before diagnostic results are known include the animal species, general appearance and behavior of the animal, whether encounter was provoked by a human, and the severity and location of bites. Discontinue postexposure prophylaxis if appropriate laboratory tests (i.e., direct fluorescent antibody test) are negative.
Euthanize the animal and test as soon as possible. Holding for observation is not recommended.
Adapted from the Recommendations of the Advisory Committee on Immunization Practices (ACIP) on Human Rabies Prevention. MMWR Recomm Rep. 2008; 57:1-28.
Because the rabies incubation period can range from 5 days to >1 year, initiate rabies postexposure prophylaxis (regardless of the length of delay) if a documented or likely exposure has occurred and clinical signs of rabies have not appeared in the exposed individual.
Postexposure prophylaxis failures have not been reported in the US when recommended immunization and wound management procedures were followed using commercially available rabies vaccines and RIG. Rare reports of failures in other countries usually involved some deviation from recommended procedures (e.g., failure to adequately cleanse wounds, IM injection of the vaccine into the gluteal rather than deltoid region, failure to passively immunize with RIG by infiltrating the wound site, use of less than the recommended dose of RIG).
Travelers with potential rabies exposure should immediately contact local health authorities for advice regarding postexposure prophylaxis and also should contact their personal clinician or state health department as soon as possible. Travelers in other countries may receive postexposure prophylaxis with regimens and/or preparations not currently recommended by ACIP, resulting in the need for additional therapy following return to the US. Consider serologic testing in these travelers to verify efficacy of the regimen used and to ensure an adequate immune response. (See Pre- and Postvaccination Serologic Testing under Cautions.)
Dosage and Administration
General
Rabies postexposure prophylaxis in previously unvaccinated individuals involves thorough cleansing of all bite and nonbite wounds followed by passiveimmunization with a single dose of RIG and active immunization with a series of 5 doses of rabies vaccine.
RIG is not indicated for postexposure prophylaxis in individuals who previously received rabies vaccine for preexposure vaccination or postexposure prophylaxis. (See Specific Drugs under Interactions.)
Because rabies virus may remain localized at the site of inoculation, immediately wash all bites and scratches with soap and water; irrigate with a virucidal agent (e.g., povidone-iodine solution). Institute tetanus prophylaxis and measures to control secondary infection as indicated. Consider cosmetic factors and the potential for bacterial infection before deciding to suture large wounds.
Administration
Administer by local infiltration with or without IM administration.
Do not administer IV. (See Administration Precautions under Cautions.)
Local Infiltration
Infiltrate the recommended dose of RIG in the area around and into the wound(s) if anatomically feasible.
When the volume required to infiltrate the wound(s) exceeds the recommended dose of RIG, some clinicians recommend diluting the calculated dose in saline to yield a two- to threefold increase in solution volume to ensure that all wound areas receive adequate infiltration.
IM Administration
After infiltrating wound(s) area, administer any remaining portion of the recommended RIG dose by IM injection into the gluteal area or anterolateral thigh.
Generally, do not administer RIG into buttock muscle in children because of potential for injection-associated injury to the sciatic nerve.
Avoid injection into or near blood vessels or nerves. Although the manufacturers and some experts recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered, ACIP and AAP state that this procedure is not required because large blood vessels are not present at recommended IM injection sites.
To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass.
Do not administer RIG in the same syringe or at the same injection site as rabies vaccine. (See Specific Drugs under Interactions.)
Do not mix with other immune globulins, vaccines, or solutions.
Commercially available 2-mL prefilled syringes provided with a fixed needle and without graduations on the syringe (HyperRAB® S/D) should not be used if doses <2 mL are indicated, if doses ≤2 mL must be injected into multiple sites, or if an alternate needle size is required because of patient, wound, or site of injection. In such situations, consult the manufacturer's literature for specific administration instructions regarding use of the 2-mL prefilled syringes.
Dosage
Pediatric Patients
Postexposure Prophylaxis of Rabies
Previously Unvaccinated Children and Adolescents
Local Infiltration followed by IM
Single dose of 20 international units/kg. Infiltrate into area of wound(s); administer any remaining portion of the dose by IM injection. (See Administration under Dosage and Administration.)
Commercially available 2-mL vials (HyperRAB® S/D, Imogam® Rabies-HT) or 2-mL prefilled syringes (HyperRAB® S/D) contain 300 international units of RIG (sufficient dose for a 15-kg child).
Give RIG dose as soon as possible after exposure (day 0), preferably at the time of the first dose of rabies vaccine.
If rabies vaccine is not immediately available, administer RIG and start active immunization with the vaccine as soon as possible. If RIG is not immediately available, it may be administered at any time through day 7 following the first vaccine dose; RIG is not necessary after day 7 since sufficient vaccine-induced antirabies antibody will be present in most vaccine recipients.
Do not exceed the recommended RIG dose; do not give repeated doses of RIG. (See Specific Drugs under Interactions.)
Adults
Postexposure Prophylaxis of Rabies
Previously Unvaccinated Adults
Local Infiltration followed by IM
Single dose of 20 international units/kg. Infiltrate into area of wound(s); administer any remaining portion of the dose by IM injection. (See Administration under Dosage and Administration.)
Commercially available 10-mL vials (HyperRAB® S/D, Imogam® Rabies-HT) contain 1500 international units of RIG (sufficient dose for a 75-kg adult).
Give RIG dose as soon as possible after exposure (day 0), preferably at the time of the first dose of rabies vaccine.
If rabies vaccine is not immediately available, administer RIG and start active immunization with the vaccine as soon as possible. If RIG is not immediately available, it may be administered at any time through day 7 following the first vaccine dose; RIG is not necessary after day 7 since sufficient vaccine-induced antirabies antibody will be present in most vaccine recipients.
Do not exceed the recommended RIG dose; do not give repeated doses of RIG. (See Specific Drugs under Interactions.)
Prescribing Limits
Pediatric Patients
Local Infiltration followed by IM
Maximum total dose of 20 international units/kg.
Adults
Local Infiltration followed by IM
Maximum total dose of 20 international units/kg.
Special Populations
Hepatic Impairment
No specific dosage recommendations.
Renal Impairment
No specific dosage recommendations.
Geriatric Patients
No specific dosage recommendations.
Cautions
Contraindications
Repeated doses of RIG after active immunization with rabies vaccine is initiated. (See Specific Drugs under Interactions.)
Warnings/Precautions
Warnings
Risk of Transmissible Agents in Plasma-derived Preparations
Because RIG (HyperRAB® S/D, Imogam® Rabies-HT) is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).
Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.
The manufacturing processes for RIG include certain chemical (solvent/detergent) treatment procedures and/or heat-treatment procedures to reduce viral infectious potential.
Solvent/detergent inactivation processes apparently can inactivate lipid-enveloped (e.g., hepatitis B virus [HBV], hepatitis C virus [HCV], HIV type 1 and type 2 [HIV-1 and HIV-2]), but are less effective against viruses that do not have a lipid envelope (e.g., hepatitis A virus [HAV], parvovirus B-19). Certain filtering procedures are effective in reducing levels of some enveloped and non-enveloped viruses.
Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge that may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, administer RIG only when a benefit is expected.
Any infection believed to have been transmitted by RIG should be reported to the appropriate manufacturer.
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylaxis has been reported rarely following administration of human immune globulins.
Use with caution in individuals with history of systemic allergic reactions to immune globulins.
Epinephrine and other appropriate therapy should be readily available in case anaphylaxis occurs.
Selective IgA Deficiency
HyperRAB® S/D may contain IgA.
Use caution in individuals with IgA deficiency since such individuals may have serum antibodies to IgA and anaphylaxis could result following administration of preparations containing IgA. Weigh potential benefits against potential for hypersensitivity reactions.
General Precautions
Administration Precautions
Do not administer RIG in the same syringe or at the same injection site as rabies vaccine. (See Specific Drugs under Interactions.)
Do not administer IV. Inadvertent IV injection may result in serious systemic reactions; epinephrine should be available if an acute anaphylactic reaction occurs.
Individuals with Altered Immunocompetence
May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.
Recommendations regarding use of RIG in individuals with altered immunocompetence are the same as those for individuals who are not immunocompromised.
If rabies postexposure prophylaxis is indicated in an immunocompromised individual, serologic testing is considered essential to confirm than an adequate antibody response is obtained. Perform serologic testing 14 days after the postexposure prophylaxis regimen is initiated (i.e., day of the fourth vaccine dose) to document seroconversion. (See Pre- and Postvaccination Serologic Testing under Cautions.)
Individuals with Bleeding Disorders
Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals.
ACIP states that IM injections can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the injection can be administered with reasonable safety. In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. If patient is receiving antihemophilia therapy, administer the IM dose shortly after a scheduled dose of such therapy.
Advise the individual and/or their family about the risk of hematoma from IM injections.
Duration of Immunity
RIG provides only short-term protection against rabies. Half-life of RIG following an IM dose is about 21–24 days.
Rabies postexposure prophylaxis includes combined passiveimmunization with RIG and active immunization with rabies vaccine to provide effective and more prolonged immunity against rabies. Additional (booster) doses of RIG not currently recommended.
Pre- and Postvaccination Serologic Testing
Serologic testing is not indicated prior to postexposure prophylaxis in previously vaccinated individuals who are exposed to rabies. Such testing is inappropriate because it would delay postexposure prophylaxis and, although antirabies neutralizing antibodies are an important component of immunity, other immune effectors also play a role in disease prevention.
Serologic confirmation of rabies immunity following postexposure prophylaxis with a combined regimen of passive immunization with RIG and active immunization with rabies vaccine is not necessary in most individuals because of the high rate of response among immunocompetent adults and children when the recommended postexposure regimen is used.
If serologic testing for serum antirabies antibody is performed 2–4 weeks after postexposure prophylaxis, the minimum antibody titer needed to confer rabies immunity as defined by the CDC is complete virus neutralization at a 1:5 serum dilution when determined by rapid fluorescent-focus inhibition test (RFFIT). WHO considers an antirabies antibody titer of ≥0.5 international units/mL a protective level of rabies immunity.
If postexposure prophylaxis is indicated in an immunocompromised individual, serologic testing is considered essential to confirm that a protective antibody response was obtained. Perform serologic testing 14 days after the postexposure prophylaxis regimen is initiated (i.e., day of the fourth vaccine dose) to document protective antibody levels in individuals receiving immunosuppressive agents (e.g., those receiving corticosteroids for the treatment of life-threatening neuroparalytic reactions to rabies vaccine).
Specific Populations
Pregnancy
Category C.
Pregnancy is not considered a contraindication for postexposure prophylaxis with RIG because of the potential risks of inadequately treated rabies exposure.
Lactation
Not known whether RIG is distributed into milk; use caution.
Pediatric Use
HyperRAB® S/D: Safety and efficacy not established in children.
ACIP and AAP recommend that postexposure prophylaxis (including use of RIG) in children follow the same guidelines as those in adults.
Geriatric Use
Information not available regarding differences in efficacy and safety between geriatric and younger individuals.
Antibodies present in immune globulins, including RIG, may interfere with the immune response to certain live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rotavirus vaccine live oral, rubella virus vaccine live, varicella virus vaccine live); these vaccines should not be administered simultaneously with or for specified intervals before or after administration of RIG. (See Specific Drugs under Interactions.) There is no evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live, typhoid vaccine live oral, influenza virus vaccine live intranasal, or poliovirus vaccine live oral (OPV; no longer commercially available in the US).
Inactivated Vaccines and Toxoids
Immune globulins, including RIG, are not expected to have a clinically important effect on the immune response to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, and toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after administration of RIG.
Potential for decreased antibody response to postexposure prophylaxis using combined active immunization with rabies vaccine and passive immunization with RIG; increased risk of rabies infection despite use of postexposure prophylaxis
Avoid immunosuppressive therapy in patients receiving rabies postexposure prophylaxis unless such therapy is considered essential for treatment of other serious conditions
If rabies postexposure prophylaxis is used in an individual receiving immunosuppressive agents, perform serologic testing for rabies antibody 14 days after postexposure regimen is initiated (i.e., day of the fourth vaccine dose) to confirm adequate immune response (See Pre- and Postvaccination Serologic Testing under Cautions.)
RIG may interfere with the immune response to measles virus vaccine live and rubella virus vaccine live; the effect of RIG on the immune response to mumps virus vaccine live is unknown
Manufacturers of HyperRAB® S/D and Imogam® Rabies-HT state that MMR (or its individual components) should not be administered simultaneously with or within 3 months before or after RIG
ACIP and AAP recommend an interval of at least 4 months between administration of MMR (or its individual components) and RIG
Rabies vaccine
Passively acquired antirabies antibody, which is present in RIG, may partially suppress the active immune response to rabies vaccine; there is evidence that a single RIG dose of 20 international units/kg given at the same time as the first dose of rabies vaccine provides maximum circulating antirabies antibody with minimal interference with the active immune response to the vaccine
Neutralization of rabies vaccine may occur if RIG and rabies vaccine are mixed in the same syringe or administered into the same injection site
If rabies postexposure prophylaxis requires active immunization with rabies vaccine and passive immunization with RIG, a single dose of RIG should be administered simultaneously with the first vaccine dose; infiltrate the full RIG dose around the wound(s) if anatomically feasible and administer any remaining portion of the RIG dose IM (using a different syringe and injection site than rabies vaccine)
To minimize potential suppression of the active immune response to the vaccine, do not give single doses of RIG >20 international units/kg and do not give repeated RIG doses
RIG may be administered simultaneously with or through day 7 after the first dose of rabies vaccine without impairing the active immune response to the vaccine
RIG is not indicated for postexposure prophylaxis in individuals who previously received recommended preexposure or postexposure regimens of human diploid-cell rabies vaccine (Imovax®), purified chick embryo cell culture (RabAvert®), Imovax® Rabies I.D. (no longer commercially available in the US]), or rabies vaccine adsorbed (RVA) (no longer commercially available in the US) or in those who previously received other rabies vaccines and have documented protective antirabies antibody titers
Rotavirus vaccine
RIG may interfere with the immune response to rotavirus vaccine
Safety and efficacy data not available regarding use of rotavirus vaccine in infants who have received an immune globulin within 42 days
If possible, defer dose of rotavirus vaccine until 42 days (6 weeks) after the immune globulin; use a shorter interval if the 42-day deferral would result in the first dose of rotavirus vaccine being scheduled at ≥13 weeks of age
Typhoid vaccine
Oral live typhoid vaccine (Vivotif®): No evidence that immune globulin preparations, including RIG, interfere with the immune response to the vaccine
Parenteral inactivated typhoid vaccine (Typhim Vi®): Specific studies evaluating concomitant use with immune globulins not available; interaction not expected since this is an inactivated vaccine
Oral live typhoid vaccine (Vivotif®): May be given simultaneously with or at any time before or after RIG
Parenteral inactivated typhoid vaccine (Typhim Vi®): May be given simultaneously with RIG (using different syringes and injection sites) or at any time before or after RIG
Varicella vaccine
Passively acquired antirabies RIG may interfere with the immune response to varicella virus vaccine live
Manufacturers of HyperRAB® S/D and Imogam® Rabies-HT state that live vaccines should not be administered simultaneously with or within 3 months after RIG
ACIP and AAP recommend an interval of at least 4 months between administration of varicella virus vaccine live and RIG
No evidence that immune globulin preparations, including RIG, interfere with the immune response to yellow fever virus vaccine live
Yellow fever vaccine may be given simultaneously with RIG (using different syringes and injection sites) or at any time before or after RIG
Pharmacokinetics
Absorption
Bioavailability
Absorbed slowly following IM administration.
Following a single IM dose of 20 international units/kg, antirabies antibody appears in serum within 24 hours, peaks within 2–13 days, and persists through day 21.
Distribution
Extent
Although specific information not available, it is likely that RIG crosses the placenta since other immunoglobulins cross the placenta.
Information on distribution of RIG into milk not available; RIG may be distributed into milk since immunoglobulins (e.g., IgA, IgM, IgG) are present in colostrum.
Elimination
Half-life
About 21–24 days following IM administration.
Stability
Storage
Parenteral
Injection
HyperRAB® S/D and Imogam® Rabies-HT: 2–8°C. Do not freeze; if freezing occurs, discard RIG.
HyperRAB® S/D and Imogam® Rabies-HT do not contain thimerosal or any other preservatives. Discard any unused portion.
Actions
RIG commercially available in the US is a sterile, nonpyrogenic solution prepared from plasma of healthy individuals with high titers of antibody to rabies antigen (average or minimum potency 150 international units/mL).
RIG is used to provide temporary passive immunity to rabies infection as part of a postexposure prophylaxis regimen in unvaccinated individuals exposed to rabies virus. Specific antirabies antibodies present in RIG neutralize rabies virus and inhibit the spread of the virus and its infective properties.
Following rabies exposure and inoculation, the virus remains close to the wound for an indeterminate time and can be partially neutralized by direct contact with RIG at this site. In susceptible individuals, the virus may move along a neural pathway toward the CNS. Following entrance into the CNS, the virus is unlikely to be affected by antibodies, and a fatal encephalomyelitis almost always develops.
Incubation period for rabies infection varies from 5 days to several years (usually 20–60 days). After severe bites to the face, neck, or arms, the incubation period may be as short as 10 days.
Development of immunity and protection from rabies infection are determined by appearance of antirabies antibody in serum. Minimum titers of antirabies antibodies conferring protection not definitely established to date (varies among laboratories and by type of test performed). CDC considers antirabies antibody titers ≥1:5 as determined by RFFIT to be indicative of a protective response to rabies immunization. WHO considers a titer of ≥0.5 international units/mL to be protective. However, presence of an adequate antibody titer may not be an absolute indication of protection against rabies.
Data from CDC indicate that 100% of individuals who receive postexposure prophylaxis with a single dose of RIG and at least 5 IM doses of rabies vaccine develop antibody titers ≥1:16. In individuals exposed to rabies within the last 2 months, a single dose of RIG and a 5-dose IM regimen of rabies vaccine results in mean titers of rabies antibody as determined by RFFIT that are 0.9 and 14.6 international units/mL at 14 and 42 days, respectively.
Advice to Patients
Advise patient and/or patient's parent or guardian of the risks and benefits of RIG.
Advise patient and/or patient's guardian that RIG is only one component of a regimen used to prevent rabies in individuals who have been bitten, scratched, or licked on an open wound by an animal known or suspected of having rabies.
When rabies postexposure prophylaxis is indicated in previously unvaccinated individuals, importance of receiving a single dose of RIG and completing a 5-dose series of rabies vaccine as soon as possible following rabies exposure.
Importance of informing clinicians if the patient has altered immunocompetence because of disease (e.g., cancer, HIV/AIDS) or immunosuppressive therapy (e.g., corticosteroids, cancer treatment).
Importance of informing clinicians if any adverse reactions (e.g., hypersensitivity reactions) occur.
Advise patient and/or patient's parent or guardian that HyperRAB® S/D and Imogam® Rabies-HT are prepared from pooled human plasma. Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, RIG is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of CJD or vCJD.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information.
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Rabies Immune Globulin (Human)
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Parenteral
Injection
150 units/mL
HyperRAB® S/D (solvent/detergent treated; with glycine 0.21–0.32 M; preservative-free; available in 10-mL single-dose vials and prefilled 2-mL single-dose syringes)
Talecris
Imogam® Rabies-HT (heat treated; with glycine 0.3 M; preservative-free; available in 2- or 10-mL single-dose vials)
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
