Human rabies virus immune globulin: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|genericName=Human rabies virus immune globulin
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|drugClass= Immunological Agent
|hasBlackBoxWarning=Yes
|indicationType=prophylaxis
|adverseReactions=<!--Black Box Warning-->
|indication=Rabies, Postexposure
|adverseReactions=Injection site reactions
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
Rabies vaccine and HyperRAB S/D 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. HyperRAB S/D 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.
* Dosing Information


:* Dosage
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]


=====Condition2=====
Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated:


* Dosing Information
1. 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.


:* Dosage
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 countries should be aware that >50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.


=====Condition3=====
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 postexposure antirabies prophylaxis.


* Dosing Information
2. 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.)


:* Dosage
3. 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:


=====Condition4=====
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]


* Dosing Information
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]


:* Dosage
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 airborne rabies have been reported rarely. Adherence to respiratory precautions will minimize the risk of airborne exposure. [24]


<!--Off-Label Use and Dosage (Adult)-->
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.


<!--Guideline-Supported Use (Adult)-->
Bite and nonbite exposures from humans with rabies theoretically could transmit rabies, although no cases of rabies acquired this way have been documented.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
4. Vaccination Status of Biting Animal
A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.


* Class of Recommendation:
5. 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.


* Strength of Evidence:
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.


* Dosing Information
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.


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


=====Condition2=====
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.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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.


<!--Non–Guideline-Supported Use (Adult)-->
[[File:Rabies Ind.png|none|400px]]
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
====Dosage===
The recommended dose for HyperRAB S/D 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 HyperRAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [26] HyperRAB S/D should never be administered in the same syringe or needle or in the same anatomical site as vaccine.


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


=====Condition2=====
[[File:Rabies Dosage.png|none|400px]]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=====Indications====
Rabies, Postexposure; Prophylaxis


* Dosing Information
====Dosage====
 
20 International Units/kg IM for 1 dose
:* Dosage
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->

Revision as of 16:59, 22 April 2015

Human rabies virus immune globulin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Overview

Human rabies virus immune globulin is a Immunological Agent that is FDA approved for the prophylaxis of Rabies, Postexposure. Common adverse reactions include Injection site reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Rabies vaccine and HyperRAB S/D 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. HyperRAB S/D 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:

1. 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 countries 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 postexposure antirabies prophylaxis.

2. 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.)

3. 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 airborne 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.

4. Vaccination Status of Biting Animal A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.

5. 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.

=Dosage

The recommended dose for HyperRAB S/D 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 HyperRAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [26] HyperRAB S/D 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Human rabies virus immune globulin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Human rabies virus immune globulin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Rabies, Postexposure; Prophylaxis

Dosage

20 International Units/kg IM for 1 dose

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Human rabies virus immune globulin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Human rabies virus immune globulin in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Human rabies virus immune globulin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Human rabies virus immune globulin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Human rabies virus immune globulin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Human rabies virus immune globulin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Human rabies virus immune globulin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Human rabies virus immune globulin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Human rabies virus immune globulin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Human rabies virus immune globulin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Human rabies virus immune globulin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Human rabies virus immune globulin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Human rabies virus immune globulin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Human rabies virus immune globulin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Human rabies virus immune globulin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Human rabies virus immune globulin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Human rabies virus immune globulin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Human rabies virus immune globulin in the drug label.

Pharmacology

There is limited information regarding Human rabies virus immune globulin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Human rabies virus immune globulin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Human rabies virus immune globulin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Human rabies virus immune globulin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Human rabies virus immune globulin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Human rabies virus immune globulin in the drug label.

How Supplied

Storage

There is limited information regarding Human rabies virus immune globulin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Human rabies virus immune globulin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Human rabies virus immune globulin in the drug label.

Precautions with Alcohol

  • Alcohol-Human rabies virus immune globulin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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