Visit RabiesWatch for more information on rabies exposures and the virus in the US.

The only human rabies immunoglobulin (HRIG) with a higher-potency formulation, offering potentially fewer injections in administration of each dose.


Use the only HRIG that offers


 

HyperRAB is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies.

Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.

For unvaccinated persons, the combination of HyperRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.


Postexposure Prophylaxis (PEP) for Rabies

More than 60,000 people report coming in contact with potentially rabid animals and receive rabies PEP each year.1

According to the Centers for Disease Control and Prevention (CDC), rabies is almost always fatal, but it is almost 100% preventable.  Comprehensive treatment can only be provided by a rabies immune globulin, such as HyperRAB (rabies immune globulin [human]) 300 IU/mL, in conjunction with a vaccine.2
 
 

Be Sure to follow the CDC postexposure prophylaxis schedule3

CDC postexposure prophylaxis schedule

For more information, recommendations, and guidelines, visit the CDC Advisory Committee on Immunization Practices (ACIP).

 

Imminent Threat-Immediate Protection

Vaccines can take weeks to build efficacy, but HyperRAB provides immediate protection. This allows the vaccine the time needed to establish active immunity, giving your patients the critical protection they need now.5

HyperRAB contains high titers of rabies antibodies for PEP, providing rapid immune protection. Along with appropriate wound cleansing, a human rabies immune globulin such as HyperRAB is recommended by the CDC and World Health Organization (WHO) to be administered at the same time as the rabies vaccine in previously unvaccinated persons, immediately following a transdermal bite or scratch by an animal suspected of being rabid.2,6
 
For unvaccinated individuals, the combination of human rabies immune globulin and vaccine is recommended for both bite and nonbite exposures, regardless of the time interval between exposure and initiation of PEP.
 
If PEP has been initiated and appropriate laboratory diagnostic testing (ie, the direct fluorescent antibody test) indicates that the animal that caused the exposure was not rabid, PEP may be discontinued.2

Neutralizing the Virus

When administering the rabies immunoglobulin (RIG), focus on neutralizing the virus:

Infiltration matters

  • The highest viral load occurs at the wound site(s)
  • The CDC recommends that if anatomically feasible, the full dose of RIG should be thoroughly infiltrated in the area around and into the wound(s)7
  • The most commonly encountered causes of PEP management failures are when RIG is not used at all, it is injected only intramuscularly (IM) and not into wound(s), or not all bite wound(s) are injected8,9

Administration of the total dose matters

  • The CDC recommends that a total dose (20 IU/kg) always be administered7
  • Any remaining volume following infiltration of the wound should be injected IM at a site distant from vaccine administration7

RIG volume matters

Weight-based dosing can create challenges with the volume required to be administered in a total dose:

  • Anatomical constraints of some wounds (eg, ear, nose, or finger) can limit the portion of the dose that can be injected10,11
  • Risk of compartment syndrome should be minimized when possible11
  • Locating sufficient distant sites on the body to complete administration of the total dose can be challenging10

HyperRAB twice the potency

 

Dosing Recommendations

The recommended dose for HyperRAB is 20 IU/kg (0.0665 mL/kg) of body weight given at time of first vaccine dose. It may also be given up to the eighth day after the first dose of vaccine.4

HyperRAB® (rabies immune globulin [human]) 300 IU/mL
High-potency formulation

HyperRAB Product Information

Trusted Dependability

Trust more than 40 years of leadership. HyperRAB1,4:

  • Mercury (thimerosal), latex, and preservative free
  • Food and Drug Administration (FDA) labeling for pathogenic prion removal
  • Low procoagulant activity
  • Low levels of IgG aggregates
  • Tamper-evident packaging
 

Manufacturing Process

Caprylate function within the caprylate/chromatography purification process

  • Caprylate is a naturally occurring octanoic fatty acid that facilitates precipitation of impurities and provides an effective capacity to remove/inactivate viruses in case of contamination12,13
  • Immunoglobulin G (IgG) remains soluble and stable during processing, which minimizes loss of functionality13
  • Protein purification is achieved by sequential passage through anion exchange chromatographic columns13

Pathogen safety

  • 5 steps with capacity to remove/inactivate viruses including emerging viruses (e.g., West Nile virus)14
  • FDA labeling for capacity to remove pathogenic prions4
  • Since the implementation of sensitive serological screening tests over 30 years ago15-17
    • No confirmed case of virus transmission by IgG products for intramuscular injection
    • No case of prion transmission, including human form bovine spongiform encephalopathy

HyperRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Indication and Usage

HYPERRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies.

Limitations of Use 

Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.

For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.

Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

Important Safety Information

For infiltration and intramuscular use only.

Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

HYPERRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain.

Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration.  

Please see full Prescribing Information for HyperRAB.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


References:

  1. Data on file, Grifols.
  2. Centers for Disease Control and Prevention. Human rabies prevention — United States, 2015: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2008;57(RR03):my1-26,28.
  3. Rupprecht CE, Briggs D, Brown CM, et al; Centers for Disease Control and Prevention (CDC). Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2010;59(RR-2):1-9.
  4. HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.
  5. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
  6. World Health Organization (WHO). Rabies. Current strategies for human rabies pre and post-exposure prophylaxis. WHO website. http://www.who.int/rabies/human/postexp/en/#. Updated 2016. Accessed April 11, 2016.
  7. Manning SE, Rupprecht CE, Fishbein D, et al; Advisory Committee on Immunization Practices Centers for Disease Control and Prevention (CDC). Human rabies prevention—United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28.
  8. Wilde H. Failures of post-exposure rabies prophylaxis. Vaccine. 2007;25(44):7605-7609.
  9. Wilde H, Sirikawin S, Sabcharon A, et al. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996;22(2):228-232.
  10. Madhusudana SN, Ashwin BY, Sudarshan S. Feasibility of reducing rabies immunoglobulin dosage for passive immunization against rabies: results of in vitro and in vivo studies. Hum Vaccin Immunother. 2013;9(9):1914-1917.
  11. SAGE Working Group on Rabies vaccines and immunoglobulins and the World Health Organization (WHO) Secretariat. Background paper: proposed revision of the policy on rabies vaccines and rabies immunoglobulins. September 22, 2017. http://www.who.int/immunization/sage/meetings/2017/october/1_Background_paper_WG_RABIES_ nal.pdf. Accessed March 8, 2018.
  12. Gelfand EW. Differences between IGIV products: impact on clinical outcomes. Int Immunopharmacol. 2006;6(4):592-599.
  13. Bertolini J. The purification of plasma proteins for therapeutic use. In: Simon TL, McCullough SJ, Snyder EL, Solheim BJ, Strauss RG, eds. Rossi's Principles of Transfusion Medicine. 5th ed. London, UK: John Wiley & Sons, Ltd; 2016.
  14. Barnette D, Roth NJ, Hotta J, et al. Pathogen safety profile of a 10% IgG preparation manufactured using a depth filtration-modified process. Biologicals.
2012;40(4):1-7.
  15. Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion. 1999;39(11-12):1160-1168.
  16. European Medicines Agency. Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. EMA/CHMP/BWP/360642/2010 rev. 1. 15 December 2011.
  17. European Medicines Agency. CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. EMA/CHMP/BWP/303353/2010. 23 June 2011.