Redefining HRIG Administration

HyperRAB (300 IU/mL) is the first and only high-potency human rabies immune globulin (HRIG) that enables the delivery of more of the total dose at the wound site.2

A higher-potency formulation, offering potentially fewer total injections in administration of each dose2

HyperRAB product advantages; high-potency formula, lowest volume per dose and more rabies antibodies per ml2

Provide immediate protection with HyperRAB

HyperRAB is an HRIG that provides rapid immune coverage, indicated for postexposure prophylaxis (PEP), along with rabies vaccine, for all persons suspected of exposure to rabies.2,3 Review CDC guidelines for PEP.

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 PEP. Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.2,4  

Grifols is the only manufacturer that has complete end-to-end control over the entire process—collection, testing, fractionation, and supply—enabling a consistent and reliable supply of HyperRAB.

Find out more about the unique manufacturing process for HyperRAB.

Dosing and Administration

Dosing recommendations for HyperRAB

The recommended dose for HyperRAB is 20 IU/kg (0.0665 mL/kg) of actual body weight administered at the time of the first vaccine dose.2 HyperRAB can be given up to 7 days after the first dose of rabies vaccine.4

Dosing Calculator

Enter your patient's actual body weight to determine their HyperRAB dose.

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The maximum weight allowed is 450 kg

The maximum weight allowed is 990 lb

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Administer HRIG and the vaccine correctly

Human body showing the routes of administration of HRIG and rabies vaccine.

The most common causes of postexposure prophylaxis (PEP) management failures are when the HRIG is not fully administered, it is not administered into the wound(s) and injected only IM, or injections are not administered to all bite wound(s).7,8‡

Watch a video to learn more about the
proper administration of HyperRAB.

Clinical Efficacy

In an open-label, single-arm study of 12 healthy volunteers, rabies virus antibody titers were assessed following a single 20 IU/kg IM injection of HyperRAB. This was measured by a rapid fluorescent focus inhibition test (RFFIT).2

HyperRAB (rabies immune globulin [human]) 300 IU/mL produced a substantial increase in antirabies virus antibody concentrations during a 21-day period in which peak values were achieved.2,9

  • Elevated antibody levels and the corresponding reciprocal titers persisted through day 21
  • Elevation in rabies antibody level was prompt and resulted in detectable titers of neutralizing antibody present by 24 hours (mean 0.113 IU/mL and mean titer 10.3 on day 1)
  • The reciprocal titer results from this study are comparable to an earlier open-label, single-center study of HyperRAB S/D in 8 subjects given a 20 IU/kg dose IM

In the clinical study, subjects underwent a screening period of up to 21 days, when safety assessments and laboratory tests were performed to ascertain eligibility. A single IM dose of HyperRAB was administered to eligible subjects on day 0, followed by repeated measurements of rabies virus antibody concentrations on days 1, 2, 4, 6, 8, 10, 14, 18, and 21.2,9

Graph showing the importance of the antirabies virus antibody in the first 25 days

Safety and Manufacturing

Always a leader. Always dependable.

Grifols has provided more than 45 years of consistent supply and product support.

HyperRAB offers1,2:

HyperRAB safety key points Main steps of the manufacturing process of HyperRAB

How the unique HyperRAB manufacturing process works

Explanation of the plasma fractionation, IgG purification and formulation processes used to develop HyperRAB

To provide additional assurance of the pathogen safety of the final product, the capacity of the HyperRAB manufacturing process to remove and/or inactivate viruses has been demonstrated by laboratory spiking studies on a scaled-down process model using a wide range of viruses with diverse physicochemical properties. This process provides the final product with a high margin of safety from the potential risk of transmission of infectious viruses. 

The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.

HyperRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the vCJD agent, and, theoretically, the CJD agent.

Additional safeguards for all plasma donations

Grifols employs a comprehensive tracking system called PediGri® that ensures full traceability from every donation.

  • Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
  • Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
    • Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product
  • Users can access the applicable product SPC/package insert for their country

For immediate, easy, and convenient access to all the information on the origin and quality of Grifols' plasma derivatives, visit www.pedigri.grifols.com.

Coding Information

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. HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.
  3. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
  4. 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.
  5. 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.
  6. Atkinson WL, Pickering LK, Schwartz B, Weniger BG, Iskander JK, Watson JC; Centers for Disease Control and Prevention. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR Recomm Rep. 2002;51(RR-2):1-35.
  7. Wilde H. Failures of post-exposure rabies prophylaxis. Vaccine. 2007;25(44):7605-7609.
  8. Wilde H, Sirikawin S, Sabcharoen A, et al. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996;22(2):228-232.
  9. Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018;10:79-88.