A Comprehensive HRIG Solution
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 per mL at the wound site, no matter the wound size or patient weight.1-3
Efficiency and flexibility matter in your choice of human rabies immune globulin (HRIG)
ALL IN A VIAL
OF HyperRAB®
(rabies immune globulin [human])
A comprehensive HRIG solution designed with patients, healthcare teams, and institutions in mind.
HyperRAB is the only HRIG that offers all of the following1,4,5
- 1/2 the volume of medication administered in a total dose, potentially resulting in fewer injections
- 2X the concentration of rabies antibodies per mL at the wound site, no matter the size
- 3 vial sizes, including 1 mL, 3 mL, and 5 mL
- 3-year shelf life
- Room temperature storage* (up to 6 months)
- A history of reliable supply
- Rabies education
- Patient assistance program
*Store HyperRAB at 2 to 8°C (36 to 46°F). Do not freeze. Store at room temperatures not to exceed 25°C (77°F) for up to 6 months at any time prior to the expiration date, after which the product must be used or discarded.
Bringing value beyond HyperRAB—A leader in plasma therapeutics for 100 years
4000+
The number of healthcare professionals who have participated in 100+ live Grifols-sponsored educational sessions on rabies postexposure prophylaxis⁴*
* Numbers reflect data collected since 2015
2500+
The number of unique emergency room facilities visited by a Grifols rep with 200+ educational sessions conducted on site at hospitals across the country4*
* Numbers reflect data collected since 2015
A history of innovation
Grifols pioneered many of the sophisticated techniques used in the industry today to collect, test and manufacture plasma-derived medicines.
A leader in plasma collection
Grifols has more than 300 plasma donation centers that provide dependable supply needed to reproduce essential plasma-derived therapies
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.1,6 Review the 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.1
End-to-end control
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.4,5
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.1 HyperRAB can be given up to 7 days after the first dose of rabies vaccine.
Be prepared with at least 22 mL of HyperRAB, enough to treat an average family of five
Administer HRIG and the vaccine correctly
1. Infiltrate the wound site7-9
Administer as much of the dose of HRIG as possible directly into or around the wound where the highest viral load occurs.
HRIG should never be administered in the same syringe or needle or in the same anatomical site as the first vaccine dose.
2. Administer the total dose of HRIG3,4,6,7
Any remaining volume (or if there is no wound) should be injected intramuscularly (IM) at a site distant from vaccine administration. The CDC recommends that the full dose always be administered.
3. Administer the vaccine7,10,11
The vaccine should be injected in the deltoid area opposite of the HRIG injection or wound. Do not inject rabies vaccine or HRIG in the gluteal area due to risk of diminished immunologic response and injury to the sciatic nerve; however, HRIG may be infiltrated in the gluteal area if that is an exposure site.
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).12,13 ‡
‡ If the HyperRAB dose has insufficient volume to infiltrate the entire wound, the HyperRAB dose may be easily diluted with an equal volume of dextrose 5% in water (DSW).1
Enhanced storage capabilities1
Store safely at room temperature
Up to 6 months*
Longest shelf life available among HRIG products4,5
3 years—may decrease some concerns around unused and expiring product
*Store HyperRAB at 2 to 8℃ (36 to 46℉). Do not freeze. Store at room temperatures not to exceed 25℃ (77℉) for up to 6 months at any time prior to the expiration date, after which the product must be used or discarded. Do not return to refrigeration.1
More than 1 million patients treated4
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).14
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.1,14
- 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
Study design
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 21.14
Data are presented as mean ± SD. Adapted from Hanna K et al. 2018.14
Antirabies virus antibody concentrations by RFFIT1,14
Importance of the antirabies virus antibody
HyperRAB provided interim protection until the host immune response to rabies vaccine produced definitive protective titers of neutralizing rabies antibody; therefore, the rabies vaccine series is also essential.1,14
SAFETY AND MANUFACTURING
Continuing to raise the bar for what's possible from HyperRAB
Grifols has provided more than 45 years of consistent supply and product support.
HyperRAB offers:
- A product that is preservative free and is not made with mercury (thimerosal) or natural rubber latex
- US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions1
- Low procoagulant activity4,15
- Low levels of immunoglobulin G (IgG) aggregates4,15
Proven virus clearance capacity4
HyperRAB is produced using a sophisticated caprylate/chromatography purification process that employs the highest quality and safety standards.
Main steps of the manufacturing process:
Caprylate precipitation
Depth filtration
Nanofiltration
Caprylate incubation
Low pH final container incubation
Column chromatography
How the unique HyperRAB manufacturing process works
watch
Learn how HRIG is manufactured
End-to-end manufacturing process
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.
Traceability and transparency of information
- 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
Coding System
HyperRAB CPT Code*
- Coding for HyperRAB
-
90375
- Description
-
Rabies immune globulin (RIG), human, for intramuscular use (150 IU)
Administration Procedures CPT Code*
- Coding for HyperRAB
-
96372
- Description
-
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular
ICD-10-CM†
- Coding for HyperRAB
-
Z20.3
- Description
-
Contact with and (suspected) exposure to rabies
- Coding for HyperRAB
-
Z23
- Description
-
Encounter for immunization
- Coding for HyperRAB
-
Z29.14
- Description
-
Encounter for prophylactic rabies immune globin
- Coding for HyperRAB
-
A82.0
- Description
-
Sylvatic rabies
- Coding for HyperRAB
-
A82.1
- Description
-
Urban rabies
- Coding for HyperRAB
-
A82.9
- Description
-
Rabies, unspecified
- Coding for HyperRAB
-
W53.XXXX
- Description
-
Contact with rodent
- Coding for HyperRAB
-
W54.XXXX
- Description
-
Contact with dog
- Coding for HyperRAB
-
W55.XXXX
- Description
-
Contact with other mammals
HyperRAB NDC‡
- Coding for HyperRAB
-
13533-0318-01
- Description
-
1-mL vial 300 IU/mL (300 IU)
- Coding for HyperRAB
-
13533-0318-03
- Description
-
3-mL vial 300 IU/mL (900 IU)
- Coding for HyperRAB
-
13533-0318-05
- Description
-
5-mL vial 300 IU/mL (1500 IU)
| Coding System | Coding for HyperRAB | Description |
|---|---|---|
|
HyperRAB CPT Code* |
90375 |
Rabies immune globulin (RIG), human, for intramuscular use (150 IU) |
|
Administration Procedures CPT Code* |
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular |
|
ICD-10-CM† |
Z20.3 |
Contact with and (suspected) exposure to rabies |
|
Z23 |
Encounter for immunization |
|
|
Z29.14 |
Encounter for prophylactic rabies immune globin |
|
|
A82.0 |
Sylvatic rabies |
|
|
A82.1 |
Urban rabies |
|
|
A82.9 |
Rabies, unspecified |
|
|
W53.XXXX |
Contact with rodent |
|
|
W54.XXXX |
Contact with dog |
|
|
W55.XXXX |
Contact with other mammals |
|
|
HyperRAB NDC‡ |
13533-0318-01 |
1-mL vial 300 IU/mL (300 IU) |
|
13533-0318-03 |
3-mL vial 300 IU/mL (900 IU) |
|
|
13533-0318-05 |
5-mL vial 300 IU/mL (1500 IU) |
Learn more
About Rabies
Gain a deeper understanding of rabies by exploring further information on this disease
Ordering Information
Interested in ordering HyperRAB? Find more information here
Resources
Discover documents and other helpful resources to help you and your patients understand rabies
Have a question about HyperRAB?
Submit a request to get in contact with a representative.
Important Safety Information for HyperRAB® (rabies immune globulin [human])
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
- HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.
- Siegel J. Rabies Immune Globulin: Ensuring Administration Safety. Pharmacy Practice News Special Edition. 2019: 47-52.
- 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.
- Data on file, Grifols.
- Kedrab. Accessed November 13, 2023. https://kedrab.com/rabies-plasma-manufacturing/
- Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
- 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.
- Mahadevan A, Suja MS, Mani RS, Shankar SK. Perspectives in diagnosis and treatment of rabies viral encephalitis: insights from pathogenesis. Neurotherapeutics. 2016;13(3):477-492.
- Bharti OK, Madhusudana SN, Wilde H. Injecting rabies immunoglobulin (RIG) into wounds only: a significant saving of lives and costly RIG. Hum Vaccin Immunother. 2017;13(4):762-765.
- 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):1-36.
- Rupprecht CE, Scholand S, Singh R. Rabies post-exposure prophylaxis: a patient-centric approach to care. Pharm Pract News. 2020;SR201:1-8.
- Wilde H. Failures of post-exposure rabies prophylaxis. Vaccine. 2007;25(44):7605-7609.
- Wilde H, Sirikawin S, Sabcharoen A, et al. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996;22(2):228-232.
- 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.
- Woznichak M, Vandeberg P, Russ C, et al. Application of a caprylate/chromatography purification process for production of a high potency rabies immune globulin from pooled human plasma. J Immunol Methods. 2021;499:113164.