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.

When rabies is suspected, trust HyperRAB

Celebrating 50 years of rabies protection and a continued commitment to innovation and support

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

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.

#1 Prescribed HRIG in the US4
More than 1 million patients treated4

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

3000+

The number of hospitals visited by a Grifols rep to provide education on rabies 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.

Dosing calculator

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

Unit

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The maximum weight allowed is 990 lbs

The maximum weight allowed is 450 kg

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Quantity

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1-mL Vial(s)

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3-mL Vial(s)

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5-mL Vial(s)

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Dose needed

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Number of vials*

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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

watch

See how to properly administer HRIG

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

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

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

Data are presented as mean ± SD. Adapted from Hanna K et al. 2018.14

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)

* Current Procedural Terminology (CPT) 5-digit codes, nomenclature, and other data are © 2019 American Medical Association (AMA).
† Optum, ICD-10-CM for Hospitals and Payers, Volumes 1, 2, and 3, publisher of the official code set issued by the Department of Health and Human Services.
‡ For billing purposes, an 11-digit National Drug Code (NDC) is required.
The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.

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

Have a question about HyperRAB?

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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

  1. HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.
  2. Siegel J. Rabies Immune Globulin: Ensuring Administration Safety. Pharmacy Practice News Special Edition. 2019: 47-52.
  3. 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.
  4. Data on file, Grifols.
  5. Kedrab. Accessed November 13, 2023. https://kedrab.com/rabies-plasma-manufacturing/
  6. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Rupprecht CE, Scholand S, Singh R. Rabies post-exposure prophylaxis: a patient-centric approach to care. Pharm Pract News. 2020;SR201:1-8.
  12. Wilde H. Failures of post-exposure rabies prophylaxis. Vaccine. 2007;25(44):7605-7609.
  13. Wilde H, Sirikawin S, Sabcharoen A, et al. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996;22(2):228-232.
  14. 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.
  15. 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.