Resources

Grifols is committed to bringing you the latest in rabies education, information, and training to help ensure you are providing the best care for patients. So when a patient presents with a potential exposure, there are fewer uncertainties around what needs to be done.

Patient Assistance Program

No patient should have to face the threat of rabies. That's why Grifols created the Patient Assistance Program (PAP), to ensure uninsured patients have access to treatment with HyperRAB. Patients applying for assistance through the PAP must meet the following criteria in order to be eligible for assistance:

  • Earn an annual gross income of 250% of the Federal Poverty Level (FPL) or less. If the annual gross income exceeds 250% of FPL, PAP denial will be issued
  • Patients must be uninsured in order to be eligible for product assistance
  • Documentation of proof of income
  • Diagnosis and dosing must be consistent with FDA-approved label
  • Must be a US citizen or resident and must physically reside in the US or US territory, Puerto Rico, or other US territories
  • Under the care of a US licensed prescriber with an established practice located in the US
  • Documentation of proof of residency will not routinely be required but may be requested at any time by the program through an audit (eg, copy of current valid driver's license or recent utility bill)
  • Patient will receive 1 dose as prescribed
  • Federally funded patients are not eligible to receive assistance through the PAP. This includes but it not limited to Medicare, Medicaid (including spend downs), Tricare, and VA benefits

Download the Patient Assistance Program application to get access to HyperRAB for your patient.

 

Frequently Asked Questions (FAQs)

HyperRAB is manufactured at twice the concentration relative to the predecessor solvent/detergent-treated product, HyperRAB S/D (150 IU/mL).2

HyperRAB is a higher concentration product, resulting in a lower volume per dose administered. For patients, this may mean fewer injections.2

HyperRAB (300 IU/mL) is a higher concentration product. Therefore, HCPs are not only able to administer more rabies antibodies directly into the wound site, but also administer a lower volume to complete the dose for each patient.2

HyperRAB does not need to be diluted except under rare circumstances where there are multiple wound sites or a very large wound to be infiltrated in a very low-weight individual, such as a small child weighing <15 kg, where the total dose volume is insufficient to infiltrate the wound completely.2

If only 1 wound site is present, the Centers for Disease Control and Prevention (CDC) recommends infiltrating that site with as much of the total dose as possible. The total dose of HyperRAB, even for a small child weighing 15 kg (3-4 years of age), is 300 IU (or 1 mL) of product volume.2 This volume is typically sufficient for infiltration into multiple wound sites, if necessary. In the United States, the majority of potentially rabid wild animal exposures involve bats. Bat exposures can result in either very small bites that do not require a large volume of rabies immune globulin infiltration at the wound site(s), or there may be no bite site evident or visible. In either case, the total dose is administered intramuscularly.3

If additional volume is needed to infiltrate the entire wound or multiple wounds, HyperRAB may be diluted with an equal volume of dextrose 5% in water (D5W). Do not dilute HyperRAB with normal saline.2

Per the labeled indication, the rabies vaccine and HyperRAB should be administered to all individuals exposed to rabies, with the exception of those who have been previously immunized with the rabies vaccine. Although the safety and efficacy of HyperRAB in the pediatric population have not been established, the dosing regimen provided in the full Prescribing Information applies to all individuals, including children. Please contact Grifols Medical Information at 1-800-520-2807 for more information.2

During the manufacture of HyperRAB S/D, solvent (TNBP) and detergent (sodium cholate) are added to the fraction II solution. HyperRAB (300 IU/mL) is manufactured using a sophisticated caprylate/chromatography purification process, which significantly reduces procoagulant activity and product impurities such as immunoglobulin G (IgG) aggregates. HyperRAB S/D is no longer sold in the United States.

Administration of both HyperRAB formulations resulted in detectable titers of neutralizing antibodies to the rabies virus that persisted throughout the 21-day study period. Caprylate/chromatography-purified HyperRAB produced a rapid increase in rabies neutralizing antibodies within 24 hours, peaked on day 4, and was maintained through day 21. These results support the conclusion that HyperRAB administration provides reproducible passive transfer of neutralizing antibodies commensurate with the HyperRAB S/D product. The single 20 IU/kg intramuscular dose of HyperRAB was safe and well tolerated. HyperRAB should provide adequate passive adjunctive treatment when combined with vaccination in accordance with guidelines for rabies postexposure prophylaxis.2

HyperRAB is available through all major specialty plasma distributors. In most instances, you should be able to gain access to HyperRAB through your existing distributor.

HyperRAB is not available on consignment through Grifols. Specialty plasma distributors previously offering HyperRAB S/D on consignment will continue to offer HyperRAB on consignment. Check with your distributor for terms and conditions.

HyperRAB contains no preservatives and is not made with natural rubber latex.2

The viscosity of HyperRAB is slightly lower than that of HyperRAB S/D; therefore, there should be no need for a different gauge needle in administration of the higher-potency product.

There are no changes to the process for billing, coding, and reimbursement.  While there will be NDC changes related to the pharmacy benefit, the medical benefit HCPCS/CPT code and the amount of billing units will remain the same for HyperRAB as they were for HyperRAB S/D—ie, 2 units of HCPCS/CPT 90375 (150 IU) for each 1 mL (300 IU) of HyperRAB. All appropriate ICD-10 codes remain the same.

HyperRAB and HyperRAB S/D both consist of human immunoglobulin G (IgG) purified from plasma of donors who have been vaccinated against the rabies virus.2 However, HyperRAB has lower levels of trace impurity proteins such as immunoglobulin A (IgA) and coagulation factors from the starting plasma. In addition, HyperRAB has lower levels of aggregated and dimeric IgG compared to HyperRAB S/D.

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. 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.