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Frequently Asked Questions (FAQs)

HyperRAB (300 IU/mL) is manufactured at twice the concentration relative to the predecessor solvent/detergent-treated product, HyperRAB S/D (150 IU/mL).

HyperRAB (300 IU/mL) is a higher concentration product, resulting in a lower volume per dose administered. For patients, it may mean fewer injections.

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.

HyperRAB (300 IU/mL) does not need to be diluted unless under rare circumstances 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.
 
If only 1 wound site is present, the CDC recommends infiltrating that site with as much of the total dose as possible. The total dose of HyperRAB (300 IU/mL), even for a small child weighing 15 kg (3-4 years of age), is 300 IU (or 1 mL) of product volume. 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, and the total dose is administered intramuscularly.
 
If additional volume is needed to infiltrate the entire wound or multiple wounds, HyperRAB (300 IU/mL) may be diluted with an equal volume of dextrose 5% (D5W). Do not dilute HyperRAB (300 IU/mL) with normal saline.

Per the labeled indication, the rabies vaccine and HyperRAB (300 IU/mL) 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 (300 IU/mL) 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.

During the manufacture of HyperRAB S/D, solvent (TNBP) and detergent (sodium cholate) is added to the Fraction II solution. HyperRAB (300 IU/mL) is manufactured using a sophisticated caprylate chromatography process, which significantly reduces procoagulant activity and product impurities such as IgG aggregates.

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 (300 IU/mL) produced a rapid increase in rabies neutralizing antibodies within 24 hours, peaked on day 4, and maintained through day 21. These results support the conclusion that HyperRAB (300 IU/mL) administration provides reproducible passive transfer of neutralizing antibodies commensurate with the HyperRAB S/D product. The single 20 IU/kg intramuscular dose of HyperRAB (300 IU/mL) was safe and well tolerated. HyperRAB (300 IU/mL) should provide adequate passive adjunctive treatment when combined with vaccination in accordance with guidelines for rabies postexposure prophylaxis.

HyperRAB (300 IU/mL) is available through all major specialty plasma distributors. In most instances, you should be able to gain access to HyperRAB (300 IU/mL) through your existing distributor.

HyperRAB (300 IU/mL) is not available on consignment through Grifols. Specialty plasma distributors previously offering HyperRAB S/D on consignment will continue to offer HyperRAB (300 IU/mL) on consignment. Check with your distributor for terms and conditions. 

HyperRAB (300 IU/mL) contains no preservatives and is not made with natural rubber latex.

The viscosity of HyperRAB (300 IU/mL) 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 (300 IU/mL) as they were for HyperRAB S/D—i.e., 2 units of HCPCS/CPT 90375 (150 IU) for each 1 mL (300 IU) of HyperRAB (300 IU/mL).  All appropriate ICD10 codes remain the same. 

HyperRAB (300 IU/mL) and HyperRAB S/D both consist of human immunoglobulin (IgG) purified from plasma of donors who have been vaccinated against the rabies virus. However, HyperRAB (300 IU/mL) has lower levels of trace impurity proteins such as IgA and coagulation factors from the starting plasma. In addition, HyperRAB (300 IU/mL) 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. 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.
  2. Centers for Disease Control and Prevention (CDC). Learning about bats and rabies. CDC website. http://www.cdc.gov/rabies/bats/education/index.html Updated April 22, 2011. Accessed December 4, 2017.
  3. Centers for Disease Control and Prevention. How is rabies transmitted? Centers for Disease Control and Prevention website. http://www.cdc.gov/rabies/transmission/index.html. Updated April 22, 2011. Accessed April 11, 2016.