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.
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.