Grifols launches new 3-mL (900-IU) vial for high-potency HyperRAB® (rabies immune globulin [human])

BARCELONA, Spain, April 28, 2020 /PRNewswire/ -- Grifols (MCE:GRF, MCE:GRF.PNASDAQ:GRFS), a leading global producer of plasma-derived medicines, today announced the launch of a new 3-mL (900-IU) vial for HyperRAB (rabies immune globulin [human]), a treatment for rabies postexposure prophylaxis.

The addition of a 3-mL (900-IU) option will now give healthcare providers greater convenience by potentially reducing the number of vials used during administration – cutting down on product and packaging waste in the process. The new vial size will also provide storage efficiencies for hospital pharmacies by decreasing the number of smaller vials they currently have to keep in stock. HyperRAB 3-mL (900-IU) was approved by the U.S. Food and Drug Administration (FDA) in November 2019, broadening the company's current HyperRAB portfolio, which presently includes 300 IU/mL potency supplied in 1-mL (300-IU) and 5-mL (1500-IU) vials.

HyperRAB, the only high-potency formulation at 300 IU/mL, was launched in 2018, offering twice the potency of currently available rabies immunoglobulin options and the potential for fewer injections by significantly reducing the volume of medication administered in each dose. The high-potency formulation has been administered to more than 100,000 patients since its launch in 2018.

"Grifols has been a trusted provider of rabies immunoglobulin for more than 45 years. With a continued commitment to improving the lives of patients, we're redefining how this critical treatment is administered," said Bill Zabel, President, North America Commercial Division. "By providing a 3-mL offering, we are giving emergency rooms and hospital pharmacies more convenient dosing options."

Approximately 60,000 people in the U.S. each year are treated with postexposure prophylaxis following exposure to an animal that is known, or thought, to have rabies. For patients who have not been vaccinated before, the Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention recommend immediate prophylaxis, including a rabies immunoglobulin injection directly into the wound site when anatomically feasible.

"With the higher-potency product, our patients already benefit from a significant reduction in the volume of medication administered in each dose," said Evelyn Chu, Director of Pharmacy, Henderson Hospital, owned by Universal Health Services. "Now with the introduction of an intermediate vial size to our inventory, it will bring us additional operational efficiencies in the pharmacy."

Grifols is the only rabies immunoglobulin manufacturer with total end-to-end control over the entire process – from plasma collection, testing, fractionation, to product supply – ensuring a consistent and reliable source of this critical treatment option. Grifols supplies over 100 million international units of rabies immunoglobulin to the U.S. market each year.

The HyperRAB 3-mL (900-IU) vial will be made available immediately to patients and healthcare professionals through all current HyperRAB distributors and wholesalers.

Please see Important Safety Information for HyperRAB below and refer to the full Prescribing Information or visit HyperRAB.com.

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.

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.

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 100 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 24,000 employees in 30 countries, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

In 2019, Grifols' economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information, please visit www.grifols.com

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