Grifols announces robust inventory of HyperRAB® S/D rabies immune globulin for treatment of rabies exposure

RESEARCH TRIANGLE PARK, N.C., Sept. 28, 2012 /PRNewswire/ -- Grifols, a global healthcare company that produces medicines derived from human plasma, announced today it has a robust inventory of HyperRAB® S/D (rabies immune globulin [human]) to overcome U.S. supply constraints caused by an increase in rabies exposures during 2012. HyperRAB® S/D provides immediate immune protection to patients who are exposed to rabies but have not yet been vaccinated against the deadly virus.

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The Centers for Disease Control and Prevention (CDC) confirmed in a September 19 announcement that Grifols' HyperRAB® S/D is the only immune globulin available in sufficient quantities to meet the market demand for rabies post-exposure prophylaxis – the recommended protocol to prevent rabies infection following exposure to the virus. Post-exposure prophylaxis consists of treatment with rabies immune globulin to provide rapid, temporary immunity against the virus followed by a series of rabies vaccines to generate permanent immunity.

According to the CDC, rabies infections among animals have increased in the past year as a result of a warm summer and a mild 2011 winter, with higher reported incidences of rabies among raccoons, skunks, foxes, beavers, and bats and an earlier start to the bat season.

No human cases of rabies infection have been reported in the U.S. in 2012, but the number of human exposures to rabid animals appears higher this year. On a typical summer day, up to 100 cases of potential contacts with a rabid animal are reported across the nation.  There were six cases of human rabies infections reported in 2011 – exceeding the typical annual numbers of only one or two.

Grifols is committed to maintaining its supply of HyperRAB® S/D to meet the needs of patients who are potentially exposed to rabies. CDC guidelines recommend administering rabies immune globulin in conjunction with a patient's first rabies vaccination to ensure immediate protection against the rabies virus until the vaccine can mount a permanent defense.

Please visit the CDC website for more information:
http://www.cdc.gov/rabies/resources/news/2012-09-19.html

About Grifols

Grifols is a global healthcare company that produces medicines derived from human plasma and manufactures hospital pharmacy products, intravenous solutions, diagnostic tools and medical devices. As the third largest global producer of plasma therapies, Grifols has a presence in more than 90 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. The centers collect protein-rich plasma, which is then tested and manufactured into life-saving medicines used to treat rare conditions such as bleeding disorders, immune deficiencies and genetic emphysema. The company's class A shares have been listed on the Spanish Stock Exchange (MCE: GRF) since 2006 and have been part of the Ibex-35 since 2008. In 2011, the company listed non-voting class B shares on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). 

HyperRAB S/D IMPORTANT SAFETY INFORMATION

Rabies vaccine and HyperRAB S/D (Rabies Immune Globulin [Human]) should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.

HyperRAB S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection so that a causal relationship between immunoglobulin and these reactions is not clear.

Administration of live virus vaccines (e.g., MMR) should be deferred for approximately 3 months after rabies immune globulin (human) administration.

HyperRAB S/D is made from human plasma. Product made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

For full Prescribing Information, please visit:
http://www.talecris-pi.info/inserts/hyperrab.pdf

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.

For product ordering inquires, please call Grifols Customer Service:  1-800-243-4153.

SOURCE Grifols