Grifols Announces Launch of the SPIRIT Registry at the NHF Annual Meeting
RESEARCH TRIANGLE PARK, N.C., Oct. 4, 2013 /CNW/ - Grifols Inc., a leading
manufacturer of life-saving plasma protein therapies, today announced the
launch of the SPIRIT (Study of Plasma-derived factor VIII/VWF in Immune
toleRance Induction Therapy) registry for patients with hemophilia A at the
National Hemophilia Foundation (NHF) annual meeting in Anaheim, Calif. The
SPIRIT registry will enroll U.S. patients with hemophilia A and inhibitors
being treated with Grifols' plasma-derived factor VIII/VWF product,
ALPHANATE(®) (antihemophilic factor/von Willebrand factor complex [human]).
(Logo: http://photos.prnewswire.com/prnh/20110304/PH59473LOGO )
According to the registry's lead investigator, Rebecca Kruse-Jarres, M.D., of
Tulane University, this observational study fills an important void.
"There is not a lot of prospective data to help us understand how patients
with inhibitors respond to treatment, especially as it relates to adherence
and quality of life. The data from the SPIRIT registry will give us more
information to treat our patients and should complement the ongoing RESIST
Dr. Kruse-Jarres will present a poster at the NHF meeting that outlines the
"The SPIRIT registry is another example of Grifols' commitment to the
hemophilia community," said Eva Bastida, Ph.D., Vice President of Scientific
and Medical Affairs at Grifols. "We are happy to launch this initiative and
further support efforts to provide information to hemophilia treaters."
About ALPHANATE(® )
Indications ALPHANATE(®) (antihemophilic factor/von Willebrand factor
complex [human]) is indicated for:
-- Control and prevention of bleeding in patients with hemophilia
-- Surgical and/or invasive procedures in adult and pediatric
patients with von Willebrand disease (VWD) in whom desmopressin
(DDAVP) is either ineffective or contraindicated. It is not
indicated for patients with severe VWD (Type 3) undergoing
Important Safety Information
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is
contraindicated in patients who have manifested life-threatening immediate
hypersensitivity reactions, including anaphylaxis, to the product or its
Anaphylaxis and severe hypersensitivity reactions are possible. Should
symptoms occur, treatment with ALPHANATE should be discontinued, and emergency
treatment should be sought.
Development of activity-neutralizing antibodies has been detected in patients
receiving FVIII containing products. Development of alloantibodies to VWF in
Type 3 von Willebrand Disease (VWD) patients has been occasionally reported in
Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD
patients, especially in the setting of known risk factors.
Intravascular hemolysis may be associated with infusion of massive doses of
AHF/VWF Complex (Human).
Rapid administration of a FVIII concentrate may result in vasomotor reactions.
Plasma products carry a risk of transmitting infectious agents, such as
viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite
steps designed to reduce this risk.
The most frequent adverse events reported with ALPHANATE(®) (antihemophilic
factor/von Willebrand factor complex [human]) in >5% of patients are
respiratory distress, pruritus, rash, urticaria, face edema, paresthesia,
pain, fever, chills, joint pain, and fatigue.
Grifols is a global healthcare company with a 70-year legacy of improving
people's health and well being through the development of life-saving plasma
medicines, hospital pharmacy products and diagnostic technology for clinical
As a leading producer of plasma medicines, Grifols has a presence in more than
100 countries and is the world leader in plasma collection, with 150 plasma
donation centers across the U.S. Grifols is committed to increasing patient
access to its life-saving plasma medicines through significant manufacturing
expansions and the development of new therapeutic applications of plasma
proteins. The company is headquartered in Barcelona, Spain and employs more
than 11,000 people worldwide.
In 2012, Grifols' sales exceeded 2,620 million euros. The company's class A
shares are listed on the Spanish Stock Exchange, where they are part of the
Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado
Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more
information visit www.grifols.com
SOURCE Grifols Inc.
Punkaj Amin, Grifols - Director of Corporate Communications for North America,
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