Donations of plasma and continued research are critical for patients with rare, chronic, serious and life-threatening illnesses to receive essential medicines
Barcelona, Spain (October 8, 2018) – The importance of plasma is recognized during International Plasma Awareness Week, October 8-12. Grifols continues its commitment to plasma-derived medical treatments. These recent developments include:
- FEBRUARY 2018: A higher potency postexposure rabies treatment received FDA approval. The new formulation of HyperRAB® rabies immune globulin (human) for rabies postexposure prophylaxis has twice the potency (300 IU/mL) of currently available rabies immune globulin options, offering patients the potential for fewer injections by significantly reducing the volume of medication administered in each dose.
- SEPTEMBER 2018: The FDA approved a new formulation of GamaSTAN® immune globulin (human) for hepatitis A virus (HAV) and measles postexposure prophylaxis. GamaSTAN® is now available to healthcare providers across the country and is the only immune globulin product on the U.S. market approved for immediate protection against HAV and measles.
- OCTOBER 2018: Top-line data results of Alzheimer's disease clinical research are expected in late October of 2018. In addition, Grifols is supporting research on two additional studies for diagnostic testing and prevention.
The need for plasma increases with every new treatment. To ensure a reliable supply of plasma, Grifols continues to increase its number of U.S. donor centers. This year, the company acquired Biotest Pharmaceuticals Corporation's 24 donor centers, and has now internationalized its plasma collection network by acquiring Haema and its 35 donation centers in Germany. Grifols has also entered into an agreement to build and manage plasma donation centers in China with Boya Bio-Pharmaceutical, a leading Chinese manufacturer of plasma-derived medicines.
"Our critically important therapies depend on plasma donations," says Peter Allen, President and CEO of Grifols-owned Biomat USA. "By expanding and diversifying our network of donation centers, we are reinforcing our global leadership position in plasma collection to ensure we meet the needs of patients around the world.''
As an example of the need for plasma, consider that it takes about 900 donations to treat a patient with alpha-1-antitrypsin deficiency (a genetic form of COPD) for one year.
Today, Grifols operates 250 plasma donor centers and is well on its way to reach its goal of 325 centers by 2023.
The use of human-derived treatments for medical conditions is not a new concept. Grifols is a world leader of plasma-derived medicines and has been researching and producing essential treatments for nearly 80 years. Grifols produces treatments for a wide range of illnesses. Many conditions are often caused by genetic and chronic diseases or by rare diseases including certain pulmonary conditions, blood and infectious diseases and autoimmune diseases.
About Plasma
Plasma is the liquid portion of human blood. The vast majority of plasma – 92 percent – is composed of water. The other 8 percent of plasma is made up of essential proteins and antibodies that help sustain our body's vital functions. A shortage of any one of these plasma proteins, such as albumin or immunoglobulins, can give rise to one of many life-threatening illnesses.
To restore or replace missing proteins, patients are often administered protein therapies that are derived from human plasma. Grifols develops and manufactures these specialized protein therapies and distributes them in more than 100 countries worldwide.
To learn more about plasma donation and hear from the patients whose lives are transformed by plasma-derived medicines, visit grifolsplasma.com.
Important Safety Information for GAMASTAN® (immune globulin [human])
Indications and Usage
GAMASTAN® (immune globulin [human]) is indicated for prophylaxis following exposure to hepatitis A infection, prevention or modification of measles in susceptible persons exposed fewer than 6 days previously, modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion.
Limitations of Use
GAMASTAN is not indicated for routine prophylaxis or treatment of viral hepatitis type B, rubella, poliomyelitis, mumps, or varicella.
Important Safety Information
Thrombosis may occur with immune globulin products, including GAMASTAN. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
For patients at risk of thrombosis, do not exceed the recommended dose of GAMASTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
GAMASTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
Administer GAMASTAN cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Have epinephrine available for treatment of acute allergic symptoms, should they occur.
Inject intramuscularly only. Do not administer GAMASTAN intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]). Do not inject into a blood vessel.
GAMASTAN is made from human blood; it 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 reaction reported for GAMASTAN S/D during post-approval use was fatigue.
Antibodies in GAMASTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GAMASTAN administration.
Please see full Prescribing Information for GAMASTAN.
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.
Important Safety Information for HYPERRAB® (rabies immune globulin [human])
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.
