FDA Approves Grifols New GamaSTAN® (immune globulin [human]) to Treat Patients Exposed to Hepatitis A and Measles


04.09.2018

  • GamaSTAN® is the only immune globulin product on the U.S. market approved for postexposure protection against hepatitis A and measles
  • New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety standards
  • The CDC recommends immune globulin as hepatitis A postexposure prophylaxis treatment for people who are immunocompromised, under 1 year of age, over 40 years of age, or have cancer or chronic liver and kidney disease
  • This new formulation marks an important milestone in Grifols' ongoing R&D efforts to provide the highest quality products possible to patients and healthcare providers


Barcelona, Spain, September 4, 2018 – Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines, announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of its GamaSTAN® immune globulin (human) for hepatitis A virus (HAV) and measles postexposure prophylaxis. GamaSTAN® is now available to healthcare providers across the country.

GamaSTAN® is the only immune globulin product on the U.S. market approved for immediate protection against HAV and measles. The FDA approval is an important R&D milestone for Grifols as a global leader in postexposure prophylaxis (the treatment of a person after exposure to a virus) and immune globulin products for patients.


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.


"Vaccination, while a valuable option for hepatitis A and measles postexposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses," said Dr. Stephen Scholand, Infectious Disease Specialist at MidState Medical Center. "Immune globulins such as GamaSTAN® have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."


The CDC states that for persons aged more than 40 years, an immune globulin is preferred for HAV postexposure prophylaxis. The CDC also recommends that immune globulin should be used for children aged less than 12 months, immunocompromised persons, persons with chronic liver disease, and persons who are allergic to the vaccine or a vaccine component. When administered within 2 weeks after exposure to HAV, immune globulin is 80 to 90 percent effective in preventing hepatitis A infection.

In addition to HAV and measles, GamaSTAN® is also approved for rubella and varicella postexposure prophylaxis.


"As a company driven by innovation, we strive to provide the highest quality products possible to our patients" said Bill Zabel, President, Grifols North America Sales and Commercial Operations. "This advancement in the GamaSTAN® formulation marks an important milestone in Grifols' ongoing R&D efforts, and we are confident that it will continue to be an important treatment option for healthcare providers."


GamaSTAN® is available to U.S. healthcare providers in two vial sizes (10 mL and 2 mL). This new formulation is manufactured using a sophisticated caprylate chromatography process according to the highest quality and safety standards and includes labeling for capacity to remove prions.


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.

About the Infectious Diseases Hepatitis A and Measles

Hepatitis A is an acute infectious disease of the liver caused by HAV. In 2018, the CDC estimates over 2,500 new cases of HAV in the U.S. across multiple states, on track to surpass the 2,984 cases in 2017. Older people and people with chronic liver disease, such as those infected with hepatitis C virus, are more likely to become seriously ill and die from HAV.

Measles is a highly contagious viral respiratory illness that is transmitted from person to person by direct contact with respiratory droplets or airborne spread, and is the most contagious of all the vaccine-preventable diseases. After exposure, up to 90 percent of susceptible persons develop measles, the deadliest of all childhood rash and fever illnesses. In 2017, 120 people in the U.S. were reported to have measles, with some states experiencing their largest outbreaks in decades.