About Grifols

Grifols is a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with the tools, information, and services they need to efficiently deliver expert medical care.

Our three divisions–Bioscience, Diagnostic, and Hospital–develop, produce, and market innovative products and services available in more than 100 countries.

With the world's largest network of plasma donation centers, the Grifols Bioscience Division is a leading producer of plasma medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable, consistent source of plasma medicines worldwide, Grifols has an all-inclusive process that begins with plasma collection and continues through the fractionation, purification, and production at its three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California).

A leader in transfusion medicine, the Grifols Diagnostic Division advances patient care with diagnostic solutions to improve disease detection and management and simplify laboratory operations. The Grifols Hospital Division provides intravenous (IV) therapies, clinical nutrition products, and hospital pharmacy systems, including systems that automate drug compounding and drug inventory control systems.

Headquartered in Barcelona, Grifols employs approximately 14,700 people in 30 countries.  Ensuring quality, integrity, and safety in all activities is a crucial to our mission, as our products are of vital importance to the health and quality of life of patients we serve.

For more information, visit www.grifols.com

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PROLASTIN®-C (alpha1-proteinase inhibitor [human]) is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency).

The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI), including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.

PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.

PROLASTIN-C is contraindicated in IgA-deficient patients with antibodies against IgA due to the risk of severe hypersensitivity and in patients with a history of anaphylaxis or other severe systemic reactions to alpha1-PI.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. Should hypersensitivity symptoms be observed, promptly stop infusion and begin appropriate therapy. Have epinephrine and other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.

Because PROLASTIN-C is made from human plasma, 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. This also applies to unknown or emerging viruses and other pathogens.

Please click here for full Prescribing Information for PROLASTIN-C.