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 more than 18,000 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

IMPORTANT SAFETY INFORMATION

PROLASTIN®-C LIQUID is an alpha1-proteinase inhibitor (human) (alpha1-PI) 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).

Limitations of Use

  • The effect of augmentation therapy with any alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in alpha1-PI 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 LIQUID are not available
  • PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established

PROLASTIN-C LIQUID is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA or patients with a history of anaphylaxis or other severe systemic reaction to alpha1-PI products.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C LIQUID infusion and begin appropriate therapy.

Because PROLASTIN-C LIQUID 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.

The most common adverse reactions during PROLASTIN-C LIQUID clinical trials in >5% of subjects were diarrhea and fatigue, each of which occurred in 2 subjects (6%).

Please see full Prescribing Information for PROLASTIN-C LIQUID.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit  http://www.fda.gov/medwatch, or call 1-800-FDA-1088.