One-stop PROLASTIN-C enrollment, delivery and support

Prolastin Direct® Patient Services secures insurance authorization, coordinates infusion services, ships PROLASTIN-C directly to the location of your choice, and connects you to health management coordinators who are experienced Alpha-1 patients themselves. Find out more about Prolastin Direct® Patient Services now.

How PROLASTIN-C Is Made

PROLASTIN-C is a sterile, freeze-dried preparation of purified human AAT.1

PROLASTIN-C is prepared by a special process from pooled donations of human plasma collected from healthy donors.2,3

All plasma used for PROLASTIN-C goes through extensive testing and purification steps to help ensure product safety. PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FDA-approved removal of prions

PROLASTIN-C is the first and only augmentation therapy with FDA-approved labeling for clearance of prions, the infection agent believed to cause mad cow disease or Creutzfeldt-Jakob disease. Prions are infectious agents that may cause human TSEs (transmissible spongiform encephalopathies), a group of neurodegenerative diseases related to mad cow disease. Steps in the manufacturing processes have been demonstrated to remove prions.1

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Important Safety Information
Prolastin-C, Alpha1-Proteinase Inhibitor (Human) is for adults who have emphysema caused by inherited alpha1-antitrypsin deficiency. The effect of therapy with any alpha1-proteinase inhibitor (alpha1-PI) on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

Prolastin-C may contain trace amounts of IgA. IgA deficient patients with antibodies against IgA should not receive Prolastin-C due to the risk of hypersensitivity.

The most common side effects during clinical trials with Prolastin-C were chills, a general feeling of being unwell, headache, rash, hot flush, and itching.

Prolastin-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Please see accompanying Prolastin-C Full Prescribing Information for complete prescribing details.

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.

References
  1. PROLASTIN-C [package insert]. Talecris Biotherapeutics.
  2. Cohn EJ, Strong LE, Hughes WL, et al. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc. 1946;68:459-475.
  3. Cohn EJ, Gurd FRN, Surgenor DM, et al. A system for the separation of the components of human blood: Quantitative procedures for the separation of the protein components of human plasma. J Am Chem Soc. 1950;72:465-474.