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

PROLASTIN-C Therapy

PROLASTIN-C is a concentrated form of alpha1-antitrypsin (AAT) that is purified from human plasma—the fluid part of your blood.2

When given as prescribed, PROLASTIN-C raises the levels of AAT in your blood and lungs. Because PROLASTIN® "augments" or replaces missing AAT, it is referred to as "augmentation therapy" or "replacement therapy."

It is important to know that PROLASTIN-C is not a cure for Alpha-1. PROLASTIN-C has been demonstrated to raise the plasma level of Alpha1-PI, but the effect of this augmentation on pulmonary exacerbations and on the rate of progression of emphysema has not been demonstrated in adequately powered, randomized, controlled clinical trials for any Alpha1-PI product.

PROLASTIN-C

Since its introduction in 1988, PROLASTIN® has been the leading augmentation therapy in the United States1 for people with Alpha-1.

Recently, Talecris, makers of original PROLASTIN, launched a more purified and concentrated formulation of alpha1-proteinase inhibitor, PROLASTIN-C. That means the infusion time for PROLASTIN-C is shorter than for PROLASTIN - only approximately 15 minutes when given at the recommended rate. Plus, 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.2 PROLASTIN is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

PROLASTIN-C is approved only for chronic, or ongoing, augmentation therapy in people with genetic emphysema caused by AAT deficiency.2 PROLASTIN-C is proven effective in raising alpha1 levels. 3,4 Learn more about the benefits of treating Alpha-1 with PROLASTIN-C.

When you receive PROLASTIN-C, the product is administered intravenously (through a vein with a needle) once a week or as prescribed by your doctor. Find out more about the dosing and administration and where you can receive infusions of PROLASTIN-C.

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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. MRB, US Plasma Fractions Market, January 1-December 31, 2007, page 161. July, 2008.
  2. PROLASTIN-C [package insert]. Talecris Biotherapeutics.
  3. American Thoracic Society/European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900.
  4. Wewers MD, Casolaro MA, Sellers SE, et al. Replacement therapy for alpha1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987;316(17):1055-1062.