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PROLASTIN® Clinical Data

Augmentation therapy maintains serum AAT levels above the protective levels of AAT. Find out more about augmentation therapy Clinical Data.

Patients enrolled in Prolastin Direct experienced 10% fewer exacerbations.1

Exacerbation Reduction Graph

Prolastin Direct Alpha-1 health management program helps improve patient outcomes.

  • Total exacerbation rate decreased (P<0.001)
  • Unscheduled physician visits decreased (P=0.03)
  • Emergency room visits decreased (P=0.02)

Learn more about Alpha-1 Disease Management and Prevention Program (ADMAPP).

PROLASTIN-C Augmentation Therapy

Grifols is proud to announce the availabiltiy of an improved formulation of PROLASTIN.

  • Since its introduction, PROLASTIN has been the #1-prescribed augmentation therapy in the United States1 for patients with Alpha-1

PROLASTIN-C

The leading Alpha-1 augmentation therapy for over 20 years is now improved.

  • Shorter Infusion Time: PROLASTIN®-C delivers twice the active protein per milliliter as PROLASTIN®, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min.
  • Higher Purity: Each dose of PROLASTIN®-C delivers ≥ 90% pure alpha-1 protein allowing it to be more concentrated than PROLASTIN®.
  • Prion Removal: Only PROLASTIN®-C has FDA-approved labeling for removal of pathogenic prions that may cause TSE disease in humans. TSEs (transmissible spongiform encephalopathies) are a group of neurodegenerative diseases related to mad cow disease.

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.

Seamless patient transitions to PROLASTIN-C

If your patient is already receiving PROLASTIN®, the conversion to PROLASTIN-C will be smooth. Prolastin Direct will contact you with more information about the transition.

next: Clinical Data >

Important Safety Information

PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency). The effect of augmentation 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 is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

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. PROLASTIN-C is contraindicated in patients with antibodies against IgA.

The most common drug related adverse reactions during clinical trials in ≥ 1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus.

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. Published July, 2008.