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

Side Effects

In clinical studies with Prolastin, reactions were observed in 1.16% of infusions, the most common events being:

  • Fever (0.77%)
  • Lightheadedness (0.19%)
  • Dizziness (0.19%)

PROLASTIN-C

In clinical trials, PROLASTIN-C demonstrated an adverse event profile consistent with PROLASTIN®.

  • The most common drug related adverse events observed at a rate of ≥ 1.0% in subjects receiving PROLASTIN®-C were chills, malaise, headache, rash, hot flush, and pruritis.
  • The most serious adverse reaction observed during clinical studies with PROLASTIN®-C was a rash on the abdomen and extremities in 1 subject.

next: Why PROLASTIN-C >

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. Campos MA, Alazemi S, Zhang G, Wanner A, Sandhaus RA. Effects of a disease management program in individuals with alpha-1 antitrypsin deficiency. COPD. 2009;6(1):31-40.