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

Side Effects

In clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common being:1

  • Fever (0.77%)
  • Light-headedness (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% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush, and pruritis.
  • The most severe adverse reaction observed during clinical studies with PROLASTIN-C was a rash on the abdomen and extremities in 1 subject.

next: How PROLASTIN-C Is Made >

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.