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Proven Safety
Prolastin® has an excellent safety profile. There have been over 2 million infusions with no documented cases of virus or prion transmission.1 The rigorous virus removal and inactivation process includes1:
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Fractionation of Effluent I to II+III |
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PEG precipitation |
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Depth filtration |
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Pasteurization |
Since Prolastin® was introduced in 1988, over 2 million doses have been administered with no confirmed reports of viral transmission.
Comprehensive safety and quality management programs provide safeguards in all stages of Prolastin® production, including donor selection, plasma collection and screening, and manufacturing. Continual evaluation and improvement of all aspects of plasma purification demonstrate Talecris’ ongoing commitment to provide the greatest possible safety for patients who receive Prolastin®.
Talecris is a leader in the area of pathogen safety research and is committed to the evaluation of new methods of viral inactivation and reduction so that high standards of pathogen safety can be maintained.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Please see full Prescribing Information. |
Proven Tolerability
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Well tolerated in clinical studies at 60 mg/kg IV weekly1 |
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In clinical studies with Prolastin®, reactions (none severe) were observed in only 1.16% of infusions, the most common events being delayed fever (0.77%), light-headedness (0.19%), and dizziness (0.19%)1 |
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Since market entry, occasional reports of other flu-like symptoms, allergic-like reactions, chills, dyspnea, rash, tachycardia, and, rarely, hypotension have been received1 |
References:
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Prolastin® full Prescribing Information Research Triangle Park, NC: Talecris Biotherapeutics, Inc; 2005. |
Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. Weekly Prolastin® therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin®, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin®, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
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.
Please click here for Prolastin® full Prescribing Information.
Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor or healthcare provider if you have any questions about your health or any of your medications.
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