Prolastin (Alpha 1-Antitrypsin) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Therapeutic administration of Alpha₁-Proteinase Inhibitor (Human), Prolastin®, 60 mg/kg weekly, has been demonstrated to be well tolerated. In clinical studies, six reactions were observed with 517 infusions of Prolastin, or 1.16%. None of the reactions was severe. ¹⁸ The adverse reactions reported included delayed fever (maximum temperature rise was 38.9°C, resolving spontaneously over 24 hours) occurring up to 12 hours following treatment (0.77%), light-headedness (0.19%), and dizziness (0.19%). ¹⁸ Mild transient leukocytosis and dilutional anemia several hours after infusion have also been noted. ¹⁸ Since market entry, occasional reports of other flu-like symptoms, allergic-like reactions, chills, dyspnea, rash, tachycardia, and, rarely, hypotension have also been received. Rare cases of transient increase in blood pressure or hypertension and chest pain have also been reported.