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.

REPORTS OF SUSPECTED PROLASTIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Prolastin side effects / adverse reactions in 28 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2011-10-12

Patient: 28 year old female

Reactions: Incorrect Drug Administration Rate, Dizziness, Coordination Abnormal, Dysphemia

Adverse event resulted in: disablity

Suspect drug(s):
Prolastin
    Dosage: 40 ml;qow;iv
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2005-01-01

Prolastin
    Dosage: 40 ml;qow;iv
    Indication: Panniculitis
    Start date: 2005-01-01

Possible Prolastin side effects / adverse reactions in 45 year old female

Reported by a physician from Germany on 2012-02-06

Patient: 45 year old female

Reactions: Anaphylactic Shock, Infusion Related Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Prolastin

Other drugs received by patient: Fluticasone Propionate W/salmeterol; Fenoterol W/ipratropium Bromide; Spiriva; Theophylline; Citalopram Hydrobromide

Possible Prolastin side effects / adverse reactions in 45 year old female

Reported by a physician from Germany on 2012-02-24

Patient: 45 year old female weighing 60.0 kg (132.0 pounds)

Reactions: Product Quality Issue, Heart Rate Decreased, Anaphylactic Shock

Suspect drug(s):
Prolastin

Other drugs received by patient: Citalopram Hydrobromide; Theophylline; Fluticasone Propionate W/salmeterol; Nasic; Fenoterol W/ipratropium Bromide; Reactine DUO; Spiriva; Omeprazole; Dipyrone TAB; Acetaminophen