Trade Names:Aralast NP- Injection, lyophilized powder for solution 400 mg (greater than or equal to 16 mg/mL of alpha-1 proteinase inhibitor when reconstituted)- Injection, lyophilized powder for solution 800 mg (greater than or equal to 16 mg/mL of alpha-1 proteinase inhibitor when reconstituted)
Trade Names:Prolastin- Injection, lyophilized powder for solution 500 mg (greater than or equal to 20 mg/mL of alpha-1 proteinase inhibitor when reconstituted)- Injection, lyophilized powder for solution 1,000 mg (greater than or equal to 20 mg/mL of alpha-1 proteinase inhibitor when reconstituted)
Trade Names:Zemaira- Injection, lyophilized powder for solution 1,000 mg
Inhibits serine proteases (eg, neutrophil elastase), which are capable of degrading protein components of the alveolar walls and are chronically present in the lung.
Aralast NP C max is 1.6 mg/mL with a steady-state Vd of about 5,632 mL.
Cl for Aralast NP is about 940 mL/day; half-life is approximately 4.7 days and the metabolic half-life is 5.9 days.
Long-term augmentation therapy in patients with congenital deficiency of alpha-1 proteinase inhibitor with clinically evident emphysema.
Patients with selective immunoglobulin A (IgA) deficiencies (IgA level less than 15 mg/dL) who have known antibodies against IgA.Zemaira
History of anaphylaxis or severe systemic response to alpha-1 proteinase inhibitor products.
IV 60 mg/kg infusion once weekly. Administer at a rate not exceeding 0.08 mL/kg/min.
Store vials in refrigerator (35° to 46°F). Do not freeze. Vials may be removed from refrigerator and stored at controlled room temperature (not to exceed 77°F). Aralast NP must be used within 1 mo once removed from refrigeration. Use solution within 3 h of reconstitution. Do not refrigerate solution after reconstitution.
None well documented.
None well documented.
Hypotension, tachycardia (postmarketing).
Headache (3%); dizziness (1%).
ALT or AST elevations (11%).
Musculoskeletal discomfort (7%).Zemaira
Cough increased (1%); COPD exacerbation, upper and lower respiratory tract infections.Prolastin
Upper respiratory tract infection (2%).
Fever (1%); allergic-like reaction, chills, flu-like symptoms (postmarketing).Zemaira
Injection-site pain, paresthesia (1%).
Monitor patient for development of infusion reaction. If infusion reaction develops, decrease the infusion rate or temporarily stop the infusion until symptoms subside. Resume infusion at rate tolerated by patient.
Monitor vital signs and carefully observe patient throughout the infusion.
Category C .
Safety and efficacy not established.
Immediately discontinue the infusion if severe anaphylactoid or anaphylactic reactions occur.
Use with caution in patients at risk of circulatory overload.
Ensure that patient receiving Prolastin is immunized against hepatitis B before beginning therapy.
Because alpha-1 proteinase inhibitor is derived from pooled human plasma, there is a risk of transmitting infectious agents (eg, viruses) and, theoretically, Creutzfeldt-Jakob disease.
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