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Pronunciation(al fa won PRO tee in ase in HI bi tor)
U.S. Brand NamesAralast™; Prolastin®; Zemaira™
SynonymsA1-PI; Alpha1-Antitrypsin; Alpha1-PI; Alpha1-Proteinase Inhibitor, Human; 1-PI
Generic AvailableNo
Canadian Brand NamesProlastin®
UseReplacement therapy in congenital alpha1-antitrypsin deficiency with clinical emphysema
Pregnancy Risk FactorC
Pregnancy ImplicationsReproduction studies have not been conducted.
LactationExcretion in breast milk unknown/use caution
ContraindicationsHypersensitivity to any component of the formulation or other A1-PI products; selective IgA deficiency with known anti-IgA antibody
Warnings/PrecautionsUse caution in patients at risk for fluid overload. Products are made from pooled human plasma; risk of infection is theoretical, however, any infections thought to be transmitted by these products should be reported to the manufacturer. Hepatitis B immunization may be considered. Safety and efficacy in pediatric patients have not been established.
Adverse Reactions>10%: Hepatic: ALT/AST increased (11%; ~4 times ULN) 1% to 10%: Respiratory: Pharyngitis (2%) <1%, postmarketing, and/or case reports: Allergic reactions, bilateral pulmonary infiltrates, bronchitis, chest pain, chills, cough increased, dizziness, dyspnea, fever <102°F (delayed up to 12 hours after treatment), flu-like syndrome, headache, hypotension, leukocytosis, lightheadedness, pain, pruritus, rash, sinusitis, somnolence, tachycardia, vasodilation, vision abnormal. Severe reactions (anaphylaxis) may occur in patients with anti-IgA antibody.
StabilityReconstitute with SWFI; to mix, swirl, do not shake. Use within 3 hours of reconstitution.Aralast™: Store under refrigeration at 2°C to 8°C (35°F to 46°F); do not freeze. May also be stored at room temperature 25°C (77°F) for up to 1 month. Prolastin®: Store under refrigeration at 2°C to 8°C (35°F to 46°F); do not freeze Zemaira™: Store up to 25°C (77°F); avoid freezing
Mechanism of ActionAlpha1-antitrypsin (AAT) is the principle protease inhibitor in the serum. Its major physiologic role is to render proteolytic enzymes (secreted during inflammation) inactive. A decrease in AAT, as seen in congenital AAT deficiency, leads to increased elastic damage in the lung, causing emphysema.
Pharmacodynamics/KineticsHalf-life elimination: Metabolic: 5.9 days (Aralast™) Time to peak, serum: Threshold levels achieved after 3 weeks
DosageI.V.: Adults: 60 mg/kg once weekly
AdministrationFor I.V. infusion only; reduce rate or temporarily discontinue infusion if adverse effects occur. Infuse at ~0.08 mL/kg/minute; actual rate may be increased or decreased based on patient response. Emergency equipment (including epinephrine) should be available during infusion. Do not mix with other agents or solutions.
Monitoring ParametersAlpha1-PI serum levels; vital signs during infusion
Dietary ConsiderationsSodium content of 1 L after reconstitution:Aralast™: 230 mEq/L Prolastin®: 100-210 mEq/L
Dental Health: Effects on Dental TreatmentKey adverse event(s) related to dental treatment: Pharyngitis.
Dental Health: Vasoconstrictor/Local Anesthetic PrecautionsNo information available to require special precautions
Mental Health: Effects on Mental StatusNone reported
Mental Health: Effects on Psychiatric TreatmentNone reported
Dosage FormsInjection, powder for reconstitution [single-dose vial]: Aralast™, Prolastin®: 500 mg, 1000 mg [packaged with diluent] Zemaira™: 1000 mg [packaged with diluent]
International Brand NamesProlastin® (CA)
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