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Alpha1-Proteinase Inhibitor


Pronunciation

 (al fa won PRO tee in ase in HI bi tor)


U.S. Brand Names

 Aralast™; Prolastin®; Zemaira™


Synonyms

 A1-PI; Alpha1-Antitrypsin; Alpha1-PI; Alpha1-Proteinase Inhibitor, Human; 1-PI


Generic Available

 No


Canadian Brand Names

 Prolastin®


Use

 Replacement therapy in congenital alpha1-antitrypsin deficiency with clinical emphysema


Pregnancy Risk Factor

 C


Pregnancy Implications

 Reproduction studies have not been conducted.


Lactation

 Excretion in breast milk unknown/use caution


Contraindications

 Hypersensitivity to any component of the formulation or other A1-PI products; selective IgA deficiency with known anti-IgA antibody


Warnings/Precautions

 Use 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.


Stability

 Reconstitute 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 Action

 Alpha1-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/Kinetics

Half-life elimination: Metabolic: 5.9 days (Aralast™)

Time to peak, serum: Threshold levels achieved after 3 weeks


Dosage

 I.V.: Adults: 60 mg/kg once weekly


Administration

 For 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 Parameters

 Alpha1-PI serum levels; vital signs during infusion


Dietary Considerations

 Sodium content of 1 L after reconstitution:

Aralast™: 230 mEq/L

Prolastin®: 100-210 mEq/L


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Pharyngitis.


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 None reported


Mental Health: Effects on Psychiatric Treatment

 None reported


Dosage Forms

Injection, powder for reconstitution [single-dose vial]:

Aralast™, Prolastin®: 500 mg, 1000 mg [packaged with diluent]

Zemaira™: 1000 mg [packaged with diluent]


International Brand Names

 Prolastin® (CA)


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