Home > Medical Reference > Encyclopedia (English)

Please install flash player to see this video.

Hospital Virtual Tour

Related Content

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:

Canadian Brand Names:

Prolastin®

Use:

Replacement therapy in congenital alpha1-antitrypsin deficiency with clinical emphysema

Pregnancy Risk Factor:

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)

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997- A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.