Alpha-1 Proteinase Inhibitor (Human)

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

Pharmacology

Inhibits serine proteases (eg, neutrophil elastase), which are capable of degrading protein components of the alveolar walls and are chronically present in the lung.

Pharmacokinetics

Absorption

Aralast NP C _max is 1.6 mg/mL with a steady-state Vd of about 5,632 mL.

Elimination

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.

Indications and Usage

Long-term augmentation therapy in patients with congenital deficiency of alpha-1 proteinase inhibitor with clinically evident emphysema.

Contraindications

Patients with selective immunoglobulin A (IgA) deficiencies (IgA level less than 15 mg/dL) who have known antibodies against IgA.

History of anaphylaxis or severe systemic response to alpha-1 proteinase inhibitor products.

Dosage and Administration

IV 60 mg/kg infusion once weekly. Administer at a rate not exceeding 0.08 mL/kg/min.

General Advice

• Follow manufacturer's instructions for reconstitution of powder with supplied diluent and final dilution for infusion solution.
• Do not shake or agitate vials during reconstitution or dilution.
• Inspect solution visually before administration. Do not administer if solution is cloudy, discolored, or contains more than a few small particles.
• Discard any unused product. Vials are for single-use only. Do not save medication for future use.
• Infuse Zemaira reconstituted solution through supplied in-line filter.
• Do not administer in same IV line with other products.
• Do not mix with other agents or diluting solutions.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension, tachycardia (postmarketing).

CNS

Headache (7%).

Headache (3%); dizziness (1%).

Dermatologic

Rash (postmarketing).

Pruritus (1%).

EENT

Pharyngitis (2%).

Sinusitis (2%).

Hepatic

ALT or AST elevations (11%).

Musculoskeletal

Musculoskeletal discomfort (7%).

Asthenia (1%).

Respiratory

Cough increased (1%); COPD exacerbation, upper and lower respiratory tract infections.

Dyspnea (postmarketing).

Upper respiratory tract infection (2%).

Miscellaneous

Fever (1%); allergic-like reaction, chills, flu-like symptoms (postmarketing).

Injection-site pain, paresthesia (1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Anaphylaxis

Immediately discontinue the infusion if severe anaphylactoid or anaphylactic reactions occur.

Circulatory overload

Use with caution in patients at risk of circulatory overload.

Hepatitis B

Ensure that patient receiving Prolastin is immunized against hepatitis B before beginning therapy.

Infection

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.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
• Advise patient, family, or caregiver to report any signs or symptoms of hypersensitivity reaction (eg, hives, rash, chest tightness, wheezing, difficulty breathing, faintness).
• Advise patient, family, or caregiver to report the following symptom complex to health care provider: fever, drowsiness, chills, and runny nose followed 2 wk later by rash and joint pain.

Copyright © 2009 Wolters Kluwer Health.