A1-Proteinase Inhibitor (Human)

Name: A1-Proteinase Inhibitor (Human)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Aralast and Zemaira must be obtained from specialty distributors; these preparations are not available through community pharmacies.4 15 For information regarding the Aralast distribution program, contact the manufacturer at 800-423-2090.4 For information regarding the distribution of Zemaira, contact the manufacturer at 866-ZEMAIRA (866-936-2472).15

α1-Proteinase Inhibitor (Human)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion only

number of mg indicated on label

Aralast (with sterile water for injection diluent, a double-ended transfer needle, and filter)

Baxter

number of mg indicated on label

Prolastin (with sterile water for injection diluent, double-ended transfer needle, filter needle)

Bayer

number of mg indicated on label

Zemaira (with sterile water for injection diluent, a double-ended transfer needle, and filter)

ZLB Behring

In Summary

Commonly reported side effects of alpha 1-proteinase inhibitor include: exacerbation of chronic obstructive pulmonary disease. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to alpha 1-proteinase inhibitor: intravenous powder for injection, intravenous solution

Respiratory

Respiratory side effects have included chest pain, pharyngitis, asthma, rhinitis, bronchitis, sinusitis, increased cough, upper and lower respiratory tract infections, dyspnea, chronic obstructive pulmonary disease (COPD) exacerbation, nasopharyngitis, pharyngolaryngeal pain, COPD, sore throat, bronchospasm, lung disorder, infective exacerbation of COPD, bilateral pulmonary infiltrates, and diffuse interstitial lung disease. Dyspnea has been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, dysgeusia, lethargy, lightheadedness, paresthesia, and migraine.[Ref]

Other

Other side effects have included pain, back pain, viral infection, peripheral edema, chills, fever, chest pain, chest discomfort, influenza-like illness, pyrexia, delayed fever, influenza-like symptoms, allergic-like reactions, malaise, hot flush, asthenia, infection, and accidental injury. Chest pain, chills, and influenza-like illness have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included vasodilation, hypertension, tachycardia, hypotension, and transient increase in blood pressure. Tachycardia, hypotension, and hypertension (including transient increases of blood pressure) have been reported during postmarketing experience.[Ref]

Hematologic

Hematologic side effects have included decreased platelet count, transient leukocytosis, dilutional anemia, ecchymosis, and hemorrhage.

Dermatologic

Dermatologic side effects have included pruritus, rash, erythema marginatum, and urticaria. Rash has been reported during postmarketing experience.[Ref]

Gastrointestinal

Gastrointestinal side effects have included bloating, nausea, abdominal pain, diarrhea, and dyspepsia.

Hepatic

Hepatic side effects have included elevations (greater than 2 times the upper limit of normal) in aminotransferases (ALT or AST), increased hepatic enzyme (unspecified), and cholangitis.[Ref]

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal discomfort, joint swelling, arthralgia, and myalgia.

Ocular

Ocular side effects have included abnormal vision.[Ref]

Local

Local side effects have included injection site pain, injection site hemorrhage, and injection site reaction.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity during postmarketing experience.

Some side effects of alpha 1-proteinase inhibitor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

Data not available

Dialysis

Data not available

Alpha 1-proteinase inhibitor Pregnancy Warnings

Alpha 1-proteinase inhibitor has been assigned to FDA pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Alpha 1-proteinase inhibitor is only recommended for use during pregnancy when benefit outweighs risk.

(web3)