alpha-1 proteinase inhibitor, Prolastin-C

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical Editor: Charles Patrick Davis, MD, PhD
    Charles Patrick Davis, MD, PhD

    Charles Patrick Davis, MD, PhD

    Dr. Charles "Pat" Davis, MD, PhD, is a board certified Emergency Medicine doctor who currently practices as a consultant and staff member for hospitals. He has a PhD in Microbiology (UT at Austin), and the MD (Univ. Texas Medical Branch, Galveston). He is a Clinical Professor (retired) in the Division of Emergency Medicine, UT Health Science Center at San Antonio, and has been the Chief of Emergency Medicine at UT Medical Branch and at UTHSCSA with over 250 publications.

Understanding COPD

What is alpha-1-proteinase inhibitor-injection, and how does it work (mechanism of action)?

Alpha-1 proteinase inhibitor (Prolastin-C) is a prescription medicine used to treat alpha-1 antitrypsin (AAT) deficiency. AAT deficiency is a genetic disorder in which abnormally low levels of the protein AAT allow certain enzymes to attack healthy tissues, especially the lungs. Over time, significant lung damage occurs, and patients develop serious lung diseases like emphysema.

Alpha-1 proteinase inhibitor contains AAT donated by human subjects. AAT is derived from the plasma, the fluid part of the blood, of healthy human donors. Prolastin-C is a new formulation of Prolastin, the original alpha-1 proteinase inhibitor that has been available since 1988. Prolastin-C is a more purified and concentrated formulation that can be infused over a shorter period of time. When administered at the recommended rate, Prolastin-C can be infused in approximately 15 minutes. Additionally, unlike Prolastin, Prolastin-C does not contain prions, the infectious agent that causes mad cow disease or Creutzfeldt-Jakob disease. However, as alpha-1 proteinase inhibitor is derived from human plasma, it carries the potential risk of transmitting other infectious agents like viruses.

There is no cure for AAT deficiency but alpha-1 proteinase inhibitor can help patients manage their condition. Alpha-1 proteinase inhibitor works in the lower respiratory tract where it inhibits neutrophil elastase (NE), the enzyme that damages lung tissue. In clinical trials, alpha-1 proteinase inhibitor therapy increased the plasma levels of AAT. The effects of augmentation therapy on lung symptoms and disease progression have yet to be proven in well-controlled clinical trials.

What brand names are available for alpha-1-proteinase inhibitor-injection?

Prolastin-C

Is alpha-1-proteinase inhibitor-injection available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for alpha-1-proteinase inhibitor-injection?

Yes

What are the side effects of alpha-1-proteinase inhibitor-injection?

The most common side effects of alpha-1 proteinase inhibitor are:

Quick GuideCOPD Lung Symptoms, Diagnosis, Treatment

COPD Lung Symptoms, Diagnosis, Treatment

What is the dosage for alpha-1-proteinase inhibitor-injection?

The recommended dose of alpha-1 proteinase inhibitor is 60 mg/kg administered into the vein (intravenously) once weekly. Alpha-1 proteinase inhibitor should be administered at a rate of up to 0.08 milliliters for each kilogram per minute. On average, each infusion takes about 15 minutes.

Patients, family members, or caregivers can be trained to administer alpha1-proteinase inhibitor at home.

Which drugs or supplements interact with alpha-1-proteinase inhibitor-injection?

Information on drug-drug interaction is not found in the medical literature and is not provided by the manufacturer.

Is alpha-1-proteinase inhibitor-injection safe to take if I'm pregnant or breastfeeding?

Alpha-1 proteinase inhibitor has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, alpha-1 proteinase inhibitor should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Alpha-1 proteinase inhibitor is classified as FDA pregnancy risk category C.

It is not known if alpha-1 proteinase inhibitor is excreted in breast milk. Because many drugs enter human milk and can potentially cause harm to the nursing infant, alpha-1 proteinase inhibitor should be used cautiously in nursing mothers.

What else should I know about alpha-1-proteinase inhibitor-injection?

What preparations of alpha-1-proteinase inhibitor-injection are available?

Alpha-1 proteinase inhibitor is available in a kit containing a single-use vial of 1000 mg alpha-1 proteinase inhibitor as a lyophilized powder, one 20 ml vial of sterile water for dilution, a transfer needle, and a filter needle.

How should I keep alpha-1-proteinase inhibitor-injection stored?

Alpha-1 proteinase inhibitor should be stored below 25 C (77 F). This medicine does not require refrigeration and should not be stored in the freezer. After mixing, the solution can be kept at room temperature for administration within 3 hours.

REFERENCE: FDA Prescribing Information

Last Editorial Review: 3/20/2015

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Reviewed on 3/20/2015
References
REFERENCE: FDA Prescribing Information

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