Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 500 mg [10 mL], 1,000 mg [20 mL], 4,000 mg [80 mL]) |
| Drug Class | Alpha1 proteinase inhibitors (human) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitripsin deficiency).
Summary
- Alpha proteinase inhibitor (human) (Prolastin-C) is employed for chronic augmentation and maintenance therapy in adults displaying clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin deficiency.
- Information regarding this drug was derived from a study that reviews the diagnosis and treatment of AATD-related lung disease, particularly in the context of Australia and New Zealand.
- There is no direct comparison between Prolastin-C and other therapies regarding safety or effectiveness provided in the study. It instead focuses on broader aspects related to alpha1 antitrypsin augmentation therapy, which includes intravenous infusions of exogenous AAT protein.
- The importance of tailored treatments for those with AATD-related lung disease has been emphasized. These include testing for AATD, monitoring disease progression, addressing conditions in heterozygous patients, and exploring various therapeutic options, including surgical interventions for severe cases.
- Broader considerations such as genetic counseling, involvement in patient support groups, monitoring of liver diseases, and the establishment of national registries specifically targeting individuals suffering from ATTD in the Australia and New Zealand region are mentioned.
- Detailed comparative data on safety or effectiveness comparisons among different subgroups using Prolastin-C relative to other treatments were not available based on this study.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prolastin-C Liquid (alpha-1 proteinase inhibitor) Prescribing Information. | 2020 | Grifols Therapeutics., Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Treatment of lung disease in alpha-1 antitrypsin deficiency: a systematic review. | 2017 | International Journal of Chronic Obstructive Pulmonary Disease |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Diagnosis and treatment of lung disease associated with alpha one-antitrypsin deficiency: a position statement from the Thoracic Society of Australia and New Zealand. | 2020 | Respirology |
| An analysis of the degree of concordance among international guidelines regarding alpha-1 antitrypsin deficiency. | 2019 | International Journal of COPD |