Drug updated on 7/25/2024
| 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).
Latest News
Summary
- Alpha proteinase inhibitor (human) (Prolastin-C) is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).
- The information was derived from one systematic review/meta-analysis document.
- Prolastin-C has shown efficacy in slowing the progression of emphysema, as demonstrated by changes in CT density, making it a unique treatment specifically effective for AATD-related cases compared to general COPD treatments.
- Safety considerations include a small increase in exacerbation rates but no significant effect on mortality rates post-lung transplant when compared to COPD unrelated to AATD.
- Lung transplantation outcomes were comparable between AATD and non-AATD-related COPD; however, surgical lung volume reduction resulted in inferior outcomes for AATD patients compared to those with non-AATD-related emphysema.
- There is less robust data on the efficacy and safety of other treatment modalities aside from augmentation therapy with Prolastin-C, indicating a need for more studies focused on alternative treatments specific to AATD.
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 |