Drug updated on 9/5/2024
| 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
- Prolastin-C (alpha proteinase inhibitor (human)) 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).
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Intravenous augmentation with alpha-1 antitrypsin (AAT) slowed emphysema progression in severe AATD patients, with a CT density change of 0.79 g/L/year compared to placebo (P=0.002).
- The therapy was associated with a small but statistically significant increase in exacerbations, 0.29/year (P=0.02).
- Mortality rates after lung transplant were similar between AATD-related COPD and non-AATD-related COPD, but surgical lung volume reduction outcomes were worse in AATD-related emphysema patients.
- No other significant safety concerns or adverse effects were mentioned in the reviewed studies.
- There is no population-type or subgroup information available in the reviewed studies.
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 |