Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 500 mg [10 mL], 1,000 mg [20 mL], 4,000 mg [80 mL]) |
| Drug Class | Human alpha-1 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
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Alpha₁-Proteinase Inhibitor, Modified Process (Alpha-1 MP) demonstrated stable pulmonary function in Japanese patients with alpha(1)-antitrypsin deficiency (AATD) over approximately four years, with no changes in forced expiratory volume in 1 second (FEV₁) or forced vital capacity (FVC).
- The average trough level (C(min)) of Alpha-1 MP was maintained at 55.73 (4.99) mg/dL throughout the study period of 213 weeks.
- Among the four patients, 54 treatment-emergent adverse events (TEAEs) were reported, with 96.3% classified as mild; five serious adverse events (SAEs) were reported in two patients, none of which were related to the treatment.
- Three mild TEAEs were deemed potentially related to Alpha-1 MP, with no clinically significant findings in COPD exacerbations, laboratory parameters, or vital signs.
- The study focused on Japanese patients with alpha(1)-antitrypsin deficiency (AATD) and reported that long-term weekly intravenous infusions of 60 mg/kg Alpha-1 MP were generally safe and well-tolerated in this population.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prolastin-C (alpha1-proteinase inhibitor (human)) Prescribing Information. | 2020 | Grifols Therapeutics LLC, Los Angeles, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Long-term safety of Prolastin(R)-C, an alpha1-proteinase inhibitor, in Japanese patients with alpha1-antitrypsin deficiency | 2022 | Respiratory Investigation |
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 |