Alpha 1 proteinase Inhibitor

Alpha 1 proteinase Inhibitor Brand Names

Aralast | Aralast NP | Glassia | Prolastin | Prolastin C | Zemaira

What is Alpha 1 proteinase Inhibitor

Alpha 1 proteinase inhibitor (A1-PI) is a sterile, parenteral preparation of purified human alpha-1-proteinase inhibitor, which is also known as alpha-1-antitrypsin (AAT).

The product is derived from pooled human plasma of healthy donors. A1-PI is FDA-approved for the augmentation treatment of patients with congenital AAT-deficiency (AATD) who have clinically evident emphysema.

Weekly infusions raise plasma and lung epithelial fluid levels of AAT to normal in AAT-deficient individuals. Findings from the RAPID/RAPID Extension program have confirmed the benefits of A1-PI therapy in slowing disease progression and provided evidence of a disease-modifying effect in patients with AATD; the study suggests that the early introduction of treatment may delay the time to death, lung transplantation, or crippling respiratory complaints in patients with emphysema related to severe AATD.

In humans, A1-PI is a broad-spectrum anti-inflammatory, immunomodulatory, and tissue-repair molecule, and the products are under investigation for other purposes.

The drug has received orphan drug designation by the FDA in the off-label treatment of graft versus host disease, and also for patients with recent onset (less than 15 years) with Type 1A diabetes mellitus with residual beta-cell function.

Several different A1-PI products are available and the first product was FDA-approved in 1987.

Indications

  • alpha-1 proteinase inhibitor (A1PI) deficiency
  • emphysema

For chronic augmentation and maintenance therapy in adults with emphysema due to alpha-1 proteinase inhibitor (A1PI) deficiency

Side Effects

  1. abdominal pain
  2. anaphylactic shock
  3. anaphylactoid reactions
  4. arthralgia
  5. asthenia
  6. back pain
  7. bronchospasm
  8. candidiasis
  9. chest pain (unspecified)
  10. chills
  11. cholangitis
  12. cough
  13. diarrhea
  14. dizziness
  15. drowsiness
  16. dyspepsia
  17. dyspnea
  18. ecchymosis
  19. elevated hepatic enzymes
  20. fatigue
  21. fever
  22. flushing
  23. headache
  24. hot flashes
  25. hypertension
  26. hypotension
  27. infection
  28. injection site reaction
  29. malaise
  30. migraine
  31. musculoskeletal pain
  32. myalgia
  33. nausea
  34. paresthesias
  35. peripheral edema
  36. peripheral vasodilation
  37. pharyngitis
  38. pruritus
  39. rash
  40. rhinitis
  41. rhinorrhea
  42. sinus tachycardia
  43. sinusitis
  44. syncope
  45. urticaria
  46. vomiting
  47. wheezing

Monitoring Parameters

  • pulmonary function tests (PFTs)

Contraindications

  • breast-feeding
  • children
  • geriatric
  • IgA deficiency
  • infants
  • neonates
  • pregnancy
  • viral infection

Interactions

There are no drug interactions associated with Alpha-1-proteinase Inhibitor products.

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