What are the common and uncommon reactions to Prolastin-C (Alpha-1 Antitrypsin) infusion?

Common and Uncommon Reactions to Prolastin-C Infusion

Prolastin-C infusions can cause a range of reactions from mild to severe, with the most common adverse reactions being headache and upper respiratory tract infections. 1

Common Reactions (≥5% of patients)

• Respiratory symptoms:

  • Cough (9% of patients) 1
  • Upper respiratory tract infection (9% of patients) 1
  • Sinusitis (9% of patients) 1

• Neurological symptoms:

  • Headache (9% of patients) 1
  • Dizziness (6% of patients) 1

• Other common reactions:

  • Chest discomfort (6% of patients) 1
  • Elevated hepatic enzymes (6% of patients) 1

Less Common Reactions (<5% of patients)

• Infusion-related reactions:

  • Flushing 2
  • Chills 2
  • Fever 2
  • Nausea 2
  • Pruritus (itching) 2
  • Rash 2

• Serious reactions:

  • Exacerbation of chronic obstructive pulmonary disease (COPD) - identified as the most serious adverse reaction in clinical trials 1
  • Hypersensitivity reactions - particularly in patients with IgA deficiency who have antibodies against IgA 1

Rare but Severe Reactions

• Anaphylaxis and severe hypersensitivity reactions:

  • These can occur particularly in patients with known antibodies to IgA 1
  • Symptoms may include bronchospasm, hypotension, widespread urticaria, and hypoxia 2
  • These reactions require immediate discontinuation of the infusion and emergency treatment 1

• Hypersensitivity vasculitis:

  • Although extremely rare, there has been a case report of hypersensitivity vasculitis following Prolastin infusion 3

Management of Infusion Reactions

• For mild to moderate reactions:

  • Slow or temporarily stop the infusion 1
  • Provide symptomatic treatment 2
  • Resume infusion at a slower rate once symptoms subside 1

• For severe reactions:

  • Immediately discontinue the infusion 1
  • Administer emergency treatment as needed 1
  • Have epinephrine and supportive therapy available for treatment of acute anaphylactic reactions 1

Risk Factors for Reactions

• Patient-specific factors:
  • History of allergies to other drugs 2
  • IgA deficiency with antibodies against IgA 1
  • Previous reaction to Prolastin-C 2

Monitoring Recommendations

• During infusion:

  • Monitor vital signs continuously throughout the infusion 1
  • Observe patients carefully for signs of hypersensitivity 1

• Post-infusion:

  • Continue monitoring for delayed reactions 2

Prevention Strategies

• Infusion technique:

  • Initial infusion rate should not exceed 0.08 mL/kg/min 1
  • Slow infusion rate (approximately 15 minutes for standard dose) 1
  • Increase rate gradually if well tolerated 1

• Important note:

  • Unlike some other biological products, premedication is not routinely recommended for Prolastin-C infusions unless there is a history of previous reactions 2

Clinical Pearls

• Distinguishing between true allergic reactions and non-immune-mediated infusion reactions is important for management decisions 2
• The risk of transmitting infectious agents (viruses, vCJD, etc.) is minimized through donor screening and viral inactivation/removal steps, but theoretical risk remains 1
• No seroconversions for HIV, hepatitis B or C, or parvovirus B19 were reported in clinical trials 1
• Low-level anti-Prolastin antibodies were detected in one subject during clinical trials but returned to negative by the end of the study 1