Does Prolastin-C (alpha-1 proteinase inhibitor) cause side effects?

Prolastin-C (alpha-1 proteinase inhibitor) is a protein used to treat alpha-1 antitrypsin (AAT) deficiency in patients with emphysema

AAT deficiency is a genetic disorder in which abnormally low levels of the protein AAT allow certain enzymes to attack healthy tissues, especially the lungs. Over time, significant lung damage occurs, and patients develop serious lung diseases like emphysema

There is no cure for AAT deficiency but Prolastin-C can help patients manage their condition. Prolastin-C works in the lower respiratory tract where it inhibits neutrophil elastase (NE), the enzyme that damages lung tissue. 

Common side effects of Prolastin-C include:

Serious side effects of Prolastin-C include:

Drug interactions of Prolastin-C are not found in the medical literature and are not provided by the manufacturer. 

Prolastin-C has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, Prolastin-C should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. 

It is not known if Prolastin-C is excreted in breast milk. Because many drugs enter human milk and can potentially cause harm to the nursing infant, Prolastin-C should be used cautiously in breastfeeding mothers.

What are the important side effects of Prolastin-C (alpha-1 proteinase inhibitor)?

The most common side effects of alpha-1 proteinase inhibitor are:

  • chills,
  • malaise,
  • headache,
  • rash,
  • hot flush, and
  • pruritus.
  • increase in enzymes used to monitor liver function,
  • shortness of breath,
  • serious hypersensitivity-type reactions or anaphylaxis, and
  • rapid heartbeat.

Prolastin-C (alpha-1 proteinase inhibitor) side effects list for healthcare professionals

Therapeutic administration of Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) , 60 mg/kg weekly, has been demonstrated to be well tolerated.

In clinical studies, six reactions were observed with 517 infusions of Prolastin (alpha), or 1.16%. None of the reactions was severe.

The adverse reactions reported included:

  • delayed fever (maximum temperature rise was 38.9°C, resolving spontaneously over 24 hours) occurring up to 12 hours following treatment (0.77%),
  • light-headedness (0.19%), and
  • dizziness (0.19%).

Mild transient leukocytosis and dilutional anemia several hours after infusion have also been noted. 

Since market entry, occasional reports of:

Rare cases of transient increase in blood pressure or hypertension and chest pain have also been reported.

What drugs interact with Prolastin-C (alpha-1 proteinase inhibitor)?

No information provided.

Summary

Prolastin-C (alpha-1 proteinase inhibitor) is a protein used to treat alpha-1 antitrypsin (AAT) deficiency. Common side effects of Prolastin-C include chills, feeling unwell (malaise), headache, rash, hot flushes, and itching. Serious side effects of Prolastin-C include increases in enzymes used to monitor liver function, shortness of breath, serious hypersensitivity-type reactions or anaphylaxis, and rapid heartbeat. It is not known if Prolastin-C is excreted in breast milk. Because many drugs enter human milk and can potentially cause harm to the nursing infant, Prolastin-C should be used cautiously in breastfeeding mothers.

Treatment & Diagnosis

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Medically Reviewed on 5/26/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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