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- Does Prolastin-C (alpha-1 proteinase inhibitor) cause side effects?
- What are the important side effects of Prolastin-C (alpha-1 proteinase inhibitor)?
- Prolastin-C (alpha-1 proteinase inhibitor) side effects list for healthcare professionals
- What drugs interact with Prolastin-C (alpha-1 proteinase inhibitor)?
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:
- increases in enzymes used to monitor liver function,
- shortness of breath,
- serious hypersensitivity-type reactions or anaphylaxis, and
- rapid heartbeat.
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:
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:
- other flu-like symptoms,
- allergic-like reactions,
- chills,
- dyspnea,
- rash,
- tachycardia, and, rarely,
- hypotension have also been received.
Rare cases of transient increase in blood pressure or hypertension and chest pain have also been reported.
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.
Related Disease Conditions
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Alpha-1 Antitrypsin Deficiency (Symptoms, Treatment, Life Expectancy)
Alpha-1 antitrypsin deficiency (AATD) is an inherited disorder caused by mutations in the SERPINA1 gene. People with the condition are at risk for developing serious lung and liver disease. Symptoms and signs of lung disease caused by this condition include:The earliest symptoms and signs of lung disease usually develop between 20 and 50 years of age, and are Wheezing The reduced ability to exercise Shortness of breath (dyspnea) following mild activity Other symptoms and signs of alpha-1 antitrypsin deficiency are: Fatigue Rapid heartbeat when going from sitting to standing Recurring respiratory infections Unintentional weight loss Lung disease: People with this condition often develop emphysema, with symptoms of a hacking cough, barrel-shaped chest, and difficulty breathing. If you have this condition and smoke or are exposed to tobacco smoke, it accelerates the appearance of emphysema symptoms and lung damage.Liver disease: Alpha-1 antitrypsin deficiency also cause liver disease in some people with the condition, that include liver cancer, cirrhosis of the liver, an abnormally large liver (hepatomegaly), liver failure, and hepatitis. Liver damage from alpha-1 antitrypsin deficiency causes symptom of a swollen abdomen, swollen legs or feet, and jaundice. Treatment of AATD depends upon the severity of symptoms. FDA approved drug for AATD is an orphan product called alpha-1-proteinase inhibitor (human), sold under the brand name "Prolastin."
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Emphysema, Chronic Bronchitis, and Colds
If you have a COPD such as emphysema, avoiding chronic bronchitis and colds is important to avoid a more severe respiratory infection such as pneumonia. Avoiding cigarette smoking, practice good hygeine, stay away from crowds, and alerting your healthcare provider if you have a sinus infection or cold or cough that becomes worse. Treatment options depend upon the severity of the emphysema, bronchitis, or cold combination.
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Emphysema
Emphysema is a COPD (chronic obstructive pulmonary disease) that often occurs with other obstructive pulmonary problems and chronic bronchitis. Causes of emphysema include chronic cigarette smoking, exposure to secondhand smoke, air pollution, and in the underdeveloped parts of the world. Symptoms of emphysema include chronic cough, chest discomfort, breathlessness, and wheezing. Treatments include medication and lifestyle changes.
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COPD vs. Emphysema
COPD (chronic obstructive pulmonary disease) is the term doctors and other healthcare professionals use to describe a group of serious, progressive (worsens over time), chronic lung diseases that include emphysema, chronic bronchitis, and sometimes asthma. The number one cause of COPD or emphysema, is smoking, and smoking is the third leading cause of death in the US.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.