Prolastin C

Drug overview for PROLASTIN C (alpha-1-proteinase inhibitor):

Generic name: ALPHA-1-PROTEINASE INHIBITOR
Drug class: Alpha-Proteinase Inhibitors
Therapeutic class: Respiratory Therapy Agents

alpha1-Proteinase inhibitor is a naturally occurring inhibitor of serine proteases such as neutrophil elastase; this enzyme aids in the proteolytic destruction of the alveolar walls and connective tissue framework of the lung parenchyma.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for PROLASTIN C (alpha-1-proteinase inhibitor) have been approved by the FDA:

Indications:
Pulmonary emphysema associated with alpha-1-proteinase inhibitor deficiency

Professional Synonyms:
Alpha-1-antitrypsin deficiency pulmonary emphysema
Pulmonary emphysema associated with alpha-1-antitrypsin deficiency

Dosing information for PROLASTIN C
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PROLASTIN C 1,000 MG/20 ML VL	Maintenance	Adults infuse 60 mg/kg at a rate of 0.08 mL/kg/min by intravenous route once weekly

Contraindication List
IgA deficiency

The following adverse reaction information is available for PROLASTIN C (alpha-1-proteinase inhibitor):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse effects reported in patients receiving Aralast(R) in clinical trials and deemed to be drug-related were headache and somnolence. Adverse effects reported with Prolastin(R) therapy in clinical trials include delayed fever (occurring up to 12 hours following treatment), lightheadedness, and dizziness. The most common treatment-related adverse effects reported with Zemaira(R) in clinical trials include asthenia, injection site pain, dizziness, headache, paresthesia, and pruritus.

There are 1 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Asthma

There are 39 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Myalgia	Cough Injection site sequelae Pharyngitis Rhinitis Sore throat Upper respiratory infection

Rare/Very Rare
Abdominal distension Back pain Bronchitis Chest pain Chills Conjunctivitis Diarrhea Dizziness Drowsy Dysmenorrhea Dyspnea Fatigue Fever Flushing General weakness Hypertonia Hypoesthesia Insomnia Leukocytosis Malaise Nausea Nervousness Peripheral edema Pruritus of skin Rhinorrhea Skin rash Tinnitus Urticaria Vasodilation of blood vessels Visual changes Vomiting

The following precautions are available for PROLASTIN C (alpha-1-proteinase inhibitor):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy not established in children younger than 18 years of age. However, symptomatic obstructive lung disease usually occurs in patients with alpha1-proteinase inhibitor deficiency and a history of smoking in the third or fourth decade of life.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category C. (See Users Guide.)

Not known whether alpha1-proteinase inhibitor is distributed into milk. Since many drugs are distributed into milk, caution is advised if the drug is administered to nursing women.

No enhanced Geriatric Use information available for this drug.

Alpha-1-proteinase inhibitor deficiency emphysema
E88.01	Alpha-1-antitrypsin deficiency