Aralast Np (alpha-1-proteinase inhibitor)
Alpha-Proteinase Inhibitors Intravenous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
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.
alpha1-Proteinase inhibitor is a naturally occurring inhibitor of serine proteases, enzymes that aid in proteolytic destruction of the connective tissue framework of the lung parenchyma. In patients with congenital alpha1-proteinase inhibitor deficiency, exogenous administration of an alpha1-proteinase inhibitor provides another source of enzyme inhibitor that protects lung tissues from proteolytic destruction.
Commercially available alpha1-proteinase inhibitors are sterile lyophilized concentrates of highly purified alpha1-proteinase inhibitor derived from pooled human plasma. Currently available alpha1-proteinase inhibitor preparations use cold alcohol fractionation to isolate the enzyme inhibitor from plasma. In addition, to reduce the risk of viral transmission, the manufacture of Aralast(R) includes a chemical (solvent/detergent) treatment procedure and additional purification steps (PEG and zinc chloride preparations, ion exchange chromatography). .
Solvent/detergent inactivation processes inactivate lipid-enveloped viruses (e.g., hepatitis B, hepatitis C, human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2)) but are less effective against viruses that do not have a lipid envelope (e.g., hepatitis A, parvoviruses). The manufacturer of Zemaira(R) also includes ion exchange chromatography to remove extraneous protein such as albumin. The manufacture of Aralast(R) or Zemaira(R) incorporates nanofiltration or ultrafiltration step(s), respectively, to reduce the risk of transmission of nonenveloped viruses.
The manufacture of Prolastin(R) or Zemaira(R) also incorporates a heat-inactivation procedure to reduce the risk of transmission of viral infections.
USES: This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed.
However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.
Generic name: alpha-1-proteinase inhibitor
Drug class: Alpha-Proteinase Inhibitors
Therapeutic class: Respiratory Therapy Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Aralast Np
Indications
The following indications are listed for Aralast Np:
- Pulmonary Emphysema Associated With Alpha-1-Proteinase Inhibitor Deficiency
Also known as: Alpha-1-Antitrypsin Deficiency Pulmonary Emphysema, Pulmonary Emphysema Associated With Alpha-1-Antitrypsin Deficiency.
Dosing
Dosage of alpha1-proteinase inhibitor in mg is expressed in terms of functionally active alpha1-proteinase inhibitor, as determined by human neutrophil (Zemaira(R)) or porcine pancreatic (Aralast(R), Prolastin(R)) elastase inhibitory activity. The specific functional activity of alpha1-proteinase inhibitor in currently available preparations (Aralast(R), Prolastin(R), Zemaira(R)) varies from lot to lot. The number of mg of functionally active alpha1-proteinase inhibitor is indicated on the label of each vial. The specific activity of functional alpha1-proteinase inhibitor in Aralast(R), Prolastin(R), or Zemaira(R) is not less than (NLT) 0.55, NLT 0.35, or NLT 0.7 mg, respectively, per mg of protein.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Aralast Np 500 Mg Vial | Maintenance | Infuse 60 mg/kg at a rate of 0.08 mL/kg/min by intravenous route onceweekly. |
| Aralast Np 1,000 Mg Vial | Maintenance | Infuse 60 mg/kg at a rate of 0.08 mL/kg/min by intravenous route onceweekly. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
alpha1-Proteinase inhibitor is contraindicated in individuals with selective IgA deficiencies (IgA concentrations less than 15 mg/dL) who have antibodies to IgA; severe adverse reactions, including anaphylaxis, could result following administration of alpha-1-proteinase inhibitor preparations, which may contain IgA.
- IgA deficiency
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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.
Rare or Very Rare
- Asthma
More Frequent
- Headache disorder
- Myalgia
Less Frequent
- Cough
- Injection site sequelae
- Pharyngitis
- Rhinitis
- Sore throat
- Upper respiratory infection
Rare or 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
Precautions
No enhanced messaging available.
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.
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 messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Pulmonary emphysema associated with alpha-1-proteinase inhibitor deficiency | ||
| E88.01 | ICD10CM | Alpha-1-antitrypsin deficiency |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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