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Drug overview for ZEMAIRA (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.
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 ZEMAIRA (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
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
The following dosing information is available for ZEMAIRA (alpha-1-proteinase inhibitor):
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.
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 enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZEMAIRA 4,000 MG VIAL | Maintenance | Adults infuse 60 mg/kg at a rate of 0.08 mL/kg/min by intravenous route once weekly |
| ZEMAIRA 5,000 MG VIAL | Maintenance | Adults infuse 60 mg/kg at a rate of 0.08 mL/kg/min by intravenous route once weekly |
No generic dosing information available.
The following drug interaction information is available for ZEMAIRA (alpha-1-proteinase inhibitor):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ZEMAIRA (alpha-1-proteinase inhibitor):
Drug contraindication overview.
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.
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.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| IgA deficiency |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for ZEMAIRA (alpha-1-proteinase inhibitor):
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.
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 ZEMAIRA (alpha-1-proteinase inhibitor):
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
Severe Precaution
Management or Monitoring Precaution
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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Alpha-1-proteinase Inhibitor | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insuff human data avail; consider maternal tx benefit vs possible infant risk |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ZEMAIRA (alpha-1-proteinase inhibitor):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZEMAIRA (alpha-1-proteinase inhibitor)'s list of indications:
| Alpha-1-proteinase inhibitor deficiency emphysema | |
| E88.01 | Alpha-1-antitrypsin deficiency |
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