Monograph: |
Alpha 1 -Proteinase Inhibitor (Human)
Class: Respiratory enzyme
Trade Names:
Aralast
- Powder for injection, lyophilized 400?mg (greater than or equal to 16 mg/mL alpha-1 proteinase inhibitor when reconstituted)
- Powder for injection, lyophilized 800?mg (greater than or equal to 16 mg/mL alpha-1 proteinase inhibitor when reconstituted)
Trade Names:
Prolastin
- Powder for injection, lyophilized 500?mg (greater than or equal to 20 mg/mL alpha-1 proteinase inhibitor when reconstituted)
- Powder for injection, lyophilized 1,000?mg (greater than or equal to 20 mg/mL alpha-1 proteinase inhibitor when reconstituted)
Trade Names:
Zemaira
- Powder for injection, lyophilized 1,000 mg
Pharmacology
Inhibits serine proteases (eg, neutrophil elastase), which are capable of degrading protein components of the alveolar walls and which are chronically present in the lung.
Pharmacokinetics
Metabolism
Metabolic t 陆 5.9 days.
Indications and Usage
Chronic augmentation therapy in patients with congenital deficiency of alpha-1 proteinase inhibitor with clinically evident emphysema.
Contraindications
Individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibodies against IgA.
Zemaira
History of anaphylaxis or severe systemic response to alpha-1 proteinase inhibitor products.
Dosage and Administration
Adults
IV 60 mg/kg infusion once weekly. Administer at a rate not exceeding 0.08 mL/kg/min.
General Advice
路 Follow manufacturer's instructions for reconstitution of powder with supplied diluent and final dilution for infusion solution.
路 Do not shake or agitate vials during reconstitution or dilution.
路 Inspect solution visually before administration. Do not administer if solution is cloudy, discolored, or contains more than a few small particles.
路 Discard any unused product. Vials are for single-use only. Do not save medication for future use.
路 Infuse prescribed dose over period of 30 min or so. Do not exceed IV infusion rate of 0.8 mL/kg/min.
路 Infuse Zemaira reconstituted solution through supplied in-line filter.
路 Do not administer in same IV line with other products.
Storage/Stability
Store vials in refrigerator (36掳 to 46掳F). Do not freeze. Vials may be removed from refrigerator and stored at controlled room temperature (not to exceed 77掳F). Aralast must be used within 1 mo once removed from refrigeration. Use solution within 3 h of reconstitution. Do not refrigerate solution after reconstitution.
Drug Interactions
None well documented.
Incompatibility
Do not mix with other agents or diluting solutions.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Prolastin
Hypotension, tachycardia (postmarketing).
CNS
Zemaira
Headache (3%); dizziness (1%).
Dermatologic
Prolastin
Rash (postmarketing).
Zemaira
Pruritus (1%).
EENT
Aralast
Pharyngitis (2%).
Zemaira
Sinusitis (2%).
Hepatic
Aralast
ALT or AST elevations (11%).
Musculoskeletal
Zemaira
Asthenia (1%).
Pulmonary
COPD.
Respiratory
Aralast
Upper and lower respiratory tract infections (96%).
Prolastin
Dyspnea (postmarketing).
Zemaira
Upper respiratory tract infection (2%).
Miscellaneous
Prolastin
Fever (1%); flu-like symptoms, allergic-like reactions, chills (postmarketing).
Zemaira
Injection-site pain, paresthesia (1%).
Precautions
Monitor Infusion reaction Monitor patient for development of infusion reaction. If infusion reaction develops, decrease the infusion rate or temporarily stop the infusion until symptoms subside. Resume infusion at rate tolerated by patient. Vital signs Monitor vital signs and carefully observe patient throughout the infusion.
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Anaphylaxis
Immediately discontinue the infusion if severe anaphylactoid or anaphylactic reactions occur.
Circulatory overload
Use with caution in patients at risk of circulatory overload.
Hepatitis B
Ensure that patient receiving Prolastin is immunized against hepatitis B before beginning therapy.
Infection
Because alpha-1 proteinase inhibitor is derived from pooled human plasma, there is a risk of transmitting infectious agents (eg, viruses) and, theoretically, Creutzfeldt-Jakob disease.
Patient Information
路 Advise patient, family, or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
路 Advise patient, family, or caregiver to report any signs or symptoms of hypersensitivity reaction (eg, hives, rash, chest tightness, wheezing, difficulty breathing, faintness).
路 Advise patient, family, or caregiver to report the following symptom complex to health care provider: fever, drowsiness, chills, and runny nose followed 2 wk later by rash and joint pain.
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