A1-Proteinase Inhibitor
Drug class: Antineoplastic Agents , Antineoplastic Agents
Usage of A1-Proteinase Inhibitor
Congenital α1-Proteinase Inhibitor Deficiency
Replacement therapy in patients with congenital α1-proteinase inhibitor (also called α1-antitrypsin) deficiency and clinically evident emphysema.
Not indicated as therapy for patients with lung disease in whom congenital α1-proteinase inhibitor deficiency has not been established.
The American Thoracic Society and the European Respiratory Society (ATS/ERS) state that α1-proteinase inhibitor therapy does not confer benefit in, and is not recommended for, patients who have α1-proteinase-associated liver disease.
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How to use A1-Proteinase Inhibitor
Administration
IV Administration
Administer by IV infusion.
Administer IV infusions of Zemaira through an IV line using an administration set that contains an inline filter (pore size 5 µm).
Monitor infusion rate and clinical status (e.g., vital signs, infusion-related reactions) of the patient continuously throughout the infusion.
Administer with caution; percutaneous puncture with a needle contaminated with blood may transmit infectious agents. (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.)
ReconstitutionVials of lyophilized α1-proteinase inhibitor and diluent should be at room temperature before reconstitution.
Reconstitute vials of lyophilized α1-proteinase inhibitor with manufacturer-supplied sterile water for injection without preservatives. Using the supplied transfer needle or device, add the appropriate volume of the supplied diluent to a vial containing α1-proteinase inhibitor. (See Table 1.) Swirl vial gently to ensure dissolution; do not shake.
Approximate amount (mg or g) of functionally active α1-proteinase inhibitor.
Manufacturer-supplied sterile water for injection without preservatives.
Table 1. Reconstitution of α1-Proteinase Inhibitor Preparationsα1-Proteinase Inhibitor Preparation
Dosage Strength Labeled on Vial
Diluent Volume
Aralast
500 mg
25 mL
Aralast
1 g
50 mL
Prolastin
500 mg
20 mL
Prolastin
1 g
40 mL
Zemaira
1 g
20 mL
Resultant solution of Aralast, Prolastin, or Zemaira contains not less than (NLT) 16 mg, NLT 20 mg, or approximately 50 mg of α1-proteinase inhibitor per mL, respectively.
For administration of large doses, several reconstituted vials may be pooled into an empty, sterile IV infusion container (e.g., empty IV bag or glass bottle) using aseptic technique.
Withdraw reconstituted solutions of Aralast and Prolastin from the vial using a filter needle provided by the manufacturer.
Reconstituted solutions contain no preservatives; administer within 3 hours after reconstitution.
Any unused solution should be discarded; discard administration equipment in accordance with biohazard waste procedures.
Rate of AdministrationAdminister Aralast at an infusion rate ≤0.08 mL/kg per minute.
Administer Zemaira at an infusion rate of approximately 0.08 mL/kg per minute.
Administer Prolastin at an infusion rate of ≥0.08 mL/kg per minute.
If adverse effects occur, reduce infusion rate or temporarily interrupt infusion until manifestations subside. Infusion may then be resumed at a rate tolerated by the patient.
Dosage
Dosage of α1-proteinase inhibitor in mg is expressed in terms of functionally active α1-proteinase inhibitor, as determined by human neutrophil (Zemaira) or porcine pancreatic (Aralast, Prolastin) elastase inhibitory activity.
Number of mg of functionally active α1-proteinase inhibitor is indicated on the label of each vial.
Specific activity of functional α1-proteinase inhibitor in Aralast, Prolastin, or Zemaira is NLT 0.55, NLT 0.35, or NLT 0.7 mg, respectively, per mg of protein.
Adults
Congenital α1-Proteinase Inhibitor Deficiency IV60 mg/kg by IV infusion once weekly.
Warnings
Contraindications
Warnings/Precautions
Warnings
Risk of Transmissible Agents in Plasma-derived PreparationsPotential vehicle for transmission of human viruses (i.e., hepatitis A [HAV] or C virus [HCV]; HIV-1 or HIV-2; parvovirus B19) or other infectious agents.
Despite stringent procedures (e.g., screening of plasma donors, application of a number of viral elimination/reduction steps) to prevent transmission of infectious agents, a risk of transmission still remains.
Risk of viral infection should be weighed against the benefits of α1-proteinase inhibitor therapy.
All infections thought possible to have been transmitted by α1-proteinase inhibitor products should be reported to the appropriate manufacturer.
Risk of Creutzfeldt-Jakob DiseaseMay carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD), although transmission via human blood, blood components, or plasma derivatives (including α1-proteinase inhibitor) has not been documented. CJD is a rare, but invariably fatal, degenerative disease of the CNS associated with a poorly understood transmissable agent.
There remains a theoretical risk that CJD can be transmitted through blood or blood products, although the risk is considered extremely remote.
Sensitivity Reactions
Hypersensitivity ReactionsPotential serious hypersensitivity reactions (e.g., anaphylactic or anaphylactoid reactions).
If acute hypersensitivity reactions (e.g., hives, generalized urticaria, tightness of the chest, dyspnea, wheezing, faintness, hypotension, anaphylaxis) occur, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).
General Precautions
Expansion of Plasma VolumeTransient expansion of plasma volume may occur during infusion; administer cautiously to patients at risk for circulatory overload.
Specific Populations
PregnancyCategory C.
LactationNot known whether α1-proteinase inhibitor is distributed into milk. Caution advised if α1-proteinase inhibitor is used.
Pediatric UseSafety and efficacy not established.
Hepatic ImpairmentUse not recommended in patients with liver disease associated with α1-proteinase inhibitor deficiency.
Common Adverse Effects
Headache, somnolence, delayed fever, lightheadedness, dizziness, asthenia, injection site pain, paresthesia, pruritus.
Disclaimer
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