|ALPHA1-PROTEINASE INHIBITOR (HUMAN)
Prolastin, Aralast, Zemaira
Classifications: enzyme inhibitor; Therapeutic: enzyme inhibitor
Pregnancy Category: C
Prolastin: 25 mg/mL; Aralast: 16 mg/mL; Zemaira: 50 mg/mL
Alpha1-proteinase inhibitor (alpha1-PI; alpha1-antitrypsin) is extracted from plasma and used in patients with panacinar emphysema who have alpha1-antitrypsin deficiency. Alpha1-antitrypsin deficiency is a chronic, hereditary, and usually fatal autosomal recessive disorder that results in a slowly
progressive, panacinar emphysema.
Prevents the progressive breakdown of elastin tissues in the alveoli, thus slowing panacinar emphysema progression.
Indicated for chronic replacement therapy in patients with alpha1-antitrypsin deficiency and demonstrable panacinar emphysema.
Individuals with selective IgA deficiencies; pregnancy (category C); lactation.
Patients with significant heart disease or other conditions that may be aggravated with slight increases in plasma volume.
Safety and efficacy in children are not established.
Route & Dosage
Adult: IV 60 mg/kg once/wk
PREPARE: IV Infusion: ??Warm unopened diluent and concentrate to room temperature.??Use the supplied, double needle transfer device to reconstitute with sterile water for injection (supplied by manufacturer)
to yield a concentration of 20 mg/mL.
ADMINISTER: IV Infusion: ?? Give within 3 h after reconstitution.??Give alone, without mixing with other agents.??Administer at rate of 0.08 mL/kg/min or more slowly as determined by response and comfort of the patient.?? Note: The recommended dosage takes about 30 min to administer to a 70 kg person.
- Store unreconstituted drug at 2°8° C (35°46° F). Do not refrigerate after reconstitution.
Discard unused solution.
Adverse Effects (≥1%)Hematologic:
Dizziness, fever (may be delayed). Respiratory:
Upper and lower respiratory tract infections. Other: Hepatitis
B if not immunized.
Crosses placenta; distributed into breast milk. Metabolism:
Undergoes catabolism in the intravascular space; approximately 33% is catabolized per day. Half-Life:
Assessment & Drug Effects
- Administer with caution in patients at risk for circulatory overload. Monitor cardiac status.
- Monitor respiratory status (rate, dyspnea, lung sounds) throughout therapy.
- Lab tests: Monitor serum alpha1-PI level (minimum serum concentration level should be 80 mg/mL); periodic pulmonary functions and ABGs.
Patient & Family Education
- Avoid smoking and notify physician of any changes in respiratory pattern.