alpha 1 proteinase inhibitor (Rx)

>10%

Increases ALT, AST >2 times upper limit or normal (11%)

1-10%

Infusion Reactions (9.6%)

• Headache (0.7%)
• Pharyngitis (1.6%)
• Increased cough (0.6%)

<1%

Headache (0.3%)

Somnolence (0.3%)

Chills and fever (0.1%)

Chest pain (0.1%)

Dizziness (0.1%)

Increased cough (0.1%)

Pruritus (0.1%)

Rash (0.1%)

Vasodilation (0.1%)

Contraindications

Hypersensitivity

Selective IgA deficiencies (IgA <15 mg/dL) with known IgA antibodies

Liver disease associated with alpha 1-proteinase inhibitor deficiency

Cautions

Patients at risk of circulatory overload

D/C immediately if anaphylactic or severe anaphylactoid reaction

Theoretical risk of pathogen transmission

• Report suspected infection
• Aralast to Alpha Therapeutic Corp. 1-888-675-2762 (US) or 1-323-225-9735 (international)
• Prolastin to Bayer Corp 1-800-288-8371
• Zemaira to ZLB Behring 1-800-504-5434

Pregnancy Category: C

Lactation: not known if distributed into breast milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Purified human alpha-1-proteinase inhibitor (alpha-1-antitrypsin, ATT) inhibits serine proteases such as neutrophil elastase in lungs; alpha1-antitrypsin deficiency leads to the development of emphysema resulting from increased elastic damage in the lung

Source: Human plasma donors

Pharmacokinetics

Half-life elimination: 5-6 days

Vd: 3.5 L

Peak plasma time: 1 hr (3 weeks to achieve threshold levels)

Metabolism: Undergoes catabolism in the intravascular space; 33% of AAT is catabolized per day

IV Preparation

Use aseptic technique

Reconstitution requires no more than 5 min for 0.5-g or 1-g vials and no more than 10 min for 4-g or 5-g vials

Gently swirl vial; do not shake

Do not invert vial until ready to withdraw contents

When reconstitution procedure is strictly followed, a few small particles may remain; will be removed by microaggregate filter

IV Administration

For IV infusion only

IV infusion rate

• Aralast NP, Prolastin C, Zemaira: Not to exceed 0.08 mL/kg/min
• Glassia: Not to exceed 0.04 mL/kg/min

Storage

Unopened vials

• Aralast NP, Prolastin C, Zemaira: Temperatures not to exceed 25°C (77°F); avoid freezing (may damage diluent vial)
• Glassia: 2-8 °C (36-46 °F); do not freeze

Opened vials

• Store at room temperature
• Use within 3 hr of entering/reconstituting the vials to avoid the potential ill effect of any inadvertent microbial contamination