Dosing & Uses
Dosage Forms & Strengths
lyphilized powder for reconstitution
- 0.5g/vial (Aralast NP)
- 1g/vial (Aralast NP, Zemaira)
- 4g/vial (Zemaira)
- 5g/vial (Zemaira)
ready-to-use IV solution
- 1g/50mL (Glassia)
- 1g/20mL (Prolastin C)
Alpha-1 Antitrypsin Deficiency
Indicated for chronic augmentation and maintenance therapy in adults with emphysema caused by congenital alpha-1-proteinase inhibitor deficiency
IV infusion rate
- Aralast NP, Prolastin C, Zemaira: Not to exceed 0.08 mL/kg/min
- Glassia: 0.04 mL/kg/min
Diabetes Mellitus, Type-1 (Orphan)
Glassia (IV): Treatment of recent onset (<15 yr) with type 1A diabetes mellitus with residual beta-cell function
Prolastin C: Orphan designation for treatment of type 1 diabetes mellitus patients with residual beta-cell function
Orphan sponsors
- Glassia: Kamada, Ltd.; Kiryat Weizmann, Science Park; Ness-Ziona 74036 Israel
- Prolastin C: Grifols Therapeutics, Inc; 8368 US Business Hwy 70 West; Clayton, NC 27520
Alpha-1 Proteinase Inhibitor Deficiency (Orphan)
Inhalation therapy for treatment of congenital deficiency of alpha-1 proteinase inhibitor
Orphan sponsor
- Kamada, Ltd.; Kiryat Weizmann, Science Park; Ness-Ziona 74036 Israel
Bronchopulmonary Dysplasia (Orphan)
Prevention of bronchopulmonary dysplasia
Orphan sponsor
- Arriva Pharmaceuticals, Inc; 1010 Atlantic Avenue; Alameda, CA 94501
Graft vs Host Disease (Orphan)
Glassia: Treatment of GVHD
Orphan sponsor
- CSL Behring LLC; 1020 First Ave, PO Box 61501; King of Prussia, PA
Cystic Fibrosis (Orphan)
Orphan Sponsor
- CSL Behring LLC; 1020 First Avenue; King of Prussia, PA 19406
- Arriva Pharmacueticals, Inc; 1010 Atlantic Avenue; Alameda, CA 94501
- PPL Therapeutics (Scotland) Limited; Roslin, Edinburgh EH259PP, Scotland, United Kingdom
Safety and efficacy not established
Adverse Effects
>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%)
Warnings
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 & Lactation
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.Pharmacology
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
Administration
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
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Formulary
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