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alpha 1 proteinase inhibitor (Rx)Brand and Other Names:Aralast NP, Glassia, more...Prolastin C, Zemaira

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for reconstitution

  • 0.4g/vial
  • 0.5g/vial
  • 0.8g/vial
  • 1g/vial

IV solution

  • 1g/50mL vial
more...

Alpha-1 Antitrypsin Deficiency

Indicated for chronic augmentation and maintenance therapy in adults with emphysema caused by congenital alpha-1-proteinase inhibitor deficiency

60 mg/kg IV infusion qWeek 

IV infusion rate

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

Orphan Designations

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
  • 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
  • Sponsor: Kamada, Ltd.; Kiryat Weizmann, Science Park;  Ness-Ziona 74036 Israel

Bronchopulmonary Dysplasia (Orphan)

  • Prevention of bronchopulmonary dysplasia
  • Sponsor: Arriva Pharmaceuticals, Inc; 1010 Atlantic Avenue; Alameda, CA 94501

Graft vs Host Disease (Orphan)

  • Glassia: Treatment of GVHD
  • Sponsor: Kamada, Ltd.; Kiryat Weizmann, Science Park;  Ness-Ziona 74036 Israel

Cystic Fibrosis (Orphan)

  • Sponsor: CSL Behring LLC; 1020 First Avenue; King of Prussia, PA 19406
  • Sponsor: Arriva Pharmacueticals, Inc; 1010 Atlantic Avenue; Alameda, CA 94501
  • Sponsor: PPL Therapeutics (Scotland) Limited; Roslin, Edinburgh EH259PP, Scotland, United Kingdom

Safety and efficacy not established

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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 & fever (0.1%)

Chest pain (0.1%)

Dizziness (0.1%)

Increased cough (0.1%)

Pruritus (0.1%)

Rash (0.1%)

Vasodilation (0.1%)

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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
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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.

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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 deficienty 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

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Administration

IV Preparation

Use aseptic technique

Reconstitution requires no more than 5 min for 0.5 g vial and no more than 10 min for a 1 g vial

Do not shake contents of the vial; 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: 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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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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