alpha1-proteinase inhibitor, Human

(redirected from Aralast)

alpha1-proteinase inhibitor, Human

,

alpha1-antitrypsin

(trade name),

Aralast

(trade name),

Aralast NP

(trade name),

Glassia

(trade name),

Prolastin-C

(trade name),

Zemaira

(trade name)

Classification

Therapeutic: pulmonary replacement enzyme inhibitor
Pharmacologic: enzyme inhibitors
Pregnancy Category: C

Indications

Replacement therapy (chronic) in patients with emphysema associated with alpha1-antitrypsin deficiency.

Action

Prevents the destructive action of elastase on alveolar tissue in patients who have alpha1-antitrypsin deficiency.

Therapeutic effects

Slowing of the destructive process on lung tissue.

Pharmacokinetics

Absorption: Following IV administration, absorption is essentially complete.
Distribution: Achieves high concentration in epithelial fluid of the lungs.
Metabolism and Excretion: Broken down in the intravascular space.
Half-life: 4.5–5.9 days.

Time/action profile (↑ serum levels of alpha1-proteinase inhibitor)

ROUTEONSETPEAKDURATION
IV2–6 dayswithin 3 wksunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to polyethylene glycol (Aralast); Emphysema associated with alpha1-antitrypsin deficiency, where risk of panacinar emphysema is small (PiMZ and PiMS phenotype). ; Selective IgA deficiency with known anti-IgA antibody (↑ risk of allergic reactions).
Use Cautiously in: Patients at risk for volume overload; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Gastrointestinal

  • ↑ liver enzymes

Hematologic

  • transient leukocytosis

Respiratory

  • cough
  • respiratory tract infection
  • sore throat

Miscellaneous

  • delayed fever

Interactions

Drug-Drug interaction

None known.

Route/Dosage

Intravenous (Adults) 60 mg/kg once weekly.

Availability

Injection: 500 mg/vial (Aralast, Aralast NP), 1000 mg/vial (Aralast, Aralast NP, Glassia, Prolastin-C, Zemaira)

Nursing implications

Nursing assessment

  • Monitor respiratory status (rate, lung sounds, dyspnea) prior to and weekly during therapy.
  • Assess for fever, chills, and dizziness. May occur up to 12 hr after infusion and disappear over 24 hr. Treat symptomatically.
  • Monitor for signs of fluid overload (dyspnea, rales/crackles, hypertension, jugular venous distention) in patients at risk for volume overload.
  • If adverse events occur during the infusion, decrease rate or discontinue until reactions resolve.
  • Lab Test Considerations: Monitor serum alpha1-proteinase inhibitor levels to determine response to therapy. Minimum serum concentration should be 80 mg/dL.
    • May cause transient mild ↑ in leukocytes.

Potential Nursing Diagnoses

Impaired gas exchange (Indications)

Implementation

  • Intravenous Administration
  • Bring drug and sterile water vials to room temperature. Follow manufacturer’s instructions for vacuum transfer using transfer device/needle. Reconstitute Aralast- NP, Prolastin-C and Zemaira with manufacurer-provided 20 mL vial of sterile water for injection. Swirl to mix; do not shake; may take 5 min for 500 mg and 10 min for 1000 mg vials until powder is dissolved. Glassia comes ready to use. Concentration: 500 mg vial: 25 mg/mL; 1000 mg vial: 50 mg/mL. Do not administer solutions that are discolored or contain particulate matter. Do not refrigerate after reconstitution. Use within 3 hr. Discard unused solution.
  • Rate: Administer direct IV at a rate of 0.08 mL/kg/min Aralast- NP, Prolastin-C or Zemairaover 15–30 min or 0.04 mL/kg/min over 60–80 min Glassia. Use the large volume 5–micron conical filter provided for administration of Zemaira.
  • Incompatibility: Administer separately. Do not mix with other drugs or diluents.

Patient/Family Teaching

  • Explain purpose of medication and need for long term weekly therapy to patient and family. Patient should avoid smoking and notify health care professional of any changes in breathing pattern or sputum production.
  • Inform patient that fever may occur within 12 hr after infusion and will resolve by 24 hr. Fever may be treated symptomatically.
  • Advise patient of need for periodic pulmonary function tests to determine disease progression and response to therapy.
  • Explain purpose of hepatitis B vaccine prior to beginning therapy. A small risk of hepatitis is caused by the manufacturing process, and vaccination is recommended.

Evaluation/Desired Outcomes

  • Slowing of the destructive process on lung tissue as measured by increased serum alpha1-proteinase inhibitor levels.
References in periodicals archive ?
The 2 percent hike in plasma protein sales was driven by strong international demand for Feiba as well as anti-inhibitor coagulant complex, and improved domestic sales of Aralast NP (Alpha 1-Proteinase Inhibitor [Human]).
The Immune Tolerance Network ("ITN") has initiated a similar trial of AAT utilizing Aralast NP in Type 1 diabetics (http://www.
Aralast and Zemaira are indicated only for patients who have established alpha 1 proteinase deficiency.
1]-proteinase inhibitor products: Aralast, from Baxter, and Zemaira, from Aventis Behring.
Contributing to the improved performance was solid growth of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia, strong demand for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the United States) and specialty plasma-based therapeutics such as FEIBA [Anti-Inhibitor Coagulation Complex] and ARALAST [Alpha1-Proteinase Inhibitor], as well as biosurgery products.
The company has a large presence in the blood derivative market including Aralast (R), intravenous immune globulin (IVIG) and clotting factor for Hemophilia.
Company to offer Glassia[TM] and Aralast NP to patients with alpha-1 antitrypsin deficiency
This performance was a result of robust growth across multiple products, including ADVATE(R) [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a therapy used in the treatment of hemophilia A, antibody therapy products for the treatment of primary immunodeficiencies, and other specialty plasma therapeutics such as FEIBA (an inhibitor therapy indicated for the control of spontaneous bleeding episodes in patients with hemophilia A and hemophilia B) and ARALAST (a human alpha-1 proteinase inhibitor (A1PI) for patients with hereditary emphysema).
Both GLASSIA[TM] and ARALAST NP therapies are administered by intravenous infusion once a week to increase the levels of alpha-1 antitrypsin in the blood and lungs.
May 9 /PRNewswire-FirstCall/ -- Baxter received Food and Drug Administration approval to transfer ARALAST processing from a third party to Baxter.
Partially offsetting this decline was continued growth of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia and ARALAST NP [Alpha 1-Proteinase Inhibitor (Human)] for the treatment of hereditary emphysema, as well as strong sales of biosurgery products.
Plasma-derived AAT therapeutics on the market include Prolastin (Talecris), Aralast (Baxter) and Zemaira (CSL Behring), and there are a number of recombinant products in development.