alpha1-proteinase inhibitor, Human

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alpha1-proteinase inhibitor, Human



(trade name),


(trade name),

Aralast NP

(trade name),


(trade name),


(trade name),


(trade name)


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


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


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.


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)

IV2–6 dayswithin 3 wksunknown


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


  • ↑ liver enzymes


  • transient leukocytosis


  • cough
  • respiratory tract infection
  • sore throat


  • delayed fever


Drug-Drug interaction

None known.


Intravenous (Adults) 60 mg/kg once weekly.


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)


  • 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 ?
On a daily basis, I follow updates from lawmakers, get opinions from teachers and school leaders, and interact with our State Director of Education Jason Glassia.
Australia, New Zealand and Canada for Glassia, a liquid alphal-proteinase inhibitor for the treatment of alpha 1 antitrypsin deficiency.
The AAT Protein in Kamada's Glassia Drug Shows Promise in a Series of Studies that Demonstrate Prevention of Lung Infection and Successful Organ Transplantation
In several pre-clinical studies performed at Ben Gurion University, led by Dr Eli Lewis, the Glassia drug by Kamada shows new therapeutic capabilities including being a potential treatment to bacterial lung infection, serving as a strong anti inflammatory agent in COPD and prevention of transplant rejection.
Furthermore, results of Glassia phase 2 study in Type 1 Diabetes (T1D) are expected to be published during the course of this month
It's a great pleasure that BioRx will be able to serve the alpha-1 community by adding Zemaira to the current portfolio that includes Glassia," Firas Koura, MD, MPH, president of Kentucky Lung Clinic, PSC.
The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been demonstrated in randomized, controlled clinical trials.
Clinical data demonstrating the long term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
BioRx will begin stocking both GLASSIA and ARALAST NP this month.
On August 24, Baxter announced an agreement with Kamada LTD, the company that manufactures GLASSIA, for exclusive commercial rights to GLASSIA in the United States, Australia, New Zealand and Canada.
This release includes forward-looking statements concerning agreements entered into between the company and Kamada, including expectations with respect to the introduction of GLASSIA in the United States and other select markets and plans to seek regulatory approvals to process GLASSIA.