alpha1-proteinase inhibitor, Human

(redirected from Glassia)

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.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
Kamada announced the extension of its strategic supply agreement with Takeda for GLASSIA, an Alpha1-Proteinase Inhibitor.
ENPNewswire-August 9, 2019--Kamada Reports Discussions with Takeda Regarding a Potential Extension of the Period for the Transition of GLASSIA Manufacturing to Takeda
Before Amgen, Haeberle was senior manager, clinical development at Baxter Healthcare Corporation, where he led post-approval clinical activities for Baxter's Alpha-1 Protease Inhibitor franchise, encompassing the brands Aralast and Glassia, used in the treatment of lung disease.
HEADCOUNT: 23,906 YEAR ESTABLISHED: 1986 REVENUES: $11,397 (+78%) NET INCOME: $327 (-75%) R&D: $1,440 (-8%) DRUGS APPROVED DRUG INDICATION Cuvitru primary immunodeficiency Xiidra dry eye disease Glassia emphysema due to severe AAT deficiency Intuniv ADHD Ady novate hemophilia A children and surgical settings ONIVYDE with 5-FU metastatic adenocarcinoma of the pancreas and leucovorin DRUGS PENDING DRUG INDICATION Natpar hypoparathroidism SHP465 ADHD DRUGS IN PHASE IIB AND BEYOND DRUG INDICATION Glassia acute graft vs.
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."
The agreement gives Baxter exclusive distribution rights in the U.S., Australia, New Zealand and Canada for Glassia, a liquid alphal-proteinase inhibitor for the treatment of alpha 1 antitrypsin deficiency.
The Food and Drug Administration granted the drug the commercial name Glassia last month--a necessary step in getting final approval for it to be marketed.
In terms of communities, both brachiopods (Streptis grayii and Glassia sp.) indicate offshore conditions, evidently a dysoxic environment perhaps also unsuitable for ostracods, but probably still in the limits of BA 4-5 (Musteikis & Juskute 1999).
Kamada (KMDA) announced the extension of its strategic supply agreement with Takeda (TAK) for GLASSIA. Kamada will now continue to produce GLASSIA for Takeda through 2021.
As a reminder, our GLASSIA supply agreement with Takeda currently extends through the end of 2020.
It is approved by the US Food and Drug Administration for the treatment of AAT deficiency and is marketed under the brand name, Glassia, through a strategic partnership with Baxalta in the United States.