Alpha-1 proteinase inhibitor, human: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Emphysema

Adult: As maintenance in patients w/ severe alpha₁-proteinase inhibitor deficiency: 60 mg/kg once wkly via infusion approx 0.08 mL/kg/min. Adjust infusion rate based upon patient tolerability.

Contraindications

Hypersensitivity. IgA deficient patients w/ antibodies against IgA.

Special Precautions

Patient at risk for fluid overload. Pregnancy and lactation.

Adverse Reactions

Significant: Risk of infection transmission (e.g. viruses such as Creutzfeldt-Jakob disease). Hypersensitivity reactions (e.g. anaphylaxis).
Nervous: Dizziness, somnolence, flu-like symptoms, headache, paraesthesia, asthenia.
CV: Flushing, chest pain or discomfort hypotension, tachycardia, vasodilatation, peripheral oedema.
GI: Nausea, oral candidiasis, sore throat.
Resp: Dyspnoea, upper resp tract infection, cough, sinusitis.
Hepatic: Increased hepatic enzyme.
Genitourinary: UTI.
Haematologic: Haemorrhage.
Musculoskeletal: Musculoskeletal pain, back pain, weakness.
Dermatologic: Pruritus, urticaria.
Others: Infusion-site reactions, fever, chills.

Patient Counseling Information

This drug may cause dizziness, if affected, do not drive or operate machinery.

Monitoring Parameters

Closely monitor clinical state (e.g. vital signs), infusion rate, and signs of infusion-related reactions e.g. anaphylactic reactions. Monitor α₁-PI serum levels and lung function.

Action

Description:
Mechanism of Action: Human alpha-1 proteinase inhibitor is the primary anti-protease in the lower resp tract inhibiting serine proteases e.g. neutrophil elastase, an enzyme that aids in the proteolytic destruction of the connective tissue framework of the lung parenchyma. It protects lung tissue proteolysis in individuals deficient in alpha₁-proteinase inhibitor.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 1 hr.
Distribution: Volume of distribution: Approx 3.5 L.
Excretion: Elimination half-life: 5-6 days (metabolic).

Storage

Store below 25°C.

MIMS Class

Other Drugs Acting on the Respiratory System

References

Anon. Alpha1-proteinase Inhibitor. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/08/2017.

Anon. Glassia Injection Solution (Baxalta US Inc.). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/08/2017.

Buckingham R (ed). Alpha1-proteinase Inhibitor. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/08/2017.

McEvoy GK, Snow EK, Miller J et al (eds). α1-Proteinase Inhibitor (Human). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 07/08/2017.

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