educating healthcare professionals and advancing public policy for the Alpha-1 Community.” 
|
JULY 2003
FACTS ABOUT ARALAST
http://www.fda.gov/cber/label/alphalp122302lb.htm#desc
Alpha1-Proteinase Inhibitor (Human)
Trade Name ARALAST
Generic Name Alpha1-Proteinase Inhibitor (Human) Product Description ARALAST is a treatment derived from human blood for a deficiency in Alpha1 antitrypsin, a major protein in the blood that protects the lung by blocking the effects of enzymes called elastases. The therapeutic is derived from human plasma that has been screened and tested for viruses. During the processing the therapeutic is treated with a solvent/detergent and nanofiltered to minimize the risk of viral transmission.
ARALAST A1PI is supplied as a sterile, stabilized, freeze-dried powder in single-dose vials. ARALAST A1PI is packaged with sterile water for injection, a sterile double-ended transfer needle and a sterile 20 micron filter.
Indications: ARALAST A1PI is indicated as chronic replacement therapy for patients who have begun to show symptoms of emphysema as a result of having inherited a deficiency of the protein alpha1 antitrypsin. Dosing Schedule ARALAST A1PI is given intravenously once a week; the dosage is determined based on the patient's weight. The recommended dose of ARALAST is 60 mg/kg body weight administered once weekly by intravenous infusion.
Efficacy for Congenital Alpha1-Protienase Inhibitor deficiency: Clinical studies have demonstrated that ARALAST A1PI is effective in maintaining target levels of the protein Alpha1 antitrypsin in the blood and the lungs, providing protection against the enzyme elastase. Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with ARALAST are not available.
Contraindications: Contraindications ARALAST A1PI is contraindicated in individuals who have a deficiency of IgA, immunoglobulin A, the class of antibodies produced predominantly against ingested antigens that prevents
the attachment of viruses and bacteria to epithelial surfaces. Epithelial surfaces refer to the tissues covering most of the internal and external surfaces of the body and its organs. Because small amounts of IgA may be present in it, ARALAST A1PI is also contraindicated in individuals who have a known antibody against IgA, since they may experience severe reactions to IgA, including anaphylaxis.
Adverse Reactions: ARALAST A1PI was evaluated for up to 96 weeks in 27 patients with a congenital deficiency of a1-PI and clinical symptoms of emphysema. Twenty-two of 27 patients experienced an adverse event, regardless of the cause. Seven of the 27 patients experienced an adverse event that was judged by investigators to be possibly, probably, or definitely related to ARALAST A1PI. The most common symptoms related to the use of ARALAST A1PI were headache and somnolence. Less frequent adverse events were symptoms of chills and fever, vasodilation, dizziness, pruritus, rash, abnormal vision, chest pain, increased cough, and dyspnea. Five of 27 patients experienced eight serious adverse reactions during the study. None of these were considered to be caused by the administration of ARALAST A1PI.
http://www.baxter.com/doctors/blood_therapies/
hyland_immuno/aralast/index.html
Telephone: 540-948-6777 or 1-866-FOR-A1AA (1-866-367-2122) Fax # 540-948-6763
Copyright © 2005 Alpha-1 Advocacy Alliance, All Rights Reserved
Home | Disclaimer | Privacy Policy