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Aralast ( Alpha 1-Antitrypsin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Congenital Alpha1-Proteinase Inhibitor deficiency

Alpha1-Proteinase Inhibitor (Human), Aralast™, is indicated for chronic augmentation therapy in patients having congenital deficiency of (alpha)1-PI with clinically evident emphysema. Clinical and biochemical studies have demonstrated that with such therapy, Aralast™ is effective in maintaining target serum (alpha)1-PI trough levels and increasing (alpha)1-PI levels in epithelial lining fluid (ELF). Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with Aralast™ are not available.

Safety and effectiveness in pediatric patients have not been established. Aralast™ is not indicated as therapy for lung disease patients in whom congenital (alpha)1-PI deficiency has not been established.

DOSAGE AND ADMINISTRATION

CHRONIC AUGMENTATION THERAPY

FOR INTRAVENOUS USE ONLY. The recommended dosage of Aralast™ is 60 mg/kg body weight administered once weekly by intravenous infusion. Each vial of Aralast™ has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. Administration of Aralast™ within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent microbial contamination occurring during reconstitution. Discard any unused contents.

INFUSION RATE

Aralast™ should be administered at a rate not exceeding 0.08 mL/kg body weight/minute. If adverse events occur, the rate should be reduced or the infusion interrupted until the symptoms subside. The infusion may then be resumed at a rate tolerated by the subject.

RECONSTITUTION

Use Aseptic Technique

  1. Aralast™ and diluent should be at room temperature before reconstitution.
  2. Remove caps from the diluent and product vials.
  3. Swab the exposed stopper surfaces with alcohol.
  4. Remove cover from one end of the double-ended transfer needle. Insert the exposed end of the needle through the center of the stopper in the DILUENT vial.
  5. Remove plastic cap from the other end of the double-ended transfer needle now seated in the stopper of the diluent vial. To reduce any foaming, invert the vial of diluent and insert the exposed end of the needle through the center of the stopper in the PRODUCT vial at an angle, making certain that the diluent vial is always above the product vial. The angle of insertion directs the flow of diluent against the side of the product vial. Refer to Figure below. The vacuum in the vial is sufficient to allow transfer of all of the diluent.
  6. Disconnect the two vials by removing the transfer needle from the diluent vial stopper. Remove the double-ended transfer needle from the product vial and discard the needle into the appropriate safety container.
  7. Let the vial stand until most of the contents is in solution, then GENTLY swirl until the powder is completely dissolved. Reconstitution requires no more than five minutes for a 0.5 gram vial and no more than 10 minutes for a 1.0 gram vial.
  8. DO NOT SHAKE THE CONTENTS OF THE VIAL. DO NOT INVERT THE VIAL UNTIL READY TO WITHDRAW CONTENTS.
  9. Use within three hours of reconstitution.
  10. After reconstitution, inspect product visually for particulate matter and discoloration prior to administration. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. These will be removed by the microaggregate filter.
  11. Reconstituted product from several vials may be pooled into an empty, sterile IV solution container by using aseptic technique. A sterile, 20 micron filter spike is provided for this purpose.

HOW SUPPLIED

Alpha1-Proteinase Inhibitor (Human), Aralast™, is supplied as a sterile, nonpyrogenic, lyophilized powder in single-dose vials. A suitable volume of Sterile Water for Injection, USP diluent is provided (25 mL/0.5 g vial; 50 mL/1.0 g vial). Each vial is labeled with the total (alpha)1-PI functional activity in mg. Aralast™ is packaged with a sterile double-ended transfer needle and a sterile 20 micron filter.

STORAGE

Aralast™ should be stored at 2-8 °C (35-46 °F). Aralast™ may be removed from refrigeration and stored at temperatures not to exceed 25 °C (77 °F). Product removed from refrigeration must be used within one month. Do not freeze. Do not use after the expiration date printed on the label.

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