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Aralast ( Alpha 1-Antitrypsin) - Indications and Dosage



Congenital Alpha–Proteinase Inhibitor deficiency

ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of α1–PI with clinically evident emphysema. Clinical and biochemical studies have demonstrated that with such therapy, ARALAST is effective in maintaining target serum α1–PI trough levels and increasing α1–PI levels in epithelial lining fluid (ELF). ARALAST NP pharmacokinetics are comparable with the pharmacokinetics of ARALAST after single-dose administration in 25 subjects with congenital deficiency of α1–PI. Clinical data demonstrating the long–term effects of chronic augmentation or replacement therapy of individuals with ARALAST NP or ARALAST are not available.

The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

ARALAST NP is not indicated as therapy for lung disease patients in whom congenital α1–PI deficiency has not been established.


Dose ranging studies using efficacy endpoints have not been performed.

Chronic Augmentation Therapy

FOR INTRAVENOUS USE ONLY. The recommended dosage of ARALAST NP is 60 mg/kg body weight administered once weekly by intravenous infusion. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. Administration of ARALAST NP 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 NP 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.


Use Aseptic Technique

1. ARALAST NP 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.


9. Use within three hours of reconstitution.

10. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. The reconstituted product should be a colorless or slightly yellow to yellowish-green solution. When reconstitution procedure is strictly followed, a few small visible 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 is provided for this purpose.


ARALAST NP is supplied as a sterile, non-pyrogenic, lyophilized powder in single–dose vials. The following product packages are available: 0.5 g (NDC 0944-2802-01) and 1 g (NDC 0944-2802-02). A suitable volume of Sterile Water for Injection, USP diluent is provided (25 mL/0.5 g vial; 50 mL/1 g vial). Each vial is labeled with the total α1–PI functional activity in mg. ARALAST NP is packaged with a sterile double–ended transfer needle and a sterile 20-micron filter.


ARALAST NP should be stored at temperatures not to exceed 25°C (77°F). Do not freeze. Do not use after the expiration date printed on the label.

Rx only

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