Zemaira (Alpha 1-Antitrypsin) - Indications and Dosage

INDICATIONS AND USAGE

Zemaira™ is indicated for chronic augmentation and maintenance therapy in individuals with alpha₁-proteinase inhibitor (A₁-PI) deficiency and clinical evidence of emphysema.

Zemaira™ increases antigenic and functional (ANEC) serum levels and lung epithelial lining fluid levels of A₁-PI.

Clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with Zemaira™ are not available.

Safety and effectiveness in pediatric patients have not been established.

Zemaira™ is not indicated as therapy for lung disease patients in whom severe congenital A₁-PI deficiency has not been established.

DOSAGE AND ADMINISTRATION

Each vial of Zemaira™ contains the labeled amount of functionally active A₁-PI in milligrams as stated on the vial label as determined by capacity to neutralize human neutrophil elastase. The recommended dose of Zemaira™ is 60 mg/kg body weight administered once weekly.

When reconstituted as directed, Zemaira™ may be administered intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg body weight will take approximately 15 minutes to infuse.

PREPARATION

Each product package contains one Zemaira™ single use vial, one 20 mL vial of Sterile Water for Injection, U.S.P. (diluent), one color-coded vented transfer device with air inlet filter, and one large volume 5 micron conical filter. Administer within three hours after reconstitution.

RECONSTITUTION

1. Bring both product (green cap) vial and diluent (white cap) vial to room temperature prior to reconstitution.
2. Remove the plastic flip-top caps from the vials. Aseptically cleanse the rubber stoppers with antiseptic solution and allow them to dry.
   NOTE: The transfer device (Fig. 1) provided in the package is comprised of a white (diluent) end, which has a double orifice, and a green (product) end, which has a single orifice. Incorrect use of the transfer device will result in loss of vacuum and prevent transfer of the diluent, thereby preventing reconstitution of the product.
   
   The transfer device is sterile. Do not touch the exposed ends of the spike after removing the protective covers.
3. Remove the protective cover from the white (diluent) end of the transfer device. Insert the white end of the transfer device into the center of the stopper of the upright diluent vial first. (Fig. 2)
4. Remove the protective cover from the green (product) end of the transfer device. Invert the diluent vial with the attached transfer device and, using minimum force, insert the green end of the transfer device into the center of the rubber stopper of the upright Zemaira™ vial (green top). (Fig. 3) The flange of the transfer device should rest on the surface of the stopper so that the diluent flows into the Zemaira™ vial.
5. Allow the vacuum in the Zemaira™ vial to pull the diluent into the Zemaira™ vial.
6. During diluent transfer, wet the lyophilized cake completely by gently tilting the Zemaira™ vial. (Fig. 4) Do not allow the air inlet filter to face downward. Care should be taken not to lose the vacuum, as this will prolong reconstitution of the product.
7. After diluent transfer is complete, the transfer device will allow filtered air into the Zemaira™ vial through the air filter. Additional venting of the product vial after diluent transfer is complete is not required. When diluent transfer is complete, withdraw the transfer device and diluent vial and properly discard in accordance with biohazard procedures.
8. Gently swirl the Zemaira™ vial until the powder is completely dissolved. (Fig. 5) DO NOT SHAKE.
9. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration. Administer at room temperature within three hours after reconstitution.
   
   

POOLING RECONSTITUTED VIALS

If more than one vial of Zemaira™ is needed to achieve the required dose, use an aseptic technique to transfer the reconstituted solution from the vials into the administration container (e.g., empty I.V. bag or glass bottle).

ADMINISTRATION

Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration. Administer at room temperature within three hours after reconstitution.

The reconstituted solution should be filtered during administration. To ensure proper filtration of Zemaira™, place the large volume 5 micron conical filter (provided) between the distal end of the I.V. administration set and the infusion set. (Fig. 6) Follow the appropriate procedure for I.V. administration.

After administration, any unused solution and administration equipment should be discarded in accordance with biohazard procedures.

HOW SUPPLIED

Zemaira™ is supplied in a single use vial containing the labeled amount of functionally active A₁-PI, as stated on the label. Each product package (NDC 0053-7201-02) contains one single use vial of Zemaira™, one 20 mL vial of Sterile Water for Injection, U.S.P. (diluent), one vented transfer device, and one large volume 5 micron conical filter.

STORAGE

When stored up to 25°C (77°F), Zemaira™ is stable for the period indicated by the expiration date on its label. Avoid freezing which may damage container for the diluent.