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Zemaira

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Zemaira

INDICATIONS

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

Zemaira™ (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) are not available.

Safety and effectiveness in pediatric patients have not been established.

Zemaira™ (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) is 60 mg/kg body weight administered once weekly.

When reconstituted as directed, Zemaira (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) 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.

Figure 1

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 (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) vial.

5. Allow the vacuum in the Zemaira (alpha-proteinase inhibitor (human)) vial to pull the diluent into the Zemaira (alpha-proteinase inhibitor (human)) vial.

6. During diluent transfer, wet the lyophilized cake completely by gently tilting the Zemaira (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) 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.

Figures 2-5

Pooling Reconstituted Vials

If more than one vial of Zemaira (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) , 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.

Figure 6

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

HOW SUPPLIED

Alpha1-Proteinase Inhibitor (Human), Zemaira (alpha-proteinase inhibitor (human)) 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 (alpha-proteinase inhibitor (human)) , 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 (alpha-proteinase inhibitor (human)) is stable for the period indicated by the expiration date on its label. Avoid freezing which may damage container for the diluent.

REFERENCES

1. Stoller JK, Brantly M, et al. Formation and current results of a patient-organized registry for a1-antitrypsin deficiency. Chest 118(3):843-848, 2000.

2. McElvaney NG, Stoller JK, et al. Baseline Characteristics of Enrollees in the National Heart, Lung, and Blood Institute Registry of a1-Antitrypsin Deficiency. Chest 111:394-403, 1997.

3. Eriksson S. Pulmonary Emphysema and Alpha1-Antitrypsin Deficiency. ACTA Med Scand 175(2):197-205, 1964.

4. Eriksson S. Studies in a1-antitrypsin deficiency. ACTA Med Scan Suppl. 432:1-85, 1965.

5. Morse JO. Alpha1-Antitrypsin Deficiency. N Engl J Med 299:1045-1048; 1099-1105, 1978.

6. Crystal RG. a1-Antitrypsin Deficiency, Emphysema, and Liver Disease; Genetic Basis and Strategies for Therapy. J Clin Invest 85:1343-1352, 1990.

7. World Health Organization. Alpha-1-Antitrypsin Deficiency; Report of a WHO Meeting. Geneva. 18-20 March 1996.

8. Gadek JE, Crystal RG. a1-Antitrypsin Deficiency. In: The Metabolic Basis of Inherited Disease 5th ed. Stanbury JB, Wyngaarden JB, Frederickson DS, et al., eds: New York, McGraw-Hill. 1983; pp. 1450-1467.

9. American Thoracic Society. Guidelines for the Approach to the Patient with Severe Hereditary Alpha-1-Antitrypsin Deficiency. Am Rev Respir Dis 140:1494-1497, 1989.

10. Gadek JE, Fells GA, Zimmerman RL, Rennard SI, Crystal RG. Antielastases of the Human Alveolar Structures; Implications for the Protease-Antiprotease Theory of Emphysema. J Clin Invest 68:889-898, 1981.

Prolastin® is a registered trademark of Bayer Corporation. 19131-01 Issued: July, 2003

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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