July 30, 2016
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Zemaira

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Zemaira




Indications
Dosage
How Supplied

INDICATIONS

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

Zemaira increases antigenic and functional (anti-neutrophil elastase capacity [ANEC]) serum levels and lung epithelial lining fluid (ELF) levels of A1-PI.

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

The effect of augmentation therapy with Zemaira or any A1-PI product on pulmonary exacerbations and on the progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical studies.

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

DOSAGE AND ADMINISTRATION

For Intravenous Use After Reconstitution Only.

The recommended dose of Zemaira is 60 mg/kg body weight administered once weekly. Dose ranging studies using efficacy endpoints have not been performed with Zemaira or any A1-PI product.

Preparation And Reconstitution

  • Check the expiration date on the vial label and carton. Do not use Zemaira after the expiration date.
  • Reconstitute prior to use.
  • Reconstitute Zemaira using aseptic technique to maintain product sterility.
  • Inspect the reconstituted solution prior to administration. The solution should be clear, colorless to slightly yellow, and free from visible particles.
  • Administer Zemaira at room temperature within 3 hours after reconstitution. Reconstituted Zemaira may be stored at room temperature. Do not freeze the reconstituted solution.

Follow the steps below to reconstitute Zemaira:

1. Ensure that the Zemaira (green cap) vial and diluent (white cap) vial are at room temperature.

2. Remove the plastic flip-top caps from the vials. Aseptically cleanse the rubber stoppers with antiseptic solution and allow

them to dry. Notes on Using the Transfer Device (Steps 3 through 7):

The transfer device (Figure 1) provided in the Zemaira carton has a white (diluent) end with a double orifice and a green (Zemaira) end with a single orifice.

Incorrect use of the transfer device will result in loss of vacuum and prevent transfer of the diluent, thereby prolonging or preventing reconstitution of Zemaira.

The transfer device is sterile. Once the protective covers have been removed (Steps 3 and 4), do not touch the exposed

ends of the spikes.

Figure 1

The transfer device - Illustration

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 (Figure 2).

Figure 2

Insert the white end of the transfer device into the center of the stopper of the upright diluent vial - Illustration

4. Remove the protective cover from the green (Zemaira) 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) (Figure 3). The flange of the transfer device should rest on the surface of the stopper so that the diluent flows into the Zemaira vial.

Figure 3

Insert the green end of the transfer device into the center of the rubber stopper of the upright Zemaira vial - Illustration

5. Allow the vacuum in the Zemaira vial to pull the diluents into the Zemaira vial.

6. During diluent transfer, wet the lyophilized cake completely by gently tilting the Zemaira vial (Figure 4). Do not allow the air inlet filter to face downward. Care should be taken not to lose the vacuum, as this will prolong or prevent reconstitution.

Figure 4

Wet the lyophilized cake completely by gently tilting the Zemaira vial - Illustration

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 Zemaira vial is not required. When diluent transfer is complete, withdraw the transfer device from the diluent vial and discard the diluent vial and transfer device.

8. Gently swirl the Zemaira vial until the powder is completely dissolved (Figure 5). DO NOT SHAKE.

Figure 5

Gently swirl the Zemaira vial - Illustration

If more than 1 vial of Zemaira is needed to achieve the required dose, use aseptic technique to transfer the reconstituted solution from the vials into the administration container (e.g., empty intravenous bag or glass bottle).

Administration

  • For intravenous use only.
  • Do not mix Zemaira with other medicinal products. Administer Zemaira through a separate dedicated infusion line.
  • Perform a visual inspection of the reconstituted solution. The solution should be clear, colorless to slightly yellow, and free from visible particles.
  • Administer at room temperature within 3 hours after reconstitution.
  • Filter the reconstituted solution during administration. To ensure proper filtration of Zemaira, use an intravenous administration set with a suitable 5 micron infusion filter (not supplied).
  • Administer Zemaira 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.
  • Monitor closely the infusion rate and the patient's clinical state, including vital signs, throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
  • Zemaira is for single use only. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements.

HOW SUPPLIED

Dosage Forms And Strengths

Zemaira is supplied in a single-use vial containing approximately 1000 mg of functionally active A1-PI as a lyophilized powder for reconstitution with 20 mL of Sterile Water for Injection, USP. The amount of functional A1-PI is printed on the vial label and carton.

Storage And Handling

Zemaira is supplied in a single use vial containing the amount of functionally active A1-PI printed on the label.

The product presentation includes a package insert and the following components:

Presentation Carton NDC Number Components
1000 mg of functionally active A1-PI 0053-7201-02
  • Zemaira in a single-use vial [NDC 0053-7211-01]
  • 20 mL vial of Sterile Water for Injection, USP [NDC 0053-7653-20]
  • One vented transfer device

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 the diluent vial.

Manufactured by: CSL Behring LLC, Kankakee, IL 60901 USA.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/18/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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