ZEMAIRA- alpha-1-proteinase inhibitor human kit ZEMAIRA- .alpha.1-proteinase inhibitor human kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN (UNII: F43I396OIS) (.ALPHA.1-PROTEINASE INHIBITOR HUMAN - UNII:F43I396OIS)

Available from:

CSL Behring LLC

INN (International Name):

.ALPHA.1-PROTEINASE INHIBITOR HUMAN

Composition:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN 1000 mg in 20 mL

Therapeutic 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. - ZEMAIRA is contraindicated in patients with a history of anaphylaxis or severe systemic reactions to ZEMAIRA or A1 -PI protein. - ZEMAIRA is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity [see Warnings and Precautions (5.2)] . Risk Summary No animal reproduction studies have been conducted with Zemaira and its safety for use in human pregnancy has not been established in controlled clinical trials. Since alpha1 -proteinase inhibitor is an endogenous human protein, it is considered unlikely that Zemaira will cause harm to the fetus when given at recommended doses. However, Zemaira should be given with caution to pregnant women. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the excretion of ZEMAIRA in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZEMAIRA and any potential adverse effects on the breastfed infant from ZEMAIRA or from the underlying maternal condition. Safety and effectiveness in the pediatric population have not been established. The safety and efficacy of ZEMAIRA in the geriatric population have not been established due to an insufficient number of subjects.

Product summary:

ZEMAIRA is supplied in a single-dose vial containing the amount of functionally active A1 -PI printed on the vial label and carton. The product presentations include a package insert and the following components. Not made with natural rubber latex. Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ZEMAIRA- ALPHA-1-PROTEINASE INHIBITOR HUMAN
ZEMAIRA- .ALPHA.1-PROTEINASE INHIBITOR HUMAN
CSL BEHRING LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZEMAIRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEMAIRA.
ZEMAIRA (ALPHA -PROTEINASE INHIBITOR (HUMAN))
LYOPHILIZED POWDER FOR RECONSTITUTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
ZEMAIRA is an alpha -proteinase inhibitor (A -PI) indicated for
chronic augmentation and maintenance
therapy in adults with A -PI deficiency and clinical evidence of
emphysema (1).
The effect of augmentation therapy with ZEMAIRA or any A -PI product
on pulmonary exacerbations
and on the progression of emphysema in A -PI deficiency has not been
demonstrated in randomized,
controlled clinical studies (1).
ZEMAIRA is not indicated as therapy for lung disease patients in whom
severe A -PI deficiency has not
been established (1).
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY (2).
The recommended weekly dose of ZEMAIRA is 60 mg/kg body weight. Dose
ranging studies using
efficacy endpoints have not been performed with ZEMAIRA or any A -PI
product (2).
Administer through a suitable 5 micron infusion filter (not supplied)
at room temperature within 3 hours
after reconstitution (2.2).
Do not mix with other medicinal products. Administer through a
separate dedicated infusion line (2.2).
Administer at a rate of approximately 0.08 mL/kg/min as determined by
the response and comfort of
the patient (2.2).
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 (2.2).
DOSAGE FORMS AND STRENGTHS
ZEMAIRA is supplied in a single-dose vial containing approximately
1000 mg, 4000 mg, or 5000 mg of
functionally active A -PI as a white to off-white