April 30, 2016
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Zemaira

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Zemaira




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity To Other A1-PI Products

Caution should be used when administering Zemaira to individuals who have experienced anaphylaxis or severe systemic reaction to another A1-PI product. IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, DISCONTINUE THE INFUSION IMMEDIATELY. Have epinephrine and other appropriate supportive therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction. Zemaira is contraindicated in patients with a history of anaphylaxis or severe systemic reactions to Zemaira or A1-PI protein.

Hypersensitivity To IgA

Zemaira may contain trace amounts of IgA. Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, DISCONTINUE THE INFUSION IMMEDIATELY. Have epinephrine and other appropriate supportive therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction. Zemaira is contraindicated in IgA-deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.

Transmissible Infectious Agents

Because Zemaira is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, and theoretically the Creutzfeldt-Jakob disease [CJD] agent). The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Zemaira [see DESCRIPTION]. Despite these measures, Zemaira, like other products made from human plasma, may still potentially contain human pathogenic agents, including those not yet known or identified. Thus, the risk of transmission of infectious agents cannot be totally eliminated.

All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare provider to the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility have not been conducted.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Zemaira. Safety and effectiveness in pregnancy have not been established. Zemaira should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Zemaira is excreted in human milk. Use Zemaira only if clearly needed when treating nursing women.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

The safety and efficacy of Zemaira in the geriatric population have not been established due to an insufficient number of subjects.

REFERENCES

1. Anthonisen NR, Connett, JE, Kiley, JP, et al. Effects of Smoking Intervention and the Use of an Inhaled Anticholinergic Bronchodilator and on the Rate of Decline of FEV1 – The Lung Study. JAMA. 1994;272(19):1497-1505.

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

Last reviewed on RxList: 3/18/2016

Warnings
Precautions

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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