Zemaira®
Alpha1-Proteinase Inhibitor (Human)
Zemaira
® is indicated for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency (Alpha-1) and clinical evidence of emphysema. Clinical data demonstrating the long-term effects of chronic augmentation therapy are not available. Safety and effectiveness in pediatric patients have not been established.
Zemaira® delivers:
High Purity
- At least 90% of the protein is A1-PI1
- Less non-therapeutic proteins per dose
Convenience
- Half or less of the infusion volume compared with other Alpha-1 therapies1,2
- Half the infusion time compared with other Alpha-1 therapies1-3*
- Room temperature storage and transport
*Based on recommended dosage as stated in the product package inserts of 60 mg/kg body weight at the infusion rate of 0.08 mL/kg/min
Support
- Single national distributor to help ensure fair delivery to patients
- CSL Behring Assurance — a gap in insurance shouldn’t mean a gap in treatment
- CSL Behring’s commitment to the Alpha-1 community
†Heat treatment in aqueous solution at 60ºC for 10 hours
NDC Number |
Product Description |
| 0053-7201-02 |
Single dose vial with diluent |
Important Safety Information
Alpha1-Proteinase Inhibitor (Human), Zemaira® is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira® are not available.
Zemaira® may not be appropriate for the following adult individuals as they may experience severe reactions, including anaphylaxis: individuals with a known hypersensitivity and/or history of anaphylaxis or severe systemic reaction to A1-PI products or their components, and individuals with selective IgA deficiencies who have known antibodies against IgA.
In clinical studies, the following treatment-related adverse reactions were reported in 1% of subjects: asthenia (fatigue), injection-site pain, dizziness, headache, paresthesia (tingling), and pruritus (itching).
Zemaira® is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see
full prescribing information.
References: 1. Prolastin® Alpha1-Proteinase Inhibitor (Human), Full Prescribing Information, March 2003. 2. AralastTM Alpha1-Proteinase Inhibitor (Human), Full Prescribing Information, January 2003. 3. Data on file, CSL Behring.
View universal billing codes for Zemaira®
CUSTOMER SUPPORT 1-800-683-1288 or
Customer Services
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
To learn more about Zemaira®, please visit www.Zemaira.com
Last Updated: 31 August 2009