Mononine®
Coagulation Factor IX (Human) Monoclonal Antibody Purified
Mononine
® is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.
- A high-purity factor IX product with a track record of over half a billion
units infused since 1992 without any confirmed cases of thrombotic events or
viral transmissions1
- Unique three-step viral inactivation and removal process designed to
protect against both lipid-enveloped and certain non-lipid-enveloped
viruses
- World Hemophilia Organization standard for potency3
- Peel-off labels designed for patient convenience
|
NDC Number |
Product Description |
|
0053-7668-02 |
Approximately 500 IU per vial |
|
0053-7668-04 |
Approximately 1000 IU per vial |
Important Safety Information
Mononine® is contraindicated in patients with known
hypersensitivity to mouse protein.
The following adverse reactions may be observed after administration:
headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives,
stinging or burning at the infusion site, or other manifestations of allergic
reactions, including anaphylaxis.
Mononine® is derived from human plasma. As with all plasma-derived
products, the risk of transmission of infectious agents, including viruses and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely
eliminated.
Since the use of Factor IX Complex concentrates has historically been
associated with the development of thromboembolic complications, the use of
Factor IX-containing products may be potentially hazardous in patients with
signs of fibrinolysis and in patients with disseminated intravascular
coagulation.
Please see the
full prescribing information.
References:
1. Data on file, CSL Behring.
2. Lynch T. Committee updates on factor IX. Presented at: Fifty-Fourth Meeting of the Blood Products Advisory Committee, Food and Drug Administration, Center for Biologics Evaluation and
Research; March 13, 1997; Rockville, MD:15-17.
View universal billing codes for Mononine®
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.
Frequently Asked Questions for Mononine®
To learn more about Mononine®, please visit www.Mononine.com
Last Updated: 22 May 2009