Contact Us | Kcentra® (Prothrombin complex concentrate [human])

Contact us

If you have a question about a medical condition, consult with a healthcare professional or, in the case of an emergency, call 911 immediately.

You can contact us by phone, fax, or email.

Are you a patient with a question?
Consumer Affairs
Phone: 1-888-508-6978
Fax: 610-290-9729
Email: cslb-consumeraffairs@cslbehring.com
(Standard business hours are 9:00 am - 5:00 pm ET)
Are you a healthcare professional with a product-related question?
Medical Information
Phone: 1-800-504-5434
Fax: 610-878-4550
Email: medinfona@cslbehring.com
(Standard business hours are 9:00 am - 5:00 pm ET)
Would you like to report an undesirable effect with use of a CSL Behring product?
If you experience any undesirable side effect(s) with a CSL Behring product, talk to your doctor, pharmacist, or nurse. If you would like to report the side effect(s) to CSL Behring, please contact us at:
CSL Behring US Pharmacovigilance
Phone: 1-866-915-6958
Email: Adverse.Events.Global@cslbehring.com
(Available 24 hrs/day)
You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Do you have a media-related question or comment?
Corporate Media Inquiries
Tom Hushen
Phone: +1 267-769-6728
Product-Related Media Inquiries
James Freeman
Phone: +1 484.832.9045
(Standard business hours are 8:30 am - 5:00 pm ET)
Do you have a question or comment about CSL Plasma or the plasma donation process?
CSL Plasma

Visit the CSL Plasma website to get more information on donating plasma or to send your questions and comments.

For all other questions, please contact...
CSL Behring Headquarters, North America
Phone: 610-878-4000
Fax: 610-878-4009
Address:

PO Box 61501
1020 First Avenue
King of Prussia, PA 19406-0901 USA

(Standard business hours are 8:30 am - 5:00 pm ET)

Top of Page Important Safety Information
Important Safety Information & Indications

Important Safety Information

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving KCENTRA, and inform them of signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. KCENTRA might not be suitable for patients with thromboembolic events in the prior 3 months.

KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. Because KCENTRA contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to KCENTRA may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving KCENTRA were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

KCENTRA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Indications

KCENTRA®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. KCENTRA is for intravenous use only.

Please see full prescribing information for KCENTRA.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You are now leaving the current website.

The site you are accessing is maintained by a third party over whom CSL Behring has no control. CSL Behring does not review, approve, or necessarily endorse viewpoints, inferences, or conclusions stated in or implied by the content of this site. CSL Behring is not responsible for third-party content or the consequences of your use thereof.

Do you want to continue?