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)
Warning and Precautions
Infusion Reactions
Infusion reactions, including hypersensitivity reactions and anaphylaxis, may occur. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved.
Hepatotoxicity/Hepatocellular Carcinoma
Post-dose, monitor for elevated transaminase levels. Consider corticosteroid treatment should elevations occur. The integration of liver-targeting AAV vector DNA into the genome may carry the theoretical risk of hepatocellular carcinoma development. For patients with preexisting risk factors for hepatocellular carcinogenicity, perform regular (eg, annual) abdominal ultrasound and alpha-fetoprotein testing following administration.
Immune-mediated neutralization of the AAV5 vector capsid
Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired levels.
Monitoring Laboratory Tests
In addition to monitoring liver function, monitor for Factor IX activity and Factor IX inhibitors after administration.
Adverse Reactions
The most common adverse reactions (incidence ≥5%) were elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, nausea, malaise, and elevated AST.
Indication
HEMGENIX®, etranacogene dezaparvovec-drlb, is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:
HEMGENIX is for single use intravenous infusion only.
Contraindications: None.
Please see full prescribing information for HEMGENIX.
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.