HEMGENIX can help your patients step into a new level of freedom in living with hemophilia B. Prepare to start conversations and field your patients’ questions by learning about the patient treatment journey and eligibility requirements.
Use these sample patient profiles to help identify which of your patients may benefit from HEMGENIX:
Eric, age 32
Robert, age 47
On prophylactic treatment and at risk for breakthrough bleeds
In clinical studies, a one-time infusion of HEMGENIX demonstrated a 54% reduction in bleeds, resulting in significant bleed protection versus routine factor IX prophylaxis and allowing Eric to experience years of a new level of freedom in living with hemophilia B.
Experiences limitations associated with routine factor IX prophylaxis
In clinical studies, a one-time infusion of HEMGENIX showed that 94% of patients discontinued factor IX prophylaxis and remained prophylaxis-free. Patients also had 37% mean factor IX activity sustained at 2 years—allowing Robert to experience years of a new level of freedom in living with hemophilia B.
Currently use factor IX prophylaxis therapy
OR  have current or historical life-threatening hemorrhage
OR  have repeated, serious spontaneous bleeding episodes
When it’s time to discuss HEMGENIX with your patients, set their expectations about eligibility (see requirements in the next section) and the risks involved with a gene therapy. It will also be important to discuss potential lifestyle adjustments and a period of health monitoring after treatment. Employing a collaborative approach throughout the discussion can equip your patients to come to the right decision.
These specific eligibility tests must be completed in advance of prescription submission. Once they are complete, fill out and submit the HEMGENIX Prescription Form to HEMGENIX Connect. Ensure eligibility tests are performed in advance of HEMGENIX administration.
To locate an administration center for your eligible patients, contact HEMGENIX Connect by calling 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.
Whether your practice is ready to administer HEMGENIX or plans on referring patients, preparation is vital. Contact CSL Behring today to discuss training and site readiness.Connect with a rep
Warning and Precautions
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.
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.
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.
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.
Please see full prescribing information for HEMGENIX.