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Enroll your patients in HEMGENIX Connect by filling out this form.
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Get more information about the steps to a one-time infusion of HEMGENIX.
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Learn about the eligibility tests required for HEMGENIX, and the optional AAV5 Neutralizing Antibody Test.
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Receive helpful direction and examples for the HEMGENIX coding and billing processes.
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Identify and meet common prior authorization requirements for HEMGENIX patients.
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Confirm your patient’s eligibility and verify coverage to get started with HEMGENIX.
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Review the 5-year data summarizing the efficacy and safety results observed in patients treated with HEMGENIX.
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Provides additional information on the HEMGENIX Connect patient support program and lets you know what to expect during your treatment journey.
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What you can expect from the first-ever gene therapy for hemophilia B, including results of HEMGENIX from studies and how to get started with treatment.
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Provides key topics to discuss with your doctor if you are considering treatment with HEMGENIX.
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Provides details about copay support, insurance coverage, and how HEMGENIX Connect can provide assistance.
Download in English En EspañolTerence’s Story: The Freedom HEMGENIX Has Provided
Listen to a patient's story of how HEMGENIX provided relief from the physical effects of prophy.
Chip's Story: Gaining the Knowledge of HEMGENIX
Hear from a pharmacist who searched for and discovered HEMGENIX on his hemophilia B journey.
Domenic’s Story: Trust in HEMGENIX
Watch the story of why one patient chose HEMGENIX over continuing with routine factor IX prophylaxis.
Greg’s Story: Never Too Late for HEMGENIX
Watch one man go from doubting if he’d qualify for HEMGENIX to celebrating more of his life after no longer needing prophylaxis.
Michael’s Story: Living Prophy-free With HEMGENIX
Learn the story of one of the many who have received HEMGENIX and how he changed how he lives his life with hemophilia B.
Expert Insights: Sharing Real-World Experiences With HEMGENIX
Listen as the experts discuss best practices to introduce HEMGENIX to appropriate patients and how they integrate shared decision-making into this process.
Real-World Experiences: How HEMGENIX Has Changed Patients’ Lives
Hear from treatment center medical staff about their first-hand experience with the impact HEMGENIX can have.
Real-World Experiences: Advice for Treatment Centers Considering HEMGENIX
Get real-world insight and encouragement from one treatment center’s positive experience with HEMGENIX.
Patient Selection
Perform baseline testing to select patients, including titer testing for Factor IX (FIX) inhibitor presence. Do not administer HEMGENIX®, etranacogene dezaparvovec-drlb, to patients with FIX inhibitors or a history of FIX inhibitors. Perform liver health assessments, consulting with a hepatologist if needed. Also perform laboratory tests to evaluate hepatitis B and C, and postpone treatment if patient has active infection, as this may reduce the efficacy of HEMGENIX and/or increase the risk of adverse reactions.
Warnings and Precautions
Hypersensitivity and Infusion Reactions
Infusion reactions, including hypersensitivity reactions and anaphylaxis, have occurred. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. When symptoms have resolved, restart administration at a slower infusion rate.
Hepatotoxicity/Hepatocellular Carcinogenicity
Hepatotoxicity with elevated liver transaminase has occurred after HEMGENIX treatment. Monitor ALT levels once per week for 3 months and thereafter monthly up to 1 year after administration. Consider corticosteroid treatment should elevations occur and as clinically indicated.
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, consider liver ultrasound and alpha-fetoprotein testing following administration, and monitor for hepatocellular carcinomas for five years following administration of HEMGENIX.
Immune-Mediated Neutralization of the AAV5 vector capsid
Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with HEMGENIX, all patients developed neutralizing anti-AAV5 antibodies to AAV5 vector capsid.
Monitoring Laboratory Tests
Monitor patients regularly for FIX activity (eg, weekly for 3 months), especially when exogenous FIX is administered, as it may take several weeks following HEMGENIX administration before hemostatic control becomes apparent. Hemostatic support may be needed for some patients. Monitor patients through appropriate clinical observations and laboratory tests for the development of inhibitors to FIX.
Adverse Reactions
The most common adverse reactions (incidence ≥5% in clinical trials) are elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, nausea, malaise, and elevated AST.
Indication
HEMGENIX is 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.
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.