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HEMGENIX®-logo-bg HEMGENIX® (etranacogene dezaparvovec)

GETTING STARTED WITH HEMGENIX

HEMGENIX is being administered across the country. Start conversations with your patients and answer their questions by learning about the patient treatment journey and eligibility requirements.

Take the next steps with your patients

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Discuss
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Identify patients who may benefit from HEMGENIX and initiate conversation. Consider discussing HEMGENIX with your adult patients with hemophilia B who:

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Currently use factor IX prophylaxis therapy

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OR  have current or historical life-threatening hemorrhage

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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.

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Confirm eligibility
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Encourage your patients to enroll in HEMGENIX ConnectSM for comprehensive support every step of the way, beginning with eligibility screening.

  • Factor IX inhibitor titer
  • Liver health screenings, including ALT, AST, ALP, total bilirubin, hepatic ultrasound, and elastography
  • Optional AAV5 neutralizing antibody test

Testing for AAV5 NAbs is not an eligibility requirement for HEMGENIX. If you choose to test your patient, please note that AAV5 NAbs do not exclude patients from receiving HEMGENIX. Learn more here.

Ensure eligibility tests are performed in advance of HEMGENIX administration. Once they are complete, fill out and submit the Patient Start Form to HEMGENIX Connect.

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Download the full treatment guide for HEMGENIX

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Learn more about the process of determining eligibility for HEMGENIX

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Patient Start Form

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One-time dose
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HEMGENIX is administered as a one-time-only intravenous infusion—delivered in 1-2 hours in an outpatient setting. No special pretreatment of patients is required.

  • Each dosing kit is personalized to your patient’s weight.
  • HEMGENIX is delivered as a single dose of 2.0 mL/kg body weight*

*Further dilution with 0.9% normal saline is required.

Get more details

To locate an administration center for your eligible patients, you can search online, or contact HEMGENIX Connect by calling 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.

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Track progress
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After administration of HEMGENIX, you and your patients will have regular follow-ups to track how HEMGENIX is working.

Post-monitoring details

Michael is one of the many who have received HEMGENIX

Michael, age 23, patient profile
Michael, age 23

Actual HEMGENIX patient. Patient experiences may vary.

Since I received HEMGENIX, I’ve had no breakthrough bleeds, no injuries, no need to self-infuse—it feels amazing to no longer have to get prophy!

  • Michael, received HEMGENIX at age 23
  • Diagnosed with hemophilia B when he was 4 years old
  • On routine prophy from middle school through college, learned how to self-infuse
  • Enjoyed an active lifestyle, including working out at the gym and spending time with his friends
  • Sometimes had difficulty self-infusing prophy due to rolling veins, necessitating a hospital visit for infusion
Watch his story

Need more information to get started? Contact CSL Behring today, or view resources for your practice or your patients.

Connect with a rep Resources for you Resources for patients

Michael, an actual HEMGENIX patient.
Patient experiences may vary.

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IMPORTANT SAFETY INFORMATION

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:

  • Currently use Factor IX prophylaxis therapy, or
  • Have current or historical life-threatening hemorrhage, or
  • Have repeated, serious spontaneous bleeding episodes.

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.