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

HEMGENIX FOR YOUR PATIENTS

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.

DNA helix with two men sitting Patient portrayal
Patient portrayal

Use these sample patient profiles to help identify which of your patients may benefit from HEMGENIX:

Eric, age 32, patient profile

Eric, age 32

Hypothetical patient
Robert, age 47, Patient profile

Robert, age 47

Hypothetical patient

Eric

Robert

On prophylactic treatment and at risk for breakthrough bleeds

  • Infuses factor IX replacement therapy regularly, yet still experiences breakthrough bleeds that impact his daily activities
  • Worries about cumulative joint damage and further reduction in mobility with every breakthrough bleed
  • Motivated to seek better bleed protection from his hemophilia B treatment

Why HEMGENIX?

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

  • Tired of being burdened with managing low trough levels with regular prophy
  • Driven to seek a new option that would nearly eliminate regular infusions and provide consistent factor IX levels
  • Robert wants to enjoy more activities with his family without being burdened by his hemophilia B treatment routine

Why HEMGENIX?

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.

Take the next steps with your patients

Take the next steps with your patients

Discuss

Confirm eligibility

One-time dose

Track progress

Discuss

Confirm eligibility

One-time dose

Track progress

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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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Encourage your patients to enroll in HEMGENIX Connect℠ 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

These specific eligibility tests must be completed in advance of prescription submission. Once they are complete, fill out and submit the Patient Start Form to HEMGENIX Connect. Ensure eligibility tests are performed in advance of HEMGENIX administration.

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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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Fill out the Patient Start Form

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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 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, contact HEMGENIX Connect by calling 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.

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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
People walking together Patient portrayal; HEMGENIX not intended for women

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.

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Get more information about what support is available

For your practice For your patients
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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.