The LYFGENIA™ treatment process begins at Qualified Treatment Centers

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Overview of treatment with LYFGENIA

LYFGENIA is a one-time treatment process that is administered at a Qualified Treatment Center. The main steps are:

  • Pre-treatment
  • Mobilization and apheresis
  • Manufacturing
  • Conditioning and washout
  • Infusion, post-infusion monitoring, and long-term monitoring

Referring to Qualified Treatment Centers

QTCs are independently owned and operated specialized hospitals. Each QTC has been carefully selected and trained to administer LYFGENIA. LYFGENIA can only be administered at a QTC.

The primary hematologist’s role is pivotal in identifying and referring potential patients for LYFGENIA, and the hematologist may be involved in collaborating with the QTC during and after the treatment process.

Find a Qualified Treatment Center

6 important steps to treatment with LYFGENIA


Time frames may vary—it is important to consider setting the appropriate expectations with your patients

Help your patients and caregivers understand important considerations about LYFGENIA

Advise patients on the following:

  • The risk of manufacturing failure. In case of manufacturing failure or the need for additional cells, additional cell collection and manufacturing of LYFGENIA would be needed
  • The risks associated with mobilization and myeloablative conditioning agents

Additionally advise patients of the following:

  • Hematologic malignancy has occured in patients treated with LYFGENIA. Patients with sickle cell disease have an increased risk of hematologic malignancy, compared to the general population. The additional hematopoietic stress associated with mobilization, conditioning, and infusion of LYFGENIA, including the need to regenerate the hematopoietic system, may increase the risk of a hematologic malignancy
  • Delayed platelet engraftment has been observed with LYFGENIA. Patients should be made aware of the risk of bleeding until platelet recovery has been achieved
  • Risk of neutrophil engraftment failure—patients who experience neutrophil engraftment failure will receive rescue treatment with their back-up collection of CD34+ cells
  • Insertional oncogenesis—there is a potential risk of insertional oncogenesis after treatment with LYFGENIA. Patients should be monitored lifelong
  • Monitoring will include assessment for hematologic malignancies with a complete blood count at least every 6 months for at least 15 years after treatment with LYFGENIA. This will include integration site analysis at Months 6, 12, and as warranted

Post-marketing long-term follow-up study:

Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENIA by calling bluebird bio at 1-833-999-6378. The study includes monitoring (at pre-specified intervals) for clonal expansion

Advise patients to:

  • Have their treating physician contact bluebird bio at 1-833-999-6378 if patients are diagnosed with a malignancy
  • Monitor for signs and symptoms of bleeding and have frequent blood draws for platelet counts until platelet recovery has been achieved
  • Not donate blood, organs, tissues, or cells at any time in the future
  • Understand that they may have a false-positive result for HIV if tested using a PCR-based assay after being treated with LYFGENIA

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