LYFGENIA™—a path to consider taking
LYFGENIA is available at Qualified Treatment Centers (QTCs), specialized hospitals trained to administer bluebird bio gene therapies.
LYFGENIA is available at Qualified Treatment Centers (QTCs), specialized hospitals trained to administer bluebird bio gene therapies.
Partner with your healthcare team
Partner with your healthcare team
When considering LYFGENIA, you should make sure to work closely with your team, including regular physicians and genegeneA sequence of DNA responsible for controlling inherited traits therapy specialists, to determine whether gene therapy is the right choice for you and your family.
Planning plays a big part in this, from healthcare coverage and impacts on daily life (including work and family responsibilities) to chemotherapy and fertility discussions.
A breakdown of the treatment process with LYFGENIA
A breakdown of the treatment process with LYFGENIA
Explore the 6 key steps
Explore the 6 key steps
Before we talk treatment, it’s important to keep in mind that these time frames are meant as an approximate guideline. Your journey may look different depending on you, your circumstances, and your care team at the QTC.
STEP 1
Pre-treatment
Talking to Your Doctor
Part of pre-treatment is understanding that you will receive other medicines, including chemotherapy, as part of your treatment with LYFGENIA.
It’s important to talk to a hematologist about the risks and benefits of all medicines involved in your treatment.
Blood Transfusions (At least 2 cycles, 1 per month)
Before stem cell collection begins, you’ll need blood transfusions. This is done to maintain the proper bone marrow health and hemoglobinhemoglobinA protein in your red blood cells that carries oxygen throughout your body levels needed for stem cell collection.
STEP 2*
Stem Cell Collection
(~1 week at the QTC)
Your Visit to the QTC
Mobilization
In order to collect your blood stem cellsblood stem cellsAn immature cell that has the potential to develop into any blood cell type, including white blood cells, red blood cells, and platelets, you’ll be treated with medicine that moves your blood stem cells from your bone marrow into your bloodstream, also known as mobilization.
Apheresis
Your hematologist will collect your blood stem cells through apheresisapheresisPart of the stem cell collection process that involves separating blood stem cells from blood cells using a machine.
“Back-up” stem cells, also called “rescue cells,” are also collected just in case there is a problem in the treatment process.
If this happens, your back-up stem cells will be given back to you. If you receive back-up cells, you will have no benefit from LYFGENIA.
IMPORTANT ABOUT STEM CELL COLLECTION
In clinical studies, most people treated with LYFGENIA provided the minimum number of blood stem cells to manufacture LYFGENIA with 1 or 2 cycles of mobilization and apheresis.
*This step may need to be repeated.
STEP 3
LYFGENIA Creation
(10-15 weeks)
LYFGENIA Creation at the Manufacturing Site
Your healthcare team will send your cells to a manufacturing site so that LYFGENIA can be made. You’ll be at home during this time. It’s a good idea to start prepping for treatment with your care team.
It typically takes 10 to 15 weeks from the time your cells are collected to make and test LYFGENIA before it is shipped to your healthcare provider. The time may vary and be up to 22 weeks.
STEP 4
Conditioning Chemotherapy
(4 days + ≥2 days of recovery at the QTC)
Your Stay at a QTC
After you’ve received chemotherapy, you’ll need to rest. You’ll need to stay at the QTC until after LYFGENIA infusioninfusionThe process by which LYFGENIA is administered into your veins.
A Talk with Your QTC Team
Thinking about chemotherapy can be both overwhelming and scary. But we want you to know it’s a critical part of your treatment process. Make sure to talk to your QTC care team about questions or concerns you may have.
IMPORTANT NOTE
After receiving chemotherapy, it may not be possible for you to become pregnant or father a child. You should consider discussing options for fertility preservation with your doctor before treatment.
STEP 5
LYFGENIA Infusion
(~30 minutes per bag at QTC)
Your QTC Team
During your stay at the QTC, a team of specialists will administer LYFGENIA through an IV infusion.
You could need anywhere from 1 to 4 bags. You’ll receive one at a time and your doctor will determine when you’re ready for each bag. The number of bags varies from person to person.
STEP 6
Recovery & Long-term Follow-up
(~3-6 weeks of monitoring at the QTC followed by long-term follow-up for at least 15 years)
Monitoring at the QTC
Following your treatment with LYFGENIA, you’ll remain at the QTC for approximately 3-6 weeks of careful observation until release by your treating physician.
Your Follow-up Plan
Make sure to work with your QTC team, along with your regular healthcare professional, to establish a long-term monitoring plan.
This will include regular checkups with your healthcare professional to detect any adverse effects and to confirm that LYFGENIA is working. If needed, your QTC may require you to return for follow-up care.
Post-treatment Risks
Because of the risk of cancer, it is important for you to be monitored at least every 6 months for a minimum of 15 years after LYFGENIA.
Monitoring will include blood tests. If these tests are abnormal, additional testing may be recommended, which can include more frequent blood tests and a bone marrow evaluation. If you are diagnosed with a cancer, have your treating physician contact bluebird bio at 1-833-999-6378.
STEP 1
Pre-treatment
Before you begin LYFGENIA, it’s important you talk to your doctor about all of the medicines involved and why blood transfusions are required.
STEP 2*
Stem Cell Collection
(~1 week at the QTC)
For stem cell collection, you’ll need mobilizationmobilizationThe first part of the stem cell collection process, moving stem cells out of the bone marrow and into the circulating blood and apheresisapheresisPart of the stem cell collection process that involves separating blood stem cells from blood cells using a machine.
*This step may need to be repeated.
STEP 3
LYFGENIA Creation
(10-15 weeks)
After stem cell collection, your cells will be sent to a manufacturing site to create LYFGENIA.
STEP 4
Conditioning Chemotherapy
(4 days + ≥2 days of recovery at the QTC)
During this stage, your body will be conditionedconditionedThe process of making room in your bone marrow for gene therapy or a stem cell transplant through chemotherapy. Conditioning is required for all transplant options—whether it’s gene therapy or a donor stem cell transplant with chemotherapy to make room in your bone marrow for LYFGENIA.
STEP 5
LYFGENIA Infusion
(~30 minutes per bag at QTC)
After conditioning, you will receive LYFGENIA through an IV infusioninfusionThe process by which LYFGENIA is administered into your veins. You may receive anywhere from 1 to 4 bags.
STEP 6
Recovery & Long-term Follow-up
(~3-6 weeks of monitoring at the QTC followed by long-term follow-up for at least 15 years)
After your LYFGENIA infusion, you’ll be monitored at the QTC and work with your team to make a follow-up monitoring plan.
STEP 1
Pre-treatment
Before you begin LYFGENIA, it’s important you talk to your doctor about all of the medicines involved and why blood transfusions are required.
STEP 2*
Stem Cell Collection
(~1 week at the QTC)
For stem cell collection, you’ll need mobilizationmobilizationThe first part of the stem cell collection process, moving stem cells out of the bone marrow and into the circulating blood and apheresisapheresisPart of the stem cell collection process that involves separating blood stem cells from blood cells using a machine.
*This step may need to be repeated.
STEP 3
LYFGENIA Creation
(10-15 weeks)
After stem cell collection, your cells will be sent to a manufacturing site to create LYFGENIA.
STEP 4
Conditioning Chemotherapy
(4 days + ≥2 days of recovery at the QTC)
During this stage, your body will be conditionedconditionedThe process of making room in your bone marrow for gene therapy or a stem cell transplant through chemotherapy. Conditioning is required for all transplant options—whether it’s gene therapy or a donor stem cell transplant with chemotherapy to make room in your bone marrow for LYFGENIA.
STEP 5
LYFGENIA Infusion
(~30 minutes per bag at QTC)
After conditioning, you will receive LYFGENIA through an IV infusioninfusionThe process by which LYFGENIA is administered into your veins. You may receive anywhere from 1 to 4 bags.
STEP 6
Recovery & Long-term Follow-up
(~3-6 weeks of monitoring at the QTC followed by long-term follow-up for at least 15 years)
After your LYFGENIA infusion, you’ll be monitored at the QTC and work with your team to make a follow-up monitoring plan.
Participate in the LYFGENIA registry
Participating in the LYFGENIA registry
- The FDA recommends long-term follow-up for patients treated with gene therapy
- The LYFGENIA registry is a database that captures data over time about long-term safety and effectiveness with LYFGENIA
- Your participation in the registry is voluntary. Ongoing research for gene therapy, like the registry study, may benefit future patients who may consider treatment with LYFGENIA and contributes to understanding of the effects of LYFGENIA
- To learn more about the registry call bluebird bio at 1-833-999-6378