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Important Safety Information

Important Safety
Information

Important Safety Information
and What is LYFGENIA?

What is the most important safety information I should know about LYFGENIA?

At the time of initial FDA approval, three patients were diagnosed with blood cancer. Two patients were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure and one patient had α-thalassemia trait.

Treatment with LYFGENIA may increase your risk of developing blood cancer, which can be life-threatening and/or cause death and can develop many years after treatment with LYFGENIA. Because of this risk, 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 that measure your blood cell counts and evaluation of the blood cells where the gene product is present with specialized tests. If these tests are abnormal, additional testing may be recommended by your doctor, which might include more frequent blood tests and a bone marrow evaluation.

You should talk to your doctor about the benefits and risks of LYFGENIA, and about your treatment options. Your doctor may evaluate if you have risk factors that increase your chances of developing blood cancer after LYFGENIA. Blood cancer may cause no symptoms, or symptoms can be general. You or your caregiver should call your healthcare provider right away for any of these signs or symptoms:

Abnormal bruising or bleeding (including nosebleed)
Blood in urine, stool, or vomit
Coughing up blood
Severe headache
Unusual stomach or back pain
Fever (100.4°F/38°C or higher)
Swollen glands
Abnormal tiredness

If you are diagnosed with a cancer, have your treating physician contact bluebird bio at 1-833-999-6378.

You may experience side effects associated with other medicines, including a chemotherapy medicine, administered as part of the LYFGENIA treatment regimen. After receiving the 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. Talk to your healthcare provider about the risks and benefits of all medicines involved in your treatment. It is important that you or your caregiver tell your healthcare providers that you have received LYFGENIA.

How will I get LYFGENIA?

STEP 1: LYFGENIA is made specifically for you from your own blood stem cells. Your healthcare provider will collect your blood stem cells through a procedure/process called mobilization and apheresis. This process takes approximately one week and may need to be repeated to obtain a sufficient number of cells.

‘Back-up’ stem cells (or ‘rescue cells’) are also collected and stored at the treatment center. This is a precaution 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.

STEP 2: Your blood stem cells will be sent to a manufacturing site where they are used to make your LYFGENIA. 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, but the time may vary and be up to 22 weeks.

STEP 3: Before you receive LYFGENIA, your healthcare provider will give you chemotherapy for a few days to make room in the bone marrow. You will be admitted to the treatment center for this step and remain there until after LYFGENIA infusion.

STEP 4: LYFGENIA is given by an intravenous infusion. You may receive more than one bag of LYFGENIA. Each bag is infused in 30 minutes or less.

After LYFGENIA infusion, you will stay in the treatment center for approximately 3-6 weeks so that your healthcare team can closely monitor your recovery. Your healthcare provider will determine when you can go home.

What should I avoid after receiving LYFGENIA?

Do not donate blood, organs, tissues or cells.

What are the possible side effects of LYFGENIA?

The possible side effects of LYFGENIA on the day of treatment include: Low blood pressure and hot flush.

The possible side effects of LYFGENIA following treatment include: Blood cancer and longer time for platelets to recover, which may reduce the ability of blood to clot and may cause bleeding.

These are not all the possible side effects of LYFGENIA. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

General Information

It is important that you have regular check-ups with your healthcare provider to detect any adverse effects and to confirm that LYFGENIA is still working. Talk to your healthcare provider about any concerns.

Patients treated with LYFGENIA are encouraged to enroll in a post-marketing study to assess the long-term safety of LYFGENIA and the risk of blood cancers occurring after treatment with LYFGENIA. Patients should discuss the option to participate with their physician.

LYFGENIA uses a vector that is based on the blueprint of the human immunodeficiency virus (HIV) to deliver genetic material to your cells. LYFGENIA will not give you a HIV infection. Treatment with LYFGENIA may cause a false-positive HIV test result by some commercial tests (specifically, a PCR-based test). If you need to have an HIV test, talk with your healthcare provider about the appropriate test to use.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide for LYFGENIA.

What is LYFGENIA?

LYFGENIA is a one-time gene therapy to treat sickle cell disease in patients 12 years of age or older and a history of vaso-occlusive events. LYFGENIA is made specifically for each patient, using the patient’s own blood stem cells (from which red blood cells are produced). It adds functional copies of the beta-globin gene to your cells leading to production of anti-sickling hemoglobin that may decrease or stop vaso-occlusive events.

Important Safety Information

Important Safety
Information

Important Safety Information
and What is LYFGENIA?

What is the most important safety information I should know about LYFGENIA?

At the time of initial FDA approval, three patients were diagnosed with blood cancer. Two patients were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure and one patient had α-thalassemia trait.

Treatment with LYFGENIA may increase your risk of developing blood cancer, which can be life-threatening and/or cause death and can develop many years after treatment with LYFGENIA. Because of this risk, 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 that measure your blood cell counts and evaluation of the blood cells where the gene product is present with specialized tests. If these tests are abnormal, additional testing may be recommended by your doctor, which might include more frequent blood tests and a bone marrow evaluation.

You should talk to your doctor about the benefits and risks of LYFGENIA, and about your treatment options. Your doctor may evaluate if you have risk factors that increase your chances of developing blood cancer after LYFGENIA. Blood cancer may cause no symptoms, or symptoms can be general. You or your caregiver should call your healthcare provider right away for any of these signs or symptoms:

Abnormal bruising or bleeding (including nosebleed)
Blood in urine, stool, or vomit
Coughing up blood
Severe headache
Unusual stomach or back pain
Fever (100.4°F/38°C or higher)
Swollen glands
Abnormal tiredness

If you are diagnosed with a cancer, have your treating physician contact bluebird bio at 1-833-999-6378.

You may experience side effects associated with other medicines, including a chemotherapy medicine, administered as part of the LYFGENIA treatment regimen. After receiving the 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. Talk to your healthcare provider about the risks and benefits of all medicines involved in your treatment. It is important that you or your caregiver tell your healthcare providers that you have received LYFGENIA.

How will I get LYFGENIA?

STEP 1: LYFGENIA is made specifically for you from your own blood stem cells. Your healthcare provider will collect your blood stem cells through a procedure/process called mobilization and apheresis. This process takes approximately one week and may need to be repeated to obtain a sufficient number of cells.

‘Back-up’ stem cells (or ‘rescue cells’) are also collected and stored at the treatment center. This is a precaution 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.

STEP 2: Your blood stem cells will be sent to a manufacturing site where they are used to make your LYFGENIA. 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, but the time may vary and be up to 22 weeks.

STEP 3: Before you receive LYFGENIA, your healthcare provider will give you chemotherapy for a few days to make room in the bone marrow. You will be admitted to the treatment center for this step and remain there until after LYFGENIA infusion.

STEP 4: LYFGENIA is given by an intravenous infusion. You may receive more than one bag of LYFGENIA. Each bag is infused in 30 minutes or less.

After LYFGENIA infusion, you will stay in the treatment center for approximately 3-6 weeks so that your healthcare team can closely monitor your recovery. Your healthcare provider will determine when you can go home.

What should I avoid after receiving LYFGENIA?

Do not donate blood, organs, tissues or cells.

What are the possible side effects of LYFGENIA?

The possible side effects of LYFGENIA on the day of treatment include: Low blood pressure and hot flush.

The possible side effects of LYFGENIA following treatment include: Blood cancer and longer time for platelets to recover, which may reduce the ability of blood to clot and may cause bleeding.

These are not all the possible side effects of LYFGENIA. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

General Information

It is important that you have regular check-ups with your healthcare provider to detect any adverse effects and to confirm that LYFGENIA is still working. Talk to your healthcare provider about any concerns.

Patients treated with LYFGENIA are encouraged to enroll in a post-marketing study to assess the long-term safety of LYFGENIA and the risk of blood cancers occurring after treatment with LYFGENIA. Patients should discuss the option to participate with their physician.

LYFGENIA uses a vector that is based on the blueprint of the human immunodeficiency virus (HIV) to deliver genetic material to your cells. LYFGENIA will not give you a HIV infection. Treatment with LYFGENIA may cause a false-positive HIV test result by some commercial tests (specifically, a PCR-based test). If you need to have an HIV test, talk with your healthcare provider about the appropriate test to use.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide for LYFGENIA.

What is LYFGENIA?

LYFGENIA is a one-time gene therapy to treat sickle cell disease in patients 12 years of age or older and a history of vaso-occlusive events. LYFGENIA is made specifically for each patient, using the patient’s own blood stem cells (from which red blood cells are produced). It adds functional copies of the beta-globin gene to your cells leading to production of anti-sickling hemoglobin that may decrease or stop vaso-occlusive events.

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