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For Sickle Cell Disease
For Beta Thalassemia
 * Patient Information
 * Prescribing Information
 * Important Safety Information
 * For Healthcare Professionals
 * Vertex Connects® Patient Support

 * Patient Information
 * Prescribing Information
 * Important Safety Information
 * For Healthcare Professionals
 * Vertex Connects® Patient Support

 * Patient Information
 * Prescribing Information
 * Important Safety Information
 * For Healthcare Professionals
 * Vertex Connects® Patient Support

For US residents only.

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Welcome to our site!
To learn about CASGEVY®, please choose one of the following conditions:

Welcome to our site!
To learn about CASGEVY®, please choose one of the following conditions:

Sickle cell disease
Transfusion-dependent beta thalassemia

IMPORTANT SAFETY INFORMATION AND INDICATION

EXPAND

COLLAPSE

What is CASGEVY® (exagamglogene autotemcel)?

CASGEVY is a one-time therapy used to treat people aged 12 years and older with:

 * sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs

 * beta thalassemia (β-thalassemia) who need regular blood transfusions

CASGEVY is made specifically for each patient, using the patient’s own edited
blood stem cells, and increases the production of a special type of hemoglobin
called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall
hemoglobin levels and has been shown to improve the production and function of
red blood cells. This can eliminate VOCs in people with sickle cell disease and
eliminate the need for regular blood transfusions in people with beta
thalassemia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CASGEVY?

After treatment with CASGEVY, you will have fewer blood cells for a while until
CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of
platelets (cells that usually help the blood to clot) and white blood cells
(cells that usually fight infections). Your doctor will monitor this and give
you treatment as required. The doctor will tell you when blood cell levels
return to safe levels.

 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of platelet cells:
   * severe headache
   * abnormal bruising
   * prolonged bleeding
   * bleeding without injury such as nosebleeds; bleeding from gums; blood in
     your urine, stool, or vomit; or coughing up blood
 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of white blood cells:
   * fever
   * chills
   * infections

You may experience side effects associated with other medicines administered as
part of the treatment regimen for CASGEVY. Talk to your physician regarding
those possible side effects. Your healthcare provider may give you other
medicines to treat your side effects.

What is CASGEVY® (exagamloglene autoemcel)?

CASGEVY is a one-time therapy used to treat people aged 12 years and older with:

 * sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs

 * beta thalassemia (β-thalassemia) who need regular blood transfusions

CASGEVY is made specifically for each patient, using the patient’s own edited
blood stem cells, and increases the production of a special type of hemoglobin
called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall
hemoglobin levels and has been shown to improve the production and function of
red blood cells. This can eliminate VOCs in people with sickle cell disease and
eliminate the need for regular blood transfusions in people with beta
thalassemia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CASGEVY?

After treatment with CASGEVY, you will have fewer blood cells for a while until
CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of
platelets (cells that usually help the blood to clot) and white blood cells
(cells that usually fight infections). Your doctor will monitor this and give
you treatment as required. The doctor will tell you when blood cell levels
return to safe levels.

 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of platelet cells:
   * severe headache
   * abnormal bruising
   * prolonged bleeding
   * bleeding without injury such as nosebleeds; bleeding from gums; blood in
     your urine, stool, or vomit; or coughing up blood
 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of white blood cells:
   * fever
   * chills
   * infections

You may experience side effects associated with other medicines administered as
part of the treatment regimen for CASGEVY. Talk to your physician regarding
those possible side effects. Your healthcare provider may give you other
medicines to treat your side effects.

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning
medicine, as part of your treatment with CASGEVY. It’s important to talk to your
healthcare provider about the risks and benefits of all medicines involved in
your treatment.

After receiving the conditioning medicine, it may not be possible for you to
become pregnant or father a child. You should discuss options for fertility
preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization
medicine(s). This medicine moves blood stem cells from your bone marrow into the
blood stream. The blood stem cells are then collected in a machine that
separates the different blood cells (this is called apheresis). This entire
process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital.
These are your existing blood stem cells and are kept untreated just in case
there is a problem in the treatment process. If CASGEVY cannot be given after
the conditioning medicine, or if the modified blood stem cells do not take hold
(engraft) in the body, these rescue cells will be given back to you. If you are
given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the
manufacturing site where they are used to make CASGEVY. It may take up to 6
months from the time your cells are collected to manufacture and test CASGEVY
before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will
give you a conditioning medicine for a few days in hospital. This will prepare
you for treatment by clearing cells from the bone marrow, so they can be
replaced with the modified cells in CASGEVY. After you are given this medicine,
your blood cell levels will fall to very low levels. You will stay in the
hospital for this step and remain in the hospital until after the infusion with
CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous
infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare
provider can closely monitor your recovery. This can take 4-6 weeks, but times
can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

 * Do not donate blood, organs, tissues, or cells at any time in the future

What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

 * Low levels of platelet cells, which may reduce the ability of blood to clot
   and may cause bleeding
 * Low levels of white blood cells, which may make you more susceptible to
   infection

Your healthcare provider will test your blood to check for low levels of blood
cells (including platelets and white blood cells). Tell your healthcare provider
right away if you get any of the following symptoms:

 * fever
 * chills
 * infections
 * severe headache
 * abnormal bruising
 * prolonged bleeding
 * bleeding without injury such as nosebleeds; bleeding from gums; blood in your
   urine, stool, or vomit; or coughing up blood

These are not all the possible side effects of CASGEVY. Call your doctor for
medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns. 

Please see full Prescribing Information including Patient Information for
CASGEVY.

 

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning
medicine, as part of your treatment with CASGEVY. It’s important to talk to your
healthcare provider about the risks and benefits of all medicines involved in
your treatment.

After receiving the conditioning medicine, it may not be possible for you to
become pregnant or father a child. You should discuss options for fertility
preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization
medicine(s). This medicine moves blood stem cells from your bone marrow into the
blood stream. The blood stem cells are then collected in a machine that
separates the different blood cells (this is called apheresis). This entire
process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital.
These are your existing blood stem cells and are kept untreated just in case
there is a problem in the treatment process. If CASGEVY cannot be given after
the conditioning medicine, or if the modified blood stem cells do not take hold
(engraft) in the body, these rescue cells will be given back to you. If you are
given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the
manufacturing site where they are used to make CASGEVY. It may take up to 6
months from the time your cells are collected to manufacture and test CASGEVY
before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will
give you a conditioning medicine for a few days in hospital. This will prepare
you for treatment by clearing cells from the bone marrow, so they can be
replaced with the modified cells in CASGEVY. After you are given this medicine,
your blood cell levels will fall to very low levels. You will stay in the
hospital for this step and remain in the hospital until after the infusion with
CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous
infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare
provider can closely monitor your recovery. This can take 4-6 weeks, but times
can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

 * Do not donate blood, organs, tissues, or cells at any time in the future

What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

 * Low levels of platelet cells, which may reduce the ability of blood to clot
   and may cause bleeding
 * Low levels of white blood cells, which may make you more susceptible to
   infection

Your healthcare provider will test your blood to check for low levels of blood
cells (including platelets and white blood cells). Tell your healthcare provider
right away if you get any of the following symptoms:

 * fever
 * chills
 * infections
 * severe headache
 * abnormal bruising
 * prolonged bleeding
 * bleeding without injury such as nosebleeds; bleeding from gums; blood in your
   urine, stool, or vomit; or coughing up blood

These are not all the possible side effects of CASGEVY. Call your doctor for
medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns.

Please see full Prescribing Information including Patient Information for
CASGEVY.

 

What is CASGEVY® (exagamglogene autotemcel)?

CASGEVY is a one-time therapy used to treat people aged 12 years and older with:

 * sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs

 * beta thalassemia (β-thalassemia) who need regular blood transfusions

CASGEVY is made specifically for each patient, using the patient’s own edited
blood stem cells, and increases the production of a special type of hemoglobin
called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall
hemoglobin levels and has been shown to improve the production and function of
red blood cells. This can eliminate VOCs in people with sickle cell disease and
eliminate the need for regular blood transfusions in people with beta
thalassemia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CASGEVY?

After treatment with CASGEVY, you will have fewer blood cells for a while until
CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of
platelets (cells that usually help the blood to clot) and white blood cells
(cells that usually fight infections). Your doctor will monitor this and give
you treatment as required. The doctor will tell you when blood cell levels
return to safe levels.

 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of platelet cells: Tell your
   healthcare provider right away if you experience any of the following, which
   could be signs of low levels of platelet cells:
   * severe headache
   * abnormal bruising
   * prolonged bleeding
   * bleeding without injury such as nosebleeds; bleeding from gums; blood in
     your urine, stool, or vomit; or coughing up blood
 * Tell your healthcare provider right away if you experience any of the
   following, which could be signs of low levels of white blood cells:
   * fever
   * chills
   * infections

You may experience side effects associated with other medicines administered as
part of the treatment regimen for CASGEVY. Talk to your physician regarding
those possible side effects. Your healthcare provider may give you other
medicines to treat your side effects.

 

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning
medicine, as part of your treatment with CASGEVY. It’s important to talk to your
healthcare provider about the risks and benefits of all medicines involved in
your treatment.

After receiving the conditioning medicine, it may not be possible for you to
become pregnant or father a child. You should discuss options for fertility
preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization
medicine(s). This medicine moves blood stem cells from your bone marrow into the
blood stream. The blood stem cells are then collected in a machine that
separates the different blood cells (this is called apheresis). This entire
process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital.
These are your existing blood stem cells and are kept untreated just in case
there is a problem in the treatment process. If CASGEVY cannot be given after
the conditioning medicine, or if the modified blood stem cells do not take hold
(engraft) in the body, these rescue cells will be given back to you. If you are
given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the
manufacturing site where they are used to make CASGEVY. It may take up to 6
months from the time your cells are collected to manufacture and test CASGEVY
before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will
give you a conditioning medicine for a few days in hospital. This will prepare
you for treatment by clearing cells from the bone marrow, so they can be
replaced with the modified cells in CASGEVY. After you are given this medicine,
your blood cell levels will fall to very low levels. You will stay in the
hospital for this step and remain in the hospital until after the infusion with
CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous
infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare
provider can closely monitor your recovery. This can take 4-6 weeks, but times
can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

 * Do not donate blood, organs, tissues, or cells at any time in the future

What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

 * Low levels of platelet cells, which may reduce the ability of blood to clot
   and may cause bleeding
 * Low levels of white blood cells, which may make you more susceptible to
   infection

Your healthcare provider will test your blood to check for low levels of blood
cells (including platelets and white blood cells). Tell your healthcare provider
right away if you get any of the following symptoms:

 * fever
 * chills
 * infections
 * severe headache
 * abnormal bruising
 * prolonged bleeding
 * bleeding without injury such as nosebleeds; bleeding from gums; blood in your
   urine, stool, or vomit; or coughing up blood

These are not all the possible side effects of CASGEVY. Call your doctor for
medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns.

Please see full Prescribing Information including Patient Information for
CASGEVY.

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning
medicine, as part of your treatment with CASGEVY. It’s important to talk to your
healthcare provider about the risks and benefits of all medicines involved in
your treatment.

After receiving the conditioning medicine, it may not be possible for you to
become pregnant or father a child. You should discuss options for fertility
preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization
medicine(s). This medicine moves blood stem cells from your bone marrow into the
blood stream. The blood stem cells are then collected in a machine that
separates the different blood cells (this is called apheresis). This entire
process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital.
These are your existing blood stem cells and are kept untreated just in case
there is a problem in the treatment process. If CASGEVY cannot be given after
the conditioning medicine, or if the modified blood stem cells do not take hold
(engraft) in the body, these rescue cells will be given back to you. If you are
given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the
manufacturing site where they are used to make CASGEVY. It may take up to 6
months from the time your cells are collected to manufacture and test CASGEVY
before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will
give you a conditioning medicine for a few days in hospital. This will prepare
you for treatment by clearing cells from the bone marrow, so they can be
replaced with the modified cells in CASGEVY. After you are given this medicine,
your blood cell levels will fall to very low levels. You will stay in the
hospital for this step and remain in the hospital until after the infusion with
CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous
infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare
provider can closely monitor your recovery. This can take 4-6 weeks, but times
can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

 * Do not donate blood, organs, tissues, or cells at any time in the future

What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

 * Low levels of platelet cells, which may reduce the ability of blood to clot
   and may cause bleeding
 * Low levels of white blood cells, which may make you more susceptible to
   infection

Your healthcare provider will test your blood to check for low levels of blood
cells (including platelets and white blood cells). Tell your healthcare provider
right away if you get any of the following symptoms:

 * fever
 * chills
 * infections
 * severe headache
 * abnormal bruising
 * prolonged bleeding
 * bleeding without injury such as nosebleeds; bleeding from gums; blood in your
   urine, stool, or vomit; or coughing up blood

These are not all the possible side effects of CASGEVY. Call your doctor for
medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns.

Please see full Prescribing Information including Patient Information for
CASGEVY.

For US residents only.

CASGEVY is manufactured for Vertex Pharmaceuticals Incorporated.

Vertex Connects, the Vertex Connects logos, Vertex, and the Vertex triangle logo
are registered trademarks of Vertex Pharmaceuticals Incorporated.

CASGEVY word mark and design are registered trademarks of Vertex Pharmaceuticals
Incorporated.

CRISPR THERAPEUTICS word mark and design are registered trademarks of CRISPR
Therapeutics AG.

All other trademarks referenced herein are the properties of their respective
owners.

50 Northern Avenue, Boston, MA 02210

© 2024 Vertex Pharmaceuticals Incorporated | www.vrtx.com

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