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

 * How CASGEVY Works
   
 * Study Results
   
 * Safety & Side Effects
   
 * Understand the Journey
    * Treatment Journey
    * Discussing CASGEVY

 * Get Resources
    * Connect with Patient Educators
    * Vertex Connects Patient Support
    * Advocacy Groups
    * Frequently Asked Questions

 * Find a Treatment Center
   

 * 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.

 * How CASGEVY Works
   
 * Study Results
   
 * Safety & Side Effects
   
 * Understand the Journey
    * Treatment Journey
    * Discussing CASGEVY

 * Get Resources
    * Connect with Patient Educators
    * Vertex Connects Patient Support
    * Advocacy Groups
    * Frequently Asked Questions

 * Find a Treatment Center
   

Could CASGEVY® Be Right for Your Sickle Cell Disease?

People living with SCD pictured may or may not have received CASGEVY.

Kiarra, living with SCD, and her grandmother, Tanique

People living with SCD pictured may or may not have received CASGEVY.

Kiarra, living with SCD, and her grandmother, Tanique

People living with SCD pictured may or may not have received CASGEVY.

Kiarra, living with SCD, and her grandmother, Tanique


CASGEVY IS A ONE-TIME* GENE THERAPY THAT MAY HELP PEOPLE 12 YEARS AND OLDER WITH
SICKLE CELL DISEASE (SCD) AND FREQUENT VASO-OCCLUSIVE CRISES (VOCS) LIVE SEVERE
VOC-FREE.†

CASGEVY uses your own blood stem cells to help your body make working red blood
cells, which can eliminate VOCs.


IN THE CLINICAL STUDY, 93.5% (29 OUT OF 31 PEOPLE) AGES 12 TO 35 DID NOT HAVE A
SEVERE VOC FOR AT LEAST 12 MONTHS IN A ROW AFTER RECEIVING CASGEVY.

Sign Up Today!

Sign Up

Register to hear from Patient Educators.

*Treatment involves a multi-step process. This includes the collection and
editing of blood stem cells to make your CASGEVY. It also includes preparing you
for CASGEVY, administration of CASGEVY, follow-up monitoring for potential side
effects, and recovery.

†In clinical studies, severe VOCs, or vaso-occlusive crises, were defined as a
pain event requiring a visit to a medical facility and pain medication or a red
blood cell (RBC) transfusion, acute chest syndrome, priapism (persistent and
often painful erection of the penis for more than 2 hours), or splenic
sequestration (blood trapped in the spleen).




GET TO KNOW CASGEVY


GET TO KNOW CASGEVY

How CASGEVY works

Learn how CASGEVY helps your body make working red blood cells.

See what it does in your body

See results from the clinical study

Learn how CASGEVY was studied.

Explore the results

The CASGEVY treatment journey

Understand the steps and what they entail.

View the treatment journey
Our Commitment to You
Vertex understands the complexity of gene therapy and significance of this
treatment decision for people living with and affected by sickle cell disease.
Vertex Patient Educators are dedicated to providing you with information and
resources about CASGEVY that will help you have meaningful conversations with
your healthcare providers.

People living with SCD pictured may or may not have received CASGEVY.

Learn more about CASGEVY

Get information about the efficacy and safety of CASGEVY, as well as how it
works, in this brochure.

Download the CASGEVY brochure Download the CASGEVY brochure

The CASGEVY treatment journey

Find out more about the treatment journey, including helpful questions to ask
your healthcare provider.

Download the treatment journey brochure Download the treatment journey brochure


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.

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 SCD.

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 with 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.

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 SCD.

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 with 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 a mobilization
medicine. 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 a mobilization
medicine. 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.

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 SCD.

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 with 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 a mobilization
medicine. 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 a mobilization
medicine. 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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