CONSIDERING SARCLISA
Find out if SARCLISA could be appropriate for you
The following 7 questions will help you understand if you or your loved one could be a candidate for SARCLISA
SARCLISA is for the treatment of adults with relapsed refractory multiple myeloma who have received at least 2 prior treatments for multiple myeloma, including Revlimid® (lenalidomide) and a proteasome inhibitor (PI).
SARCLISA is given together with Pomalyst® (pomalidomide) and dexamethasone, or Pd.
No personal information will be requested or collected, and responses will be anonymous.
Please note that SARCLISA is only for people who are 18 years of age or older.
Question : 1
…been treated with at least 2 different medicines for multiple myeloma?
…been treated with at least 2 different medicines for multiple myeloma?
Find out how SARCLISA was studied and see the results.
Based on your responses, you or your loved one
could be a candidate for SARCLISA
Talk with your doctor to learn more
Your doctor will know if SARCLISA is an appropriate treatment option for you.
Have you or your loved one…
Your answer
1
…been treated with at least 2 different medicines for multiple myeloma?
Yes
2
…had multiple myeloma return after a prior treatment
(commonly referred to as relapsed multiple myeloma)?
Yes
3
…had multiple myeloma not respond, or stop responding, to a current or prior
treatment (commonly referred to as refractory multiple myeloma)?
Yes
4
…been treated with Revlimid® (lenalidomide)?
Yes
5
…been treated with a proteasome inhibitor (PI)?
I don’t know
6
…been diagnosed with impaired kidney function?*
Yes
7
…been diagnosed with asthma or
chronic obstructive pulmonary disease (COPD)?*
No
Share these answers with your doctor and use
the attached Doctor Discussion Guide to help start the conversation.
What is SARCLISA?
SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat
adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to
treat multiple myeloma.
It is
not known if SARCLISA is safe and effective in children.
Important Safety Information
Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any
of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).
Please see additional Important Safety Information on the following pages, and full
Prescribing Information, including Patient Information.
*People with impaired kidney function, asthma, and COPD participated in the SARCLISA study.
1
Important Safety Information (cont’d)
Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:
•
are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive
SARCLISA during
pregnancy.
— Females who are able to become pregnant should
use an
effective method of birth
control during treatment
and for 5 months after their last dose of SARCLISA. Talk to your healthcare provider about birth control methods
that you can use during this time.
Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment
with SARCLISA.
•
are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not
breastfeed during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and
herbal supplements.
How will I receive SARCLISA?
•
SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
•
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide
and dexamethasone.
— In cycle
1, SARCLISA is usually given weekly.
— Starting in cycle 2, SARCLISA is usually given
every 2 weeks.
Your healthcare provider will decide how long you should receive
SARCLISA.
•
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
•
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion
reactions (make them less frequent and severe).
What are the possible side
effects of SARCLISA?
SARCLISA may cause serious side effects, including:
•
Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
— Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your
risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion
reactions during each dose of SARCLISA.
— Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA,
if you have an infusion reaction.
Tell your healthcare provider right away if you develop any of the following symptoms of infusion
reaction during or within 24 hours after an infusion of SARCLISA:
— feeling short of breath
— chills
— cough
— nausea
•
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and
certain white blood cells can be severely decreased. You may have an increased risk of getting certain
infections, such as
upper and lower respiratory infections.
Your healthcare provider will check
your blood cell counts during treatment with SARCLISA. Your healthcare
provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help
increase your white blood cell counts during treatment with SARCLISA.
Please see additional Important Safety Information on the next page,
and full Prescribing Information, including Patient Information.
2
Revlimid is a registered trademark of Celgene Corporation.
© 2020 sanofi-aventis U.S. LLC. All rights reserved. MAT-US-2001907 07/20
Important Safety Information (cont’d)
Tell your healthcare provider right away if you develop any fever or symptoms of infection during
treatment with SARCLISA.
•
Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your
healthcare provider will monitor you for new cancers during treatment with SARCLISA.
•
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your
healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA.
Tell all of your healthcare providers that you are being treated with SARCLISA before receiving
blood transfusions.
The most common side effects of SARCLISA include:
•
lung infection (pneumonia)
•
decreased red blood cell counts (anemia)
•
upper respiratory tract infection
•
decreased platelet counts (thrombocytopenia)
•
diarrhea
These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider
or pharmacist.
Please see full Prescribing Information, including Patient Information.
3
Find out more by visiting SARCLISA.com.
Treatment with SARCLISA
•
How will I receive treatment with SARCLISA?
•
How will I know if SARCLISA is working?
•
How will you monitor my results?
•
What are the possible side effects?
Considering SARCLISA
•
Is there a study that shows SARCLISA may work for my condition?
•
Was SARCLISA studied in people like me?
•
What were the study results for SARCLISA?
•
Based on my treatment history, is SARCLISA an option for me?
•
Is there a patient support program that may help with the cost of SARCLISA?
Talk with your doctor about SARCLISA
If you or your loved one is considering treatment with SARCLISA, the questions
below can help you have a productive conversation with your doctor
Notes and questions
Use this space to write down additional questions you may have
or information you want to share with your doctor
New to SARCLISA
®
(isatuximab-irfc)?
Sign up for updates at SARCLISA.com to get the latest information.
Already signed up?
For information about
our patient support program, CareASSIST from Sanofi Genzyme,
please call
1-833-WE+CARE (1-833-930-2273), Mon – Fri, 9 am - 8 pm ET,
or visit SanofiCareAssist.com/sarclisa.
© 2020 sanofi-aventis U.S. LLC. All rights reserved. MAT-US-2004871 07/20
SARCLISA may be appropriate for you or your loved one
Talk with your doctor to learn more
Your doctor will know if SARCLISA is an appropriate treatment option for you.
Have you or your loved one…
Your answer
1
"…been treated with at least 2 different medicines for multiple myeloma?
Yes
2
…had multiple myeloma return after a prior treatment
(commonly referred to as relapsed multiple myeloma)?
Yes
3
…had multiple myeloma not respond, or stop responding, to a current or prior
treatment (commonly referred to as refractory multiple myeloma)?
Yes
4
…been treated with Revlimid® (lenalidomide)?
Yes
5
…been treated with a proteasome inhibitor (PI)?
Yes
6
…been diagnosed with impaired kidney function?*
Yes
7
…been diagnosed with asthma or
chronic obstructive pulmonary disease (COPD)?*
Yes
Share these answers with your doctor and use
the attached Doctor Discussion Guide to help start the conversation.
What is SARCLISA?
SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat
adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor,
to treat multiple myeloma.
It
is not known if SARCLISA is safe and effective in children.
Important Safety Information
Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any
of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).
Please see additional Important Safety Information on the following pages, and full
Prescribing Information, including Patient Information.
*People with impaired kidney function, asthma, and COPD participated in the SARCLISA study.
1
Important Safety Information (cont’d)
Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:
•
are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive
SARCLISA during
pregnancy.
— Females who are able to become pregnant should
use an
effective method of birth
control during treatment
and for 5 months after their last dose of SARCLISA. Talk to your healthcare provider about birth control methods
that you can use during this time.
Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment
with SARCLISA.
•
are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not
breastfeed during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and
herbal supplements.
How will I receive SARCLISA?
•
SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
•
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide
and dexamethasone.
— In cycle
1, SARCLISA is usually given weekly.
— Starting in cycle 2, SARCLISA is usually given
every 2 weeks.
Your healthcare provider will decide how long you should receive
SARCLISA.
•
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
•
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion
reactions (make them less frequent and severe).
What are the possible side
effects of SARCLISA?
SARCLISA may cause serious side effects, including:
•
Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
— Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your
risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion
reactions during each dose of SARCLISA.
— Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA,
if you have an infusion reaction.
Tell your healthcare provider right away if you develop any of the following symptoms of infusion
reaction during or within 24 hours after an infusion of SARCLISA:
— feeling short of breath
— chills
— cough
— nausea
•
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and
certain white blood cells can be severely decreased. You may have an increased risk of getting certain
infections, such as
upper and lower respiratory infections.
Your healthcare provider will check
your blood cell counts during treatment with SARCLISA. Your healthcare
provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help
increase your white blood cell counts during treatment with SARCLISA.
Please see additional Important Safety Information on the next page,
and full Prescribing Information, including Patient Information.
2
Revlimid is a registered trademark of Celgene Corporation.
© 2020 sanofi-aventis U.S. LLC. All rights reserved. MAT-US-2002028 07/20
Important Safety Information (cont’d)
Tell your healthcare provider right away if you develop any fever or symptoms of infection during
treatment with SARCLISA.
•
Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your
healthcare provider will monitor you for new cancers during treatment with SARCLISA.
•
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your
healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA.
Tell all of your healthcare providers that you are being treated with SARCLISA before receiving
blood
transfusions.
The most common side effects of SARCLISA include:
•
lung infection (pneumonia)
•
decreased red blood cell counts (anemia)
•
upper respiratory tract infection
•
decreased platelet counts (thrombocytopenia)
•
diarrhea
These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider
or pharmacist.
Please see full Prescribing Information, including Patient Information.
3
Find out more by visiting SARCLISA.com.
Treatment with SARCLISA
•
How will I receive treatment with SARCLISA?
•
How will I know if SARCLISA is working?
•
How will you monitor my results?
•
What are the possible side effects?
Considering SARCLISA
•
Is there a study that shows SARCLISA may work for my condition?
•
Was SARCLISA studied in people like me?
•
What were the study results for SARCLISA?
•
Based on my treatment history, is SARCLISA an option for me?
•
Is there a patient support program that may help with the cost of SARCLISA?
Talk with your doctor about SARCLISA
If you or your loved one is considering treatment with SARCLISA, the questions
below can help you have a productive conversation with your doctor
Notes and questions
Use this space to write down additional questions you may have
or information you want to share with your doctor
New to SARCLISA® (isatuximab-irfc)?
Sign up for updates at SARCLISA.com to get the latest information.
Already signed up?
For information about
our patient support program, CareASSIST from Sanofi Genzyme,
please
call 1-833-WE+CARE (1-833-930-2273), Mon –
Fri, 9 am - 8 pm ET,
or visit SanofiCareAssist.com/sarclisa.
© 2020 sanofi-aventis U.S. LLC. All rights reserved. MAT-US-2004871 07/20