REBLOZYL
®
(luspatercept-aamt) is a prescription medicine used to
treat anemia (low red blood cells) without previous erythropoiesis
stimulating agent use (ESA-naïve) in adult patients with very low- to
intermediate-risk myelodysplastic syndromes (MDS) who may require regular
red blood cell (RBC) transfusions.
REBLOZYL is not for use as a substitute for RBC transfusions in people who
need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children under 18 years
of age.
REBLOZYL
®
(luspatercept-aamt) is a prescription medicine used to
treat anemia (low red blood cells) in adults with myelodysplastic syndromes
with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative
neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need
regular RBC transfusions and have not responded well to or cannot receive an
erythropoiesis stimulating agent (ESA).
REBLOZYL is not for use as a substitute for RBC transfusions in people who
need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children under 18 years
of age.
REBLOZYL
®
(luspatercept-aamt) is a prescription medicine used to
treat anemia (low red blood cells) in adults with beta thalassemia who need
regular red blood cell (RBC) transfusions.
REBLOZYL is not for use as a substitute for RBC transfusions in people who
need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children.
It is not known if REBLOZYL is safe or effective in children.
An EMA helps immature RBCs (called
erythroid cells
) develop and become mature, working RBCs. This may result in more healthy RBCs and improved
anemia.
How does REBLOZYL work?
Before starting REBLOZYL for MDS-related anemia, it’s important that you learn about how
REBLOZYL works. It can also make you feel more confident when talking with your healthcare
team.
Watch this short video to see how REBLOZYL works.
One of the nicest things about REBLOZYL
is that I would be able to
go
3 weeks between injections.
- Teri, a real REBLOZYL patient
Individual results may vary.
Hear from someone who has managed MDS-related anemia with REBLOZYL.
When it comes to your managing your MDS-related anemia, you and your care team are in it together.
Keeping open lines of communication can help your doctor determine the right treatment plan for you.
Remember: you and your caregiver(s) are your best advocates, and it all starts with asking the right
questions.
Select (+) to find answers for some of the most commonly-asked questions:
REBLOZYL is available either as a first medicine for MDS-related anemia or later in your journey. Your care team will review your medical history to help determine if REBLOZYL could be the right fit for you.
Some specific questions to ask include:
How is REBLOZYL different from other treatments?
How might REBLOZYL help me reach my treatment goals?
Because everyone's experience is different, communicating openly with your healthcare team is the best way to feel prepared for what's ahead:
While taking REBLOZYL, you can expect to:
Visit your doctor's office about every three weeks for your injection
Get a blood test to check Hgb levels before treatment
Be asked about any recent RBC transfusions
Some specific questions to ask include:
How will I receive my REBLOZYL dose? And how often?
What are possible side effects with REBLOZYL?
What should I track and monitor in between appointments?
After starting REBLOZYL, your doctor may adjust your dosing during visits. Dose adjustments are normal and give your care team the flexibility to make the most of your medicine based on your body's response.
Specific questions to ask about dosing include:
What does it mean if my dose needs to go up or down?
Could my REBLOZYL dose change over time?
What's important to track and share about my REBLOZYL dose?
Talk to your care team about what you should track between appointments. Some examples include:
New or changing symptoms
Bloodwork results, including hemoglobin (Hgb) levels
Transfusion history, including date of last transfusion and how many units received
Any questions or concerns that come up between appointments, including details about any new or continuing side effects
Everybody responds differently to medicine, so it's important that you and your care team work together to set the right treatment goals and track them over time. Examples of treatment goals in MDS-related anemia could be to become transfusion independent or to raise hemoglobin levels.
Specific questions to ask about treatment goals include:
What should my goal(s) be while on REBLOZYL?
Based on how I'm responding to REBLOZYL, is my current dose right for me?
Should I be adjusting my goals over time?
Get the conversation started with our
Doctor Discussion Guide
Download our complete Doctor Discussion Guide for more information about navigating
conversations with your care team. The guide also includes worksheets and places to take notes
to help you get organized.
REBLOZYL
®
(luspatercept-aamt)
This is a summary of important information that you need to know about REBLOZYL. Your healthcare team can work with you to help answer any questions you may have about this medication.
Keep this information in a safe place so you can refer to it before and during your treatment.
Look out for the following icons as you read:
Talk to your healthcare team
Call a healthcare provider right away
Helpful information to remember
What is REBLOZYL?
REBLOZYL is a prescription medicine for injection, and is used to treat anemia (low red blood cells) in adults with:
β (beta) thalassemia
who need regular red blood cell (RBC) transfusions.
MDS
who may need regular RBC transfusions and have never received another type of medicine called an erythropoiesis stimulating agent (ESA).
MDS
:
m
yelo
d
ysplastic
s
yndromes
MDS-RS or MDS/MPN-RS-T
who need 2 or more RBC units over 8 weeks and have not responded well to an ESA.
MDS-RS:
m
yelo
d
ysplastic
s
yndromes with
r
ing
s
ideroblasts
MDS/MPN-RS-T:
m
yelo
d
ysplastic syndromes or
m
yelo
p
roliferative
n
eoplasms with
r
ing
s
ideroblasts and
t
hrombocytosis
REBLOZYL is not a substitute for RBC transfusions in people who need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children under 18 years of age.
What should I discuss with my healthcare team before starting treatment?
Talk to your healthcare team about
all of your health problems and risk factors,
including if you:
have or have had blood clots
take hormone replacement therapy or birth control pills (oral contraceptives)
have had your spleen removed (splenectomy)
smoke
have or have had high blood pressure (hypertension)
have a history of extramedullary hematopoietic (EMH) masses
have or have had enlarged spleen or liver
Talk to your healthcare team about
all the medicines you are taking,
including:
prescription medicines
over-the-counter medicines
vitamins
herbal supplements
These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.
What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?
Talk to your healthcare team
if:
You are
pregnant
or
plan to become pregnant
— REBLOZYL may harm your unborn baby
If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving REBLOZYL. You should use an effective method of birth control during treatment and for at least 3 months after your last dose of REBLOZYL. Talk to your healthcare team about birth control methods that you can use with REBLOZYL.
Call your healthcare provider right away
if you become pregnant or think you are pregnant during treatment with REBLOZYL.
REBLOZYL may affect your
ability to become pregnant.
Talk to your healthcare team if fertility problems are a concern for you.
You are
breastfeeding
or
plan to breastfeed
Do not breastfeed during treatment and for 3 months after the last dose of REBLOZYL. It is not known if REBLOZYL passes into your breast milk. Talk to your healthcare team about the best way to feed your baby during this time.
What are the serious side effects of REBLOZYL?
A
serious side effect
is a side effect that can sometimes become life-threatening and can lead to death. They may happen any time during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.
Blood clots (thrombosis/thromboembolism)
—
Blood clots in the arteries, veins, brain, and lungs have happened in people with β-thalassemia during treatment with REBLOZYL. The risk of blood clots may be higher in people who have had their spleen removed or who take hormone replacement therapy or birth control pills.
Call your healthcare provider or get medical help right away
if you have any of these symptoms:
chest pain
trouble breathing or shortness of breath
pain in your leg, with or without swelling
a cold or pale arm or leg
sudden numbness or weakness that is short-term or continues to happen over a long period of time, especially on one side of the body
severe headache or confusion
sudden problems with vision, speech, or balance (such as trouble speaking, difficulty walking, or dizziness)
High blood pressure (hypertension)
—
REBLOZYL may cause an increase in your blood pressure. Your healthcare provider will check your blood pressure before you receive your REBLOZYL dose. Your healthcare provider may prescribe you medicine to treat high blood pressure or increase the dose of medicine you already take to treat high blood pressure, if you develop high blood pressure during treatment with REBLOZYL.
Extramedullary Hematopoietic (EMH) Masses
—
EMH masses have happened in people with beta thalassemia during treatment with REBLOZYL. You may have a higher risk for developing EMH masses if you have a history of EMH masses, have had your spleen removed, have or have had enlarged spleen or liver, or have low hemoglobin levels. Your healthcare provider will monitor you before you start and during treatment with REBLOZYL. Call your healthcare provider or get medical help right away if you get any of these symptoms:
severe pain in the back
numbness or weakness or loss of voluntary movement in feet, legs, hands or arms
loss of bowel and bladder control
What are the most common side effects of REBLOZYL?
The most common side effects of REBLOZYL include:
tiredness
headache
back, joint, muscle, or bone pain
joint pain
dizziness
nausea
diarrhea
cough
stomach (abdominal) pain
trouble breathing
swelling of your hands, legs, or feet
high blood pressure
allergic reactions
These are not all of the possible side effects.
Talk to your healthcare team
for more information about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA by visiting
www.fda.gov/medwatch
or calling
1-800-FDA-1088
.
How will I receive REBLOZYL?
REBLOZYL is given as a subcutaneous injection (under your skin)
in the upper arm, thigh, or stomach by your healthcare provider. The recommended starting dose of REBLOZYL is 1 mg/kg, once every 3 weeks. Work with your healthcare team to determine the right treatment plan for you.
REBLOZYL is a type of medicine called an erythroid maturation agent (EMA), and comes in single-dose vials that need to be prepared for injection by a healthcare professional.
Before each REBLOZYL injection, your healthcare provider will do a blood test to check your hemoglobin and review your transfusion record to see how your anemia is responding to REBLOZYL. Your healthcare provider may adjust your dose or stop treatment depending on how you respond to REBLOZYL.
What if I delayed or missed a dose?
Call your healthcare provider as soon as possible
to reschedule your next appointment if you delayed or missed a dose. Your healthcare provider will give your dose of REBLOZYL as soon as possible. Your treatment with REBLOZYL will continue as prescribed, with at least 3 weeks between doses.
BEFORE RECEIVING REBLOZYL, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL OF YOUR MEDICAL CONDITIONS, INCLUDING IF YOU:
have or have had blood clots
have or have had high blood pressure (hypertension)
take hormone replacement therapy or birth control pills (oral contraceptives)
have had your spleen removed (splenectomy)
smoke
are pregnant or plan to become pregnant. REBLOZYL may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with REBLOZYL.
REBLOZYL
®
(luspatercept-aamt)
This is a summary of important information that you need to know about REBLOZYL. Your healthcare team can work with you to help answer any questions you may have about this medication.
Keep this information in a safe place so you can refer to it before and during your treatment.
Look out for the following icons as you read:
Talk to your healthcare team
Call a healthcare provider right away
Helpful information to remember
What is REBLOZYL?
REBLOZYL is a prescription medicine for injection, and is used to treat anemia (low red blood cells) in adults with:
β (beta) thalassemia
who need regular red blood cell (RBC) transfusions.
MDS
who may need regular RBC transfusions and have never received another type of medicine called an erythropoiesis stimulating agent (ESA).
MDS
:
m
yelo
d
ysplastic
s
yndromes
MDS-RS or MDS/MPN-RS-T
who need 2 or more RBC units over 8 weeks and have not responded well to an ESA.
MDS-RS:
m
yelo
d
ysplastic
s
yndromes with
r
ing
s
ideroblasts
MDS/MPN-RS-T:
m
yelo
d
ysplastic syndromes or
m
yelo
p
roliferative
n
eoplasms with
r
ing
s
ideroblasts and
t
hrombocytosis
REBLOZYL is not a substitute for RBC transfusions in people who need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children under 18 years of age.
What should I discuss with my healthcare team before starting treatment?
Talk to your healthcare team about
all of your health problems and risk factors,
including if you:
have or have had blood clots
take hormone replacement therapy or birth control pills (oral contraceptives)
have had your spleen removed (splenectomy)
smoke
have or have had high blood pressure (hypertension)
have a history of extramedullary hematopoietic (EMH) masses
have or have had enlarged spleen or liver
Talk to your healthcare team about
all the medicines you are taking,
including:
prescription medicines
over-the-counter medicines
vitamins
herbal supplements
These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.
What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?
Talk to your healthcare team
if:
You are
pregnant
or
plan to become pregnant
— REBLOZYL may harm your unborn baby
If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving REBLOZYL. You should use an effective method of birth control during treatment and for at least 3 months after your last dose of REBLOZYL. Talk to your healthcare team about birth control methods that you can use with REBLOZYL.
Call your healthcare provider right away
if you become pregnant or think you are pregnant during treatment with REBLOZYL.
REBLOZYL may affect your
ability to become pregnant.
Talk to your healthcare team if fertility problems are a concern for you.
You are
breastfeeding
or
plan to breastfeed
Do not breastfeed during treatment and for 3 months after the last dose of REBLOZYL. It is not known if REBLOZYL passes into your breast milk. Talk to your healthcare team about the best way to feed your baby during this time.
What are the serious side effects of REBLOZYL?
A
serious side effect
is a side effect that can sometimes become life-threatening and can lead to death. They may happen any time during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.
Blood clots (thrombosis/thromboembolism)
—
Blood clots in the arteries, veins, brain, and lungs have happened in people with β-thalassemia during treatment with REBLOZYL. The risk of blood clots may be higher in people who have had their spleen removed or who take hormone replacement therapy or birth control pills.
Call your healthcare provider or get medical help right away
if you have any of these symptoms:
chest pain
trouble breathing or shortness of breath
pain in your leg, with or without swelling
a cold or pale arm or leg
sudden numbness or weakness that is short-term or continues to happen over a long period of time, especially on one side of the body
severe headache or confusion
sudden problems with vision, speech, or balance (such as trouble speaking, difficulty walking, or dizziness)
High blood pressure (hypertension)
—
REBLOZYL may cause an increase in your blood pressure. Your healthcare provider will check your blood pressure before you receive your REBLOZYL dose. Your healthcare provider may prescribe you medicine to treat high blood pressure or increase the dose of medicine you already take to treat high blood pressure, if you develop high blood pressure during treatment with REBLOZYL.
Extramedullary Hematopoietic (EMH) Masses
—
EMH masses have happened in people with beta thalassemia during treatment with REBLOZYL. You may have a higher risk for developing EMH masses if you have a history of EMH masses, have had your spleen removed, have or have had enlarged spleen or liver, or have low hemoglobin levels. Your healthcare provider will monitor you before you start and during treatment with REBLOZYL. Call your healthcare provider or get medical help right away if you get any of these symptoms:
severe pain in the back
numbness or weakness or loss of voluntary movement in feet, legs, hands or arms
loss of bowel and bladder control
What are the most common side effects of REBLOZYL?
The most common side effects of REBLOZYL include:
tiredness
headache
back, joint, muscle, or bone pain
joint pain
dizziness
nausea
diarrhea
cough
stomach (abdominal) pain
trouble breathing
swelling of your hands, legs, or feet
high blood pressure
allergic reactions
These are not all of the possible side effects.
Talk to your healthcare team
for more information about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA by visiting
www.fda.gov/medwatch
or calling
1-800-FDA-1088
.
How will I receive REBLOZYL?
REBLOZYL is given as a subcutaneous injection (under your skin)
in the upper arm, thigh, or stomach by your healthcare provider. The recommended starting dose of REBLOZYL is 1 mg/kg, once every 3 weeks. Work with your healthcare team to determine the right treatment plan for you.
REBLOZYL is a type of medicine called an erythroid maturation agent (EMA), and comes in single-dose vials that need to be prepared for injection by a healthcare professional.
Before each REBLOZYL injection, your healthcare provider will do a blood test to check your hemoglobin and review your transfusion record to see how your anemia is responding to REBLOZYL. Your healthcare provider may adjust your dose or stop treatment depending on how you respond to REBLOZYL.
What if I delayed or missed a dose?
Call your healthcare provider as soon as possible
to reschedule your next appointment if you delayed or missed a dose. Your healthcare provider will give your dose of REBLOZYL as soon as possible. Your treatment with REBLOZYL will continue as prescribed, with at least 3 weeks between doses.
