“HAVE YOU HEARD?”

Transcription

“HAVE YOU HEARD?”

For people on dialysis with anemia due to chronic kidney disease (CKD)
“HAVE YOU HEARD?”
Let’s talk about
EPOGEN AND
YOUR ANEMIA
®
EPOGEN® (epoetin alfa) is a prescription medicine used to treat a lower than normal number of red blood cells (anemia)
caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
EPOGEN® should not be used in place of emergency treatment for anemia (red blood cell transfusions).
EPOGEN® has not been proven to improve quality of life, fatigue, or well-being.
Using EPOGEN® can lead to death or other serious side effects. If you decide to take EPOGEN®,
your healthcare provider should prescribe the smallest dose that is necessary to reduce your
chance of needing red blood cell transfusions.
Join the conversation...visit www.EPOGEN.com
Please read the Important Safety Information for EPOGEN® on pages 17–22.
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GETTING STARTED
Your doctor may have prescribed EPOGEN® (epoetin alfa) for you to treat your anemia
caused by chronic kidney disease. Anemia is very common in people on dialysis. Your healthcare team will work to manage your anemia, and EPOGEN® treatment may
be a part of that. You may have some questions or may be wondering what you can do. To start, you can learn more about your anemia so you are able to take an active role in your care.
EPOGEN® is not right for everyone. Talk to your doctor about your medical condition and if EPOGEN® is right for you.
Please read the Important Safety Information for EPOGEN® on pages 17– 22 and refer to the Medication Guide included with the full prescribing information for EPOGEN®.
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With this booklet, YOU WILL LEARN:
• What causes anemia due to chronic kidney disease
• What hemoglobin is and why it is important
• How EPOGEN® treatment works
• The benefits and risks of transfusion
• The benefits and risks of EPOGEN® treatment
• Some things you can do to help manage your anemia
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“DID YOU KNOW?”
What causes ANEMIA?
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RED BLOOD CELLS
To understand what causes anemia, first you have to
know about red blood cells. Red blood cells have the
important job of carrying oxygen around the body. Every
part of the body needs oxygen to work and survive.
red blood cells
Hemoglobin [HEE-mow-glow-bin]
is the part of the red blood cell that holds the oxygen.
Every minute, a healthy human body makes
MILLIONS OF RED
BLOOD CELLS.
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THE KIDNEYS
The kidneys play an important role in making red blood cells.
They make a “messenger” hormone that tells the body to
create red blood cells.
This “messenger” hormone
made by the kidneys is called
ERYTHROPOIETIN
[ee-rith-row-PO-eh-tin].
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ANEMIA Anemia is a condition in which the body has fewer red
blood cells than normal. Because of this, the body
does not get enough oxygen. So, the body has to work
harder to do all its jobs (like making the heart beat and
the muscles move).
normal levels of
red blood cells
As a result, you may find it harder to do physical activities
like walking and exercising or daily tasks like getting ready
in the morning and running errands.
anemic levels of
red blood cells
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Your ANEMIA Anemia has many causes.
kidney making
enough erythropoietin
In your case, your doctor has diagnosed you with
anemia caused by chronic kidney disease.
That means your kidneys are not making enough
of the hormone erythropoietin.
kidney not making
enough erythropoietin
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“I JUST LEARNED...”
What is
EPOGEN
TREATMENT?
®
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EPOGEN®
EPOGEN® (epoetin alfa) is a medicine that acts like the hormone
erythropoietin. EPOGEN® helps the body create more red blood
cells, which raises the hemoglobin (Hb) level.
It is important for your doctor to monitor your Hb levels regularly
to ensure that they do not go up too high or too quickly.
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EPOGEN® TREATMENT schedule
EPOGEN® is given 3 times a week for patients on
dialysis. If prescribed by your doctor, your EPOGEN®
treatment will probably be on the same schedule
as your dialysis. EPOGEN® is injected either into
your skin or directly into your dialysis line. If you are
on hemodialysis, it is recommended that you get
EPOGEN® through your dialysis line.
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Monitoring your EPOGEN® TREATMENT
Your doctor will test your blood regularly (at least weekly at the beginning of treatment)
to make sure EPOGEN® (epoetin alfa) is working. These tests will measure either your
hemoglobin (Hb) or your hematocrit (hee-MATT-a-crit) levels.
• Hb levels show how much oxygen your blood can carry.
• Hematocrit levels show the percentage of red blood cells in your blood.
Most doctors use Hb because it is a better way to check for anemia.
Throughout your EPOGEN® treatment, your doctor will also check your iron levels.
Having enough iron in your blood is important for EPOGEN® to work.
It is very important to get your Hb level checked on a regular basis.
STAY INVOLVED BY TALKING TO YOUR DIALYSIS
CARE TEAM ABOUT YOUR Hb LEVEL.
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Know your HEMOGLOBIN
It takes time for your body to make new red blood cells. With EPOGEN® treatment, Hb levels usually increase in 2 to 6 weeks.
Your doctor may prescribe EPOGEN® when your Hb level is less than 10 g/dL.
IMPORTANT SAFETY INFORMATION
EPOGEN® may cause serious side effects that can lead to death, including:
For all people who take EPOGEN ®, including people with cancer or chronic kidney disease:
• Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with EPOGEN® to increase red blood cells (RBCs) to near the same level found in healthy people.
If you decide to take EPOGEN®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.
If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take EPOGEN®, even if you do not have an increase in your hemoglobin level.
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“LISTEN TO THIS...”
What else
do I need to
know about
EPOGEN
TREATMENT?
®
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Benefits of EPOGEN
®
EPOGEN® (epoetin alfa) may improve your exercise tolerance and allow
you to function better physically. In a study, patients on hemodialysis
with anemia experienced improvements in exercise tolerance and
in patient-reported physical functioning after taking EPOGEN® for
2 months.
Patients showed improvement in the number of minutes walked
on a treadmill. During the test, the treadmill increased in speed and
steepness the longer the patients walked.
Patients reported improvement in overall physical function,
with activities like:
• Getting around (mobility)
• Walking (ambulation)
• Movements needed to take care of oneself (body
care and movement)
Please note that EPOGEN® has not been shown to improve
quality of life, fatigue, or patient well-being.
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EPOGEN® decreases the need for TRANSFUSIONS
EPOGEN® is used to treat a lower than normal number of red blood cells (anemia) caused
by chronic kidney disease in patients on dialysis to reduce or avoid the need for red
blood cell transfusions. If you decide to take EPOGEN®, your healthcare provider should
prescribe the smallest dose that is necessary to reduce your chance of needing RBC
transfusions. EPOGEN® should not be used in place of emergency treatment for anemia
(red blood cell transfusions).
Transfusions are sometimes needed because of their ability to quickly increase red blood
cells, which carry oxygen to the body. At the same time, transfusions may also have
risks, such as different types of reactions and infections.
Talk to your doctor about any questions you have about transfusions.
• Blood clots. Blood clots may happen at any time while taking EPOGEN®.
If you are receiving EPOGEN® for any reason and are going to have surgery,
talk with your healthcare provider about whether you need to take a blood
thinner to lessen the chance of blood clots during or following surgery.
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EPOGEN® may cause serious side effects that can lead to
death, including:
For people with cancer:
• In patients with breast, non-small cell lung, head and neck, lymphoid,
and cervical cancers: Your tumor may grow faster and you may die
sooner if you choose to take EPOGEN®.
• Your healthcare provider has received special training in order to
prescribe EPOGEN® and will talk with you in detail about these risks.
For all people who take EPOGEN ®, including people with cancer
or chronic kidney disease:
• Serious heart problems, such as heart attack or heart failure,
and stroke. You may die sooner if you are treated with EPOGEN®
to increase red blood cells (RBCs) to near the same level found in
healthy people.
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IMPORTANT SAFETY INFORMATION (continued)
• Blood clots. Blood clots may happen at any time while taking EPOGEN®. If you are
receiving EPOGEN® for any reason and are going to have surgery, talk with your
healthcare provider about whether you need to take a blood thinner to lessen the
chance of blood clots during or following surgery.
• Call your healthcare provider or get medical help right away if you have any of these symptoms:
• Chest pain
• Sudden trouble seeing
• Trouble breathing or shortness of breath
• Pain or swelling in your legs
• Sudden trouble walking, dizziness, loss of balance or coordination
• A cool or pale arm or leg
• Loss of consciousness (fainting)
• Sudden confusion, trouble speaking, or
trouble understanding others’ speech
• Hemodialysis vascular access
stops working
• Sudden numbness or weakness in your
face, arm, or leg, especially on one side of your body
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If you decide to take EPOGEN®, your healthcare provider should prescribe the smallest
dose that is necessary to reduce your chance of needing RBC transfusions.
If your hemoglobin level stays too high or goes up too quickly, this may lead to serious
health problems which may result in death. These serious health problems may happen if
you take EPOGEN®, even if you do not have an increase in your hemoglobin level.
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Do not take EPOGEN® if you:
• Have cancer and have not been counseled by your healthcare provider about treatment with EPOGEN®.
• Have high blood pressure that is not controlled (uncontrolled hypertension).
• Have been told by your healthcare provider that you have, or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with EPOGEN® or other erythropoietin medicines.
• Have had a serious allergic reaction to EPOGEN®.
Pregnant women, breastfeeding women, and babies should not receive EPOGEN®
from multidose vials.
Before taking EPOGEN®, tell your doctor if you: have heart disease; have high blood
pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan to
become pregnant or breastfeed.
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EPOGEN ® may cause other serious side effects:
• High blood pressure. High blood pressure is a common side effect of EPOGEN® in
patients with chronic kidney disease. Your blood pressure may go up or be difficult to
control with blood pressure medication while taking EPOGEN®. This can happen even if
you have never had high blood pressure before. Your healthcare provider should check
your blood pressure often.
• Seizures. If you have seizures while taking EPOGEN®, get medical help right away
and tell your healthcare provider.
• Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can
block or lessen your body’s ability to make RBCs and cause you to have severe anemia.
Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or
fainting. You may need to stop taking EPOGEN®.
• Serious allergic reactions. Serious allergic reactions can cause a rash over your
whole body, shortness of breath, wheezing, dizziness and fainting due to a drop in
blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you
have a serious allergic reaction, stop using EPOGEN® and call your healthcare
provider or get medical help right away.
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Common side effects of EPOGEN® include:
• Joint, muscle, or bone pain • Vomiting
• Fever
• Soreness of mouth
• Cough
• Itching
• Rash
• Headache
• Nausea
• Redness and pain in the
skin where EPOGEN® shots were given
These are not all of the possible side effects of EPOGEN®. Tell your healthcare provider
about any side effects that bother you or do not go away.
You are encouraged to report negative side effects of prescription drugs to the US Food
and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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What else do I NEED TO KNOW?
Use this page for notes or questions you want to ask your doctor.
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How is my HEMOGLOBIN DOING?
Use this page to keep track of your hemoglobin (Hb) test results.
date:
level:
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Your doctor will determine the appropriate Hb level for you
to reduce your need for blood transfusions.
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You know that your doctor will do everything
he or she can to treat your anemia.
BUT THERE ARE MANY THINGS YOU CAN DO AS WELL
earn more about your chronic kidney
L
disease, anemia, and dialysis.
alk with your healthcare team and T
other patients with anemia.
eep all your dialysis appointments and
K
stay for your full treatment time.
eep track of your lab test results, K
particularly your hemoglobin.
Follow your doctor’s advice.
ake all your medicines as they T
are prescribed.
ork with a dietitian to improve W
your eating habits.
emember, talk to your doctor
R
before you make any changes
to your treatment or lifestyle.
Using EPOGEN ® (epoetin alfa) can lead to death or other serious side effects. If you decide to take
EPOGEN ®, your healthcare provider should prescribe the smallest dose that is necessary to reduce
your chance of needing red blood cell transfusions.
Please read the Important Safety Information for EPOGEN ® on pages 17–22.
Please see accompanying EPOGEN ® full prescribing information, including Boxed WARNINGS
and Medication Guide.
Amgen
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
www.amgen.com
© 2014 Amgen Inc. All rights reserved. Not for reproduction. 83063-R1-V1 11-14
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“HAVE YOU HEARD?”

Transcription

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