PRALUENT alirocumab User manual

PRALUENT PRE-FILLED PEN
QUICK REFERENCE GUIDE
Please see full Prescribing Information available at
www.PRALUENT.com.
STEP-BY-STEP INSTRUCTIONS
on how to use PRALUENT

IMPORTANT SAFETY INFORMATION
Do not use PRALUENT if you are allergic to alirocumab
or to any of the ingredients in PRALUENT.
WHAT IS PRALUENT® (alirocumab)?
PRALUENT is an injectable prescription medicine called
a PCSK9 inhibitor. PRALUENT is used along with diet and
maximally tolerated statin therapy in adults with heterozygous
familial hypercholesterolemia (an inherited condition
that causes high levels of LDL-C) or atherosclerotic heart
problems, who need additional lowering of LDL cholesterol.
The eect of PRALUENT on heart problems such as heart
attacks, stroke, or death is not known.
It is not known if PRALUENT is safe and eective in children.
Support to help you use PRALUENT at home
This guide provides step-by-step instructions for using
PRALUENT at home. If you need more help, you can:
• Watch our self-injection training video at PRALUENT.com
• Call us at 1-844-PRALUENT (1-844-772-5836)
and press 1 to speak with a live nurse
2
Please see full Prescribing Information available at
www.PRALUENT.com.
PRALUENT COMES IN AN
EASY-TO-USE PRE-FILLED PEN
•Injected under the skin* every 2 weeks (75 mg or 150 mg
doses) or every 4 weeks (300 mg monthly dose)†
Green (75 mg)/
Gray (150 mg) button
Blue
needle
cap
Medication
and dosage label
Inspection
window
Yellow safety
needle cover
(needle inside)
*Subcutaneously.
†You should start with the dose prescribed by your
healthcare provider. If your healthcare provider prescribes
you the monthly dose, you will give yourself 2 separate
150 mg injections in a row, using a dierent pen
for each injection, at two dierent injection sites.
3

Please see full Prescribing Information available at
www.PRALUENT.com.
• The device is an easy-to-use, single 1 mL pre-filled pen.
It contains 75 mg or 150 mg of PRALUENT® (alirocumab)
•If your healthcare provider prescribes you the monthly dose,
you will give yourself 2 separate 150 mg injections in a row,
using a dierent pen for each injection, at two dierent
injection sites
•The pen is not made with natural rubber latex
•The medicine is injected under your skin and can be given
by yourself or someone else (caregiver)
•This pen can only be used for 1 single injection and must be
thrown away after use. For the monthly 300 mg dose,
throw out the first 150 mg pen before repeating the steps
to administer your second injection
•If needed, PRALUENT may be kept at room temperature
up to 77°F in the original carton and must be used within
30 days or discarded
IMPORTANT INFORMATION DO DO NOT
Keep the PRALUENT Pen
out of the sight and reach
of children
Read the Patient
Information and Instructions
For Use carefully before
using the PRALUENT Pen
Follow these instructions
every time you use a
PRALUENT Pen
Store unused pens in the
refrigerator at 36°F to
46°F in the original carton
to protect from light
Do not try to give yourself
or someone else the
injection unless you have
received training from your
healthcare provider
Do not store at
temperatures above 77°F
Do not leave out of the
refrigerator for more than
30 days
IMPORTANT SAFETY INFORMATION
Before starting PRALUENT, tell your healthcare provider about
all your medical conditions, including allergies, and if you are
pregnant or plan to become pregnant or if you
are breastfeeding or plan to breastfeed.
4 5

Please see full Prescribing Information available at
www.PRALUENT.com.
PRALUENT® (alirocumab) PEN
KEY FEATURES
Before you start your injection, you will need:
The ready-to-use PRALUENT Pen was
designed for self-injection at home
The yellow safety needle cover keeps
the needle hidden throughout the
entire injection
A “click” sound tells you that the injection
has started
The window turns yellow when the
injection is completed so you know
the full dose has been delivered
click!
1 alcohol
wipe
The
PRALUENT
Pen
1 cotton ball
or gauze
pad
A sharps
disposal
container
(see step 8
on page 19)
For self-injecting the monthly 300 mg dose,
prepare two 150 mg pens.
IMPORTANT SAFETY INFORMATION
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking
or plan to take, including natural or herbal remedies.
6 7
Alcohol
Wipe
Alcohol
Wipe
Alcohol
Wipe

Please see full Prescribing Information available at
www.PRALUENT.com.
GETTING READY FOR AN INJECTION
1. LOOK at the label
•Check that you have the correct
product and the correct dose
•Check the use-by date on the label;
do not use if this date has passed
•DO NOT use the pen if it has been
dropped or damaged
2. LOOK at the window
B
A
•Check that liquid is clear, colorless to
pale yellow, and free from particles
(see picture A). If not, do not use
• You may see air bubbles.
This is normal
•DO NOT use if the window appears
solid yellow (see picture B)
8 9

Please see full Prescribing Information available at
www.PRALUENT.com.
3. BRING to room temperature
for30-40 minutes 4. PREPARE the injection site
• Let two 150 mg pens come to room
temperature for the monthly 300 mg dose
• DO NOT heat the pen; let it warm up
on its own
• DO NOT expose the pen to direct sunlight
• You may want to set a timer for
30-40 minutes to remind you when
PRALUENT has reached room
temperature and is ready to be injected
• DO NOT put the pen back in
the refrigerator • Wash your hands with soap and water and dry with a towel
• Clean skin in the injection area with an alcohol wipe
• DO NOT use on skin that is tender, hard, red, or hot
• DO NOT use any area near a visible vein
• Change your injection site each time you give yourself
an injection. If you need to use the same
injection site, make sure it is not the same spot
you used last time
• Use a dierent injection site for the
second injection for the monthly
300 mg dose
GETTING READY FOR AN INJECTION (cont’d)
INJECTION SITES
• Top of thigh
• Belly (except for
the 2-inch area
around your navel)
• Outer side of your
upper arms (for
caregivers)
10 11
If needed, PRALUENT may
be kept at room temperature up
to 77°F in the original carton
and must be used within
30 days or discarded

Please see full Prescribing Information available at
www.PRALUENT.com.
HOW TO INJECT
1. PULL o the blue needle cap
•DO NOT pull o the cap until you are ready to inject
•DO NOT use the pen if the blue needle cap is missing
or not securely attached
•DO NOT put the cap back on
2. HOLD the pen like this so you can see
the window
Blue
needle
cap
• DO NOT shake the pen
• DO NOT touch the yellow safety
needle cover
• Make sure the inspection window is
facing you and that you can see it
Your thumb should not touch the green button yet
DO NOT touch the yellow safety needle cover
12 13

Please see full Prescribing Information available at
www.PRALUENT.com.
3. PRESS down the yellow safety needle
cover on your skin
• Press the yellow safety needle
cover straight down on your
skin at roughly a 90 angle
• DO NOT lift the pen from
your skin
• Use the same pressure
for the entire injection • Firmly press down until
the yellow safety needle
cover disappears into
the pen and is no
longer visible
•DO NOT touch the
green button yet
The pen will not work if the yellow safety
needle cover is not pushed all the way down
90°
HOW TO INJECT (cont’d)
•If needed, pinch the skin to
make sure injection site is firm
–It is important to keep the
skin pinched while injecting
14 15
OR

Please see full Prescribing Information available at
www.PRALUENT.com.
4. PUSH and immediately release the button
•You will hear a “click.” Your
injection has now started
•Immediately release the button
•The window will start to
turn yellow
•Continue to firmly press down
so that the yellow safety needle
cover is not visible
click!
5. HOLD in place until entire window is yellow
• Use the same pressure for the entire injection
• The injection may take up to 20 seconds
HOW TO INJECT (cont’d)
16 17

Please see full Prescribing Information available at
www.PRALUENT.com.
• DO NOT remove the pen until the entire
window has turned yellow
• You may hear a second “click” when the
injection is complete
• If the window does not turn completely
yellow, call 1-844-PRALUENT
(1-844-772-5836) and press 1. Do not give
yourself a second dose without speaking
to your doctor, pharmacist, or nurse
Injection is complete when window turns completely yellow
When self-injecting the monthly 300 mg dose, repeat ALL
steps with a second 150 mg pen at a different injection site
6. CHECK that the window has turned yellow
• DO NOT rub the skin after the injection
• You may see a drop of blood at the
injection site
• DO NOT put the blue needle
cap back on
• Throw away pen and needle
cap into a puncture-resistant
container right after use
• For the monthly 300 mg dose,
throw out the first 150 mg pen
before repeating the steps for
your second injection
• Always keep the container
out of the sight and reach
of children
• DO NOT reuse the pen
7. LIFT pen away from your skin
8. THROW away pen and needle cap
HOW TO INJECT (cont’d)
18 19

Please see full Prescribing Information available at
www.PRALUENT.com.
•Put your used pens in an FDA-
cleared sharps disposal container
right away after use. DO NOT
throw out pens and caps in your
household trash
•For the monthly 300 mg dose,
throw out the first 150 mg pen
before repeating the steps for
your second injection
•If you do not have an
FDA-cleared sharps disposal
container, you may use a
household container that is:
–made of a heavy-duty plastic;
–can be closed with a tight-fitting; puncture-resistant lid,
without sharps being able to come out;
–upright and stable during use;
–leak resistant; and
–properly labeled to warn of hazardous waste inside
the container
HOW TO THROW OUT YOUR PEN
•MyPRALUENT® can provide you with an FDA-cleared
sharps disposal container. Call 1-844-PRALUENT
(1-844-772-5836) and press 1 to speak with a live nurse
and request a container
•When your sharps disposal container is almost full, you will
need to follow your community guidelines for the right way
to dispose of your sharps disposal container. There may be
state or local laws about how you should throw away used
needles and syringes. For more information about safe
sharps disposal, and for specific information about sharps
disposal in the state where you live, go to the FDA’s website
at: http://www.fda.gov/safesharpsdisposal
Keep PRALUENT and all medicines out of the reach
of children.
20 21

Please see full Prescribing Information available at
www.PRALUENT.com.
FREQUENTLY ASKED QUESTIONS
3. What should I do if I can’t push the yellow safety
needle cover all the way into the pen while pressing
on my skin?
• It may help to pinch the skin to make sure the injection
site is firm. You may also consider injecting into an
area on your thighs
• Be sure that you keep your thumb off of the green/gray
button while pushing the yellow safety needle cover on
your skin
1. How should I store PRALUENT® (alirocumab)?
• PRALUENT should be stored in the refrigerator at
36°F-46°F in the original carton protected from light.
DO NOT freeze the pen. DO NOT expose to extreme
heat. DO NOT shake
• You should remove the PRALUENT Pen from the
refrigerator 30 to 40 minutes prior to use and allow
it to come to room temperature on its own. This will
make the injection less uncomfortable
• If you have been prescribed the monthly 300 mg
dose, you will need to let two 150 mg pens come to
room temperature
•If needed, PRALUENT may be kept at room
temperature (up to 77°F) in the original carton for
up to 30 days. DO NOT store at temperatures
above 77°F
•After removal from the refrigerator, PRALUENT
must be used within 30 days or discarded
2. Is it okay to use the pen if I see air bubbles in
the window?
•Yes, it is normal to see air bubbles in the window.
This is okay
IMPORTANT SAFETY INFORMATION
PRALUENT can cause serious side eects, including allergic
reactions that can be severe and require treatment in a
hospital. Call your healthcare provider or go to the nearest
emergency room right away if you have any symptoms of
an allergic reaction, including a severe rash, redness, severe
itching, a swollen face, or trouble breathing.
22 23

Please see full Prescribing Information available at
www.PRALUENT.com.
FREQUENTLY ASKED QUESTIONS (cont’d) If you inject every 4 weeks:
• Inject your missed dose as soon as you remember
within 7 days of your missed dose
• Then, take your next dose 4 weeks from the day you
missed your dose. This will put you back on your
original schedule
• If you missed a dose by more than 7 days, start a new
schedule from the time you remember to take your dose
6. Who should I contact if I need help or have any
questions about how to take PRALUENT?
•Please talk to your healthcare provider about any
questions you may have. For more information
about using PRALUENT, call 1-844-PRALUENT
(1-844-772-5836) and press 1 to speak with a
MyPRALUENT® nurse
•You can also visit PRALUENT.com to watch an
on-demand self-injection training video
4. What should I do if I can’t push the
green/gray button?
•First, release the button and check that you have taken
off the blue needle cap
•Place the pen on your skin, and press down firmly until
the yellow safety needle cover is pushed all the way
into the pen. You won’t be able to push the button if the
yellow safety needle cover is still showing. You might
need to pinch the skin with your other hand so it’s firm
• Now, push the green/gray button again. You should
hear a click. Then release the button
5. What do I do if I forget a dose?
If you inject every 2 weeks:
• Inject your missed dose as soon as you remember,
within 7 days of your missed dose
• Then, take your next dose 2 weeks from the day you
missed your dose. This will put you back on your
original schedule
• If you missed a dose by more than 7 days, wait until
your next scheduled dose to restart PRALUENT. This
will keep you on your original schedule
IMPORTANT SAFETY INFORMATION
The most common side eects of PRALUENT include:
redness, itching, swelling, or pain/tenderness at the injection
site, symptoms of the common cold, and flu
or flu-like symptoms. Tell your healthcare
provider if you have any side eect that
bothers you or that does not go away.
24 25

Please see full Prescribing Information available at
www.PRALUENT.com.
Do not use PRALUENT® (alirocumab) if you are allergic
to alirocumab or to any of the ingredients in PRALUENT.
Before starting PRALUENT, tell your healthcare provider
about all your medical conditions, including allergies, and
if you are pregnant or plan to become pregnant or if you
are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking
or plan to take, including natural or herbal remedies.
PRALUENT can cause serious side effects, including allergic
reactions that can be severe and require treatment in a
hospital. Call your healthcare provider or go to the nearest
emergency room right away if you have any symptoms of
an allergic reaction, including a severe rash, redness, severe
itching, a swollen face, or trouble breathing.
The most common side effects of PRALUENT include:
redness, itching, swelling, or pain/tenderness at the injection
site, symptoms of the common cold, and flu or flu-like
symptoms. Tell your healthcare provider if you have any
side effect that bothers you or that does not go away.
IMPORTANT SAFETY INFORMATION
26
Talk to your healthcare provider about the right way to
prepare and give yourself a PRALUENT injection and follow
the “Instructions For Use” that comes with PRALUENT.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
For questions on the safety information for PRALUENT or to
report an adverse event, please call The Resource Center for
PRALUENT at 1-844-772-5836.
27

Please see full Prescribing Information available at
www.PRALUENT.com.
©2017 Sanofi and Regeneron Pharmaceuticals, Inc.
07/2017 SAUS.PRL.17.03.0824(1)
*Eligible patients with commercial insurance not funded through a government
healthcare program subject to an annual cap and other program terms and restrictions.
†Eligible patients subject to program restrictions.
SUPPORT TO HELP
YOU GET STARTED ON
PRALUENT® (alirocumab)
$0 copay oer*
and other
programs to
help with the
cost of
PRALUENT†
Text message
injection
reminders and
free reminder
magnet to
help you build
a routine
Tools to help you
stay on track,
including a
sharps disposal
container and
travel kit
per
Tex t
Sign up for MyPRALUENT® on PRALUENT.com
or by calling 1-844-PRALUENT (1-844-772-5836).