Organon Follistim Pen User manual

TM
INSTRUCTIONS FOR USE
®
For use only with
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INTRODUCTION
The main actions contained in this booklet that must be learned are:
1. Loading the Follistim Pen™
2. Dialing the prescribed dose
3. Using the Follistim Pen™ to give yourself an injection of Follistim®AQ Cartridge
The Follistim Pen™ is a very precise injection device. It is easy to use and convenient. The special features allow you to inject
Follistim®AQ Cartridge safely and effectively.
Follistim Pen™ can be set to any dose from 50 International Units (IU) up to 450 IU, in marked increments. The Dosage Scale
on the Pen has easy-to-read numbers and audible clicks to help you set the correct dose. Incorrect settings are easily corrected
without loss of drug.
1
BEFORE USING FOLLISTIM PEN™ FOR THE FIRST TIME, READ THESE
INSTRUCTIONS CAREFULLY. THEY ARE DIVIDED INTO SECTIONS.
EACH SECTION HAS A NUMBER OF STEPS.
KEEP THIS BOOKLET IN A SAFE PLACE AND REFER TO IT WHEN QUESTIONS ARISE.
IMPORTANT NOTICE:
Please read this safety information first.
1. Follistim Pen™ is a precision device. It is very important that you read and follow all directions for its use. As with all injection
systems, failure to do so could result in an incorrect dose being given.
2. Injecting cold drug is likely to cause discomfort. Therefore, it is recommended you allow the drug to reach room temperature
before taking the injection. The needle should not be attached until just before the injection.
3. Follistim®AQ Cartridge (follitropin beta injection) is NOT the same formulation as Follistim®in the freeze-dried powder
presentation.
4. When injecting beneath the skin, always fully depress the Injection Button for a full 5 seconds. During these 5 seconds,
leave the needle in the skin to ensure delivery of the full dose of Follistim®AQ Cartridge.
5. Follistim Pen™ is designed for use by one person only and should not be shared with others.
6. The BD Micro-Fine™ Pen Needle is for use only with Follistim Pen™. Each BD Micro-Fine™ Pen Needle is for one injection
only.
7. Follistim Pen™ is not recommended for the blind or visually impaired user without the assistance of an individual with good
vision, trained in the proper use of the device.
8. It is advisable to keep a record of every injection that has been taken from a Follistim®AQ Cartridge. This will allow you to
calculate the daily amount of medication remaining in the cartridge by subtracting the injected amount from the 300 IU
and/or 600 IU as indicated on the cartridge label.
9. Your doctor will decide on the dose of Follistim®AQ Cartridge to be given. This dose may be increased or decreased as your
treatment progresses depending on your individual type of treatment. If you have previously used gonadotropins, your dose
may be different with Follistim®AQ Cartridge. Again, your doctor will decide the dose based upon your medical history.
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FOLLISTIM PEN™ AND THE FOLLISTIM
®
AQ CARTRIDGE
General Information
Follistim®AQ solution for injection in cartridges has been developed for use
with the Follistim Pen™ and should be given subcutaneously (beneath the skin).
The daily dose (IU of Follistim®AQ Cartridge to be injected each day) will be determined by your healthcare professional.
A Treatment Diary is located in the back of this booklet. Use it to keep a record of your Follistim®AQ Cartridge injections.
During your treatment cycle, your healthcare professional will advise you of the best time of the day to inject yourself.
Try to inject yourself at the same time of day every day.
WHAT YOU WILL NEED FOR GIVING YOURSELF THE INJECTION
• Follistim Pen™, a Follistim®AQ Cartridge, the BD Micro-Fine™ Pen Needle provided with the cartridge.
• Alcohol, cotton balls or alcohol pads/swabs, sterile gauze, antibacterial soap and a special safety container to discard
the used needles, cartridges and/or other supplies.
3
Protective Cap Cartridge Holder
Body
Cartridge Holder
Pocket Clip
Dosage Scale
Injection
Button
Follistim Pen™ Parts Follistim®AQ Cartridge and BD Micro-Fine™ Needle Unit Parts
Follistim®AQ Cartridge
Rubber Piston
Rubber Stopper
Metal Rimmed
Cap
BD Micro-Fine™ Needle Unit
Protective Paper Seal
Inner Needle
Shield
BD Micro-
Fine™ Pen
Needle
Clear
Threaded Hub
2
Dosage Window
Black Rod
Outer Needle Shield
Dosage Knob
• Follistim
®
AQ Cartridges and BD Micro-Fine™ Pen Needles may only be used
with Follistim Pen™.
• Do not separate these three parts of the Follistim Pen™ until told to do so in
the instructions.
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3. Take a Follistim®AQ Cartridge
out of its package. Do not use
the Follistim®AQ Cartridge if
the medicine contains particles
or it is not clear. Make sure the
medicine is at room temperature
before using. Clean the Rubber
Stopper on the cartridge with
an alcohol pad. Pick up the
Cartridge Holder and place the
cartridge into the Cartridge
Holder. Insert the Metal
Rimmed Cap end first.
4. Pick up the Pen Body and lower it
into the Cartridge Holder. The black
rod must press against the Rubber
Piston on the cartridge. Screw the
Pen Body fully onto the Cartridge
Holder. Make sure there is no gap
between the Pen Body and the
Cartridge Holder. The arrow on
the Cartridge Holder should point to
the middle of the yellow alignment
mark on the blue Pen Body.
5
LOADING THE FOLLISTIM PEN™
Follow these steps:
• Before you use the Follistim Pen™ for the first time
• When you replace the cartridge
Note: Always wash your hands thoroughly
with antibacterial soap and water before
you use the Follistim Pen™ or when
you replace the cartridge.
1. While holding the Pen Body firmly
with one hand, pull off the Protective
Cap with your other hand. Put the
cap aside on a clean, dry surface.
USING THE FOLLISTIM PEN™
2. Unscrew the entire
Pen Body from the
Cartridge Holder.
Place the Cartridge
Holder and the Pen
Body aside on a
clean, dry surface.
4
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8. The best place for injection is in the abdomen, which is the
stomach area below the belly button (navel) or in the upper
leg. Your healthcare provider can show you other places
where you can inject Follistim®AQ Cartridge. Change your
injection site a little bit with each injection to lower your
chances for skin reactions.
PREPARING THE INJECTION SITE
7
9. Use a swab moistened with
alcohol to clean the skin
area where the needle will
enter to remove any surface
bacteria. Clean about two
inches around the injection
site where the needle will be
inserted. Let the alcohol dry
on your skin for at least one
minute before injecting the
medicine.
5. You must use a new BD Micro-Fine™
Pen Needle with each injection. Never
reuse a needle. Attach a BD Micro-Fine™
Pen Needle after you make sure there is
a Follistim®AQ Cartridge in the Cartridge
Holder. Clean the open end of the
Cartridge Holder with an alcohol pad.
6. Pick up your BD Micro-Fine™ Pen
Needle that is in an Outer Needle
Shield. Peel off the Protective Paper
Seal. Do not touch the needle or
place an open needle on any surface.
ATTACHING THE BD MICRO-FINE™ PEN NEEDLE
6
7. Hold the Outer Needle Shield firmly
in one hand while holding the
Cartridge Holder firmly in the other
hand. Push the end of the Cartridge
Holder into the Outer Needle Shield.
Screw them tightly together. Place
your Follistim Pen™ with the attached
needle, flat on a clean, dry surface.
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Important:
• Always check the
drug flow by follow-
ing the directions in
Step 12. This will
ensure that the correct
dose of Follistim®AQ
Cartridge is injected.
If you do not check
drug flow, you may
receive less drug
than the dose that
you dialed.
11. Carefully remove the Inner
Needle Shield and discard it.
Do not touch the needle or
let it touch any surface while
uncapped.
12. Hold the Follistim Pen™ with the needle pointing
upwards. Tap the Cartridge Holder gently with your
finger to help air bubbles rise to the top of the
needle. The small amount of air bubble will not
affect the amount of medicine you receive. Look for
a droplet forming at the tip of the needle. If you see
a droplet, go to Step 13. If you do not see a droplet,
continue with this step.
If you do not see a droplet at the tip of the needle:
a. Dial the Dosage Knob until you hear one click.
With the needle pointing upwards, push in the
Injection Button.
b. Look for the droplet.
c. If you still do not see a droplet, repeat Step a
(above) until you see droplet. You must make
sure you see a droplet of medicine or you may
not inject the right amount of medicine.
CHECKING THE FLOW OF FOLLISTIM
®
AQ CARTRIDGE THROUGH THE
BD MICRO-FINE™ PEN NEEDLE - CONTINUED
9
10. Pull the Outer Needle Shield gently, leaving the Inner
Needle Shield in place (covering the needle, which is now
attached to the Pen). Do not throw the Outer Needle
Shield away. You will need it to dispose of the needle after
injecting the medicine. (See REMOVING & DISPOSING OF
THE BD MICRO-FINE™ PEN NEEDLE.)
CHECKING THE FLOW OF FOLLISTIM
®
AQ CARTRIDGE THROUGH THE
BD MICRO-FINE™ PEN NEEDLE
Important:
• Do not touch the needle or leave it
uncapped without Inner Needle Shield
so that it remains sterile.
• Use a new, sterile BD Micro-Fine™ Pen
Needle for each injection. Only use the
BD Micro-Fine™ 0.33 mm x 12.7 mm
(29G) Pen needles as supplied with the
Follistim®AQ Cartridge.
8
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USING THE FOLLISTIM PEN™ TO GIVE YOURSELF AN INJECTION OF
FOLLISTIM™ AQ CARTRIDGE
Once you have set the Follistim Pen™ to the correct dose, you are ready for your injection.
15. Pinch the already swabbed area of the skin
between two fingers. With the other hand,
insert the entire BD Micro-Fine™ Pen Needle
straight into the skin. Press the injection
button all the way in to make sure you give
yourself a full injection. Wait for five seconds
before pulling the needle out of the skin. The
middle of the Dosage Window should display
a dot next to the “0”. If the injection button
does not push in all the way, and the number
in the Dosage Window does not read “0”, it
means there is not enough medication left in
the cartridge. The number in the Dosage
Window will give you the amount of medicine
needed to complete your dose. Write this
number down. This will be the number you dial for the
completion of your dose. Start over with a new Follistim
®
AQ
Cartridge and a new needle and follow all the instructions up
to this step. Make sure you choose a different injection site
to complete your dose of Follistim
®
AQ Cartridge.
11
16. Pull out the BD Micro-
Fine™ Needle and firmly
press down on the
injection site with an
alcohol swab. Use the
BD Micro-Fine™ Pen Needle
for one injection only.
Important:
• If the dot next to the “0” is not in the
middle of the Dosage Window and
you cannot push the Injection Button
all the way in, do not try to force down
the button. Your Follistim
®
AQ
Cartridge is probably empty. This
means you have not received your
full dose. Do not adjust the setting
on the Dosage Scale. Follow the
instructions for ‘IF THERE IS NOT
ENOUGH FOLLISTIM
®
AQ IN THE
CARTRIDGE’.
DIALING THE PRESCRIBED DOSE
13. Your Follistim®AQ Cartridge will
contain either 300 IU or 600 IU.
Record the Follistim®AQ Cartridge
content in your Follistim Pen™
Treatment Diary (refer to CHECK-
ING THE DRUG LEVEL for more
information). For doses of 50 IU up
to 450 IU, turn the Dosage Knob
until the dot beside the correct
number on the Dosage
Scale is sitting in the mid-
dle of the Dosage Window.
14. If by mistake you dial past the
correct number, do not try
to turn the Dosage Knob
backward to fix the mistake.
Continue to turn the Dosage
Knob in the same direction past
the 450 IU mark, as far as it will turn. The Dosage Scale must move
freely. Push the Injection Button in all the way. Start to dial again starting
from “0” upwards.
By following these directions, you will not lose any Follistim®AQ Cartridge.
10
Important:
• If you do turn the Dosage Knob
backward to correct the mistake,
it will not hurt the Pen, but you
will lose some drops of
Follistim
®
AQ Cartridge from
the tip of the needle.
• Never dial your dose or try to
correct a dialing mistake when
the needle is still in your skin as
this may result in your receiving
an incorrect dose.
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REMOVING THE EMPTY FOLLISTIM
®
AQ CARTRIDGE
19. Before you remove the empty
Follistim®AQ Cartridge from
the Follistim Pen™, unscrew
the needle by following Steps
17 and 18. Unscrew the Pen
Body from the Cartridge Holder.
20. Put the Pen Body down on a
clean, dry surface and remove the
empty Follistim®AQ Cartridge
from the Cartridge Holder. Safely,
dispose of the empty Follistim®AQ
Cartridge right away in the same
special container that you used for
the needle disposal. Do not put the
cartridge in a trash can.
13
REMOVING AND DISPOSING OF THE BD MICRO-FINE™ PEN NEEDLE
Important:
• Use the BD Micro-Fine™ Pen Needle
for one injection only. Dispose of the
used needle inside the Outer Needle
Shield immediately in a properly secured
container as instructed by your healthcare
provider.
• Always unscrew the needle by following
the directions in Steps 17 and 18 before
you put the Follistim Pen™ away.
• Never store the Follistim Pen™ with a
needle attached to it. If you store the
Follistim Pen™ with the needle attached,
the drug could leak out and there is risk
of contamination.
• Never leave needles where others can
pick them up.
18. Grip the Outer
Needle Shield
and use it
to unscrew the
needle from
the Cartridge
Holder. Your
healthcare
provider can
advise you
on how to obtain a special container for proper needle
disposal. Safely, dispose of the Outer Needle Shield with the
used needle right away. Do not throw away in a trash can.
If there is Follistim
®
AQ Cartridge medicine left for more
injections, put the Pen Cap back on the Pen Body and store
your Follistim Pen™ in a safe place in the refrigerator (not
in the freezer) or at room temperature. Never store the
Follistim Pen™ with a needle attached to it.
17. Place the Outer
Needle Shield
on a flat table
surface with
the opening
pointing up.
The opening
of the Outer
Needle Shield
is the wider
end with the
rim. Without
holding on to
the Outer Needle Shield, carefully
insert the needle (attached to the
Follistim Pen™) into the opening of
the Outer Needle Shield and push
down firmly. The Outer Needle
Shield should now be attached to
the Cartridge Holder and
cover the needle.
12
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CHECKING THE DRUG LEVEL
When you are advised on the number of prescribed doses which can be extracted from the full unused Follistim®AQ
Cartridge (follitropin beta injection), then do not use the cartridge beyond the advised number of doses. Otherwise,
you will run the risk that there will not be enough volume of drug for your prescribed dose.
Starting with the initial injection, you should begin using your Follistim Pen™ Treatment Diary (located in the back of this
booklet) as follows:
A. Record the Follistim®AQ Cartridge content. This will either be 300 or 600 IU depending on what your doctor has prescribed
for you.
B. Record the daily dose you have been prescribed for your injection.
C. Subtract your Day 1 dose from the Follistim®AQ Cartridge content (300 or 600 IU) (see example below). This will give you
the remaining Follistim®AQ Cartridge content.
15
REMOVING THE EMPTY FOLLISTIM
®
AQ CARTRIDGE - CONTINUED
Now, you may either:
• Put the Follistim Pen™ back together without a Follistim®AQ Cartridge and store for your next injection.
OR
• Insert a new Follistim®AQ Cartridge into the Cartridge Holder, put your Follistim Pen™ back together, and
store safely in the refrigerator or at room temperature.
14
Important:
• Upon dispensing, the product may be stored by the patient at 2–8°C (36–46°F) until the
expiration date, or at 25°C (77°F) for 3 months or until expiration date, whichever occurs first.
Do not freeze. Protect from light.
• Once the Rubber Stopper of the Follistim®AQ Cartridge has been pierced by a needle, the
product can only be stored for a maximum of 28 days at 2–25°C (36–77°F).
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IF THERE IS NOT ENOUGH FOLLISTIM
®
AQ IN THE CARTRIDGE
If you realize before you inject that you do not have enough drug remaining in your Follistim®AQ Cartridge for your complete
dose, proceed to Step 1 (page 18).
OR
If you have already inserted the needle at the injection site and the Injection Button will not push in all the way, then there is
not enough drug contained in the cartridge. The number in the Dosage Window will not read “0” – this means that there is not
enough drug remaining in the Follistim®AQ Cartridge to complete your dose. In this case, proceed to Step 2 (page 19).
17
Important:
• When there is not enough drug contained in the Follistim®AQ Cartridge to
complete your injection, the Injection Button will not push in all the way and the
number in the Dosage Window will not read “0”. If this occurs, proceed with the
steps that follow.
CHECKING THE DRUG LEVEL - CONTINUED
After Day 1, continue to record your daily injections in your Treatment Diary as follows:
D. Place the number recorded on Day 1 in the remaining Follistim®AQ Cartridge contents box in the Day 2 Follistim®AQ
Cartridge content box.
E. Subtract your Day 2 dose from the Follistim®AQ Cartridge content you just recorded in Step D. This will give you the
remaining Follistim®AQ Cartridge content. Again, record this number in the correct box.
If there is any doubt that there is not enough drug in the Follistim®AQ Cartridge for your prescribed dose,
see section ‘IF THERE IS NOT ENOUGH FOLLISTIM®AQ IN THE CARTRIDGE’ on page 17.
16
Date Daily Dose to be Used Follistim®AQ Remaining Follistim®AQ
(IUs/day) Cartridge Content Cartridge Content
mm/dd/yy 150 600 450
mm/dd/yy 150 450 300
mm/dd/yy 150 300 150
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