Skytrofa Auto-Injector User manual

www.skytrofa.com
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Single-patient use

• For full instructions, read your Instructions for Use
• For training video, go to www.skytrofa.com
• If you are unsure about your dose, contact your
healthcare provider.
www.skytrofa.com
Instructions
for Use
Quick
Reference Guide
Training
Video
This is your
Quick Reference Guide
Ascendis Pharma Customer Support
1-844-44ASCENDIS
(1-844-442-7236)
2021-12-16 13500600

Green Button
To turn on the SKYTROFA Auto-Injector
or to reject mixed medicine
Needle
SKYTROFA Cartridge
Contains medicine
and water for injection
Battery Icon
Status Icons
Constant green
Battery is fully charged
The SKYTROFA
Auto-Injector is ready to use
Flashing red
Battery
needs charging
Flashing green
At least 1 injection
remaining, but charging
recommended after use
Green check mark
Injection successfully completed
Green eye
Mixed medicine is ready for
inspection in window
Green mixing
Medicine mixing is in progress
Green Top
Starts injection when pressed
against skin
Inspection Window
Allows for inspection of mixed medicine
Progress Bar
Shows progress of mixing and injection
Parts overview
• For full instructions, read your Instructions for Use
• For training video, go to www.skytrofa.com
• If you are unsure about your dose, contact your
healthcare provider.

Insert
cartridge
into
flashing
green
top.
3.1 3.2
Click
cartridge
in place.
(Green top
will stop
flashing, mixing
icon will
light up, and
battery icon
will switch off)
After
click,
remove
finger
from
cartridge.
3.3
1Check and assemble cartridge and needle
1.1 1.2 1.3
2Turn on the auto-injector
3Insert cartridge
Check expiration
date and cartridge
dose on cartridge
pack.
Press and
release the green
button to turn on
the auto-injector.
(You will hear 2
loud beeps.
Battery icon
will light up and
green top will
start flashing)
Check
expiration
date on
needle.
Remove
paper
from
needle.
year month
YYYY MM-
day
DD-
Expiration date
Expiration date
year month
YYYY MM-
Cartridge dose
Screw needle
straight and
tightly on cartridge.
Do not remove
needle
cover.
Prepare

Keep upright
until you hear
2loud beeps
and the entire
progress bar
lights up.
Pull off needle
cover.
Do not twist.
Keep needle
cover for
later.
6.1 6.2
6Finish mixing
5Turn the auto-injector up and down
4Wait while mixing
Wait until you
hear 2loud
beeps and the
entire progress
bar flashes.
(Eye icon will
light up)
Wait 4 to 8
minutes for the
auto-injector to
mix medicine.
Watch progress
bar gradually
light up.
Turn the auto-injector up and
down. A tick sound confirms
the turns are correct.
Turn 5 to 10 times until
you hear 2loud beeps
and the progress bar,
except the top
element, lights up.
Do not press
the green button.
Mix
Wait 4 to 8
minutes

9.29.1
Wash hands.
Medicine is ok to use if it is colorless
and clear (some air bubbles are ok).
Go to Step 8.
Do not use the mixed
medicine if it has visible
particles. Press the green
button for 3seconds and
go to Step 10.
Press and hold
green top against
the injection site for
10 to 15 seconds
until you hear 2
loud beeps.
Remove the
auto-injector
from skin and
wait until you
hear 2loud
beeps.
(Green top
will flash 2times
and check
mark icon
will light up)
(Green top will
start flashing)
Back
Front
Stomach (abdomen)
Thighs Buttocks
8Prepare for injection
9Inject medicine
7Check mixed medicine
8.1 8.2 8.3
Choose an injection site:
Stomach (abdomen),
thighs, or buttocks.
Change the injection site for
every injection.
Clean injection
site with alcohol
wipe. Do not
inject through
clothes.
Inject

Then take the second injection by repeating
Step 1 to Step 11 with a new cartridge and needle
before continuing to Step 12.
Check that
cartridge is empty.
Put used cartridge and
needle in a sharps
disposal container.
Put on the protective cover.
Store at room temperature
between 59°F to 86°F (15°C to 30°C),
to be ready for next use.
10.1 10.2 10.3
11 Check cartridge and throw away
12 Store the auto-injector
10 Remove cartridge
Press
needle
cover into
flashing
green top. Press
needle
cover
down to
release
cartridge.
Remove
used
cartridge.
Does your weekly dose require 2 cartridges?
After injection
(More info:
See Instructions for Use - page 34)

If the SKYTROFA Auto-Injector
is not in an upright position
during mixing and air
removal:
If the green top is removed
from skin before the
injection is complete:
You will hear a repeating
warning sound. Check mark
icon will flash slowly and
progress bar will freeze.
Do this: Press green top
against skin and the
injection will continue.
You will hear a repeating
warning sound. Mixing icon
will flash slowly and progress
bar will freeze.
Do this: Place the SKYTROFA
Auto-Injector in an upright
position and the mixing or
air removal will continue.
SKYTROFA Auto-Injector not upright (Step 4 and 6.1)
Skin contact lost (Step 9)
If the battery level
is low:
You will see a flashing red
battery icon.
Do this: Insert charger cable
into the SKYTROFA Auto-Injector
at rear lower side and connect
to a power outlet.
Charging required (Step 2)
IFU page 45
IFU page 42
IFU page 43
For more detailed information, see Instructions for Use (IFU).
Quick troubleshooting