AVONEX AVOSTARTGRIP User manual

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Instructions for Use
AVOSTARTGRIP®Titration Kit
Use with AVONEX®(interferon beta-1a) Prefilled Syringe Only
Read the Instructions for Use before you start using AVONEX and each time you get a
refill. There may be new information. This information does not take the place of talking
to your healthcare provider about your medical condition or your treatment.
Preparing the AVONEX Prefilled Syringe:
Find a well lit, clean, flat work surface like a table and collect all the supplies you will
need to give yourself or receive an injection.
Take 1 AVONEX Administration Dose Pack out of the refrigerator about 30 minutes
before you plan on injecting the AVONEX dose to allow it to reach room temperature.
Do not use external heat sources such as hot water to warm the AVONEX prefilled
syringe.
Check the expiration date printed on the AVONEX prefilled syringe, AVONEX
prefilled syringe Administration Dose Package carton, and the outer carton. Do not
use the AVONEX prefilled syringe past the expiration date.
Wash your hands with soap and water.
Supplies you will need for the AVONEX injection:
1 AVONEX Administration Dose Pack that contains:
1 AVONEX prefilled syringe
23 gauge, 1¼ inch long sterile needle
1 alcohol wipe
1 gauze pad
1 adhesive bandage
a puncture resistant container for disposal of used syringes and needles

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Identifying parts of the AVONEX prefilled syringe (See Figure A):
Preparing the AVONEX injection:
Step 1: Hold the AVONEX prefilled
syringe with the cap pointing down
and with the 0.5 mL mark at eye
level (See Figure A).
Check the syringe:
oThe syringe should not have
any cracks or damage.
oCheck that the cap is intact
and has not been removed.
oThe amount of liquid in the
syringe should be at or very
close to the 0.5 mL mark.
oAVONEX should look clear,
colorless, and should not
have any particles in it.
Do not use the AVONEX
prefilled syringe if:
the syringe is cracked or
damaged
the solution is cloudy,
colored, or has lumps or
particles in it
the cap has been removed or
is not tightly attached or
there is not enough liquid in
the syringe
Do not use that syringe. Get a new
syringe. Contact MS ActiveSource
at 1-800-456-2255.
(Figure A)

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Step 2: With 1 hand, hold the
AVONEX prefilled syringe right
under the cap and with the cap
pointing up (See Figure B).
oMake sure you are holding the
AVONEX prefilled syringe by the
ridged part, directly under the
cap.
(Figure B)
Step 3: With the other hand, grasp
the cap and bend it at a 90º angle
until the cap snaps off (See Figure C
and Figure D).
(Figure C)
(Figure D)
Step 4: Open the sterile needle
package and take out the covered
needle. Hold the AVONEX prefilled
syringe with the glass syringe tip
pointing up. Press the needle on the
AVONEX prefilled syringe glass tip
(See Figure E).
(Figure E)

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Step 5: Gently turn the needle
forward (clockwise) until it is tight
and firmly attached (See Figure F).
If the needle is not firmly
attached, it may leak and you
may not get your full dose of
AVONEX.
Do not remove the plastic cover
from the needle.
(Figure F)
Using the AVONEX prefilled syringe with the AVOSTARTGRIP titration kit:
Your AVONEX dose may be titrated over 3 weeks by using AVONEX prefilled
syringe with the AVOSTARTGRIP titration kit. The AVOSTARTGRIP is used for
giving the week 1, 2, and 3 (¼, ½, ¾) injections.
oWeek 1: ¼ dose (white device)
oWeek 2: ½ dose (yellow device)
oWeek 3: ¾ dose (purple device)
oWeek 4: a full dose
The 3 AVOSTARTGRIP devices are for single-use only with the AVONEX prefilled
syringe. Do not re-use the AVONEX prefilled syringe and AVOSTARTGRIP
devices.
You must prepare the AVONEX prefilled syringe and needle before you put it into
the AVOSTARTGRIP device. Follow steps 1 to 5 above to prepare the AVONEX
prefilled syringe.

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Identifying the parts of AVOSTARTGRIP titration kit (See Figure G):
(Figure G)
AVOSTARTGRIP has a “collar” on top of the device that will stop the syringe from
injecting a full dose (See Figure H). The “collar” makes sure that you do not get the
full dose of AVONEX.
(Figure H)

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Attaching the AVOSTARTGRIP device:
Step 6: Choose the right
AVOSTARTGRIP titration device for your
weekly dose.
Week 1 Injection: Choose the white
device to give ¼ dose (See Figure I).
Week 2 Injection: Choose the
yellow device to give ½ dose (See
Figure J).
Week 3 Injection: Choose the
purple device to give ¾ dose (See
Figure K).
(Figure I)
(Figure J)
(Figure K)
Step 7: Put the right AVOSTARTGRIP
device on a flat surface with the door
open (See Figure L).
(Figure L)
Step 8: Line up the AVONEX prefilled
syringe over the AVOSTARTGRIP device
with the plunger pointing to the left and
the needle pointing to the right (See
Figure M).
(Figure M)

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Step 9: Push the AVONEX prefilled
syringe down into the AVOSTARTGRIP
device until both ends “snap” into place
(See Figure N).
(Figure N)
Step 10: Using two fingers, push the
door down until it closes over the
AVONEX prefilled syringe (See Figure
O).
You will hear a “snap” when the door
is closed the right way. Do not open
door after it is closed.
(Figure O)
Step 11: Check to make sure that the
AVONEX prefilled syringe is in the
AVOSTARTGRIP device the right way
and that the door is tightly closed.
Giving the AVONEX injection:
Your healthcare provider should show you or a caregiver how to prepare and inject
the dose of AVONEX before AVONEX prefilled syringe is used for the first time.
Your healthcare provider or nurse should watch you inject the dose of AVONEX the
first time AVONEX prefilled syringe is used.
Inject your AVONEX exactly as your healthcare provider has shown you.
AVONEX is injected into the muscle (intramuscularly).
AVONEX should be injected into the thigh or upper arm (See Figures P and Q).
Change (rotate) your injection sites for each dose. Do not use the same injection
site for each injection.
Do not inject into an area of the body where the skin is irritated, reddened, bruised,
infected or scarred in any way.

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Step 12:Choose an injection site and
wipe the skin with an alcohol wipe (See
Figures P and Q). Let the injection site
dry before injecting the dose.
Do not touch this area again before
giving the injection.
(Figure P) (Figure Q)
Step 13:Pull the protective cover
straight off the needle (See Figure R).
Do not twist the cover off.
(Figure R)
Step 14:With 1 hand, stretch the skin
out around the injection site. With the
other hand, hold the syringe like a
pencil. Use a quick dart-like motion and
insert the needle at a 90º angle, through
the skin and into the muscle (See Figure
S). Once the needle is in, let go of the
skin.
(Figure S)
Step 15:Make sure that you push the
plunger all the way down until it touches
the collar (See Figure T).
(Figure T)
Step 16:Pull the needle out of the
skin (See Figure U). Press down on
the injection site with the gauze pad
for a few seconds or rub gently in a
circular motion.
If you see blood after you press
the injection site for a few
seconds, wipe it off with gauze
and apply an adhesive bandage.
(Figure U)

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After the AVONEX injection:
Do not recap the needle. Recapping the needle can lead to a needle stick injury.
Throw away the used AVONEX prefilled syringes, AVOSTARTGRIP devices, and
needles in a sharps container or some type of hard plastic or metal container with a
screw cap such as a detergent bottle or coffee can. Check with your healthcare
provider about the right way to throw away the container. There may be local or
state laws about how to throw away used AVONEX prefilled syringes,
AVOSTARTGRIP devices, and needles. Do not throw away used AVONEX prefilled
syringes, AVOSTARTGRIP devices, and needles in household trash or recycling
bins.
After 2 hours, check the injection site for redness, swelling or tenderness. If you
have a skin reaction and it does not clear up in a few days, contact your healthcare
provider.
General information about the safe and effective use of AVONEX
Always use a new AVONEX prefilled syringe, AVOSTARTGRIP device, and needle
for each injection. Do not re-use your AVONEX prefilled syringe, AVOSTARTGRIP
device, or needles.
Do not share your AVONEX prefilled syringe, AVOSTARTGRIP device, or needles.
Keep the AVONEX prefilled syringe, AVOSTARTGRIP device, and needles out of
the reach of children.
You can use the table below to keep track of your weekly injections.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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Manufactured for:
Biogen Idec Inc.
14 Cambridge Center
Cambridge, MA 02142 USA
©2012-2014 Biogen Idec Inc. All rights reserved.
1-800-456-2255
Revised: 08/2014
I10073-04