Rebif 22 mcg Rebidose User manual

1
Instructions For Use
subcutaneous injection

This guide contains information on
how to use Rebif® Rebidose®, a
pre‑assembled, single‑use autoinjector
that administers one dose of Rebif®
(interferon beta‑1a) for the treatment of
relapsing forms of multiple sclerosis.
Please read these instructions carefully
before you start using the Rebif® Rebidose®
and remember, you must have received
the appropriate training before injecting.
If at any time, you have questions
or concerns, please contact your
health care provider or call
MS LifeLines at 1‑877‑477‑3243.
Rx Only
Welcome

Contents
Rebif® Rebidose®features �������������������������4
Warnings�������������������������������������������������6
Important Information ��������������������������������8
How Supplied ������������������������������������������� 10
Titration����������������������������������������������������� 12
Choosing an injection site������������������������ 13
Step 1: Prepare for your injection������������ 14
Examine syringe and expiration date �������15
Step 2: Administer your injection������������� 18
Step 3: Finish your injection���������������������20
Disposal ����������������������������������������������������22
Storage �����������������������������������������������������25
Travel ���������������������������������������������������������26
Notes���������������������������������������������������������27

4
Before injection:
Injector button
Injector body
Dose label area
Syringe plunger
Transparent
syringe housing
Needle cap
containing the
needle shield
Safety guard
Needle
Syringe plunger
Rebif® Rebidose®features

5
After injection:
Safety guard
Needle
Needle cap containing
the needle shield
Syringe plunger
Rebif® Rebidose®features

6
Warnings
•Alwaysusetheinjectiontechniqueadvised
byyourhealthcareproviderandcontact
themwithanyquestionsyoumighthave.
•AlwayskeeptheRebidose®autoinjector
outofthereachofchildren.
• DonotsharetheRebidose®withanyone.
Doingsomayresultininjury,including
thetransmissionofinfectiousblood-borne
diseases.Adheretostrictsafetyand
antisepticprecautionsatalltimes.
- Donotinsertyourfingersintothe
openingofthesafetyguard.
- Donottrytore-useaRebidose®single-use
autoinjectorthathasalreadybeenused.
- Adheretoproperdisposalprocedures
toavoidaneedlestickinjury.

7
Warnings
•ChecktheexpirationdateontheRebidose®
autoinjectorlabelanditscarton.Ifthe
medicationhasexpired,Donotuseit.
•Examinethecontentsofthesyringe
carefullythroughthetransparenthousing.
Theliquidshouldbeclearorslightlyyellow.
Inspectforcracksorbreakageinthesyringe
orotherparts.Donot use Rebidose®if
it is cracked or broken or if the liquid is
cloudy, discolored or contains particles.
•IftheRebidose®hasbeendroppedmorethan
3feet,orifitlooksdamagedforanyreason,
Donotuseit.Instead,disposeofitin
anacceptablebiohazard(sharps)container
anduseanewRebidose®autoinjector.
•Contactyourhealthcareproviderabout
anydamagedRebidose®autoinjector.

8
•StoreyourRebidose®autoinjectorsin
arefrigeratoruntilreadyforuse.
•Ifyouorsomeonearoundyouisinjuredby
theneedle,contactyourhealthcareprovider
immediatelyanddisposeoftheRebidose®in
anacceptablebiohazard(sharps)container.
•InjectingRebif®themedicineintheRebidose®
autoinjectormaycauseskinreactions
includingsoreness,redness,pain,bruising,
orswelling.Tellyourhealthcareprovider
aboutanyskinreactionsthatbecomeswollen,
painful,orlookinfectedanddonotheal
withinafewdays.
Important Information

9
Important Information
•Useadifferentsiteeachtimeyouinject.
DonotinjectRebif®whereyourskinis
irritated,reddened,bruised,infectedor
abnormalinanyway.
•TheRebidose®autoinjectorcontainsaglass
syringe.Inveryrarecases,thesyringemay
breakduringtheinjection.Ifthishappens,
immediatelydisposeofanybrokenglass
andthedamagedRebidose®autoinjector
inthebiohazard(sharps)container,taking
necessaryprecautionstoavoidinjury.
Contactyourhealthcareprovideror
MSLifeLinesat1-877-477-3243immediately.

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Rebidose®isavailablein3dosesizes.Check
thatthedoseofRebif®istheoneprescribedfor
youbylookingattheRebidose®cartonandat
thedoselabelontheRebidose®autoinjector.
Rebidose®autoinjectorsaresuppliedinthese
3packagingpresentations:
•TitrationPack
6Rebif®8.8mcgRebidose®autoinjectors
withalimegreeninjectorbutton.
6Rebif®22mcgRebidose®autoinjectors
withayellowinjectorbutton.
•12Rebif®22mcgRebidose®autoinjectorswith
ayellowinjectorbutton.
•12Rebif®44mcgRebidose®autoinjectorswith
atealgreeninjectorbutton.
How Supplied

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How Supplied
22 mcg
(yellow)
8.8 mcg
(lime green)
44 mcg
(teal green)

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Titration
AtthebeginningofRebif®treatment,your
healthcareprovidermayprescribeatitration
phasetograduallyincreasetotheintended
dosage.
TheRebif®TitrationPackcontainssix8.8mcg
Rebidose®autoinjectorswithalimegreen
injectorbuttonandsix22mcgRebidose®
autoinjectorswithayellowinjectorbutton.
Thetitrationperiodlasts4weeksandduring
thistime,youwilladminister12injections:
• Weeks1and2:Useone8.8mcgautoinjector
threetimesaweek,atleast48hoursapart.
• Weeks3and4: Useone22mcgautoinjector
threetimesaweek,atleast48hoursapart.
Yourhealthcareprovidermayprovideadifferent
doseandschedule.

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Thebestsitesforgivingasubcutaneousinjection
arethoseareaswithalayeroffatbetweenthe
skinandmuscle.Theseincludethethigh,the
outersurfaceoftheupperarm,thestomach
andthebuttocks.Donotusetheareanearyour
waistlineorwithin
2inchesofyournavel.
Onlychooseonesite
forinjection.Usea
differentsiteeachtime
youinject.
Choosing an injection site
Caution
DonotinjectRebif®whereyourskinisirritated,
reddened,bruised,infectedorabnormalinany
way.
Front Back

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1.1)Beforeyoubegin,youmayfindinjecting
morecomfortableifyouallowtimefortheRebif®
towarmuptoroomtemperaturebeforeinjecting.
Therefore,itisrecommendedthatyouremove
theRebidose®autoinjectorfromtherefrigeratorat
least30minutespriortouse.
Caution
DonotheatormicrowaveaRebidose®auto i njector.
1.2)Putalloftheitemslistedbelowwithineasy
reachonatableorotherstablesurface:
•1Rebidose®autoinjectorcontainingRebif®
•Alcoholwipes/swabsorcottonballs
andrubbingalcohol
•Smalladhesivebandagestrip(ifneeded)
•Abiohazard(sharps)container
(seeDisposalsectiononpage22)
Step 1: Prepare for your injection

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1.3)Washyourhandsthoroughlywith
antibacterialsoap.
1.4)Openthetrayoveratableorsoftsurface
bypeelingbacktheplasticcoveringandremove1
Rebidose®autoinjector.Donotremovetheneedle
capuntilyouarereadytoinjectbecausethe
autoinjectorcouldrolloffthetableandbecome
unsterile.
1.5)ChecktheexpirationdateontheRebidose®
autoinjectorlabelanditscarton.Ifthe
medicationhasexpired,donotuseit.
1.6)Examinethecontentsofthesyringe
carefullythroughthetransparenthousing.
Theliquidshouldbeclearorslightlyyellow.
1.7)Inspectforcracksorbreakageinthesyringe
orotherparts.DonotuseRebidose®ifitis
crackedorbrokenoriftheliquidiscloudy,
discoloredorcontainsparticles.
Step 1: Prepare for your injection

16
1.8)Useanalcoholwipetocleantheinjection
site.Letyourskindrytopreventstinging
duringinjection.
1.9)HoldtheRebidose®bytheinjectorbody
(fig  a)andpullofftheneedlecap.
1.10)Lookinsidetheneedlecaptomakesureyou
seeablackneedleshieldinsidethecap(fig b).
1.11)Disposeoftheneedlecapandproceedto
theinjectionstepwithoutdelay.
Warning
IftheRebidose®hasbeendroppedmorethan3
feet,orifitlooksdamagedforanyreason,do
notuseit.Instead,disposeofitinanacceptable
biohazard(sharps)containeranduseanew
Rebidose®autoinjector.
Step 1: Prepare for your injection (continued)

17
a
b
Step 1: Prepare for your injection (continued)
Needle shield

18
2.1)HoldtheRebidose®autoinjectorinyourpalm
withyourthumbabovetheinjectorbutton.
2.2)PlacetheRebidose®uprightwiththeneedle
endflatagainstyourskinata90°angle.Push
theRebidose®againstyourskinuntilyoufeel
resistance;thisactionunlockstheinjectorbutton
(fig c).
2.3)KeeptheRebidose®pressedfirmlyagainst
theskinanduseyourthumbtopushtheinjector
button(fig d).Youwillhearaclick,which
meanstheinjectionhasbegun.
2.4)KeeptheRebidose®pressedfirmlyagainst
yourskinforatleast10secondswhilethe
medicationisdispensed(fig e).
Ifyouhaveanyproblems,contactMSLifeLines
at1-877-477-3243.
Step 2: Administer your injection

19
c d
e
Caution
Iftheinjectiondoesnotstart,releasetheinjector
buttonandmakesurethattheRebidose®isstill
pressedrmlyagainstyourskin.enpush
rmlyontheinjectorbutton,listeningforthe
clickthatindicatesthestartoftheinjection.
90°
10 seconds
Step 2: Administer your injection

20
3.1)BeforeliftingtheRebidose®fromyour
skin,makesurethatthesyringeplungerhas
movedtothebottomandthattheentiredose
hasbeeninjected(fig f).
3.2)LifttheRebidose®fromtheinjectionsite.
Thesafetyguardslidesdownandlocksinto
placetoprotectyoufromtheneedle(fig g).If
anyliquidisleftinthesyringeorifyouhaveany
otherproblems,contactyourhealthcareprovider
orMSLifeLinesat1-877-477-3243.
Donottrytoputtheneedlecapontheused
Rebidose®autoinjector.Itisnolongerneeded.
3.3)Ifdesired,useasmalladhesivebandageto
covertheinjectionsite.
Step 3: Finish your injection