HIV-associated wasting and treatment with Serostim

A Guide to Treatment with Serostim®

Pharmacy name:

Pharmacy number:

Notes:

If you have been recently diagnosed with HIV-associated wasting and prescribed Serostim®, this guide has been designed to help educate and assist you throughout your treatment. Please read this booklet before you begin taking Serostim®. If you have any questions or concerns about your Serostim® therapy, ask your healthcare provider or pharmacist.

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Please see Important Risk Information on pages 6–7 and enclosed Full Prescribing Information for Serostim®.

Table of Contents

I. Questions about HIV-associated wasting 2 Whatisgradual,unintentionalweightloss?

II. Understanding HIV-associated wasting 3 Whatishappeningtomybodyandwhy?

III. What is Serostim® [somatropin (rDNA origin) for injection] and how can it help me? 4 HowcanSerostim®affectmyphysicalenduranceandmyweight?

IV. Important Risk Information 6

V. Your Serostim® prescription and insurance coverage 8 HowdoIgetmyprescriptionfilled?

DoIhavecoverageforSerostim®?

VI. How do I take Serostim® ? 9 WhatifIneedhelpinjectingSerostim®?

HowdoIstoreSerostim®?

VII. Injecting Serostim® using a needle and syringe 10 WhatdoIneedforSerostim®injection?

HowdoIinjectSerostim®?

VIII. Injecting Serostim® with cool.click® 2 17 Whatiscool.click®2?

HowdoIusecool.click®2?

IX. My Personal Tracker 28

X. My Injection Tracker 29

XI. Glossary 30

XII. References 31

XIII. Notes 32

2 I. Questions about HIV-associated wasting

Have you noticed a loss of energy associated with gradual, unintentional weight loss? To determine whether you are experiencing symptoms of this condition, you may have discussed the following questions with your healthcare provider:

• DoIhavealossofphysicalendurancealongwithalossofweight?

• Areanyactivitiesdifficulttoperform?

• AmIexercisingless?

• DoIneedtorestmoreoften?

• DoIfrequentlyfeeltiredaftercertainactivities?

• DoIhaveunintentionalweightloss?

• DothechangesinmyweightnegativelyaffectmyhealthandhowIfeel?

• Domyclothesfitmorelooselythannormalduetounintentionalweightloss?

• HaveIlostweightwithouttrying?

• Havemyfamily,friendsorco-workersnoticedanychangesinthewayIlookormybodybasedonchangesinmyweight?

Answering yes to one or more of these questions may be the reason your healthcare provider has prescribed Serostim® [somatropin (rDNA origin) for injection]. Only your healthcare provider can diagnose HIV-associated wasting and prescribe Serostim®.

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II. Understanding HIV-associated wasting

What is happening to my body and why?Gradual,unintentionalweightlossmaycauseyoutofeelthatyouhavelessphysicalendurancethatyouusedtohave.Youmaybelosingweightwithouttrying.But,itismorethanjustalossofweight;itisalossofleanbodymass,whichismadeupofmuscles,organs,bloodandwater.Thislossofleanbodymassmayimpactyourabilitytocompletetasksthatneedacertainlevelofphysicalendurance.1-3

Thereisn’tonedirectcauseforHIV-associatedwasting.Forsomeitcouldbeanissuethatdevelopswiththewaythebodyusesenergy;insteadofdrawingenergyfromfat,thebodybeginstodrawenergyfromleanbodymass.1-3

Who can be affected by HIV-associated wasting?HIV-associatedwastingmayimpactanypersonlivingwithHIV.IndividualswithHIVthatcouldhaveunintentionalweightlossanddecreasedphysicalendurancemayinclude:newlydiagnosedpatientsonHIVmeds,longtermsurvivorswithHIV,HIV-positivepeoplewhoareundetectableandhavenormalCD4counts,andpeopleonHIVmedswithacuteinfection.2,4-7

How common is HIV-associated wasting?A2004-2005analysisofamanagedcaredatabaseinvolving55millionpatientsand75healthplansfoundthat7%to8%ofHIV/AIDSpatientshadadiagnosisof,orwerereceivingtreatmentfor,cachexia,orHIV-associatedwasting.8Inanotheranalysisofacommercialmanagedcaredatabasefrom2005-2007consistingof22,535patientswithanHIV/AIDSdiagnosis,9.3%ofthepatientsmetthecriteriaforweightloss.9

4 III. What is Serostim® [somatropin (rDNA origin) for injection] and how can it help me?

What is Serostim®?

Serostim®isaninjectableprescriptionmedicineusedforthetreatmentofHIV-positivepatientswithwastingorcachexiatoincreaseleanbodymassandbodyweight,andimprovephysicalendurance.Treatmentwithantiretroviraltherapyatthesametimeisnecessary.

You should not take Serostim® if you have:• Acriticalillnessfromsurgery,seriousinjuries,oraseverebreathingproblem

• Cancerorundergoingtreatmentforcancer

• Eyeproblemscausedbydiabetes

• Allergiestogrowthhormone

Serostim® Clinical Trial Results

TotesthowwellSerostim®works,itwasstudiedin757peoplewithHIV-associatedwasting.Thisclinicaltrialtookplaceacrossmultiplesitesin8countries.ParticipantsinthestudyreceivedSerostim®everyday,everyotherday,oraplacebo(aninactivesubstance)for12weeks.Asubsetofpatientscontinuedontreatmentto24or48weeks.Serostim®improvedphysicalenduranceandincreasedleanbodymassandweight.

Serostim® improved physical endurance2 in people with HIV-associated wasting

Inthisstudy,peopletakingSerostim®significantlyimprovedtheirphysicalenduranceasassessedbyastationarybikeexerciseafter12weeksoftreatment.Onaverage,thosepatientswhoreceivedSerostim®dailyhada9.1%increaseinphysicalendurance,andthosewhoreceivedthedrugeveryotherdayincreasedphysicalenduranceby8.9%.Participantsthatweregivenaplacebohadanaverage0.2%decreaseintheirphysicalendurance.1,10

Make Serostim® [somatropin (rDNA origin) for injection] the follow-up to any conversation about decreased physical endurance and gradual, unintentional weight loss in HIV positive individuals

In clinical trials, patients with HIV-associated wasting taking Serostim® showed statistically and clinically significant improvement in physical endurance and increases in lean body mass and weight9,10

Serostim® significantly improved physical endurance for patients, as assessed by a stationary bike exercise in a 12-week clinical study.9

Only Serostim® is FDA approved to treat 3 key elements of HIV-associated wasting9

In a 12-week, double-blind placebo-controlled study, followed by a 12-week open-label extension phase, Serostim® increased lean body mass and weight10

Increases in lean body mass were maintained or improved through 24 weeks. Increases in weight were maintained through 24 weeks.10

PLACEBO(n=203)

+1.6 lbs TOTAL WEIGHT

+1.4 lbs LEAN BODY MASS(median increase)

SEROSTIM®

0.1 mg/kg daily(n=178)





-0.2% DECREASE IN

PHYSICAL ENDURANCE (median decrease)

+9.1% INCREASE IN

PHYSICAL ENDURANCE (median increase)

SEROSTIM®

0.1 mg/kg daily (n=218)

PLACEBO(n=222)

+8.9% INCREASE IN


SEROSTIM®

0.1 mg/kg every other day(n=230)

SEROSTIM®


PHYSICAL ENDURANCE

LEAN BODY MASS

WEIGHT

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Serostim® [somatropin (rDNA origin) for injection] increased lean body mass and weight1,2 in people with HIV-associated wasting

Inthesamestudy,thosewhoweretreateddailywithSerostim®experiencedamedianincreaseof6.5poundsintotalweightand11.5poundsinleanbodymassafter12weeks.ThosetreatedwithSerostim®everyotherdayexperiencedamedianincreaseof4.9poundsintotalweightand7.3poundsinleanbodymass.

Theplacebo-treatedgroupexperiencedamedianincreaseof1.6poundsintotalweightand1.4poundsinleanbodymass.TheaverageincreaseinweightandleanbodymassweresignificantlygreaterinbothSerostim®treatmentgroupscomparedtotheplacebogroupafter12weeksoftreatment.Increasesinleanbodymassandweightweremaintainedthrough24weeksinstudypatientswhocompletedanadditional12weeksofactivetreatment.1,10

PatientswithHIV-associatedwastingtreatedwithSerostim®completedaquestionnairecalledtheBACRI.TheirperceptionoftheimpactofSerostim®therapyontheirwastingsymptomswasreported.ThosetreatedwithSerostim®reportedimprovementsintheirsymptoms.AftertakingSerostim®,patients’perceptionsincluded:

• Havingabetterappetite

• Moreenjoymentineating

• Positivechangesinappearance

What are the most common side effects of Serostim® reported in clinical trials?

• Swelling,especiallyinthehandsorfeet

• Bone,muscle,andjointpainorstiffness

• Tinglingandnumbness

Make Serostim® [somatropin (rDNA origin) for injection] the follow-up to any conversation about decreased physical endurance and gradual, unintentional weight loss in HIV positive individuals

In clinical trials, patients with HIV-associated wasting taking Serostim® showed statistically and clinically significant improvement in physical endurance and increases in lean body mass and weight9,10

Serostim® significantly improved physical endurance for patients, as assessed by a stationary bike exercise in a 12-week clinical study.9

Only Serostim® is FDA approved to treat 3 key elements of HIV-associated wasting9

In a 12-week, double-blind placebo-controlled study, followed by a 12-week open-label extension phase, Serostim® increased lean body mass and weight10

Increases in lean body mass were maintained or improved through 24 weeks. Increases in weight were maintained through 24 weeks.10

PLACEBO(n=203)



SEROSTIM®

0.1 mg/kg daily(n=178)





-0.2% DECREASE IN

PHYSICAL ENDURANCE (median decrease)

+9.1% INCREASE IN


SEROSTIM®

0.1 mg/kg daily (n=218)

PLACEBO(n=222)

+8.9% INCREASE IN


SEROSTIM®


SEROSTIM®


PHYSICAL ENDURANCE

LEAN BODY MASS

WEIGHT

• Improvementsinhowtheyfelt

• Thatincreasesinweightsignificantlyimprovedtheirhealth10

• Unusualskinsensations

• Breastenlargementinmen

• Nausea

• Extremetiredness

6 IV. Important Risk Information

What is Serostim® [somatropin (rDNA origin) for injection]?Serostim®isaninjectableprescriptionmedicineusedforthetreatmentofHIV-positivepatientswithwastingorcachexiatoincreaseleanbodymassandbodyweight,andimprovephysicalendurance.Treatmentwithantiretroviraltherapyatthesametimeisnecessary.

You should not take Serostim® if you have:

• Acriticalillnessfromsurgery,seriousinjuries,oraseverebreathingproblem

• Cancerorundergoingtreatmentforcancer

• Eyeproblemscausedbydiabetes

• Allergiestogrowthhormone

What should I tell my doctor before using Serostim®?

• Ifyouhavecancerorhadcancerinthepast.

• Ifyouhavediabetes,areatriskforgettingdiabetes,orhavebloodsugarlevelsthatarehigherthannormal.Newcasesoftype2diabeteshavebeenreportedinpatientstakingSerostim®.

• Ifyouaretakinganyothermedicines(bothprescriptionoroverthecounter),vitamins,orsupplementsbecausethesemedicinesmayaffecteachother.YourdoctormayneedtoadjustthedoseofSerostim®orothermedicinesyouaretaking.

• Ifyouareallergictogrowthhormoneorbenzylalcohol(aningredientintheliquidusedtomixSerostim®).

• Ifyouarenursing,pregnant,orplantobecomepregnant.ItisnotknownifSerostim®passesintoyourbreastmilkorcouldharmyourunbornbaby.

What are the most common side effects of Serostim® reported in clinical trials in patients treated for HIV-associated wasting or cachexia?

• Swelling,especiallyinthehandsorfeet

• Bone,muscle,andjointpainorstiffness

• Tinglingandnumbness

• Unusualskinsensations

• Breastenlargementinmen

• Nausea

• Extremetiredness

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Other less common but serious side effects of Serostim® [somatropin (rDNA origin) for injection] are:

• AnincreasedamountofHIVvirus,soitisimportanttocontinuetakingantiretroviraltherapyduringtreatmentwithSerostim®

• Highbloodsugar(hyperglycemia/diabetes)whichcanincludesymptomsofincreasedthirstandurination,tiredness,ortroubleconcentrating

• Headaches,changesinvision,nauseaorvomiting,whichrequiresimmediatemedicalattention

• Numbnessandtinglinginthehandorarmcausedbyapinchednerveinthewrist

• Injectionsitereactions(suchaspain,numbness,redness,andswelling)

• Tumorsorcancerousgrowths

• Painandtendernessintheabdomen,whichcouldbeasignofaproblemwiththepancreas

These are not all of the possible side effects. Let your doctor know about your side effects.

How should you administer Serostim®?PatientsandcaregiversshouldbetrainedbyahealthcareprofessionalonhowtomixandinjectSerostim®priortouse.NevershareSerostim®withanotherperson,eveniftheneedleischanged.

Please see the Prescribing Information enclosed for a complete list of Serostim® risk information.

8 V. Your Serostim® [somatropin (rDNA origin) for injection] prescription and insurance coverage

How do I get my prescription filled?IfyourhealthcareproviderhasprescribedSerostim®,theAXISCentercanhelpguideyouthrougheverystepofyourtreatment—fromhelpinggetthepriorauthorizationandconfirmingyourapprovaltoansweringinsurancequestions,arrangingandofferinginjectiontraining,andnavigatingtheinsuranceprocess.

Will my insurance cover Serostim®?Serostim®iscoveredbymostinsuranceplans.Inmanystates,itiscoveredbyMedicaidandADAP.TheAXISCenterofferstrainedreimbursementspecialistswhocanhelpyouverifyyourinsurancebenefits,determinecoverageoptions,andlocatepharmaciesinyourarea.

Will I be able to afford Serostim®?

Patient Assistance Program

Ifyoudon’thavehealthinsurance,theSerostim®PatientAssistanceProgram(PAP)helpspeoplewhohaveHIV-associatedwastinggettheSerostim®treatmenttheyhavebeenprescribed.EligiblepatientswhomeetcertainfinancialandmedicalcriteriareceiveSerostim®freeofcharge.

Serostim® Copay Assistance Program

TheCopayAssistanceProgramcandecreaseorpotentiallyeliminateout-of-pocketcostsforeligible,commerciallyorprivatelyinsuredpatients.AskyourhealthcareproviderforinformationabouttheSerostim®CopayAssistanceProgram.

• YoumusthaveaprescriptiondrugbenefitthatcoversSerostim®andavalidSerostim®prescription.

• You may not use card if you receive drug benefits from Medicaid, a Medicare drug benefit plan, or other federal or state programs (includes state Medicaid assistance program and/or pharmaceutical patient assistance programs).

AskyourdoctorformoreinformationabouttheSerostim®CopayAssistanceProgramandforacopaycard.

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Please see Important Device Risk Information on page 17 for cool.click® 2.

VI. How do I take Serostim® [somatropin (rDNA origin) for injection]?

ThissectionisintendedtoassistwithSerostim®injectiontraining.YourhealthcareproviderorinjectiontrainerwillshowyouhowtoprepareandinjectSerostim®beforeyouuseitforthefirsttime.Serostim®isinjectedundertheskin,subcutaneously,throughashortandthinneedle.Serostim®canbeselfadministeredeverydayoreveryotherday,usuallyatbedtime.

Dependingonyourweight,yourdoctorwillprescribeoneofthreedosagestrengthsforyou:4mg,5mg,or6mg.Serostim®comesinpackagescontainingvialsofSerostim®powderanddiluentformixing.The5-mgand6-mgsingle-dosevialscomewithSterileWaterforInjection,USP;the4-mgmultidosevialcomeswithBacteriostaticWaterforInjection,USP.1

Youwillalsoneedsterilesyringesandmixingneedlesorthecool.click®2needle-freedevice.

PleasereadallinstructionsbeforetakingSerostim®andinjectSerostim®exactlyasyourhealthcareprovidertellsyou.DonotchangeyourSerostim®doseunlessinstructedtobyyourhealthcareprovider.

What if I need help injecting Serostim®?NomatterwhichmethodyouchooseforadministrationofSerostim®,theAXISCenteroffersin-homeorin-officeinjectiontrainingprovidedthroughanationalnetworkofproductadministrationtrainers.Patientsupportisavailable24/7toassistpatientswithtreatmenteducationandsupport.

How do I store Serostim®?

Before reconstitution:

KeepyourSerostim®vialsatroomtemperature—between59°Fand86°F.

After reconstitution with Sterile Water for Injection, USP:

Thereconstitutedsolutionshouldbeusedimmediatelyandanyunusedportionshouldbediscarded.

After reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol):

Thereconstitutedsolutionshouldbestoredunderrefrigeration(between36°Fand46°F)forupto14days.AvoidfreezingreconstitutedvialsofSerostim®.

10 VII. Injecting Serostim® [somatropin (rDNA origin) for injection] using a needle and syringe

The 6-mg single-dose vial is displayed in the instructions below. Please note that the characteristics may vary.

What do I need for my Serostim® injection?

The Serostim® vialcontainingthemedicationinafreeze-driedpowder.

Diluent for injection vialholdingtheliquidyouwillmixwiththeSerostim®powder.

A syringeusedtomixthediluentwiththeSerostim®powder.

Two needles,alonger,20-gaugeneedletoaddthediluenttotheSerostim®vialandwithdrawthesolutionpriortoyourinjection,andashorter,27-gaugeneedletogiveyourselftheinjection.*Youmaybegivena

29-or30-gaugeneedle.

Alcohol swabstocleantheskinbeforeyouinjectandtowipethevialtops.

A bandage or gauze padtocovertheinjectionsiteafteryouinject.

Sharps containertodisposeofyourusedneedlesandsyringes.

Disposable glovesifsomeoneelseisgivingyoutheinjection.Youdonotneedthemifyouareinjectingyourself.

Note: Not all materials used for the injection are provided. Make sure all injection items are unopened prior to use. If you find an open needle or syringe packet, do not use it. Dispose of it in your sharps container. Needles and syringes should never be shared or reused. Check the expiration date and do not use if the medication is expired.

*NOTshownatactualsize.

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How do I inject Serostim® [somatropin (rDNA origin) for injection]?Beforeeachinjection,gatherthematerialsoutlinedonthepreviouspage.Placethemonaclean,flatsurface,inaplacewithgoodlight.Makesuretowashyourhandswithsoapandwaterbeforeyoubegin.Ifsomeoneelseisgivingyoutheinjection,thispersonshouldputonapairofdisposableglovesnow.

1 Remove the flip tops from the drug and diluent vials,andthrowthemaway.

2 Clean both rubber stoppers with a fresh alcohol swab,thenthrowtheswabaway.Do not touch the vial tops with your hands or gloves after cleaning them.Ifyoudo,wipethetopsagainwithafreshalcoholswab.

3 Prepare your needle.

Unwrapthesyringeandthelargerneedlewithouttouchingthehuboftheneedlewhereitconnectstothesyringe.Removetheplastictipprotectorfromthesyringe.

Keepingtheneedleinitscap,attachitsecurelytothesyringe.

If you touch the hub of the needle or the bottom of the syringe where the needle attaches, or if you drop the needle or syringe, dispose of them in your sharps container and use new ones.

12 VII. Injecting Serostim® [somatropin (rDNA origin) for injection] using a needle and syringe (continued)

4 Prepare your syringe.

Pullbackonthesyringeplungeruntilitreachesthe1cc/1mLpointonthesyringebarrel,ortothevolumeindicatedbyyourhealthcareprovider.

Whileholdingthesyringeinonehand,pulltheneedlecapstraightoffwiththeotherhand.Settheneedlecapasideforuselater.

Iftheneedleandsyringecomeapartandtheyhavenottouchedanything,simplyputthembacktogetheragain.Iftheneedleorsyringehastouchedanything,disposeoftheminyoursharpscontainer,andstartoveragainfromStep3.

5 Fill your syringe with diluent.

Placethevialofdiluentonyourcleanworksurface.

Carefullyinserttheneedlestraightdownthroughthecenteroftherubberstopperintothevialofdiluent.(SeeStep5a.)

Gentlyinjectalltheairfromthesyringeintothevialbypushingdownontheplunger.(Theinjectedairwillmakeiteasiertowithdrawthesolution.)(SeeStep5b.)

Withoutremovingtheneedle,holdtheplungerwithonehandandturnthevialupsidedown.Pullbackthesyringetomakesurethattheneedletipisbelowthediluentlevelinthevial.Pulltheplungertoallowthediluenttofillthebarrelofthesyringetotheappropriatelevelasinstructedbyyourhealthcareprovider.(SeeStep5c.)

Whenyouhavetherightamountofdiluentinthesyringe,removetheneedlefromthevial,beingcarefulnottotouchtheneedleorallowittotouchanysurface.

Throwthevialofdiluentaway.

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6 Prepare your Serostim® [somatropin (rDNA origin) for injection] for injection.

PlacethevialcontainingSerostim®powderonyourworksurface.

Usingthesamesyringeandneedle,inserttheneedletheneedlethroughthecenteroftherubberstopperintotheSerostim®vial.Slowlyandgentlypushtheplunger,allowingthediluenttoflowdownthesideofthevial.

Donotsquirtthediluentbecausethiswillmakethesolutionfoamy.Ifitbecomesfoamy,letitsituntilthebubblesdisappearandtheliquidbecomesclear.

Keepingtheneedleinthevial,gentlyswirlthevialuntilthepowderisdissolved.Donotshakeorturnthevialupsidedown.

Oncethemedicationhasbeenmixed,giveyourselftheinjectionasindicatedintheinstructionsinthenextsteps.DonotinjectSerostim®iftheproductiscloudyimmediatelyafterreconstitutionorrefrigeration(withthe4-mgmultidosevialonly).Inthiscase,prepareanothervialandcontactyourhealthcareprovider.

Thesolutionfromthesingle-dose5-mgand6-mgvials,reconstitutedwithWaterforInjection,USP,mustbeusedimmediately.Anyunusedsolutionmustbediscarded.

Thesolutionfromthe4-mgmultidosevial,reconstitutedwithBacteriostaticWaterforInjection,USP,canbestoredrefrigeratedforupto14days.Occasionally,afterrefrigeration,smallcolorlessparticlesmayappearintheSerostim®liquid.Thisisnotunusualanddoesnotpreventitsuse.

7 Fill the syringe with the solution.

Turnthevialupsidedown,makingsurethetipoftheneedleisbelowthefluidlevel.

Slowlypulltheplungerbackuntilthesyringefillstoslightlymorethantheunitmarkingthatcorrespondstoyourprescribeddose.

Makesurethatthetipoftheneedleremainsinthesolutionwhileslowlybackingtheneedleoutofthevialtowithdrawasmuchsolutionaspossible.

Carefullyremovetheneedlefromthevialwithouttouchingtheneedleorallowingittotouchanysurface.


8 Change the needle.

Beforeyougiveyourselftheinjection,youmustreplacethelargerneedlewiththesmallerone.

Taketheneedlecapyousetaside,placeitonyourworksurface,andrecaptheneedlewithascoopingmovement,asindicatedinthephotoontheright.Thecapshouldsnapdownontheneedle.Donottouchtheneedleorallowittotouchanysurface.

Oncethecapisontheneedle,gentlytwisttheneedleandcapoffofthesyringeandplacetheminyoursharpscontainer.

Donotsquirtanyofthesolutionoutofthesyringe.

9 Put on the smaller needle.

Unwrapthesmallerneedleandtwistitontothesyringe,thencarefullyremovetheneedlecap.

Holdthesyringestraightwiththeneedlefacingup.

Toremoveanyairfromthesyringebarrelandtheneedle,gentlytapthesideofthesyringewithyourfingertipsuntilthebubblesfloattothetopofthesyringe.Thengentlypushtheplungeruntilasmalldropofliquidappearsonthetipoftheneedle.

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10 Pick an injection site.

Findaplaceonyourbodywhereitwillbeeasyforyoutogiveyourselfaninjection.Yourhealthcareproviderwillrecommendtheappropriateinjectionsite.Examplesofcommoninjectionsitesinclude:thetopsideofthethigh,theareasaroundthebellybutton,therearend,andthefleshypartofyourarm.Makesuretochangethelocationofyourinjectioneachdaysothatoneareadoesnotgetinjectedtoomanytimes.

Beforeyouinject,takeanalcoholswabandcarefullycleanafour-inch-squareareaaroundyourinjectionsite.Throwtheswabawayandlettheskindry.

11 Inject Serostim® [somatropin (rDNA origin) for injection].

Holdthesyringeinonehandandremovethecapfromtheneedle.

Withyourotherhandgentlypinchathree-inchfoldofskin.

Pointtheneedledownward,withtheslanted,cuttingedgeoftheneedlefacingup,aboutaninchawayfromtheareayouplantoinject.

Pushtheneedletipintothepinchedskinasfarasitwillgo.Holdthesyringesteadyandletgooftheskin.

Pushtheplungerdownslowlyandgentlyasfarasitwillgo.

Whenthesyringeisempty,pullthesyringeandattachedneedlestraightoutoftheskinandputitinyoursharpscontainer.


Ifyouaccidentallystickyourselfwiththeneedleafteryourinjection,cleanthestuckareacarefullywithsoapandwatertopreventinfection.Thenplacea2”x2”gauzepatchovertheareaandapplygentlepressuretostopanybleeding.

Ifsomeoneelsegetsprickedbytheneedleafteryourinjection,lettheareableedfreely.Thenwashtheareathoroughlywithsoapandwaterandcalltheirdoctorimmediatelytoexplainwhathappened.

12 Clean up after injecting.

Immediatelydiscardtheinjectionneedle,needlecap,syringeandusedgauzepatchesinyoursharpscontainer.

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VIII. Injecting Serostim® [somatropin (rDNA origin) for injection] with cool.click® 2

What is cool.click® 2?cool.click®2isaneedle-freedeviceformixingandinjectingSerostim®.Ahealthcareproviderwillteachyouhowtousecool.click®2andgiveyouasetofinstructionstofollowwhenusingthedevice.Toviewthecool.click®2trainingvideo,visitwww.Serostim.com/cc2.

Warning• Physicianornursetrainingshouldbeprovidedtoyoubeforeyouusecool.click®2

• cool.click®2mustbeusedonlywithSerostim®andnotwithanyotherbrandofhumangrowthhormoneormedication

• Aswithanyinjectiondevice,improperuseofcool.click®2mayresultininjury,includingthetransmissionofblood-bornediseases.Adheretostrictsafetyandantisepticprecautionsatalltimes.Donotsharethedevice.Alwayschangethenozzleandpistonaftereachuse.

Important Device Risk Information for cool.click® 2• Inordertousecool.click®2properly,youmustfirstunderstandandfollowthesteps

describedonthefollowingpages.Itisimportanttousecool.click®2onlyasindicatedandreplacedisposablepartsasrecommended

• Patientswhousecool.click®2mustbeabletoseethenumbersonthedosedisplayclearly,turntherearhousinguniteasily,andpressthereleasebutton

• cool.click®2shouldnotbeusedinpatientswhohavelowplateletcounts,bruiseorbleedeasily,aretakinganticoagulants(bloodthinners),oraretakingothermedication/therapythatmaycontributetoexcessbleedingorbruising.Hemophiliacsshouldnotusethisdevice

• cool.click®2isnotrecommendedforpatientswhodonothaveadequatesubcutaneoustissueornormalhematopoieticfunction

• Ifaftertryingavarietyofdeliverysitesyouarestillunabletousecool.click®2comfortably,contactyourdoctorornurse

• cool.click®2isavailablebyprescriptiononly.Askyourhealthcareproviderifcool.click®2isrightforyou.

18 VIII. Injecting Serostim® [somatropin (rDNA origin) for injection] with cool.click® 2 (continued)

What do I need for cool.click® 2 injection?

• cool.click® 2 device• The Serostim®

[somatropin (rDNA origin) for injection] vial and Diluent for injection vial

• Nozzle and piston set

• Alcohol swabs

• Reconstitution kit

• Sterile gauze pad or cotton ball

Please refer to full device Instructions for Use for cool.click® 2.

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How do I use cool.click® 2?BeforeyoustartadministeringSerostim®withcool.click®2,youmustbetrainedbyacertifiednurseorhealthcareprovider.Thefollowingisanoverviewofhowtousecool.click®2.PleaserefertotheInstructionsforUseprovidedwiththedevicefordetailedinformation.YoucanfindmoreinformationthroughtheAXISCenterat1-877-714-AXIS(2947).

Beforeeachinjection,gatherthetoolsoutlinedonthepreviouspage.Placethemonaclean,hard,flatworksurfaceinaplacewithgoodlight.Makesuretowashyourhandsthoroughlybeforeyoubegin.

1 Turnthewindinggriptoward>0asfarasitwillgo.Removethecap.

2 Openthenozzleandpistonblisterpack.Checkthattheexpirationdate(indicatedbythesandglasssymbol)hasnotpassed.

3 Holddownthenozzlelocksandgetreadytoinsertthenozzleandpistonintotheopening.


4 Holdthenozzlebyitssides,donottouchtheendsofthenozzleorallowthemtotouchanysurface.Pushthenozzlefirmlysothatyouhearthepistonclickintoplace.Releasethenozzlelocks.Youwillhearanotherclick.

5 Ifitdoesn’tclick,gentlypushthenozzleintoplaceuntilthelocksspringforward.Checkthatthenozzleiscorrectlyfittedbypullingitandmakingsurethatitstaysinthedevice.Itisimportantthatthenozzlebeinstalledonlyoncetoavoidbreakage.

6 RemovetheplasticcapsfromthetopsofthevialsofSerostim®[somatropin(rDNAorigin)forinjection]andthediluent.

7 Cleanthetopsofbothvialswithanalcoholswab.DoNOTtouchthetopsofthevialsoncetheyarecleaned.


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8 Removethevialconnectorsfromthereconstitutionkit.Holdeachconnectorbytheprotectivecap.

Note:Whenusing5mgor6mg,youwillhavetwovialconnectorsofthesamesize.Whenusing4mg,youwillhaveonesmallconnectorfortheSerostim®vialandonelargeconnectorforthediluentvial.

9 PressonevialconnectoroverthetopoftheSerostim®vialuntilitsnapsintoplace.Then,presstheothervialconnectoroverthetopofthediluentvial.

10 Opentheblisterpackcontainingthereconstitutionsyringe.Drawairintothesyringebypullingtheplungerouttothe0.5mLmark.

11 Removetheprotectivecapfromtheconnectoronthediluentvial.Holdthevialonyourcleanworksurface.Carefullylineupthesyringewiththecenterofthevialconnector’sgripandpressfirmlyuntilitsnapsintoplace.

12 Pushtheplungerdowntoinjecttheair.Theinjectedaircreatespressure,makingwithdrawingdiluenteasier.

13 Holdingtheplungerinplace,turnthevialofdiluentupsidedown.Slowlypulltheplungerbacktothe0.5mlmarktodrawthediluentintothesyringe.

14 Ifairbubblesappearinthesyringe,gentlypushtheplungertomovetheairbackintothediluentvial.Lightlytapthesyringewithyourfingertipstoloosenanyairbubblesthatmayremain.Ifneeded,drawmorediluentuntilyoureachthe0.5mLmark.


15 Tilttoremovethesyringefromthediluentvial.

16 RemovetheprotectivecapfromtheconnectorontheSerostim®[somatropin(rDNAorigin)forinjection]vial.Holdthevialonyourcleanworksurface.Carefullylineupthesyringewiththecenterofthevialconnector’sgripandpressfirmlyuntilitsnapsintoplace.

17 Usingtheplunger,slowlypushallthediluentintotheSerostim®vial.

18 TilttoremovethesyringefromtheSerostim®[somatropin(rDNAorigin)forinjection]vial.Discardthesyringe.

19 GentlyswirltheSerostim®vialuntilthepowderisdissolved.DoNOTshakethevial.Puttheprotectivecapbackontheconnectorattachedtothevial.

20 Presstheyellowon/offswitchonthecool.click®2.Thedosedisplayshouldshow“0.00ml”.Ifthedisplayflashes“8.88”,tightenthewindinggrip.

21 Removetheprotectivecapfromthevialconnector.


23

22 Attachtheconnectorfirmlyontothenozzle.

23 Holdthecool.click®2uprightwiththedisplayfacingyou.Turnthewindinggriptoward1<todrawyourSerostim®doseintothenozzle.

Note:PleasetalktoyourhealthcareproviderifyouhavequestionsaboutthecorrectSerostim®doseforyou.PleaserefertotheSettingthedoserangesectiononpage26formoreinformation.

24 Whenthecorrectdoseappearsonthedisplay,turnthewindinggriptoward1<anotherfullturn.Tapthenozzlegentlytoreleaseanyairbubbles.Then,turnthewindinggriptoward>0untilthecorrectdoseappearsagain.

Note:Ifairbubblesremain,turnthewindinggripafullturntoward1<again,tapgently,andthenturnbacktoward>0tothecorrectdose.Repeatuntilairbubblesaregone.

25 Removethevialfromthenozzle.




26 Re-fittheprotectivecapontothevial.

27 Chooseaninjectionsite.Somegoodplacesincludethetopsideofthethigh,theareaaroundthebellybutton,therearend,andthefleshypartofyourarms.Remembertochangeyourinjectionsiteoften.

28 Cleanthechoseninjectionsitewithanalcoholwipeandallowtheareatodry.

29 Holdthegripontherearhousingunitandplacethenozzleagainsttheskin.Pushtherearhousingunitdownfirmlyenoughtoslightlydimpletheskin.Youwillfeelthegripmovedownalittle.

30 Firmlypressthereleasebutton.Holdthenozzleagainsttheskin,maintainingthepressure,forapproximately3seconds.


25



31 Afterdeliveringthedose,applypressuretotheinjectionsitewithasterilegauzepad.

Note:Itisnormaltoseeslightbleedingafterinjection.Ifyouseearaisedwhitebumpontheskinimmediatelyafterinjection,itmeansSerostim®didn’tgodeepenoughintoyourskin.Wetnessaroundtheinjectionsitemeansincompletedelivery.Bothcanbecausedbyeithernotpushingthenozzledownhardenoughagainsttheskinorbymovingthenozzleduringdelivery.Itisimportantthattheinjectionprocessiscorrectedtoavoidsuchsituations.

32 Removethenozzleandpistonaftereachuse.First,pressthenozzlelocksandremovethenozzle.Then,pushthepistontoonesideuntilitsnapsoutofthecool.click®2.Safelydisposeofthenozzleandthepiston.

Important:InjectyourdoseimmediatelyafterfillingthenozzlewithSerostim®.Ifyouleavethecool.click®2formorethan5minutes,itwillgointoarestmodewithablankdisplay.

33 Presstheyellowon/offswitchuntilthedisplaygoesblank.Placethecapbackonthecool.click®2andkeepitinitsstoragebox.Theboxshouldbekeptsafelyindoorsatroomtemperature.


Remember:• Neverpressthereleasebuttononthecool.click®2withoutthenozzleinplace,if

thenozzleisempty,orifthereisairinthenozzle.DoNOTsharenozzles,pistons,orvialconnectors

• Improperuseofthecool.click®2mayresultininjury,includingthetransmissionofblood-bornediseases.Adheretostrictsafetyandantisepticprecautionsatalltimes

• DoNOTpinchtheskinwhendeliveringthedose

• Toavoidinjuryordamage,onlypressthereleasebuttononcool.click®2whenthedeviceisfilledwiththeappropriatedose

• Alwaysfitthecaponthecool.click®2whennotinuse

• Neversubmergethecool.click®2inwater.Theinsideofthedeviceshouldnevergetwet.Youcancleanthecool.click®2withadampclothandmilddetergent

Changing the batteryThecool.click®2issuppliedwithabatteryalreadyinstalled.Ifthebatterygetslow,thedisplaywillflash“bAT”alternativelywitheither“0.00”or“8.88.”Ifthedisplayonlyshows“bAT,”thebatteryneedstobechangedbeforeyoucanusethecool.click®2.

B1 Usethedosesettingkeytowithdrawthebatteryhousingunit.

B2RemovethebatteryandfitinanewCR2032coincellbattery(3Vlithium).Makesurethatthebatteryispositionedthesamewayastheoldbattery.

B3Pushthebatteryhousingunitbackinplaceuntilyouhearaclick.

B4Disposeoftheusedbatterythroughproperrecyclingmethods.DoNOTthrowitawaywithhouseholdwaste.


27



Setting the dose rangeYourcool.click®2willbepresettothedoseyourdoctorprescribedforyoubeforeitissenttoyou.

S1 Holdthecapandfronthousingunitinonehandandtherearhousingunitintheother.Rotatetherearhousingunittothefrontasfarasitwillgo.Youmayhearaclick.

S2 Removethecapandturnonthecool.click®2bypressingtheyellowon/offswitch.

S3 Takethedosesettingkeyandinsertitintothefronthousingunit.Whenbothprongsarefullypushedin,removethekeyimmediately.Thedisplaywillstarttoflash.

S4 Presstheyellowon/offswitchonce.Thedisplaywillshow“0.00”with“ml”flashing.Ifyouseesomethingelseonthedisplay,presstheon/offswitchuntilyousee0.00with“ml”flashing.

S5 Pushthekeyinagainandthenpullitout.Thedisplaywillstopflashing.Thisconfirmsthesetting.

Warning:DoNOTattempttochangethedosesettingunlessyourhealthcareprovidertellsyouto.Injectingwiththecool.click®2settothewrongdoserangewilldeliverthewrongamountofSerostim®.Makesurethedosesettingiscorrectbeforeusingthecool.click®2.

If you have questions about the cool.click® 2,

talk to your healthcare provider or contact

the AXIS Center toll free at 1-877-714-AXIS (2947).

TM

28 IX. My Personal Tracker

Ifyoufeelyouhavebeenexperiencinggradual,unintentionalweightlossandadecreaseinphysicalendurance,usethistrackertokeepaweeklyrecordofyourweight,yourlevelofphysicalactivityandotherimportantsymptoms.Thiscouldbehelpfulinformationtosupplytoyourhealthcareprovideratyournextappointment.

NAME INITIALWEIGHT INITIALDATE

Keeparecordofthechangesyouexperienceandshareitwithyourhealthcareprovideratyournextvisit.

Date

Weight

Physical endurance

Forexample:Areanyactivitiesmoredifficult?Areyouexercisingless?Doyouneedtorestmorefrequently?

Usethisspaceforanyadditionalinformationornotesthatyouwouldliketoshare.

29


X. My Injection Tracker

Serostim®[somatropin(rDNAorigin)forinjection]shouldbeinjectedsubcutaneously(undertheskin)atthesitesrecommendedbyyourhealthcareprovider.Examplesofcommoninjectionsitesinclude:thetopsideofthethigh,theareasaroundthebellybutton,therearend,andthefleshypartofyourarm.Useadifferentsiteeachtimeyouinjecttohelpavoidtissuedamage.

FRONT BACK

30 XI. Glossary

Alcohol swab.Asoft,antisepticpadusedtocleananareaofthebodybeforegivinganinjection.

cool.click® 2. Theneedle-freedeviceforinjectingSerostim®[somatropin(rDNAorigin)forinjection].

Diluent.TheliquidusedtodissolveSerostim®powder.

Disposable gloves.Rubberglovesthatarethrownawayafteroneuse.Theseareusedwhengivingsomeoneelseaninjection.

Gauge.Thediameterorthicknessofaslenderobject(asawireorneedle).

HIV-associated wasting.Alossofweightwithouttrying,orinvoluntarylossofleanbodymass(LBM)andbodyweightinpersonsinfectedwithHIV.

Injection site. Theplaceonthebodywhereonechoosestoinject.

Lean body mass.Leanbodymassismadeupofmuscles,organtissue,blood,andwater.

Metabolism.Theprocessbywhichthebodyturnsthefoodweeatintothereservesofenergyweneedtofunctionandthenusesthesereservestoreleasetheenergyweneedtolive.

Needle.Athin,hollow,sharp-pointedinstrumentusedforinjection.

Longer needle.The20-gaugeneedleusedtomixtheSerostim®solution.

Shorter needle.The27-,29-or30-gaugeneedleusedtoinjectSerostim®.

Needle cap.Theprotective,removablecoveringonaneedle.

Nozzle.Thedevicethatregulatesanddirectstheflowoffluidoncool.click®2.

Physical Endurance.Thetimethatittakesfromthestartofaphysicalactivitytocompletionoftheactivitybecauseofexhaustion.

Reconstitution.TheprocessofmixingthedrySerostim®powderwithdiluent.

Sharps container.Thesealedcontainerusedfordisposingofusedsyringesandneedles.

Sterile.Freefromlivebacteriaorothermicroorganisms.

Subcutaneous. Theareadirectlyundertheskin.

Syringe.Amedicalinstrumentusedforinjectingorwithdrawingfluids.

Barrel. Thehollowshaftofthesyringethatisfilledwithliquids.

Plunger.Thepartofthesyringethatpushesfluidorairoutofthebarrel.

Vial.Asmall,closed,disposablecontainer.

31


XII. References

1. Serostim®[somatropin(rDNAorigin)forinjection]PrescribingInformation,EMDSerono,Inc.

2. RoubenoffR,GrinspoonS,SkolnikPR,etal.RoleofcytokinesandtestosteroneinregulatingleanbodymassandrestingenergyexpenditureinHIV-infectedmen.Am J Physiol Endocrinol Metab.2002;283:E138-E145.

3. GelatoM,McNurlanM,FreedlandE.RoleofrecombinanthumangrowthhormoneinHIV-associatedwastingandcachexia:pathophysiologyandrationalefortreatment.Clin Ther.2007;29:2269-2288.

4. AshbyJ,GoldmeierD,Sadeghi-NejadH.Hypogonadisminhumanimmunodeficiencyvirus-positivemen.Korean J Urol.2014;55:9-16.

5. MangiliA,MumanDJ,ZampiniAM,WankeCA.NutritionandHIVinfection:reviewofweightlossandwastingintheeraofhighlyactiveantiretroviraltherapyfromthenutritioninhealthylivingcohort.Clin Infect Dis.2006;42:836-842

6. WassermanP,etal.Wastingdisease,chronicimmuneactivation,andinflammationintheHIV-infectedpatient.Top Clin Nutr.2011;26(1):14-28.

7. ChangE,SekharR,PatelS,etal.DysregulatedenergyexpenditureinHIV-infectedpatients:amechanisticreview.Clin Infect Dis.2007;44:1509-1517.

8. BoulangerL,MillerJD,MacEachernS,etal.Prevalenceofcachexia(wastingsyndrome)diagnosisandtreatmentamongpatientswithHIV/AIDS:amedicalclaimsdatabaseanalysis.Posterpresentedatthe12thInternationalSocietyforPharmacoeconomicsandOutcomesResearch;May19-23,2007;Arlington,VA.

9. SiddiquiJ,PhillipsAL,FreedlandES,etal.PrevalenceandcostofHIV-associatedweightlossinamanagedcarepopulation.Curr Med Res Opin.2009;25:1307-1317.

10. MoyleGJ,DaarES,GertnerJM,etal,onbehalfoftheSerono9037StudyTeam.Growthhormoneimprovesleanbodymass,physicalperformance,andqualityoflifeinsubjectswithHIV-associatedweightlossorwastingonhighlyactiveantiretroviraltherapy.J Acquir Immun Defic Syndr.2004;35:367-375.

32 XIII. Notes

33


EMD Serono Inc is a subsidiary of Merck KGaA,Darmstadt, Germany

©2016 EMD Serono, Inc. US-SER-1115-0005 All rights reserved.

1-877-714-AXIS (2947)

TM

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HIV-associated wasting and treatment with Serostim