a guide to treatment with serostim€¦ · gradual, unintentional weight loss may cause you to feel...

A Guide to Treatment with Serostim®

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Notes:

If you have been recently diagnosed with HIV-associated wasting and prescribed Serostim® [somatropin (rDNA origin) for injection], 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. Glossary 17

IX. My Personal Tracker 18

X. My Injection Tracker 19

XI. Notes 20

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:

• DoIhavealossofphysicalendurancealongwithanunintentionallossofweight?

• 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.

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

Who can be affected by HIV-associated wasting?UnintentionalweightlossanddecreasedphysicalendurancecanimpactanyonewithHIV,including:

• Newlydiagnosedpatientsonantiretroviraltherapy

• Long-termsurvivorswithHIV

• HIV-positiveindividualswithnormalCD4countsandundetectableviralloads

• Patientsonantiretroviraltherapywithacuteinfection

Eventhoughaperson’smedications,diet,andactivityhaven’tchanged,theystillmaybeatrisk.

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

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 endurance in people with HIV-associated wasting

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

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 weight in people with HIV-associated wasting

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

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

PatientswithHIV-associatedwastingtreatedwithSerostim®completedaquestionnairecalledtheBACRI.TheirperceptionoftheimpactofSerostim®therapyontheirwastingsymptomswasreported.PatientswithSerostim®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

• Thatincreasesinweightsignificantlyimprovedtheirhealth

• Unusualskinsensations

• Breastenlargementinmen

• Nausea

• Extremetiredness

6 IV. Important Risk Information

Indication

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

Important Risk Information

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®.

• Ifyouareallergictogrowthhormone,orotheringredientssuchasbenzylalcohol,sucrose,phosphoricacid,sodiumhydroxide,ormetacresol

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

• 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® are:

• Tumorsorcancerousgrowths

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

• Headaches,changesinvision,nauseaorvomiting,whichrequiresimmediatemedicalattention

• Seriousallergicreactionsthatrequireimmediatemedicalattention.

• Numbnessandtinglinginthehandorarmcausedbyapinchednerveinthewrist

• Injectionsitereactions(suchaspain,numbness,redness,andswelling)

• 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.

To Patient: Present this card with your Serostim® [somatropin (rDNA origin) for injection] prescription to a participating pharmacy to receive up to $1500 off the amount of your copay or coinsurance. If you have any questions pertaining to the use of this card, please call 1-866-962-1128. Patients may not use card if they 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).

Program requirements: Patients must have a prescription drug benefit that covers Serostim® and a valid Serostim® prescription. Card expires on 12/31/2018. Card can be used up to 12 times prior to 12/31/2018, no more than once every 21 days. Patient can have multiple cards but is only allowed a max of 12 Serostim® prescription discounts per lifetime. This is not an insurance program. Additionally, patients may not use card if their private insurance, HMO, or other health or pharmacy benefit program paid for the entire Serostim® prescription. Void in any state where prohibited by law, taxed, or otherwise restricted. Patients may not combine this card with any other rebate, coupon, free trial, or similar offer. EMD Serono reserves the right to rescind, revoke or amend this offer at any time without notice.

To Pharmacist: For Insured Patients: Process a Coordination of Benefits (COB/split bill) claim using the patient's prescription insurance for the PRIMARY claim. Submit the SECONDARY claim to PDM under BIN: 610020. For pharmacy processing questions, please call 1-866-962-1128. Please return card to patient for future use. Please see program requirements above.

BIN: 610020 GROUP: 99990964ID: 01234567891 This is not an insurance program.

$0 Copay

US/SER/1016/0008To Pharmacist: Do not use for patients receiving drug benefits

from Medicare, Medicaid or other federal or state programs

With this card most eligible patients will have a

*

Copay benefit of $1500 off your monthly prescription

*

EMD Serono is a business of Merck KGaA, Darmstadt, Germany

Place the copay card you receive from your MD here

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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.

Youwillalsoneedsterilesyringesandmixingneedles.

PleasereadallinstructionsbeforetakingSerostim®andinjectSerostim®exactlyasyourhealthcareprovidertellsyou.DonotchangeyourSerostim®doseunlessinstructedtobyyourhealthcareprovider.

What if I need help injecting Serostim®?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.

*Sharpscontainersmayvaryinappearance

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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.

If you have questions about your injection,

talk to your healthcare provider or contact

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

TM

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VIII. Glossary

Alcohol swab.Asoft,antisepticpadusedtocleananareaofthebodybeforegivinganinjection.

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.

Physical Endurance.Thetimethatittakesfromthestartofaphysicalactivitytocompletionoftheactivitybecauseofexhaustion.

Reconstitution.TheprocessofmixingthedrySerostim®powderwithdiluent.

Sharps container.Thesealedcontainerusedfordisposingofusedsyringesandneedles.

Sterile.Freefromlivebacteriaorothermicroorganisms.

Subcutaneous. Theareadirectlyundertheskin.

Syringe.Amedicalinstrumentusedforinjectingorwithdrawingfluids.

Barrel. Thehollowshaftofthesyringethatisfilledwithliquids.

Plunger.Thepartofthesyringethatpushesfluidorairoutofthebarrel.

Vial.Asmall,closed,disposablecontainer.

18 IX. My Personal Tracker

Ifyoufeelyouhavebeenexperiencinggradual,unintentionalweightlossandadecreaseinphysicalendurance,usethistrackertokeepaweeklyrecordofyourweight,yourlevelofphysicalactivityandotherimportantsymptoms.Thiscouldbehelpfulinformationtosupplytoyourhealthcareprovideratyournextappointment.

NAME INITIALWEIGHT INITIALDATE

Keeparecordofthechangesyouexperienceandshareitwithyourhealthcareprovideratyournextvisit.

Date

Weight

Physical endurance

Forexample:Areanyactivitiesmoredifficult?Areyouexercisingless?Doyouneedtorestmorefrequently?

Usethisspaceforanyadditionalinformationornotesthatyouwouldliketoshare.

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X. My Injection Tracker

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

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