Trusted to take a bite out * of G-CSF acquisition costs GRANIX X® has gained >3 34% share of the t US short-actting G-CSF hospita al marrket in its first 17 monthss1 » A 71% red duction in duration of severe e neutrropenia vs placebo (1.1 days vs 3.8 days, p<0.000 01)2 – Efficacy was evaluated in a mu ultinattional, m multi ltice t center, random mizzed e , co c ntrolllled ed d, Ph P a asse IIIII st stu udy of che h mo moth th her erap apyap y-na naïv ïve e pati patien ents ts V bo olu us))/d /doc occet etax axel ax el (75 mg/ g/m m2)2 with high h-risk breast cancer re eceivin ng doxo orubicin n (60 mg/m2 IV » The safetyy of GRANIX was esttab blish hed in 3 Ph Phasse II III trria alss, wi with th 680 80 pat atie ie ent ntss re recce ceivin ceiv ivving g ch hem emo othera othe rapy py for eithe herr br breast cancer,, lung cance er, or non-Hodgkin lyym mpho oma ma (NH NH HL)2 » Offering a prese entatio i n fo for se elf--a adm dmin nisstr trat atio at io on
Indication » GRAN GRANIX X is a le eukkoc o yt yte e gr grow owth ow th fa acto ac t r indi to d ca cate ted te d fo forr re redu duct ctio ion n in the durat atio ion of severe neutropeniia in patients with nonmyeloid malilign ma g a gn an nci c es es rec ecei eivi ei ving vi ng mye yelo losu lo supp pre r sssive an anti tica canc ncer er dru rugs gs ass ssoc o ia ated with a clinically significant incidence of febrile neutropenia.
Important Safety Information » Sp Sple leni le nicc ru ni upt ptur ure: ur e: Spl e: p en e ic rup uptu turre e, in incl clu udin ng fatal ca c ses, can occur following the administration of human granulocyte colonystim st imul im ulat ul atin at ing in g fa fact c or ct o s (h ( GG-CS CSFs Fs). ). Dis isco ont ntinue GRANIX and evaluate for an enlarged spleen or splen nic rupture in patients who repo re port po rt upp pper abd b om omin inal al or sh s ou ould der pain a after receiving GRANIX. » Ac Acut ute ut e re resp spiirrat sp ator orry di dist stre ress ss syn y drom me (A ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and an d lu lung ng g inf n ililtr trat ates es or re resp spir irat atory distresss after receiving GRANIX, for ARDS. Discontinue GRANIX in n patients with ARDS. » Al Alle lerg le rgic ic react eactio ionss: Ser eriouss allerrgic reactions, including anaphylaxis, can occur in patients receivving hG-CSFs. Reactions can occu oc cu ur on ini niti tial al exp xpos o urre. Perrma anently discontinue GRANIX in patients with serious allergic reacctions. Do not administer GRAN GR ANIX IX to pa pati tien ents t wit ith h a hi h st sto oryy of se erious allergic reactions to filgrastim or pegfilgrastim. » Us U e in pattie ient ntss wi with th sickl kle ce c ll diseasse: Severe and sometimes fatal sickle cell crises can occurr in patients with sickle cellll dis ce isea easse s rec ecei eivi ving n hG-CSFs F . Consid der the p potential risks and benefits prior p to the administrattion of GRANIX in patients with sick si ckle le cel elll di dise seas ase. e Dissco c ntinue GRANIX X in patients undergoing a sickle cell crisis. » Capi Capilllar ary y le leak ak syndr d ome (CLS):: CLS ca an occur in patients receiving hG-CSFs and is characte erize ed by hypotension, hypo hy poal albu b mi m ne emi mia, ede ema and h hemoco oncentration. Episodes vary in frequency, severity and may be life-threatening if treatment is del elay ayed ed d. Pati t ents who develo op symp ptoms of CLS should be closely monitored and receive sta andard symptomatic treatmen e t, whic wh ich h ma mayy includ de a need for in ntensive e care. » Pote Po ent ntia al for tumor growth stim mulatory effects on malignant cells: The granulocyte colony-stim mulating factor (G-CSF) receptor, thro th roug gh wh which GR RANIX X acts, hass been found f on tumor cell lines. The possibility that GRANIX act c s as a growth factorr for any tumor type ty p , in nclu u uding myeloi myeloid o d maligna ancies and myelodysplasia, diseases for which GRANIX is not apprroved, cannot be excluded. »M Most s com mmon treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in n pattientss treated wi w th GRANIX X at the e recommended dose with an incidence of at least 1% or greater and tw wo times more freq fr e ue ent n than in the placebo gro oup wa as bone pain. Plea Pl e se e see e brief summary of Fulll Prescribing Information on adjacent page.
For more information, visit GRANIXhcp.com. *Ba Base sed d on o who ole lesa ale e acquisiition n cost (WA AC) of all short-acting G-CSF products as of March 2015. WAC represents pub blished catalogue or list prices and mayy no ma nott re repr pre e en es nt actual tra ans nsactional p prices. Ple ease contact your supplier for actual prices. ease prices R fe Re fere renc nces es: 1. Th Thiss inf nfo orma mati tion n iss an a estim mate de derived from the use of information under license from the following IMS S Health Information Service: IMS Nati Na t on ti onal al Sal ales es Per ersp spec ecti tive ve, GR GRAN ANIX X mic i rro ogr g ams byy non-federal hospital channel March 2015. IMS expressly reserves all rights, including right h s of copying, d st di stri ribu b ti bu t on on, an nd re epu publ b ic icat atio on (m mic icro rogr gram ams ca alcul ullate ed as eaches x strrength). 2. GRANIX® (tbo-filgrastim) Inje j ction Presccribing Information. North Wales, PA A: Teva Te va Pha harm rmac a euti ac eutica cals ls;; 20 2014 14..
©2015 ©201 5 Ce Ceph phal alon on,, In Inc. c , a wh w olllyy-o -owned e sub u sidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a registered t ad tr adem emar arkk of Tev eva a Ph Phar arma m ce ceut utic iccal a Ind ndustrries Ltd. All rights reserved. GRX-40681 May 2015.