MEDICATION GUIDE Prolia (PRÓ-lee-a) (denosumab) Injection, for subcutaneous use

Transcription

1 MEDICATION GUIDE Prlia (PRÓ-lee-a) (densumab) Injectin, fr subcutaneus use Read the Medicatin Guide that cmes with Prlia befre yu start taking it and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking with yur dctr abut yur medical cnditin r treatment. Talk t yur dctr if yu have any questins abut Prlia. What is the mst imprtant infrmatin I shuld knw abut Prlia? If yu receive Prlia, yu shuld nt receive XGEVA. Prlia cntains the same medicine as Xgeva (densumab). Prlia can cause serius side effects including: Serius allergic reactins. Serius allergic reactins have happened in peple wh take Prlia. Call yur dctr r g t yur nearest emergency rm right away if yu have any symptms f a serius allergic reactin. Symptms f a serius allergic reactin may include: lw bld pressure (hyptensin) truble breathing thrat tightness swelling f yur face, lips, r tngue rash itching hives Lw calcium levels in yur bld (hypcalcemia). Prlia may lwer the calcium levels in yur bld. If yu have lw bld calcium befre yu start receiving Prlia, it may get wrse during treatment. Yur lw bld calcium must be treated befre yu receive Prlia. Mst peple with lw bld calcium levels d nt have symptms, but sme peple may have symptms. Call yur dctr right away if yu have symptms f lw bld calcium such as: Spasms, twitches, r cramps in yur muscles Numbness r tingling in yur fingers, tes, r arund yur muth Yur dctr may prescribe calcium and vitamin D t help prevent lw calcium levels in yur bld while yu take Prlia. Take calcium and vitamin D as yur dctr tells yu t. Severe jaw bne prblems (stenecrsis). Severe jaw bne prblems may happen when yu take Prlia. Yur dctr shuld examine yur muth befre yu start Prlia. Yur dctr may tell yu 1

2 t see yur dentist befre yu start Prlia. It is imprtant fr yu t practice gd muth care during treatment with Prlia. Ask yur dctr r dentist abut gd muth care if yu have any questins Unusual thigh bne fractures. Sme peple have develped unusual fractures in their thigh bne. Symptms f a fracture include new r unusual pain in yur hip, grin, r thigh. Serius infectins. Serius infectins in yur skin, lwer stmach area (abdmen), bladder, r ear may happen if yu take Prlia. Inflammatin f the inner lining f the heart (endcarditis) due t an infectin als may happen mre ften in peple wh take Prlia. Yu may need t g t the hspital fr treatment if yu develp an infectin. Prlia is a medicine that may affect the ability f yur bdy t fight infectins. Peple wh have weakened immune system r take medicines that affect the immune system may have an increased risk fr develping serius infectins. Call yur dctr right away if yu have any f the fllwing symptms f infectin: Fever r chills Skin that lks red r swllen and is ht r tender t tuch Fever, shrtness f breath, cugh that will nt g away Severe abdminal pain Frequent r urgent need t urinate r burning feeling when yu urinate Skin prblems. Skin prblems such as inflammatin f yur skin (dermatitis), rash, and eczema may happen if yu take Prlia. Call yur dctr if yu have any f the fllwing symptms f skin prblems that d nt g away r get wrse: Redness Itching Small bumps r patches (rash) Yur skin is dry r feels like leather Blisters that ze r becme crusty Skin peeling Bne, jint, r muscle pain. Sme peple wh take Prlia develp severe bne, jint, r muscle pain. Call yur dctr right away if yu have any f these side effects. 2

3 What is Prlia? Prlia is a prescriptin medicine used t: Treat steprsis (thinning and weakening f bne) in wmen after menpause ( change f life ) wh: are at high risk fr fracture (brken bne) cannt use anther steprsis medicine r ther steprsis medicines did nt wrk well Increase bne mass in men with steprsis wh are at high risk fr fracture Treat bne lss in men wh are at high risk fr fracture receiving certain treatments fr prstate cancer that has nt spread t ther parts f the bdy Treat bne lss in wmen wh are at high risk fr fracture receiving certain treatments fr breast cancer that has nt spread t ther parts f the bdy It is nt knwn if Prlia is safe and effective in children. Wh shuld nt take Prlia? D nt take Prlia if yu: have been tld by yur dctr that yur bld calcium level is t lw. are pregnant r plan t becme pregnant are allergic t densumab r any f the ingredients in Prlia. See the end f this leaflet fr a cmplete list f ingredients in Prlia. What shuld I tell my dctr befre taking Prlia? Befre taking Prlia, tell yur dctr if yu: Are taking a medicine called Xgeva (densumab). Xgeva cntains the same medicine as Prlia. Have lw bld calcium Cannt take daily calcium and vitamin D Had parathyrid r thyrid surgery (glands lcated in yur neck) Have been tld yu have truble absrbing minerals in yur stmach r intestines (malabsrptin syndrme) Have kidney prblems r are n kidney dialysis Plan t have dental surgery r teeth remved. Are pregnant r plan t becme pregnant. Prlia may harm yur unbrn baby. Tell yur dctr right away if yu becme pregnant while taking Prlia. Pregnancy Surveillance Prgram: Prlia is nt intended fr use in pregnant wmen. If yu becme pregnant while taking Prlia, talk t yur dctr abut enrlling in Amgen s Pregnancy Surveillance Prgram r call ( AMGEN). The purpse f this prgram is t cllect infrmatin abut wmen wh have becme pregnant while taking Prlia. Are breastfeeding r plan t breastfeed. It is nt knwn if Prlia passes int yur breast milk. Yu and yur dctr shuld decide if yu will take Prlia r breastfeed. Yu shuld nt d bth. 3

4 Tell yur dctr abut all the medicines yu take, including prescriptin and nnprescriptin drugs, vitamins, and herbal supplements. Knw the medicines yu take. Keep a list f medicines with yu t shw t yur dctr r pharmacist when yu get a new medicine. Hw will I receive Prlia? Prlia is an injectin that will be given t yu by a healthcare prfessinal. Prlia is injected under yur skin (subcutaneus). Yu will receive Prlia 1 time every 6 mnths. Yu shuld take calcium and vitamin D as yur dctr tells yu t while yu receive Prlia. If yu miss a dse f Prlia, yu shuld receive yur injectin as sn as yu can. Take gd care f yur teeth and gums while yu receive Prlia. Brush and flss yur teeth regularly. Tell yur dentist that yu are receiving Prlia befre yu have dental wrk. What are the pssible side effects f Prlia? Prlia may cause serius side effects. See What is the mst imprtant infrmatin I shuld knw abut Prlia? It is nt knwn if the use f Prlia ver a lng perid f time may cause slw healing f brken bnes. The mst cmmn side effects f Prlia in wmen wh are being treated fr steprsis after menpause are: pain in yur arms and legs high chlesterl muscle pain bladder infectin The mst cmmn side effects f Prlia in men with steprsis are: jint pain cmmn cld (runny nse r sre thrat) The mst cmmn side effects f Prlia in patients receiving certain treatments fr prstate r breast cancer are: jint pain pain in yur arms and legs muscle pain Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. 4

5 These are nt all the pssible side effects f Prlia. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre Prlia if I need t pick it up frm a pharmacy? Keep Prlia in a refrigeratr at 36 F t 46 F (2 C t 8 C) in the riginal cartn. D nt freeze Prlia. When yu remve Prlia frm the refrigeratr, Prlia must be kept at rm temperature [up t 77 F (25 C)] in the riginal cartn and must be used within 14 days. D nt keep Prlia at temperatures abve 77 F (25 C). Warm temperatures will affect hw Prlia wrks. D nt shake Prlia. Keep Prlia in the riginal cartn t prtect frm light. Keep Prlia and all medicines ut f reach f children. General infrmatin abut Prlia. D nt give Prlia t ther peple even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut Prlia. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut Prlia that is written fr health prfessinals. Fr mre infrmatin, g t r call Amgen at What are the ingredients in Prlia? Active ingredient: densumab Inactive ingredients: srbitl, acetate, plysrbate 20 (prefilled syringe nly), Water fr Injectin (USP), and sdium hydrxide Amgen Inc. One Amgen Center Drive Thusand Oaks, Califrnia This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. 1xxxxxx v8 Revised: 02/2015 5