%PDF-1.3 % Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. <> The detailed information for Amgen Prolia Log In is provided. Prolia contains the same active ingredient (denosumab) found in XGEVA . 211 0 obj <> endobj PDF PATIENT INFORMATION ON DENOSUMAB - Arthritis Australia Prolia | European Medicines Agency Prolia es un medicamento de venta con receta que se usa para aumentar la . 030322_amgpro_rems_ptnt_hdout_fa2 Patients receiving Prolia should not receive XGEVA . Denosumab is a human monoclonal antibody. 1 0 obj Prolia - Patient Information Leaflet (PIL) - (emc) - medicines All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.3)]. PDF Prolia Finder ). l&%g`?m>;Bd^vMQC+.Tq 3rS_& L#SgkX/#f?qhoT2S ^k>Z@ObohXC(F GyN4DC.PT0+sOVU~n]8lo&Mh|ESlqpC-W=> rC"8IvS?@ Para el tratamiento de Osteoporosis Postmenopusica en mujeres con alto ]7bb", tP$\Y`0oSYcEII`=t`p/$g'|w|GT'k8(+tn4G[:j:"`G9+4&x}?E) h Lower risk of vertebral fracture 1. Reactions have included anaphylaxis, facial swelling and urticaria. (Brand name: Prolia) Denosumab is an osteoporosis medication that can help to strengthen your bones and reduce your risk of breaking a bone. PDF label - Food and Drug Administration %PDF-1.7 Prolia es un medicamento de venta con receta que se usa para tratar la osteoporosis despus de la menopausia en mujeres que tienen un alto riesgo de sufrir fracturas o no pueden usar otro medicamento para la osteoporosis o a quienes otros medicamentos para la osteoporosis no les dieron buenos resultados. Denosumab (Prolia) is a biologic medication used to . S{` The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia group. Printed name of patient Signature of patient (or legal guardian) Name of legal guardian (if needed) Dated MM/DD/YYYY v24-Apr-2022 PO Box 18769, Louisville, KY 40261-7821 Phone: 1-888-762-6436 Fax: 1-866-549-7239 amgensafetynetfoundation.com Page 3 of 4 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 PDF HIGHLIGHTS OF PRESCRIBING INFORMATION PROLIA. - Food and Drug PDF Prolia (denosumab) Guide for Patients: Important Things YOU Need to Know bIL =3t55B`z=/*zPX0oCc2c!8w|AK r:8T2V(ts2i NNi^Jy^KHUZ?j;|WQIH"(E^e!f1J&).y9&%Z!H)AI5sT( The most common side effects of Prolia in patients receiving certain treatments for . % / Same Active Ingredient: Prolia contains the same active ingredient (denosumab) found in XGEVA . Brand name: Prolia This information sheet has been produced by the Australian Rheumatology Association to help you understand the medicine that has been prescribed for you. ho0?2M[BHekARl5%RTmNKnPgl9qgl$LAfpb3mFhO#J08#B8%$a.7o+i~u+^3AGyy[64-=[>YK0~KA&[1'8u9YE/Y{~=c4I`1E8{QNzlQI .jvYL:3lz8M@0BM+m_9>OX-a[E5!]027?:Lf`oa\W]-F k3w^z;DkS5%\4.=N)C3d6q4FGYNX#F)J1RR`+eTM\}| G'iuY}>6kLhlApX endstream endobj 77 0 obj <> endobj 78 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/Type/Page>> endobj 79 0 obj <>stream In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia . Reactions have included anaphylaxis, facial swelling and urticaria. In addition, after three years the risk of new spine fractures was lower in patients who received Prolia. Prolia is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. Prolia-PatientBrochure-English.pdf - Free download as PDF File (.pdf), Text File (.txt) or view presentation slides online. -TSKBar15^ds KE&=K Lg6/z*~Qf:Ae1-`QTPEKJ&JO$[ azpp42D^g80{&+((=d:KCM3TPJ\3m~|TI#3#=3O,HcQO# eaTg$R*d KXJ^/J/szOu\bt'$XF B;z,CP|O`%,ZhTfLQ Patients receiving Prolia should not receive XGEVA . xmp.id:37356D7B3620681183D1F3A2082A7D7C Prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. 1 endstream endobj startxref Protect bones by increasing bone density 1. 100 0 obj <>/Filter/FlateDecode/ID[<8C68941A3831A33D31CAC3819F8C2074><6FD8252A01BB23408DF1862C831F4435>]/Index[76 39]/Info 75 0 R/Length 109/Prev 376118/Root 77 0 R/Size 115/Type/XRef/W[1 3 1]>>stream Prolia (denosumab) | Postmenopausal Osteoporosis Treatment Treatment for Postmenopausal Osteoporosis | EVENITY and Prolia Treatment with Prolia makes bone stronger and less likely to break. PDF/X-1:2001 False endstream endobj 82 0 obj <>stream Prolia: Package Insert / Prescribing Information - Drugs.com HUj18=Ah[)}HI?T]dCeg~ww!VGv\ \pBqR!'C%/ ;sO\>Fui=#v}N@>MrD'mI>21j9zM8Mti[/ZS/AH@BePZ(V-EQ!1jJZe1_ n SW{u Q@&Xp PRODUCT ORDERING SHEET FOR PROLIA (denosumab) Prolia FDA-Approved Indications Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Preexisting hypocalcemia must be corrected prior to initiating Prolia .Prolia is contraindicated in women who are pregnant and may cause fetal harm. 10 However, data suggest that few patients with hip fracture actually receive pharmacologic therapy for osteoporosis . disclose my personal information, including my personal health information, only for the following purposes: To operate, administer, enroll me in, and/or continue my participation in the Prolia Co-pay Program or any other Amgen-affiliated patient support services and activities related to my condition or treatment (for example, co-pay card . Contents of the pack and other information 1. stream endstream endobj startxref www.ACRPatientInfo.org WHAT IS IT? 030322_amgpro_rems_ptnt_hdout_fa2 PDF Prolia (PR-lee-a) - Amgen Bone is a living tissue and is renewed all the time. Same Active Ingredient: Prolia contains the same active ingredient (denosumab) found in XGEVA . Benefits of Prolia for other indications Important Safety Information tswqurvp60351624PWSUQVRT`gceafKk? In this case, it stops a The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs and bone, joint and/or muscle pain. What is the risk associated with Prolia? yeYs0f1jdOWlw;o?KsFW-P 0K)_s IF iGqM #.Gcvl|a!2FnM phx.N];hq9xF;\}lr8N|)|xfyeSw;=Mpq&cM` > converted DINOT-Light Help users access the login page while offering essential notes during the login process. Resources - Osteoporosis Patients at High Risk | Prolia (denosumab) Patients receiving Prolia should not receive XGEVA . Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and 4 0 obj Prolia is approved to help many people Bones are bones. In these patients Prolia also reduced the incidence of vertebral fractures. 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Treatment with Prolia makes bone stronger and less likely to break. It includes important information about: how you should take your medicine the possible side effects other precautions you should take while taking denosumab. Contraindications Prolia is contraindicated in patients with . %%EOF proof:pdf . PDF MEDICATION GUIDE Prolia (PR-lee-a) (denosumab) Injection, for 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 Xgeva includes the same active ingredient (denosumab) found in Prolia. Adobe InDesign CS6 (Macintosh) Brand name: Prolia This information sheet has been produced by the Australian Rheumatology Association to help you understand the medicine that has been prescribed for you. It is taken as a six-monthly injection. 406 0 obj <>stream m_ W The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. XlB6d+DFDB?H)$DXH - c`M(IMqh8'KWX?0 %m Support Services & Osteoporosis Resources | Prolia (denosumab) PDF t1'orolia' CO-PAY AND PATIENT SUPPORT PROGRAM mab)injection PATIENT Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Adobe InDesign CS6 (Macintosh) 6. endstream endobj 85 0 obj <>stream %PDF-1.6 % x=ks6]3[C< n]NnU*{-"L !th4~,+2U\HW}eU^gXXm]Cuo?u7~_ w>YJgZ\LW&+rYV[~"^\5kzh[a}VY]~e,|+Dy%#tBmj^a Q|Uc U1Ps*1xWfRLE1%r Vzru>[Zenck_3jko^nnZopitBEYuy>PWy)2F;# L .3"gw)9]ytXZ@'^N;sADfWUaf9 s5KFFx)sbHoXmdX(@'.dHHG1:"Jg`&+Id3yTv gsq]frrK,>Z"YtZ!?#O 'cX)ptnTVOK8pvK. PATIENT FACT SHEET. For the treatment of postmenopausal women with osteoporosis at high risk for fracture. endobj endstream endobj 81 0 obj <>stream 5.3 76 0 obj <> endobj endstream endobj 80 0 obj <>stream endstream endobj 84 0 obj <>stream IMPORTANT SAFETY INFORMATION FOR PROLIA . Same Active Ingredient. Contraindications. o~ Prolia is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body. prevent fragile bones, also known as osteoporosis, and bone fractures. Digitally signing pdf cac . <> HelveticaLTStd-Cond PATH: ~/Desktop/030322_amgpro_rems_ptnt_hdout_fa2.indd saved by rloos DINOT 3 0 obj from application/x-indesign to application/pdf hbbd```b``"4dad%d*KIX/s'X"]&0DHgK0;H2O`0 ? 6X 2015-05-22T14:54:22-04:00 Prolia is a medicine that may affect the ability of your body to fight infections Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Prolia Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Prolia This Medication Guide summarizes the most important information about Prolia. For your patients with a PRIOR FRACTURE OR VERY LOW T-SCORE (eg, less than -3.0) with other risk factors, start with the sequence of EVENITY followed by PROLIA to help build and protect her bone 1,4,5. yN(SYuKQF-9@en{g; `:WyP/N? default Prolia can help strengthen your bones by helping to increase bone density and lower your risk of fracture. 1 0 obj <>]/Pages 3 0 R/Type/Catalog/ViewerPreferences<>>> endobj 2 0 obj <>stream If you would like more information, talk with your doctor. <> Same Active Ingredient: Prolia contains the same active ingredient (denosumab) found in XGEVA . Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. PDF MEDICATION GUIDE Prolia (PR-lee-a) (denosumab) Injection, for 238 0 obj <>stream Prolia : EPAR - Product Information (PDF/768.19 KB) For more information, go to www.Prolia.com or call Amgen at 1-800-772 . 198 0 obj <>/Filter/FlateDecode/ID[<94C1A384C891BC4A8971893360C97495><60100AFAF654B14A902B051BE38F6C28>]/Index[45 362]/Info 44 0 R/Length 255/Prev 319660/Root 46 0 R/Size 407/Type/XRef/W[1 3 1]>>stream TELL YOUR . Patients receiving Prolia should not receive XGEVA . 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Because Prolia works for a long time, you will not need another dose of Prolia for 6 months. v`1Z &|F;Rjouqy NKA9mulFK Prolia Resources for Patient Access | Prolia PDF/X-1:2001 PDF HIGHLIGHTS OF PRESCRIBING INFORMATION PROLIA. - Food and Drug xmp.did:8E2608F91A236811822AAC5D9D3312BB ,kUPH.rK!|$3-nQl2Z-\MjLi/ L:\[/l2IaPwgnY]%,. hb```"VaAd`B flP.el:` WXs 85$3;9}\aA@G.~.b BF~0i O=0/)QbF1rK83b2iqnL o#9[fG.fk[wOnl]}{w~xII[8%;ZkxJT97=l(Zsq' .DOW44Pp,IABEm. for nonmetastatic prostate cancer. wSy~+0.`EW5"$!==#TWWJRuV>UK^G$LBSBRzN( JBob> A. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. hb``a``sb``Lcd@ AG7@~ 5u- -{z (f I )?@, A0JC0x8B "L@Q@$#|P(Sggfe^mAx*'y@x?`/X=:XniF nb~x5H1pL,+/)-*./HKOIMJNL xmp.did:CEB75C2609206811822ADC4CC0888CC2 Who should not use Prolia? Important Safety Information Prolia can cause serious side effects. 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