My Symptms and Medical Histry fr Adult Chrnic Immune Thrmbcytpenia (ITP) Call t talk t a registered nurse 1-855-7Nplate (1-855-767-5283), Mnday Friday, 9:00 AM 9:00 PM ET Indicatin Nplate is a man-made prtein medicine used t treat lw bld platelet cunts in adults with chrnic immune thrmbcytpenia (ITP), when certain ther medicines, r surgery t remve yur spleen, have nt wrked well enugh. Nplate is nt fr use in peple with a precancerus cnditin called myeldysplastic syndrme (MDS) r lw platelet cunt caused by any cnditin ther than chrnic (lasting a lng time) immune thrmbcytpenia (ITP). Nplate is nly used if yur lw platelet cunt and medical cnditin increase yur risk f bleeding. Nplate is used t try t keep yur platelet cunt abut 50,000 per micrliter in rder t lwer the risk fr bleeding. Nplate is nt used t make yur platelet cunt nrmal. It is nt knwn if Nplate wrks r if it is safe in peple under the age f 18. 1. Please fill ut yur persnal infrmatin. Tday s date My name My dctr s name My mst recent platelet cunt 2. Bleeding symptm(s) I have recently experienced Please check all that apply. Bruising (purpura) Bldy nse Heavy perid Tiny red dts n the skin caused by brken bld vessels (petechiae) Muth blisters/bleeds Other Nne 3. Sme imprtant things that my dctr shuld knw abut me Please check all that apply. I have had surgery t remve my spleen (splenectmy). I have a bne marrw prblem, including a bld cancer r myeldysplastic syndrme (MDS). I have had a bld clt. I am pregnant, r I am thinking abut r planning t becme pregnant. I am breastfeeding r I am planning t breastfeed. I have been diagnsed with chrnic ITP. (If yes, g t 4, if n, g t 5) I have had bleeding prblems (specify). Nplate can cause serius side effects: wrsening f a precancerus bld cnditin t a bld cancer (leukemia) in patients with MDS, higher risk fr bld clts, and lss f respnse. Please see additinal n page 5. Please see Prescribing Infrmatin and Medicatin Guide n www.nplate.cm fr mre infrmatin abut Nplate. 1
4. My recent chrnic ITP treatment histry My recent chrnic ITP treatment histry Hw lng have yu been diagnsed with ITP? I am currently nt taking any treatment fr my chrnic ITP. Please check all that apply, indicating whether it is yur previus r current treatment. Surgery Previus treatment Planned treatment Splenectmy (remval f spleen) Medicatin given by injectin r infusin Previus treatment Current treatment Rh(D) Immune Glbulin (anti-d antibdy) Cyclphsphamide* Intravenus immune glbulin (IVIG) Rituxan (rituximab)* Nplate (rmiplstim) Vincristine* Oral medicatin (taken by muth) Previus treatment Current treatment Oral crticsterid (fr example, prednisne, prednislne, dexamethasne) Imuran (azathiprine) * Danazl (dancrine) * Aczne (dapsne) * CellCept (mycphenlate mfetil) * Prmacta (eltrmbpag) * Other Previus treatment Current treatment Fr example, reiki, acupuncture, macrbitics, chlrphyll, vitamin C * Nt FDA-apprved fr the treatment f chrnic ITP. Rituxan is a registered trademark f Genentech Inc. Nplate is a registered trademark f Amgen Inc. Prmacta is a registered trademark f GlaxSmithKline. Nplate can cause serius side effects: wrsening f a precancerus bld cnditin t a bld cancer (leukemia) in patients with MDS, higher risk fr bld clts, and lss f respnse. Please see additinal n page 5. Please see Prescribing Infrmatin and Medicatin Guide n www.nplate.cm fr mre infrmatin abut Nplate. 2
5. My current verall health status Please check all that apply. Diagnsed health cnditins (eg, ITP, diabetes, high bld pressure) List cnditins: Other medicatins I am taking (prescriptin and OTC) List medicatins: Vitamins, supplements, and herbal prducts I am taking List prducts: 6. Changes since my last reprted health status Please check all that apply. Pregnancy Newly diagnsed cnditins List cnditins: New symptms List symptms: New medicatins r supplements List medicatins r supplements: 7. My upcming health-related events Please check all that apply. Surgery List type f surgical prcedure: Dental wrk List type f prcedure: New medicatins r physical therapy List medicatins r type f physical therapy: Nplate can cause serius side effects: wrsening f a precancerus bld cnditin t a bld cancer (leukemia) in patients with MDS, higher risk fr bld clts, and lss f respnse. Please see additinal n page 5. Please see Prescribing Infrmatin and Medicatin Guide n www.nplate.cm fr mre infrmatin abut Nplate. 3
8. Regular activities I enjy (health cnditins permitting) Please check all that apply. Vlleyball Ging ut t eat Sccer Camping Walking Wrking ut Swimming Glf Bwling Cycling Jgging Hiking Reading Entertaining Traveling Ging t the mvies Hrseback riding Other Nne Ntes Nplate can cause serius side effects: wrsening f a precancerus bld cnditin t a bld cancer (leukemia) in patients with MDS, higher risk fr bld clts, and lss f respnse. Please see additinal n page 5. Please see Prescribing Infrmatin and Medicatin Guide n www.nplate.cm fr mre infrmatin abut Nplate. 4
Indicatin Nplate is a man-made prtein medicine used t treat lw bld platelet cunts in adults with chrnic immune thrmbcytpenia (ITP), when certain ther medicines, r surgery t remve yur spleen, have nt wrked well enugh. Nplate is nt fr use in peple with a precancerus cnditin called myeldysplastic syndrme (MDS) r lw platelet cunt caused by any cnditin ther than chrnic (lasting a lng time) immune thrmbcytpenia (ITP). Nplate is nly used if yur lw platelet cunt and medical cnditin increase yur risk f bleeding. Nplate is used t try t keep yur platelet cunt abut 50,000 per micrliter in rder t lwer the risk fr bleeding. Nplate is nt used t make yur platelet cunt nrmal. It is nt knwn if Nplate wrks r if it is safe in peple under the age f 18. What is the mst imprtant infrmatin I shuld knw abut Nplate? Nplate can cause serius side effects: Wrsening f a precancerus bld cnditin t a bld cancer (leukemia): Nplate is nt fr use in peple with a precancerus cnditin called myeldysplastic syndrmes (MDS) r fr any cnditin ther than chrnic (lasting a lng time) immune thrmbcytpenia (ITP). If yu have MDS and receive Nplate, yur MDS cnditin may wrsen and becme an acute leukemia. If MDS wrsens t becme acute leukemia yu may die sner frm the acute leukemia. Higher risk fr bld clts: Yu may have a higher risk f getting a bld clt if yur platelet cunt becmes high during treatment with Nplate. Yu may have severe cmplicatins r die frm sme frms f bld clts, such as clts that spread t the lungs r that cause heart attacks r strkes. Yur healthcare prvider will check yur bld platelet cunts and change yur dse r stp Nplate if yur platelet cunts get high. If yu have a chrnic liver disease, yu may get bld clts in the veins f yur liver. This may affect yur liver functin. Lss f respnse: If yu d nt experience results frm Nplate, yur immune system may have created a respnse that is cunteractive t Nplate. Yur healthcare prvider will mnitr yur platelet cunts and test yur bld regularly t determine if this is an issue. Bld test mnitring: Yur healthcare prvider will check yur platelet cunt every week and change yur dse f Nplate as needed. This will cntinue until yur healthcare prvider decides that yur dse f Nplate can stay the same. After that, yu will need t have bld tests every mnth. When yu stp receiving Nplate, yu will need bld tests fr at least 2 weeks t check if yur platelet cunt drps t lw. What are the pssible side effects f Nplate? Nplate may cause serius side effects. See What is the mst imprtant infrmatin I shuld knw abut Nplate? The mst cmmn side effects f Nplate are: - Headache - Muscle tenderness r weakness - Indigestin - Jint pain - Pain in arms and legs - Tingling r numbness in hands and feet - Dizziness - Stmach (Abdmen) pain - Truble sleeping - Shulder pain Peple wh take Nplate may have an increased risk f develping new r wrsening changes in the bne marrw called increased reticulin. These changes may imprve if yu stp taking Nplate. Yur healthcare prvider may need t check yur bne marrw fr this prblem during treatment with Nplate. These are nt all the pssible side effects f Nplate. If yu have any questins abut this infrmatin, be sure t discuss them with yur dctr. Yu are encuraged t reprt negative side effects f prescriptin drugs t the FDA. Visit www.fda.gv/medwatch, r call 1-800-FDA-1088. Pregnancy Surveillance Prgram: Wmen wh becme pregnant during Nplate treatment are encuraged t enrll in Amgen s Pregnancy Surveillance Prgram. The purpse f this prgram is t cllect safety infrmatin abut the health f yu and yur baby. Cntact the prgram as sn as yu becme aware f the pregnancy, r ask yur healthcare prvider t cntact the prgram fr yu. Yu r yur healthcare prvider can get infrmatin and enrll in the prgram by calling 1-800-77-AMGEN (1-800-772-6436). Please see Prescribing Infrmatin and Medicatin Guide fr mre infrmatin abut Nplate. Nplate is a registered trademark f Amgen, Inc. 2018 Amgen Inc. All rights reserved. USA-531-80021 5