I-Pomalidomide

-Delile

• Ngaphambi kokuthatha i-pomalidomide,
• I-Pomalidomide ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezibalwe ezigabeni EZIBALULEKILE ZESEXWAYISO noma ZOKUQAPHA, yeka ukuthatha i-pomalidomide bese ushayela udokotela wakho ngokushesha:

Ubungozi bezinkinga zokuzalwa ezinzima, ezisongela ukuphila ezibangelwa yi-pomalidomide.

Kuzo zonke iziguli ezithatha i-pomalidomide:

I-Pomalidomide akumele ithathwe yiziguli ezikhulelwe noma ezingakhulelwa. Kunengozi enkulu yokuthi i-pomalidomide izodala ukulahleka kokukhulelwa noma izodala ukuthi ingane izalwe inokukhubazeka kokuzalwa (izinkinga ezikhona ngesikhathi sokuzalwa).

Uhlelo olubizwa ngePomalyst REMS^® kubekiwe ukuze kuqinisekiswe ukuthi abesifazane abakhulelwe abayithathi i-pomalidomide nokuthi abesifazane abakhulelwa ngenkathi bethatha i-pomalidomide. Zonke iziguli, kufaka phakathi abesifazane abangakwazi ukukhulelwa nabesilisa, bangathola i-pomalidomide kuphela uma bebhaliswe ne-Pomalyst REMS^®, thola incwadi kadokotela obhaliswe ne-Pomalyst REMS^®, bese ugcwalisa imishanguzo ekhemisi ebhaliswe ne-Pomalyst REMS^®.

Uzothola ulwazi mayelana nezingozi zokuthatha i-pomalidomide futhi kufanele usayine iphepha lokuvuma elinolwazi elisho ukuthi uyaluqonda lolu lwazi ngaphambi kokuthola umuthi. Uzodinga ukubona udokotela wakho ngesikhathi sokwelashwa kwakho ukuze ukhulume ngesimo sakho kanye nemiphumela emibi obhekene nayo noma ukuhlolwa okhulelwe njengoba kunconyiwe uhlelo.

Tshela udokotela wakho uma ungakuqondi konke otshelwe ngakho mayelana ne-pomalidomide ne-Pomalyst REMS^® Uhlelo nokuthi uzisebenzisa kanjani izindlela zokulawula ukubeletha okuxoxwe ngazo nodokotela wakho, noma uma ungacabangi ukuthi uzokwazi ukugcina ama-aphoyintimenti.

Unganikeli ngegazi ngenkathi uthatha i-pomalidomide namasonto ama-4 ngemuva kokwelashwa kwakho.

Ungabelani nge-pomalidomide nanoma ngubani omunye umuntu, ngisho nomuntu onezimpawu ezifanayo onazo.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa nge-pomalidomide futhi isikhathi ngasinye lapho ugcwalisa umuthi wakho. Funda imininingwane ngokucophelela bese ubuza udokotela noma usokhemisi wakho uma unemibuzo. Ungavakashela futhi iwebhusayithi ye-Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) noma ku-http: //www.celgeneriskmanagement.com ukuthola uMhlahlandlela Wezokwelapha.

Khuluma nodokotela wakho ngezingozi zokuthatha i-pomalidomide.

Ezigulini zesifazane ezithatha i-pomalidomide:

Uma ungakhulelwa, kuzodingeka uhlangabezane nezimfuneko ezithile ngesikhathi sokwelashwa kwakho nge-pomalidomide. Udinga ukuhlangabezana nalezi zidingo noma ngabe uke waba ne-tubal ligation ('amashubhu aboshiwe,' ukuhlinzwa ukuvimbela ukukhulelwa). Ungaxolelwa ukuhlangabezana nalezi zidingo kuphela uma ungazange uye esikhathini izinyanga ezingama-24 zilandelana futhi udokotela wakho athi usudlulile ukuya esikhathini ('change of life') noma uke wahlinzwa ukukhipha isizalo sakho kanye / noma womabili amaqanda. Uma kungekho kulokhu okuyiqiniso kuwe, kuzofanela uhlangabezane nezimfuneko ezingezansi.

Kufanele usebenzise izindlela ezimbili ezamukelekayo zokulawula ukubeletha amasonto ama-4 ngaphambi kokuqala ukuthatha i-pomalidomide, ngesikhathi sokwelashwa kwakho, kufaka phakathi ngezikhathi lapho udokotela wakho ekutshela ukuthi uyeke ukuthatha i-pomalidomide okwesikhashana, kanye namasonto ama-4 ngemuva kokwelashwa kwakho. Udokotela wakho uzokutshela ukuthi yiziphi izindlela zokulawula ukubeletha ezamukelekayo futhi uzokunikeza imininingwane ebhaliwe mayelana nokulawulwa kokuzalwa. Kufanele usebenzise lezi zinhlobo ezimbili zokulawulwa kokubeletha ngaso sonke isikhathi ngaphandle kokuthi ungathembisa ukuthi ngeke ube nokuxhumana ngokocansi nowesilisa amasonto ama-4 ngaphambi kokwelashwa kwakho, ngesikhathi sokwelashwa kwakho, noma yikuphi ukuphazamiseka ekwelashweni kwakho, nasemasontweni amane ngemuva ukwelashwa kwakho.

Uma ukhetha ukuthatha i-pomalidomide, kuyisibopho sakho ukugwema ukukhulelwa amasonto ama-4 ngaphambi, phakathi, kanye namasonto ama-4 ngemuva kokwelashwa kwakho. Kufanele uqonde ukuthi noma yiluphi uhlobo lokulawulwa kokuzalwa lungahluleka. Ngakho-ke, kubaluleke kakhulu ukunciphisa ubungozi bokukhulelwa ngengozi ngokusebenzisa izindlela ezimbili zokulawula ukubeletha. Tshela udokotela wakho uma ungakuqondi konke otshelwe ngakho mayelana nokulawulwa kokuzalwa noma ungacabangi ukuthi uzokwazi ukusebenzisa izindlela ezimbili zokulawula inzalo ngaso sonke isikhathi.

Kufanele ube nokuhlolwa okubili kokukhulelwa ngaphambi kokuba uqale ukuthatha i-pomalidomide. Uzodinga futhi nokuhlolelwa ukukhulelwa elabhoratri ngezikhathi ezithile ngesikhathi sokwelashwa kwakho. Udokotela wakho uzokutshela ukuthi uzozihlola nini futhi kuphi.

Yeka ukuthatha i-pomalidomide bese ushayela udokotela wakho ngokushesha uma ucabanga ukuthi ukhulelwe, uphuthelwa ukuya esikhathini, noma uya ocansini ngaphandle kokusebenzisa izindlela ezimbili zokulawula ukubeletha. Uma ukhulelwa ngesikhathi sokwelashwa kwakho noma zingakapheli izinsuku ezingama-30 ukwelashwa kwakho, udokotela wakho ezoxhumana nePomalyst REMS^® uhlelo, umenzi we-pomalidomide, kanye ne-Food and Drug Administration (FDA).

Ezigulini zesilisa ezithatha i-pomalidomide:

IPomalidomide ikhona embewini (uketshezi oluqukethe isidoda esikhishwa ngepipi ngesikhathi se-orgasm). Kufanele usebenzise i-latex noma ikhondomu yokwenziwa, noma ngabe une-vasectomy (ukuhlinzwa okuvimbela owesilisa ekubangeleni ukukhulelwa), ngaso sonke isikhathi lapho uhlangana ngokocansi nowesifazane okhulelwe noma okwazi ukukhulelwa ngenkathi uthatha i-pomalidomide futhi izinsuku ezingama-28 ngemuva kokwelashwa kwakho. Tshela udokotela wakho uma uhlanganyela ocansini nowesifazane ngaphandle kokusebenzisa ikhondomu noma uma umlingani wakho ecabanga ukuthi kungenzeka ukuthi ukhulelwe ngesikhathi sokwelashwa kwakho nge-pomalidomide.

Unganikeli isidoda ngenkathi uthatha i-pomalidomide namasonto ama-4 ngemuva kokwelashwa kwakho.

Ubungozi bamahlule egazi:

Uma uthatha i-pomalidomide ukwelapha i-myeloma eminingi (uhlobo lomdlavuza womnkantsha wethambo), kunengozi yokuthi uzohlaselwa yisifo senhliziyo, isifo sohlangothi, noma ihlule legazi emlenzeni wakho (deep vein thrombosis; DVT) that Ungadabula phakathi kwegazi uye emaphashini akho (embolism pulmonary embolism, PE). Tshela udokotela wakho uma uke wahlaselwa yinhliziyo noma wahlaselwa isifo sohlangothi. Udokotela wakho angakutshela ukuthi ungathathi i-pomalidomide. Tshela nodokotela wakho uma ubhema noma ubhema ugwayi, uma uke wahlaselwa yisifo senhliziyo noma isifo sohlangothi, futhi uma uke waba nengcindezi ephezulu yegazi, noma amazinga aphezulu egazi e-cholesterol noma amafutha, Udokotela wakho angakunikeza eminye imithi kuthathwe kanye ne-pomalidomide ukunciphisa le ngozi. Uma uhlangabezana nanoma yiziphi kulezi zimpawu ezilandelayo ngenkathi uthatha i-pomalidomide, tshela udokotela wakho ngokushesha: ikhanda elibuhlungu kakhulu; ukuhlanza; izinkinga zokukhuluma; isiyezi noma ukuquleka; ukulahleka okungazelelwe okuphelele noma okuncane kombono; ubuthakathaka noma ukuba ndikindiki kwengalo noma komlenze; ubuhlungu besifuba obungasakazeka ezandleni, entanyeni, emhlathini, emuva, noma esiswini; ukuphelelwa umoya; ukudideka; noma ubuhlungu, ukuvuvukala, noma ubomvu emlenzeni owodwa.

Khuluma nodokotela wakho ngezingozi zokuthatha i-pomalidomide.

I-Pomalidomide isetshenziswa ngokuhlangana ne-dexamethasone ukwelapha i-myeloma eminingi (uhlobo lomdlavuza womnkantsha wethambo) ongazange uthuthuke phakathi noma ezinsukwini ezingama-60 zokwelashwa okungenani ngeminye imithi emibili, kufaka phakathi i-lenalidomide (Revlimid) kanye ne-proteasome inhibitor efana i-bortezomib (i-Velcade) noma i-carfilzomib (i-Kyprolis). Ibuye isetshenziselwe ukwelapha i-Kaposi's sarcoma (uhlobo lomdlavuza olwenza ukuthi izicubu ezingavamile zikhule ezingxenyeni ezahlukahlukene zomzimba) ezihlobene ne-immunodeficiency syndrome (i-AIDS) ngemuva kokwelashwa okungaphumelelanga neminye imithi noma kubantu abane-Kaparc's sarcoma ukutheleleka ngegciwane lesandulela ngculaza (i-HIV). I-Pomalidomide isekilasini lemithi ebizwa ngama-immunomodulatory agents. Isebenza ngokusiza umongo wethambo ukuthi ukhiqize amangqamuzana egazi ajwayelekile nangokubulala amaseli angajwayelekile emnkantsheni wethambo.

IPomalidomide iza njengephilisi elizothathwa ngomlomo. Imvamisa kuthathwa kanye nsuku zonke ngokudla noma ngaphandle kokudla ngezinsuku 1 kuya ku-21 zomjikelezo wezinsuku ezingama-28. Le patheni yezinsuku ezingama-28 ingaphindwa njengoba kunconywe udokotela wakho. Thatha i-pomalidomide ngasikhathi sinye nsuku zonke. Landela izinkomba ezikulebuli kadokotela wakho ngokucophelela, bese ubuza udokotela noma usokhemisi wakho ukuthi akuchaze nganoma iyiphi ingxenye ongayiqondi. Thatha i-pomalidomide njengoba nje kuqondisiwe. Ungayithathi kancane noma uyithathe kaningi kunokuyalelwa ngudokotela wakho.

Gwinya wonke amaphilisi ngamanzi; ungawaphuli noma uwahlafune. Ungavuli amaphilisi noma uwaphathe ngaphezu kwesidingo. Uma isikhumba sakho sihlangana nama-capsule noma i-powder ephukile, geza indawo esobala ngensipho namanzi. Uma ngabe kukhona okuqukethwe okuyi-capsule emehlweni akho, geza amehlo akho ngaso leso sikhathi ngamanzi.

Udokotela wakho angadinga ukumisa unomphela noma okwesikhashana ukwelashwa kwakho noma anciphise umthamo wakho uma uhlangabezana nemiphumela ethile emibi. Qiniseka ukuthi utshela udokotela wakho ukuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho nge-pomalidomide.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokuthatha i-pomalidomide,

• Tshela udokotela kanye nosokhemisi wakho uma uneguliswa ne-pomalidomide, noma imiphi eminye imishanguzo, noma ezinye izithako kumaphilisi we-pomalidomide. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Qiniseka ukuthi usho noma yikuphi okulandelayo: carbamazepine (Carbatrol, Tegretol, Teril, others); i-ciprofloxacin (Cipro); i-fluvoxamine (i-Luvox); ne ketoconazole (Nizoral). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imithi eminingi ingaxhumana ne-pomalidomide, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho naleyo engabonakali kulolu hlu.
• utshele udokotela wakho uma uthola i-dialysis (ukwelashwa ukuhlanza igazi lapho izinso zingasebenzi kahle) noma unesifo sesibindi noma owake waba naso.
• ungancelisi ibele ngenkathi uthatha i-pomalidomide.
• utshele udokotela wakho uma usebenzisa imikhiqizo kagwayi. Ukubhema ugwayi kunganciphisa ukusebenza kwalo muthi.
• kufanele wazi ukuthi i-pomalidomide ingakwenza uzizwe unesiyezi noma udidekile. Ungashayeli imoto, sebenzisa imishini, noma wenze eminye imisebenzi edinga ukuthi uqaphele ngokuphelele uze wazi ukuthi lo muthi ukuthinta kanjani.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

Thatha umthamo ongabanjwanga ngokushesha nje lapho uwukhumbula. Kodwa-ke, uma kungaphansi kwamahora angu-12 kuze kufike umthamo wakho olandelayo ohleliwe, weqa umthamo ongabanjwanga bese uqhubeka nesimiso sakho sokulinganisa okujwayelekile. Ungathathi umthamo ophindwe kabili ukwenza okulahlekile.

I-Pomalidomide ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ukuqunjelwa
• isifo sohudo
• isicanucanu
• ukuhlanza
• ukulahlekelwa isifiso sokudla
• izinguquko zesisindo
• ukuzamazama okungalawuleki kwengxenye yomzimba
• ukujuluka okungajwayelekile noma ukujuluka ebusuku
• ukukhathazeka
• isikhumba esomile
• ukuvuvukala kwezingalo, izandla, izinyawo, amaqakala, noma imilenze engezansi
• ubuhlungu obuhlangene, besisipha, noma beqolo
• unenkinga yokulala noma ukuhlala ulele

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezibalwe ezigabeni EZIBALULEKILE ZESEXWAYISO noma ZOKUQAPHA, yeka ukuthatha i-pomalidomide bese ushayela udokotela wakho ngokushesha:

• ukuqubuka
• ukulunywa
• isifuba
• isikhumba esiqhumayo nesikhanyayo
• ukuvuvukala kwamehlo, ubuso, ulimi, umphimbo, izandla, izingalo, izinyawo, amaqakala noma imilenze engezansi
• ukuphefumula kanzima noma ukugwinya
• ukushaqeka
• umkhuhlane, umphimbo obuhlungu, amakhaza, ukukhwehlela, noma ezinye izimpawu zokutheleleka
• amehlo aphuzi noma isikhumba
• umchamo omnyama
• ubuhlungu noma ukungaphatheki kahle endaweni engaphezulu yesisu
• ukuchama okunzima, okuvamile, noma okubuhlungu
• isikhumba esiphaphathekile
• ukukhathala okungajwayelekile noma ubuthakathaka
• ukopha okungajwayelekile noma ukulinyazwa
• ekhaleni
• ukuba ndikindiki, ukushiswa, noma ukuncinza ezandleni noma ezinyaweni
• isithuthwane

IPomalidomide ingakhuphula ubungozi bokuthi uzoba namanye umdlavuza. Khuluma nodokotela wakho ngezingozi zokuthatha i-pomalidomide.

I-Pomalidomide ingadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthatha lo muthi.

Uma uthola imiphumela emibi kakhulu, wena noma udokotela wakho ungathumela umbiko kuhlelo lwe-Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting online (http://www.fda.gov/Safety/MedWatch) noma ngocingo ( 1-800-332-1088).

Gcina le mithi esitsheni efike ngayo, ivalwe ngokuqinile, futhi lapho izingane zingafinyeleleki khona.Gcina ekamelweni lokushisa futhi kude nokushisa okweqile nomswakama (hhayi endlini yangasese). Buyisela noma imuphi umuthi ongasadingeki ekhemisi noma kumenzi wakho. Buza usokhemisi wakho uma unanoma yimiphi imibuzo mayelana nokubuyisa imithi yakho.

Kubalulekile ukugcina yonke imishanguzo ingabonakali futhi ifinyeleleke ezinganeni njengoba iziqukathi eziningi (njengezingqondo zamaphilisi zamasonto onke kanye nalawo amaconsi wamehlo, okhilimu, amabala, kanye nama-inhalers) azimeleki ezinganeni futhi izingane ezincane zingazivula kalula. Ukuvikela izingane ezisencane ekufakeni ubuthi, hlala uvala amakepisi okuphepha bese ubeka umuthi endaweni ephephile - eyodwa ephezulu futhi engekho futhi engabonakali kubo futhi efinyelela kuyo. http://www.upandaway.org

Uma kwenzeka ukweqisa ngokweqile, shayela ucingo losizo lokulawula ubuthi ku-1-800-222-1222. Imininingwane iyatholakala online ku-https: //www.poisonhelp.org/help. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile zelebhu ukuze ahlole impendulo yomzimba wakho ku-pomalidomide.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nokugcwalisa umuthi wakho.

Kubalulekile ukuthi ugcine uhlu olubhaliwe lwayo yonke imishanguzo oyisebenzisayo kadokotela kanye nokungabhaliswanga (ngaphezulu kokuthenga), kanye nanoma yimiphi imikhiqizo efana namavithamini, amaminerali, noma ezinye izithako zokudla. Kufanele uze nalolu hlu njalo uma uvakashela udokotela noma uma ungeniswa esibhedlela. Kubaluleke kakhulu futhi nemininingwane ebalulekile ukuthi uphathe uma kwenzeka kunezimo eziphuthumayo.

• Pomalyst^®