Palbociclib

Umxholo

• Ngaphambi kokuba uthathe i-palbociclib,
• I-Palbociclib inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba unazo naziphi na kwezi mpawu, biza ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

[Ngeposi 09/13/2019]

Abaphulaphuli: Isigulana, iNgcali yezeMpilo, iOncology

KHUPHA: I-FDA isilumkiso sokuba i-palbociclib (Ibrance^®), I-ribociclib (Kisqali^®), kunye ne-abemaciclib (Verzenio^®) esetyenziselwa ukunyanga ezinye izigulana ezinomhlaza wamabele osele unokubangela kunqabile kodwa ukudumba okukhulu kwemiphunga. I-FDA ivume izilumkiso ezitsha malunga nalo mngcipheko kulwazi olumiselweyo kunye nePakeji yePatent Patient Insert yeklasi yonke yala machiza axhomekeke kwi-cyclin 4/6 (CDK 4/6). Isibonelelo esipheleleyo se-CDK 4/6 inhibitors sisengaphezulu komngcipheko xa sisetyenziswe njengoko kumiselwe.

Imvelaphi: I-CDK 4/6 inhibitors ludidi lwamayeza kagqirha asetyenziswa ngokudibana nonyango lwehomoni ukunyanga abantu abadala abanehormone receptor (HR) -positive, ukukhula kwesifo somntu esikhulayo 2 (HER2) -uhlaselo oluphambili okanye umhlaza wamabele osasazekileyo amanye amalungu omzimba. I-CDK 4/6 inhibitors ibhloka iimolekyuli ezithile ezibandakanyekayo ekukhuthazeni ukukhula kweeseli zomhlaza. I-FDA ivume i-palbociclib ngo-2015, kwaye zombini i-ribociclib kunye ne-abemaciclib ngo-2017. I-CDK 4/6 inhibitors ibonakalisiwe ukuphucula ixesha emva kokuqala konyango umhlaza awukhuli kakhulu kwaye isigulana siyaphila, esibizwa ngokuba kukuqhubeka kokungabikho (Jonga uluhlu lwe-CDK 4/6 Inhibitors engezantsi).

UKUQONDA:Izigulana Kuya kufuneka wazise ukhathalelo lwempilo yakho kwangoko ukuba unayo nayiphi na impawu ezintsha okanye ezibaxekileyo ezibandakanya imiphunga yakho, njengoko zinokubonisa imeko enqabileyo kodwa esongela ubomi enokuthi ikhokelele ekufeni. Iimpawu zokubukela zibandakanya:

• Ubunzima okanye ukungathandeki ngokuphefumla
• Ukuphefumla kancinci ngexesha lokuphumla okanye ngomsebenzi ophantsi

Sukuyeka ukuthatha amayeza akho ungakhange uthethe nonyango. Onke amayeza aneziphumo ebezingalindelekanga nokuba asetyenziswe ngokuchanekileyo njengoko kumiselwe, kodwa ngokubanzi izibonelelo zokuthatha la mayeza zingaphezulu kobu bungozi. Kubalulekile ukuba wazi ukuba abantu baphendula ngokwahlukileyo kuwo onke amayeza kuxhomekeke kwimpilo yabo, izifo abanazo, izinto zofuzo, amanye amayeza abawathathayo, kunye nezinye izinto. Imeko ezithile zomngcipheko wokumisela ukuba kunokwenzeka njani ukuba umntu othile abe namava okuqhaqha komphunga xa ethatha i-palbociclib, i-ribociclib, okanye i-abemaciclib ayichongwanga.

Abaqeqeshi bezempilo Kufuneka ukuba zibeke iliso kwizigulana rhoqo kwiimpawu ze-pulmonary ezibonisa isifo se-lung (interstitial lung disease) Iimpawu kunye neempawu zingabandakanya:

• hypoxia
• ukukhohlela
• Dyspnea
• ukungena ngaphakathi kwiimviwo ze-radiologic kwizigulana ekungafakwanga kusuleleka kuzo, isifo se-neoplastic, kunye nezinye izizathu.

Ukuphazamisa unyango lwe-CDK 4/6 unyango kwizigulana ezineempawu ezintsha zokuphefumla okanye ezenza mandundu, kwaye uyeke ngokusisigxina unyango kwizigulana ezine-ILD kunye / okanye inyumoniya.

Ngolwazi oluthe kratya ndwendwela iwebhusayithi ye-FDA apha: http://www.fda.gov/Safety/MedWatch/SafetyInformation kunye ne-http: //www.fda.gov/Drugs/DrugSafety.

I-Palbociclib isetyenziswa ngokudibanisa ne-anastrozole (Arimidex), i-exemestane (i-Aromasin), okanye i-letrozole (i-Femara) ukunyanga uhlobo oluthile lwe-hormone receptor-positive, umhlaza webele ophambili (umhlaza webele oxhomekeke kwiihomoni ezifana ne-estrogen ukukhula) okanye ibele umhlaza osasazeke kwamanye amalungu omzimba kwabasetyhini abanamava okuyeka ukuya exesheni (utshintsho lobomi, ukuphela kwexesha lokuya exesheni) okanye emadodeni. I-Palbociclib ikwasetyenziswa kunye ne-fulvestrant (Faslodex) ukunyanga uhlobo oluthile lwe-hormone receptor-positive, umhlaza webele osele uhambile (umhlaza webele oxhomekeke kwiihomoni ezinje nge-estrogen ukukhula) okanye umhlaza wamabele osasazeke kwamanye amalungu omzimba ngaphakathi. abantu abaye baphathwa ngamayeza e-antiestrogen anjenge tamoxifen (Nolvadex). I-Palbociclib ikudidi lwamayeza abizwa ngokuba yi-kinase inhibitors. Isebenza ngokuthintela isenzo seprotein engaqhelekanga ebonisa iiseli zomhlaza ukuba zande. Oku kunceda ukumisa okanye ukucothisa ukusasazeka kweeseli zomhlaza.

I-Palbociclib iza njengephilisi ukuba ithathe ngomlomo. Kuhlala kuthathwa kunye nokutya kube kanye yonke imihla kwiintsuku ezingama-21 zokuqala komjikelo weentsuku ezingama-28. Ugqirha wakho uya kuthatha isigqibo sokuba mangaphi amaxesha ekufuneka uphinde umjikelo. Thatha i-palbociclib malunga nexesha elifanayo yonke imihla. Landela izikhokelo kwileyibhile yakho yonyango ngononophelo, kwaye ubuze ugqirha wakho okanye usokhemesti ukuba achaze nayiphi na indawo ongayiqondiyo. Thatha i-palbociclib ngokuchanekileyo njengoko kuyalelwe. Musa ukuthatha ngaphezulu okanye ngaphantsi kwayo okanye uthathe rhoqo kunokuba umiselwe ngugqirha wakho.

Ginya zonke iifomsile; sukuwavula, uwahlafune, okanye uwaqhekeze. Musa ukuthatha iifomsile ezaphukileyo okanye eziqhekekileyo.

Ukuba uyagabha emva kokuthatha i-palbociclib, musa ukuthatha elinye idosi. Qhubeka neshedyuli yakho yesiqhelo.

Ugqirha wakho anganciphisa umthamo wakho okanye ayeke unyango lwakho okwethutyana okanye ngokusisigxina ukuba uneziphumo ebezingalindelekanga ezithile. Qiniseka ukuba uxelela ugqirha wakho indlela oziva ngayo ngexesha lonyango lwakho nge palbociclib.

Buza usokhemesti okanye ugqirha wakho ngekopi yolwazi lomenzi wesigulana.

Eli yeza linokumiselwa ezinye izinto; buza ugqirha wakho okanye usokhemesti ngolwazi oluthe kratya.

Ngaphambi kokuba uthathe i-palbociclib,

• xelela ugqirha wakho kunye nosokhemisti ukuba ngaba uxabisa i-palbociclib, nawaphi na amanye amayeza, okanye naziphi na izithako kwiipilisi ze-palbociclib. Buza usokhemesti wakho uluhlu lwezithako.
• xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Qiniseka ukuba ukhankanya oku kulandelayo: ii-antifungals ezinje nge-itraconazole (Onmel, Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), kunye ne-voriconazole (Vfend); amayeza athile okunyanga ukuxhuzula okunje nge-carbamazepine (Carbatrol, Equetro, Epitol, Tegretol, abanye) kunye ne phenytoin (Dilantin, Phenytek); I-clarithromycin; enzalutamide (Xtandi); I-ergot alkaloids ezinje nge-dihydroergotamine (DHH 45, Migranal) kunye ne-ergotamine (Ergomar, eCafergot, eMigergot); amayeza athile kwintsholongwane kaGawulayo (i-HIV) okanye i-immunodeficiency syndrome (i-AIDS) kubandakanya indinavir (Crixivan), lopinavir (e-Kaletra), nelfinavir (Viracept), ritonavir (Norvir, e-Kaletra, e-Viekira Pak), saquinavir (Invirase), kunye ne-telaprevir (ayisafumaneki e-US); fentanyl (Abstral, Fentora, Lazanda, Subsys, nabanye); ii-immunosuppressants ezinje ngecyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), kunye ne-tacrolimus (Astagraf XL, Envarsus XR, Prograf); midazolam; nefazodone; ipimozide (Orap); quinidine (kwiNuedexta); irifampin (Rimactane, Rifadin, eRifater, eRifamate); kunye ne-telithromycin (Ketek). Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga. Uninzi lwamanye amayeza anokusebenzisana ne-palbociclib, ke qiniseka ukuxelela ugqirha wakho ngawo onke amayeza owathathayo, nkqu nalawo angaveli kolu luhlu.
• xelela ugqirha wakho kunye nosokhemisti ukuba zeziphi iimveliso zemithi ozithathayo, ngakumbi i-wort yaseSt.
• xelela ugqirha wakho ukuba unentsholongwane okanye ukuba unesifo sesibindi okanye sezintso.
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye ukuba ucwangcisa ukuba ngutata womntwana. Ukuba ungowasetyhini, kuya kufuneka uthathe uvavanyo lokukhulelwa ngaphambi kokuba uqale unyango kwaye usebenzise ulawulo lokuzalwa ukuthintela ukukhulelwa ngexesha lonyango lwakho kwaye ubuncinci iiveki ezi-3 emva kwethamo lakho lokugqibela. Ukuba uyindoda, wena kunye neqabane lakho kufuneka nisebenzise ulawulo lokuzalwa ngexesha lonyango lwenu nge palbociclib kunye neenyanga ezi-3 emva kwedosi yenu yokugqibela. Thetha nogqirha wakho ngeendlela zolawulo lokuzalwa onokuzisebenzisa ngexesha lonyango lwakho. Ukuba wena okanye iqabane lakho ukhulelwe ngelixa uthatha i-palbociclib, biza ugqirha ngokukhawuleza. I-Palbociclib inokulimaza umbungu.
• xelela ugqirha wakho ukuba uncelisa. Akufanele uncancise ngelixa uthatha i-palbociclib kunye neeveki ezi-3 emva kwedosi yokugqibela.
• ukuba wenza utyando, kubandakanya utyando lwamazinyo, xelela ugqirha okanye ugqirha wamazinyo ukuba uthatha i-palbociclib.
• Kuya kufuneka uyazi ukuba eli yeza linciphisa ukuzala emadodeni. Thetha nogqirha wakho malunga nemingcipheko yokuthatha i-palbociclib.

Musa ukuyitya i-grapefruit okanye usele ijusi yeziqhamo ngelixa uthatha eli yeza.

Tsiba idosi ephosiweyo kwaye uqhubeke neshedyuli yakho yesiqhelo yokulinganisa Musa ukuthatha idosi ephindwe kabini ngemini enye ukwenza into ephosiweyo.

I-Palbociclib inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• isicaphucaphu
• urhudo
• ukugabha
• ukunciphisa ukutya
• utshintsho kwincasa
• ukudinwa
• Ukuba ndindisholo okanye ukubetha ezingalweni, ezandleni, emilenzeni nasezinyaweni
• izilonda emilebeni, emlonyeni, nasemqaleni
• ukucheba kweenwele okungaqhelekanga okanye ukulahleka kweenwele
• isikhumba esomileyo
• irhashalala

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba unazo naziphi na kwezi mpawu, biza ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

• umkhuhlane, Ukugodola, okanye iimpawu zosulelo
• ukuqhawukelwa ngumphefumlo
• isiyezi
• ngokukhawuleza, ngokungaqhelekanga, okanye ukubetha kwentliziyo
• ubuthathaka
• ukopha okungaqhelekanga okanye ukugruzuka
• impumlo

I-Palbociclib inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unengxaki engaqhelekanga ngelixa uthatha eli yeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Gcina eli yeza kwisikhongozeli lifikile, livalekile, kwaye alifumaneki ebantwaneni.Yigcine kubushushu begumbi kwaye kude nobushushu obuninzi kunye nokufuma (hayi kwigumbi lokuhlambela).

Amayeza angafunekiyo kufuneka achithwe ngeendlela ezizodwa zokuqinisekisa ukuba izilwanyana zasekhaya, abantwana kunye nabanye abantu abanakuzisebenzisa. Nangona kunjalo, akufuneki uligungxule eli yeza kwindlu yangasese. Endaweni yoko, eyona ndlela yokulahla amayeza akho yinkqubo yokubuyisa amayeza. Thetha kumayeza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga i-FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) ngolwazi oluthe kratya ukuba awunakho ukufikelela kwinkqubo yokubuyisa.

Kubalulekile ukugcina onke amayeza ngaphandle kwamehlo kunye nokufikelela kwabantwana njengezikhongozeli ezininzi (ezinje ngeeveki zeepilisi zeveki kunye nezo zamehlo, iikhrim, iipatches, kunye ne-inhalers) azinyangeki kwaye abantwana abancinci banokuzivula ngokulula. Ukukhusela abantwana abancinci kwiityhefu, soloko ukhiya iminqwazi yokhuseleko kwaye ubeke amayeza kwindawo ekhuselekileyo-leyo iphakame kwaye iphakame kwaye ingabonakali kubo kwaye ifikelele kuyo. http://www.upandaway.org

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Ulwazi lukwafumaneka kwi-Intanethi kwi-https: //www.poisonhelp.org/help. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho angayalela iimvavanyo ezithile zebhu ngaphambi nangexesha lonyango lwakho ukujonga impendulo yomzimba wakho kwi-palbociclib.

Musa ukuvumela nabani na ukuba athathe amayeza akho. Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nokuzalisa amayeza akho.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

• Ibrance^®