Jekeseni wa Eculizumab

Zamkati

• Asanalandire jekeseni wa eculizumab,
• Jekeseni wa Eculizumab ungayambitse zovuta. Uzani dokotala wanu ngati zina mwazizindikirozi ndizolimba kapena sizichoka:
• Zotsatira zina zoyipa zingakhale zazikulu. Ngati mukumane ndi izi kapena izi zomwe zalembedwa M'CHENJEZO CHOFUNIKA, itanani dokotala wanu mwachangu kapena pitani kuchipatala mwadzidzidzi:

Kulandila jakisoni wa eculizumab kumachulukitsa chiopsezo choti mungakhale ndi matenda a meningococcal (matenda omwe angakhudze chophimba cha ubongo ndi msana wam'mimba komanso / kapena kufalikira m'magazi) mukamalandira chithandizo kapena kwakanthawi. Matenda a meningococcal amatha kuyambitsa imfa munthawi yochepa. Muyenera kulandira katemera wa meningococcal osachepera milungu iwiri musanayambe mankhwala anu ndi jekeseni wa eculizumab kuti muchepetse chiopsezo chotenga matendawa. Ngati munalandirapo katemerayu m'mbuyomu, mungafunike kulandira mankhwala owonjezera musanayambe kumwa mankhwala. Ngati dokotala akuwona kuti muyenera kuyamba kulandira chithandizo ndi jakisoni wa eculizumab nthawi yomweyo, mudzalandira katemera wanu wa meningococcal posachedwa.

Ngakhale mutalandira katemera wa meningococcal, pali chiopsezo kuti mutha kudwala matenda a meningococcal nthawi kapena mutalandira chithandizo cha jekeseni wa eculizumab. Ngati mukukumana ndi izi, pitani kuchipatala msanga kapena mulandire chithandizo chamankhwala mwadzidzidzi: kupweteka mutu komwe kumabwera ndi nseru kapena kusanza, malungo, khosi lolimba, kapena msana wolimba; malungo a 103 ° F (39.4 ° C) kapena kupitilira apo; zidzolo ndi malungo; chisokonezo; kupweteka kwa minofu ndi zina monga chimfine; kapena ngati maso anu ali ndi chidwi ndi kuwala.

Uzani dokotala wanu ngati muli ndi malungo kapena zizindikiro zina za matenda musanayambe mankhwala anu ndi jekeseni wa eculizumab. Dokotala wanu sangakupatseni jakisoni wa eculizumab ngati muli ndi matenda a meningococcal.

Dokotala wanu adzakupatsani khadi yachitetezo cha wodwala yokhudzana ndi chiopsezo chokhala ndi matenda a meningococcal nthawi yayitali kapena kwakanthawi mukamalandira chithandizo. Nyamulani khadi ili nthawi zonse mukamalandira chithandizo komanso kwa miyezi itatu mutalandira chithandizo. Onetsani khadi kwa onse othandizira zaumoyo omwe amakuthandizani kuti adziwe za chiopsezo chanu.

Pulogalamu yotchedwa Soliris REMS yakhazikitsidwa kuti ichepetse kuopsa kolandila jekeseni wa eculizumab. Mutha kulandira jekeseni wa eculizumab kuchokera kwa dokotala yemwe walembetsa nawo pulogalamuyi, walankhula nanu za kuopsa kwa matenda a meningococcal, wakupatsani khadi yachitetezo cha wodwala, ndikuwonetsetsa kuti mwalandira katemera wa meningococcal.

Dokotala wanu kapena wamankhwala adzakupatsani pepala lazidziwitso za wopanga (Medication Guide) mukayamba chithandizo ndi jekeseni wa eculizumab ndipo nthawi iliyonse yomwe mumalandira jakisoni. Werengani nkhaniyi mosamala ndikufunsani dokotala kapena wamankhwala ngati muli ndi mafunso. Muthanso kuyendera tsamba la Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) kapena tsamba laopanga kuti mupeze Medication Guide.

Lankhulani ndi dokotala wanu za kuopsa kolandila jakisoni wa eculizumab.

Jekeseni wa Eculizumab umagwiritsidwa ntchito pochizira paroxysmal nocturnal hemoglobinuria (PNH: mtundu wa kuchepa kwa magazi komwe maselo ofiira ochuluka kwambiri amathyoledwa mthupi, ndiye kuti mulibe maselo athanzi okwanira kubweretsa mpweya kumadera onse a thupi). Jekeseni wa Eculizumab imagwiritsidwanso ntchito kuthana ndi atypical hemolytic uremic syndrome (aHUS; mkhalidwe wobadwa nawo momwe magazi amaundana pang'ono amapangidwa mthupi ndipo amatha kuwononga mitsempha yamagazi, maselo amwazi, impso, ndi ziwalo zina za thupi). Jekeseni wa Eculizumab imagwiritsidwanso ntchito kuthana ndi mtundu wina wa myasthenia gravis (MG; vuto lamanjenje lomwe limayambitsa kufooka kwa minofu). Amagwiritsidwanso ntchito pochiza matenda a neuromyelitis optica spectrum disorder (NMOSD; matenda am'magazi amthupi omwe amakhudza mitsempha yamaso ndi msana) mwa achikulire ena. Jekeseni wa Eculizumab uli mgulu la mankhwala otchedwa monoclonal antibodies. Zimagwira ntchito poletsa zochitika za gawo la chitetezo cha mthupi zomwe zitha kuwononga maselo amwazi mwa anthu omwe ali ndi PNH ndipo zimayambitsa kuundana mwa anthu omwe ali ndi aHUS. Zimagwiranso ntchito poletsa magwiridwe antchito amthupi omwe angawononge ziwalo zina zam'mimba mwa anthu omwe ali ndi NMOSD kapena kusokoneza kulumikizana pakati pa mitsempha ndi minofu mwa anthu omwe ali ndi MG.

Jekeseni wa Eculizumab umabwera ngati yankho (madzi) ojambulidwa kudzera m'mitsempha (mumtsempha) osachepera mphindi 35 ndi dokotala kapena namwino kuofesi yazachipatala. Nthawi zambiri amaperekedwa kwa akulu kamodzi pamlungu kwa milungu isanu kenako kamodzi kamodzi sabata iliyonse. Ana atha kulandira jakisoni wa eculizumab panthawi ina, kutengera msinkhu wawo ndi thupi lawo. Mlingo wowonjezera wa jakisoni wa eculizumab amaperekedwanso isanachitike kapena itatha mankhwala ena a PNH, aHUS, MG, kapena NMOSD.

Dokotala wanu mwina angakuyambitseni pa jakisoni wochepa wa jekeseni wa eculizumab ndikuwonjezera mlingo wanu pakatha milungu inayi.

Jekeseni wa Eculizumab ungayambitse zovuta zina. Dokotala wanu amakuyang'anirani mosamala mukalandira jekeseni wa eculizumab komanso kwa ola limodzi mutalandira mankhwala. Dokotala wanu amatha kuchepetsa kapena kuyimitsa kulowetsedwa kwanu ngati mukumana ndi vuto linalake. Ngati mukumane ndi izi, uzani dokotala nthawi yomweyo: kupweteka pachifuwa; kumva kukomoka; zidzolo; ming'oma; kutupa kwa maso, nkhope, milomo, lilime, kapena mmero; ukali; kapena kupuma movutikira kapena kumeza.

Mankhwalawa amatha kupatsidwa ntchito zina; funsani dokotala wanu kapena wamankhwala kuti mudziwe zambiri.

Asanalandire jekeseni wa eculizumab,

• uzani dokotala wanu komanso wamankhwala ngati muli ndi vuto la jakisoni wa eculizumab, mankhwala ena aliwonse, kapena zina zilizonse zophatikizira jekeseni wa eculizumab. Funsani wamankhwala wanu kapena onani Chithandizo cha Mankhwala kuti mupeze mndandanda wazosakaniza.
• Uzani dokotala wanu komanso wamankhwala mankhwala ndi mankhwala osapatsirana, mavitamini, zowonjezera zakudya, ndi mankhwala azitsamba omwe mukumwa kapena omwe mukufuna kumwa. Dokotala wanu angafunike kusintha kuchuluka kwa mankhwala anu kapena kukuyang'anirani mosamala zotsatira zake.
• uzani dokotala wanu ngati mwakhalapo kapena mudakhalapo ndi matenda ena aliwonse.
• Uzani dokotala wanu ngati muli ndi pakati, konzekerani kutenga pakati, kapena mukuyamwitsa. Mukakhala ndi pakati mukalandira jakisoni wa eculizumab, itanani dokotala wanu.
• ngati mwana wanu adzalandira jakisoni wa eculizumab, mwana wanu ayenera katemera wa Streptococcus pneumoniae ndi Haemophilus fuluwenza mtundu wa b (Hib) asanayambe kulandira chithandizo. Lankhulani ndi dokotala wa mwana wanu za kupereka mwana wanu katemera ndi katemera wina aliyense amene mwana wanu amafunikira.
• ngati mukulandira PNH, muyenera kudziwa kuti matenda anu atha kupangitsa kuti maselo ofiira ochulukirapo awonongeke mukasiya kulandira jakisoni wa eculizumab. Dokotala wanu adzakuwunikirani mosamala ndipo atha kuyitanitsa mayeso a labotale milungu isanu ndi itatu yoyamba mukamaliza kumwa mankhwala. Itanani dokotala wanu nthawi yomweyo ngati mungakhale ndi izi: kusokonezeka, kupweteka pachifuwa, kupuma movutikira, kapena zizindikilo zina zachilendo.
• ngati mukulandira aHUS, muyenera kudziwa kuti vuto lanu lingayambitse magazi kuundana mutasiya kulandira jakisoni wa eculizumab. Dokotala wanu adzakuwunikirani mosamala ndipo atha kuyitanitsa mayeso a labotale m'masabata 12 oyamba mukamaliza kumwa mankhwala. Itanani dokotala wanu nthawi yomweyo ngati mungakhale ndi izi: mwadzidzidzi kuvuta kulankhula kapena kumvetsetsa mawu; chisokonezo; kufooka kwadzidzidzi kapena dzanzi la mkono kapena mwendo (makamaka mbali imodzi ya thupi) kapena nkhope; kuyenda mwadzidzidzi, chizungulire, kutayika bwino kapena kulumikizana; kukomoka; kugwidwa; kupweteka pachifuwa; kuvuta kupuma; kutupa m'manja kapena m'miyendo; kapena zizindikiro zina zachilendo.

Pokhapokha dokotala atakuwuzani zina, pitirizani kudya zomwe mumadya.

Ngati mwaphonya nthawi kuti mulandire jakisoni wa eculizumab, itanani dokotala wanu nthawi yomweyo.

Jekeseni wa Eculizumab ungayambitse zovuta. Uzani dokotala wanu ngati zina mwazizindikirozi ndizolimba kapena sizichoka:

• mutu
• mphuno
• kupweteka kapena kutupa m'mphuno kapena pakhosi
• chifuwa
• kuvuta kugona kapena kugona
• kutopa kwambiri
• chizungulire
• kupweteka kwa minofu kapena molumikizana
• kupweteka kwa msana
• kupweteka kwa mikono kapena miyendo
• zilonda mkamwa
• kutsegula m'mimba
• nseru
• kusanza
• kupweteka m'mimba
• pokodza kowawa kapena kovuta

Zotsatira zina zoyipa zingakhale zazikulu. Ngati mukumane ndi izi kapena izi zomwe zalembedwa M'CHENJEZO CHOFUNIKA, itanani dokotala wanu mwachangu kapena pitani kuchipatala mwadzidzidzi:

• malungo
• kutupa kwa mikono, manja, mapazi, akakolo, kapena miyendo yakumunsi
• kugunda kwamtima mwachangu
• kufooka
• khungu lotumbululuka
• kupuma movutikira

Jekeseni wa Eculizumab ungayambitse zovuta zina. Itanani dokotala wanu ngati muli ndi zovuta zina mukalandira mankhwalawa.

Mukakumana ndi zovuta zina, inu kapena adokotala mutha kutumiza lipoti ku pulogalamu ya Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting pa intaneti (http://www.fda.gov/Safety/MedWatch) kapena pafoni ( 1-800-332-1088).

Mukadwala mopitirira muyeso, itanani foni yothandizira poyizoni pa 1-800-222-1222. Zambiri zimapezekanso pa intaneti pa https://www.poisonhelp.org/help. Ngati wozunzidwayo wagwa, watenga khunyu, akuvutika kupuma, kapena sangathe kudzutsidwa, nthawi yomweyo itanani anthu azadzidzidzi ku 911.

Sungani maimidwe onse ndi dokotala wanu ndi labotale. Dokotala wanu amalamula mayeso ena a labu kuti aone momwe thupi lanu lingayankhire jekeseni wa eculizumab.

Funsani wamankhwala wanu mafunso aliwonse omwe muli nawo okhudza jekeseni wa eculizumab.

Ndikofunika kuti musunge mndandanda wamankhwala onse omwe mumalandira komanso osalembetsa (owerengera) omwe mukumwa, komanso zinthu zilizonse monga mavitamini, michere, kapena zakudya zina. Muyenera kubwera nawo pamndandandawu nthawi iliyonse mukapita kukaonana ndi dokotala kapena ngati mwalandiridwa kuchipatala. Ndikofunikanso kuthana nanu pakagwa mwadzidzidzi.

• Soliris^®