Ukuhlanganiswa Okuthuthukisiwe Izidakamizwa Zihlinzeka Ngezimbalwa Ezingezansi
Ukuhlukaniswa
I-Odefsey iyi-single-tablet, i-dose eqondile yokuhlanganiswa kwezidakamizwa ezisetshenziselwa ukwelashwa kwe-HIV, enama- antiretroviral amathathu ahlukene:
- i-rilpivirine , i-non-nucleoside reverse transcriptase inhibitor (i-NNRTI)
- emtricitabine, i-nucleotide reverse transcriptase inhibitor (i-NtRTI)
- i-tenofovir alafenamide (TAF) , enye i-NtRTI
I-Odefsey iyisidakamizwa sesibili sokuhlanganisa ukusebenzisa i-TAF, inguqulo "ethuthukisiwe" ye-tenofovir disoproxil fumarate (TDF) etholakala kwizidakamizwa iTruvada ne- Atripla .
Njengalokhu, kungabhekwa njengokuthuthukiswa ku-Complera, ukwakheka kwethebhulethi eyodwa okuhlanganisa i-rilpivirine + emtricitabine + TDF.
I-TAF ibhekwa njengephakeme kune-TDF njengoba ikwazi ukuletha izidakamizwa ezisebenzayo ngokuphumelelayo emaqenjini nasezinkalweni ezincane kakhulu-okusho ukuthi kukhona ukuqoqwa okuncane kwesidakamizwa egazini kanye nethuba eliphansi lokuthuthukisa izidakamizwa eziphathelene nezinso ezihlobene nezidakamizwa.
(Nakuba ubungozi be-TDF obuhlobene ne-kidney toxicity bubhekwa njengamazwe asethuthukile, leyo ngozi ibonakala ikhula kakhulu emazweni asathuthuka lapho kunomthelela omkhulu wezifo ezingasebenzi ngaphambili.)
Isiqondiso Sokwelapha
U-Odefsey wamukelwa yi-US Food and Drug Administration ngoMashi 1, 2016 ukuze kusetshenziswe kokubili abadala nabantwana abangaphezu kweminyaka engu-12 abangakaze babe ne-HIV yokwelapha , abanomthwalo wegciwane wamangqamuzana angu-100 000 / m noma ngaphansi Amakhilogremu angu-77 (35kg) noma ngaphezulu.
I-Odefsey ingasetshenziselwa ukuthatha indawo yokwelashwa kwamanje (njengalezo eziseComplera) uma isiguli sinomthwalo wegciwane elingenakutholakali (<50 amaselula / mL) okungenani izinyanga eziyisithupha, awunalo umlando wokuhluleka kokwelashwa, futhi awunaziwa ukumelana nanoma yiziphi izidakamizwa ezitholakala e-Odefsey.
Ukubunjwa
I-Odefsey iyithebulethi eboshiwe, e-oblong, elinefilimu, enama-25mg we-rilpivirine, 200mg we-emtricitabine no-25 mg we-TAF.
Ihlanganiswa ne "GSI" ngakolunye uhlangothi futhi "255" ngakolunye uhlangothi.
Isilinganiso
Ithebulethi eyodwa nsuku zonke ithathwe ngokudla. U-Odefsey akufanele athathwe nanoma imuphi omunye umuthi we-antiretroviral osetshenziselwa ukuphatha i-HIV.
Okuqhamuka uma udla imishanguzo
Imithi emibi yemiphumela yezidakamizwa iye yaqashelwa ezigulini zesivivinyo somtholampilo ezithatha i-rilpivirine kanye / noma i-emtricitabine + i-TAF, ejwayelekile kunazo zonke:
- I-nausea
- Izinwele
- Ukungalali
- Ukucindezeleka
Imiphumela emibi ngokuvamile yayihamba isikhathi eside, kanti iziguli ezimbalwa zayeka ngenxa yokungabekezelelani kwelashwa.
Ukungafani
U-Odefsey akufanele athathwe nalezi zidakamizwa noma izithako ezilandelayo:
- Imithi elwa no-anti-convulsive: Tegretol, Trilepta, phenobarbital, phenytoin
- Imithi yokulwa nesifo sofuba: i-Mycobutin, i-Rifater, i- Rifamate, i-Rimactane, i- Rifadin, i-Priftin
- I-Proton pump inhibitors (i-PPIs): i-Nexium, i-Kapidex, i-Dexilant, i-Prevacid, i-Losec, i-Prilosec, i-Protonix, i- Aciphex noma enye i-PPI
- Imithi ye-steroid: i-dexamethasone (nakuba ingase isetshenziswe ngomthamo owodwa, uma kuboniswa ngemithi)
- Wort St. John's Wort
Njalo utshele udokotela wakho nganoma yisiphi isidakamizwa noma ukwesekwa, okushiwo noma okungenqunyiwe, ukuthi ungathatha ngaphambi kokuqala noma yiluphi ukwelashwa kwama-antiretroviral.
Okunye okucatshangwayo
I-Odefsey ayinconywa iziguli ezinokukhubazeka kwezinso (ezichazwe njengokuthi imvume yokudalulwa kwama-creinine engaphansi kuka-30mL ngomzuzu).
Sicela ukutshela udokotela wakho uma ukhona noma ulashwa nganoma yisiphi isifo sezinso somunye udokotela.
I-Odefsey ayikhuthazwa iziguli ezinokukhubazeka kwesibindi noma kulabo abanesifo sengculaza esingapheli nesifo sohlobo lwe-hepatitis B (HBV) ngoba singabangela kakhulu izinkinga zesibindi. Kunconywa ukuthi abantu abane-HIV bahlolwe i-HBV ngaphambi kokubeka u-Odefsey. Sicela utshele udokotela wakho uma unenkinga yesibindi kanye / noma umlando we-hepatitis.
I-rilpivirine ingxenye ye-Odefsy ingabangela ukusabela kwe-hypersensitivity kwinani elincane leziguli, ngokuvamile ngesimo sokuqhaqhazela, ukuvuvukala kweso ("amehlo e-pink"), ukuvuvukala ebusweni, umkhuhlane, noma ezinye izimpendulo.
Ngokujwayelekile, ukusabela kwe-hypersensitivity sekukhona amasonto angu-1-6 ngemuva kokuqala kokuthola ukwelashwa. Memeze udokotela wakho ngokushesha nganoma yiziphi izimpawu ezinjalo zivela. Ezimweni ezinzima, ukwelashwa kuyodingeka kuphele.
Imithombo:
Ama-Reuters. "I-BRIEF - I-Sciences eGileyadi ithi i-US FDA ivumela u-Odefsey." Ikhishwe ngomhla ka-1 Mashi, 2015.
I-Sciences yaseGileyadi. " Odefsey - Amaphuzu avelele ekuchazeni ulwazi." Foster City, California; kufinyelelwe kuMashi 18, 2016.