I-Fixed Dose Imithi Edidiyelwe Ihlinzeka Ngesikhathi Sonke-Nsuku Zonke, Ukwelashwa Kwamaphilisi Okukodwa
Ukuhlukaniswa
I-Complera iyithebhu elilodwa, ithebhulethi ehlanganisiwe yokusebenzisa imithi esetshenziselwa ukwelashwa kwe-HIV, equkethe ama- antiretroviral amathathu ahlukene:
- i-rilpivirine , i- non-nucleoside reverse transcriptase inhibitor (i-NNRTI)
- emtricitabine, i- nucleotide reverse transcriptase inhibitor (i-NtRTI)
- i-tenofovir disoproxil fumarate (TDF), enye i-NtRTI
I-Complera yamukelwa yi-US Food and Drug Administration (FDA) ngo-Agasti 10, 2011 ukuze isetshenziswe kokubili abadala nabantwana abangaphezu kweminyaka engu-12 abangakaze babe ne-HIV yokwelashwa , abanomthwalo wegciwane wamangqamuzana angu-100,000 / m noma ngaphansi , futhi ulinganisa amapremu angu-77 (35kg) noma ngaphezulu.
I-Complera ingasetshenziselwa ukuthatha indawo yokwelashwa kwamanje uma isiguli sinomthwalo wegciwane elingenakutholakali (
Ukubunjwa
I-Complera iyi-tablet eqoshiwe, efana ne-capsule, eqoshwe ngefilimu, enama-25mg we-rilpivirine, i-200mg ye-emtricitabine ne-300mg ye-TDF. Ihlanganiswa ne "GSI" ngakolunye uhlangothi futhi iyacaca komunye.
Isilinganiso
Ithebulethi eyodwa nsuku zonke ithathwe ngokudla. I-Complera akufanele ithathwe nganoma imuphi omunye umuthi we-antiretroviral osetshenziselwa ukuphatha i-HIV.
Okuqhamuka uma udla imishanguzo
Imithwalo yemiphumela emibi yezidakamizwa iye yaqashelwa ezigulini zesivivinyo somtholampilo ezithatha i-Complera, okujwayelekile kakhulu kuzo:
- I-nausea
- Izinwele
- Ukungalali
- Ukucindezeleka
Imiphumela emibi ngokuvamile yayihamba isikhathi eside, kanti iziguli ezimbalwa zayeka ngenxa yokungabekezelelani kwelashwa.
Ukungafani
I-Complera akufanele ithathwe ngezidakamizwa 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 ngesilinganiso esisodwa 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-Complera ayikhuthazwa iziguli ezinokukhubazeka kwezinso (ezichazwe njengokuthi imvume yokudalulwa kwe-creatinine engaphansi kuka-30mL ngomzuzu). Sicela ukutshela udokotela wakho uma ukhona noma ulashwa nganoma yisiphi isifo sezinso somunye udokotela.
I-Complera 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 i-Complera. Sicela unxuse udokotela wakho uma unezinkinga zesibindi kanye / noma umlando we-hepatitis.
I-rilpivirine ingxenye ye-Complera 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.
Ukuvuselela Ukwelapha
Ukwakhiwa okusha kweComplera kwamukelwa yi-FDA ngoMashi 1, 2016, kuthengiswa ngaphansi kwegama elithi Odefsey . Lokhu kwakha okusha kubeka esikhundleni se-TDF ingxenye ngedakamizwa ebizwa ngokuthi i-tenofovir alafenamide (TAF), ekugcineni kwayo ebizwa ngokuthi i-pro-drug.
Ngokungafani ne-TDF, i-TAF ayikho isidakamizwa esisebenzayo kodwa kunalokho isebenzisa umzimba wesimo somzimba ukuze uyiguqule ibe ifomu layo esebenzayo. Ngenxa yalokho, lesi sidakamizwa sithunyelwa ngokuphumelelayo emaqenjini amanani aphansi kakhulu, kanye nokudakwa kwezidakamizwa eziphansi kakhulu (ikakhulukazi mayelana nokukhubazeka kwezinso ezihlobene nokusetshenziswa kwe-TDF).
Imithombo:
Ukuphathwa kwe-US Food and Drug (FDA_. "Ukuvunyelwa kwe-Complera: i-emtricitabine / rilpivirine / i-tenofovir DF ehleliwe inhlanganisela ye-dose." Isiliva Srping, Maryland; sikhishwe ngo-Agasti 10, 2011.
I-Sciences yaseGileyadi. "I-Complera - Amaphuzu Avelele Wokubhala Ulwazi." Foster City, California; kufinyelelwe kuMashi 18, 2016.
Ama-Reuters. "I-BRIEF - I-Sciences eGileyadi ithi i-US FDA iyavuma i-Odefsey" Ikhishwe ngo-Mashi 1, 2015.