Insulin aspart: Perbedaan antara revisi
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| image = Insulin Aspart Structural Formula.gif
| alt = <!-- Clinical data -->
| tradename = Sansulin, NovoLog, NovoRapid, Fiasp, dll
| Drugs.com = {{drugs.com|monograph|insulin_aspart}}
| MedlinePlus = a605013
Baris 62:
==Kegunaan dalam medis==
Insulin aspart diindikasikan untuk meningkatkan kontrol glikemik pada penderita [[diabetes melitus]].<ref name="Fiasp FDA label">{{cite web | title=Fiasp- insulin aspart injection injection, solution | website=DailyMed | date=19 December 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=834e7efc-393f-4c55-9125-628562a8a5cf | access-date=12 November 2020 | archive-date=13 November 2020 | archive-url=https://web.archive.org/web/20201113025955/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=834e7efc-393f-4c55-9125-628562a8a5cf | url-status=live }}</ref><ref name="NovoLog FDA label">{{cite web | title=NovoLog- insulin aspart injection, solution Insulin Diluting Medium For NovoLog- water injection injection, solution | website=DailyMed | date=15 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | access-date=12 November 2020 | archive-date=12 November 2020 | archive-url=https://web.archive.org/web/20201112193904/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | url-status=live }}</ref>
===Onset aksi===
Baris 71:
==Formulasi==
Insulin aspart dapat digunakan dalam [[pompa insulin]] dan pena insulin untuk injeksi subkutan. Selain itu, dapat digunakan dengan port injeksi seperti ''I-port''.<ref>{{cite web|url=https://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605013.html |title=Aspart insulin (rDNA origin) injection |access-date=8 June 2007 |archive-url=https://web.archive.org/web/20070610074313/http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605013.html |archive-date=10 June 2007 |url-status=dead }}</ref>
Insulin aspart memiliki onset yang lebih cepat, dan durasi aktivitas yang lebih pendek daripada insulin manusia normal.<ref name=www.fda.gov>{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4254b_13_04_KP%20InsulinAspartFDAlabel102005.pdf |title=Novolog: insulin aspart |website=[[Food and Drug Administration]] |access-date=16 December 2019 |archive-date=17 May 2017 |archive-url=https://web.archive.org/web/20170517041656/https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4254b_13_04_KP%20InsulinAspartFDAlabel102005.pdf |url-status=live }}</ref> Insulin aspart juga dapat digunakan dengan pompa insulin eksternal.<ref name="NovoLog FDA label" />
===Variasi===
NovoLog Mix 70/30 adalah produk yang mengandung 30% insulin aspart dan 70% insulin aspart protamin. Bagian insulin aspart protamin adalah bentuk kristal insulin aspart, yang menunda aksi insulin, sehingga memberikan profil penyerapan yang lebih lama setelah injeksi.<ref name="NovoLog Mix FDA label">{{cite web | title=NovoLog Mix 70/30- insulin aspart injection, suspension | website=DailyMed | date=15 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1861fcee-7673-4afe-a206-08fa05c0add2 | access-date=12 November 2020 | archive-date=29 September 2020 | archive-url=https://web.archive.org/web/20200929013529/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1861fcee-7673-4afe-a206-08fa05c0add2 | url-status=live }}</ref> Kombinasi bentuk kerja cepat dan bentuk kerja lama memungkinkan pasien menerima lebih sedikit suntikan sepanjang hari.<ref>{{cite web | work = Rx List | title = NovoLog Mix 70/30 | date = 6 August 2008 | url = http://www.rxlist.com/novolog-mix-70-30-drug.htm | archive-url = https://web.archive.org/web/20090420190334/http://www.rxlist.com/novolog-mix-70-30-drug.htm | archive-date = 20 April 2009 }}</ref>
NovoLog Mix dipasarkan untuk digunakan dengan [[Novo Nordisk]] FlexPen.<ref>{{cite web | work = Novo Nordisk | title = NovoLog Mix 70/30 | date = 2008 | url = http://www.novologmix70-30.com/starting-with-novolog-mix.asp | archive-url = https://web.archive.org/web/20090508145759/http://www.novologmix70-30.com/starting-with-novolog-mix.asp | archive-date = 8 May 2009 }}</ref> Onset aksinya kurang dari 30 menit, aksi puncaknya tercapai dalam 1–4 jam, dan durasinya kurang dari 24 jam.<ref name="Pharmaceutical Biotechnology">{{cite book | vauthors = Beals JM, DeFelippis MR, Kovach PM | chapter = Insulin | veditors = Crommelin DJ, Sindelar RD, Meibohm B | date = 2008 | title = Pharmaceutical Biotechnology: Fundamentals and Applications. | location = New York, NY | publisher = Informa Healthcare USA, Inc. | page = 265–280 (270) | isbn = 978-1-4200-4437-9 }}</ref> NovoLog Mix dipasarkan di beberapa negara sebagai NovoMix 30.<ref>{{cite web | title=NovoMix 30 FlexPen 100 units/ml - Summary of Product Characteristics (SmPC) | website=(emc) | date=27 March 2019 | url=https://www.medicines.org.uk/emc/product/1600/smpc | access-date=12 April 2020 | archive-date=13 April 2020 | archive-url=https://web.archive.org/web/20200413050707/https://www.medicines.org.uk/emc/product/1600/smpc | url-status=live }}</ref><ref name="NovoMix EPAR">{{cite web | title=NovoMix EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/novomix | access-date=12 April 2020 | archive-date=13 April 2020 | archive-url=https://web.archive.org/web/20200413050741/https://www.ema.europa.eu/en/medicines/human/EPAR/novomix | url-status=live }}</ref>
NovoRapid diproduksi
Versi insulin aspart yang bekerja lebih cepat, yang dikenal sebagai insulin fast-aspart (Fiasp), dikaitkan dengan pengendalian kenaikan glukosa darah pasca makan yang lebih efisien, tanpa meningkatkan risiko hipoglikemia dan variabilitas glikemik.<ref>{{cite journal | vauthors = Dutta D, Mohindra R, Mahajan K, Sharma M | title = Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis | journal = Diabetes & Metabolism Journal | volume = 47 | issue = 1 | pages = 72–81 | date = January 2023 | pmid = 35746893 | pmc = 9925142 | doi = 10.4093/dmj.2022.0035 }}</ref><ref>{{cite journal | vauthors = Evans M, Ceriello A, Danne T, De Block C, DeVries JH, Lind M, Mathieu C, Nørgaard K, Renard E, Wilmot EG | title = Use of fast-acting insulin aspart in insulin pump therapy in clinical practice | journal = Diabetes, Obesity & Metabolism | volume = 21 | issue = 9 | pages = 2039–2047 | date = September 2019 | pmid = 31144428 | pmc = 6773364 | doi = 10.1111/dom.13798 }}</ref><ref>{{cite journal | vauthors = Evans M, Wilkinson M, Giannpolou A | title = Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin | journal = Diabetes Therapy | volume = 10 | issue = 5 | pages = 1793–1800 | date = October 2019 | pmid = 31485918 | pmc = 6778592 | doi = 10.1007/s13300-019-00685-0 }}</ref>
==Kemiripan biologis==
Pada bulan Desember 2020, ''Committee for Medicinal Products for Human Use'' (CHMP) dari [[Badan Pengawas Obat
Trurapi disetujui untuk penggunaan medis di Kanada pada bulan Oktober 2020.<ref>{{cite web | title=Summary Basis of Decision (SBD) for Trurapi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00515&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530050752/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00515&lang=en | url-status=live }}</ref>
Truvelog dan Truvelog Solostar disetujui untuk penggunaan medis di Australia pada bulan Oktober 2020.<ref name="Truvelog APMDS">{{cite web | title=Truvelog | website=Therapeutic Goods Administration (TGA) | date=23 October 2020 | url=https://www.tga.gov.au/apm-summary/truvelog | access-date=12 June 2021 | archive-date=13 June 2021 | archive-url=https://web.archive.org/web/20210613062838/https://www.tga.gov.au/apm-summary/truvelog | url-status=live }}</ref><ref name="Truvelog Solostar ARTG">{{cite web | title=Truvelog Solostar ARTG | website=[[Therapeutic Goods Administration]] (TGA) | url=https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=325474 | access-date=12 June 2021 | archive-date=13 June 2021 | archive-url=https://web.archive.org/web/20210613062838/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=325474 | url-status=live }}</ref>
Pada bulan Oktober 2021, Kirsty disetujui untuk penggunaan medis di Kanada.<ref name="Kirsty SBD">{{cite web | title=Summary Basis of Decision (SBD) for Kirsty | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00570&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529194843/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00570&lang=en | url-status=live }}</ref>
Pada bulan Februari 2022, CHMP mengadopsi opini positif, merekomendasikan pemberian otorisasi pemasaran untuk produk obat Truvelog Mix 30, yang ditujukan untuk pengobatan diabetes. Pemohon untuk produk obat ini adalah sanofi-aventis groupe.<ref name="Truvelog Mix 30: Pending EC decision">{{cite web | title=Truvelog Mix 30: Pending EC decision | website=European Medicines Agency | date=24 February 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/truvelog-mix-30 | access-date=27 February 2022 | archive-date=27 February 2022 | archive-url=https://web.archive.org/web/20220227042953/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/truvelog-mix-30 | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Produk ini disetujui untuk penggunaan medis di Uni Eropa pada bulan April 2022.<ref name="Truvelog Mix 30 EPAR">{{cite web | title=Truvelog Mix 30 EPAR | website=European Medicines Agency | date=23 February 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30 | access-date=16 June 2022 | archive-date=17 June 2022 | archive-url=https://web.archive.org/web/20220617060422/https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30 | url-status=live }}</ref><ref>{{cite web | title=Truvelog Mix 30 Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1639.htm | access-date=3 March 2023}}</ref>
==Dalam budaya masyarakat==
Pada tahun 2018, belum ada bukti kuat yang menyimpulkan keunggulan insulin aspart dibandingkan insulin manusia pada diabetes tipe 2.<ref>{{cite journal | vauthors = Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, Gerlach FM | title = Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus | journal = The Cochrane Database of Systematic Reviews | volume = 12 | issue = 12 | pages = CD013228 | date = December 2018 | pmid = 30556900 | pmc = 6517032 | doi = 10.1002/14651858.CD013228 }}</ref> Oleh karena itu, masih belum jelas mengapa orang beralih dari insulin manusia ke insulin aspart.<ref>{{cite journal | vauthors = Cohen D, Carter P | title = How small changes led to big profits for insulin manufacturers | journal = BMJ | volume = 341 | pages = c7139 | date = December 2010 | pmid = 21159773 | doi = 10.1136/bmj.c7139 | s2cid = 30709912 }}</ref> Pada diabetes tipe 1, insulin aspart tampaknya menghasilkan kontrol gula darah yang sedikit lebih baik.<ref>{{cite journal | vauthors = Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, Plank J, Pieber TR, Gerlach FM | title = Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus | journal = The Cochrane Database of Systematic Reviews | volume = 2016 | issue = 6 | pages = CD012161 | date = June 2016 | pmid = 27362975 | pmc = 6597145 | doi = 10.1002/14651858.CD012161 }}</ref>
== Referensi ==
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