Insulin aspart: Perbedaan antara revisi
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Baris 4:
| 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===
Onset aksi sekitar lima belas menit, aksi puncak dicapai dalam 45–90 menit, dan durasinya selama 3–5 jam.<ref name="NovoLog FDA label" />
==Efek samping==
Keamanan insulin aspart pada penderita diabetes tidak berbeda dengan insulin biasa. Efek samping yang umumnya terkait dengan terapi insulin meliputi reaksi alergi, [[iritasi]] pada tempat suntikan, [[ruam]], dan [[hipoglikemia]].<ref name= www.novolog.com>{{cite web |url=http://www.novolog.com/questions-default.asp?s=faqs-6 |title=Novolog: most FAQ |access-date=18 April 2011 |archive-url=https://web.archive.org/web/20111003061851/http://www.novolog.com/questions-default.asp?s=faqs-6 |archive-date=3 October 2011 |url-status=dead }}</ref> Efek samping yang paling umum adalah hipoglikemia. Penggunaan insulin jangka panjang termasuk insulin aspart dapat menyebabkan [[lipodistrofi]] pada tempat suntikan atau infus berulang. Untuk mengurangi risiko lipodistrofi, putar tempat suntikan dalam daerah tubuh yang sama. Penambahan berat badan juga dapat terjadi dengan penggunaan insulin aspart dan telah dikaitkan dengan efek anabolik insulin dan penurunan [[glikosuria]]. Penggunaan insulin aspart juga telah dikaitkan dengan retensi [[natrium]] dan [[sembap|edema]].<ref name="www.novo-pi.com">{{cite web |url=http://www.novo-pi.com/novolog.pdf |title=Novolog: insulin aspart (rDNA origin) injection |work=Novo Nordisk |access-date=18 April 2011 |archive-date=22 March 2011 |archive-url=https://web.archive.org/web/20110322204803/http://www.novo-pi.com/novolog.pdf |url-status=live }}</ref>
==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 dari ''[[Saccharomyces cerevisiae]]'' melalui teknologi DNA rekombinan.<ref name="NovoRapid SmPC">{{cite web | title=NovoRapid 100 units/ml in a vial - Summary of Product Characteristics (SmPC) | website=(emc) | date=25 May 2018 | url=https://www.medicines.org.uk/emc/product/7919/smpc | access-date=9 September 2020 | archive-date=16 January 2021 | archive-url=https://web.archive.org/web/20210116143931/https://www.medicines.org.uk/emc/product/7919/smpc | url-status=live }}</ref>
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 ==
{{reflist}}
{{DEFAULTSORT:Insulin Aspart}}
[[Kategori:Agonis reseptor insulin]]
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[[Kategori:Protein rekombinan]]
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[[Kategori:Terapi peptida]]
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