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Insulin lispro
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<h2 id="medical-uses">Medical uses</h2> <p>Insulin lispro is used to treat people with <a href="/facts/Type_1_diabetes/IkuQadGx">type 1 diabetes</a> or <a href="/facts/Type_2_diabetes/zCMXksmt">type 2 diabetes</a>.<a class="footnote-ref" id="fnref:16" href="#fn:16"><sup>16</sup></a> People doing well on short-acting insulin should not routinely be changed to insulin lispro, but may benefit from some advantages like flexibility and responsiveness.<a class="footnote-ref" id="fnref:17" href="#fn:17"><sup>17</sup></a> </p> <h2 id="side-effects">Side effects</h2> <p>Common <a href="/facts/Side_effect/PhuX2haY">side effects</a> include <a href="/facts/Injection_site_reactions/fREM9zKV">skin irritation</a> at the site of <a href="/facts/Injection_(medicine)/fvkH58gk">injection</a>, <a href="/facts/Hypoglycemia/BlAmuP6k">hypoglycemia</a>, <a href="/facts/Hypokalemia/XvS1S7s6">hypokalemia</a>, and <a href="/facts/Lipodystrophy/j3x0A9MU">lipodystrophy</a>.<a class="footnote-ref" id="fnref:18" href="#fn:18"><sup>18</sup></a> Other serious side effects include <a href="/facts/Anaphylaxis/F9IDQxeL">anaphylaxis</a>, and <a href="/facts/Hypersensitivity/j2AWmqCD">hypersensitivity</a> reactions.<a class="footnote-ref" id="fnref:19" href="#fn:19"><sup>19</sup></a> </p> <h2 id="mechanism-of-action">Mechanism of action</h2> <p>Through <a href="/facts/Recombinant_DNA/dT3PL7M6">recombinant DNA</a> technology, the final <a href="/facts/Lysine/CEetgA9L">lysine</a> and <a href="/facts/Proline/x1ABSW5A">proline</a> residues on the C-terminal end of the B-chain are reversed. This modification does not alter receptor binding, but blocks the formation of insulin <a href="/facts/Protein_dimer/c8LwFJPG">dimers</a> and hexamers. This allows larger amounts of active monomeric insulin to be immediately available for <a href="/facts/Postprandial/XxmbWREj">postprandial</a> injections.<a class="footnote-ref" id="fnref:20" href="#fn:20"><sup>20</sup></a> </p> <h2 id="chemistry">Chemistry</h2> <p>It is a manufactured form of human insulin where the <a href="/facts/Amino_acid/WDxYwBny">amino acids</a> <a href="/facts/Lysine/CEetgA9L">lysine</a> and <a href="/facts/Proline/x1ABSW5A">proline</a> have been switched at the end of the B chain of the insulin molecule.<a class="footnote-ref" id="fnref:21" href="#fn:21"><sup>21</sup></a> This switch of amino acids mimics <a href="/facts/Insulin-like_growth_factor_1/2n0nPvtD">Insulin-like growth factor 1</a> which also has lysine (K) and proline (P) in that order at positions 28 and 29.<a class="footnote-ref" id="fnref:22" href="#fn:22"><sup>22</sup></a> </p> <h2 id="history">History</h2> <p>Insulin lispro (brand name Humalog) was granted marketing authorization in the European Union in April 1996,<a class="footnote-ref" id="fnref:23" href="#fn:23"><sup>23</sup></a> and it was approved for use in the United States in June 1996.<a class="footnote-ref" id="fnref:24" href="#fn:24"><sup>24</sup></a><a class="footnote-ref" id="fnref:25" href="#fn:25"><sup>25</sup></a> </p><p>Insulin lispro (brand name Liprolog) was granted marketing authorization in the European Union in May 1997,<a class="footnote-ref" id="fnref:26" href="#fn:26"><sup>26</sup></a> and again in August 2001.<a class="footnote-ref" id="fnref:27" href="#fn:27"><sup>27</sup></a> </p><p>Combination drugs combining insulin lispro and other forms of insulin were approved for use in the United States in December 1999.<a class="footnote-ref" id="fnref:28" href="#fn:28"><sup>28</sup></a><a class="footnote-ref" id="fnref:29" href="#fn:29"><sup>29</sup></a><a class="footnote-ref" id="fnref:30" href="#fn:30"><sup>30</sup></a> </p><p>Insulin lispro Sanofi was granted marketing authorization as a biosimilar in the European Union in July 2017.<a class="footnote-ref" id="fnref:31" href="#fn:31"><sup>31</sup></a> </p><p>Insulin lispro injection (brand name Admelog) was approved for use in the United States in December 2017.<a class="footnote-ref" id="fnref:32" href="#fn:32"><sup>32</sup></a><a class="footnote-ref" id="fnref:33" href="#fn:33"><sup>33</sup></a><a class="footnote-ref" id="fnref:34" href="#fn:34"><sup>34</sup></a> </p><p>In January 2020, the <a href="/facts/Committee_for_Medicinal_Products_for_Human_Use/yCkJTISe">Committee for Medicinal Products for Human Use</a> (CHMP) of the <a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a> recommended granting of a marketing authorization for insulin lispro acid (brand name Lyumjev) for the treatment of <a href="/facts/Diabetes/2xeHXbsI">diabetes</a> in adults.<a class="footnote-ref" id="fnref:35" href="#fn:35"><sup>35</sup></a><a class="footnote-ref" id="fnref:36" href="#fn:36"><sup>36</sup></a> Insulin lispro (Lyumjev) was approved for use in the European Union in March 2020, and in the United States in June 2020.<a class="footnote-ref" id="fnref:37" href="#fn:37"><sup>37</sup></a> </p> <h2 id="society-and-culture">Society and culture</h2> <h3>Economics</h3> <p>In the United States, the price of for a vial of Humalog increased from US$35 in 2001 to $234 in 2015,<a class="footnote-ref" id="fnref:38" href="#fn:38"><sup>38</sup></a> or $10.06 and $29.36 per 100 units.<a class="footnote-ref" id="fnref:39" href="#fn:39"><sup>39</sup></a> In April 2019, <a href="/facts/Eli_Lilly_and_Company/e5Pw7RmR">Eli Lilly and Company</a> announced they would produce a version selling for $137.35 per vial.<a class="footnote-ref" id="fnref:40" href="#fn:40"><sup>40</sup></a> The chief executive said that this was a contribution "to fix the problem of high out-of-pocket costs for Americans living with chronic conditions", but <a href="/facts/Patients_for_Affordable_Drugs_Now/YmIybdnA">Patients for Affordable Drugs Now</a> said it was just a public relations move, as "other countries pay $20 for a vial of insulin."<a class="footnote-ref" id="fnref:41" href="#fn:41"><sup>41</sup></a> In March 2023, Lilly announced a program capping their insulin prices at $35 per month.<a class="footnote-ref" id="fnref:42" href="#fn:42"><sup>42</sup></a> </p> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 698. ISBN 9780857113382. <a href="9780857113382" target="_blank">9780857113382</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> <li id="fn:8"><p>"Insulin lispro Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 19 September 2020. Retrieved 3 March 2019. <a href="https://www.drugs.com/pregnancy/insulin-lispro.html" target="_blank">https://www.drugs.com/pregnancy/insulin-lispro.html</a> <a href="#fnref:8" class="footnote-back-ref">↩</a></p></li> <li id="fn:9"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:9" class="footnote-back-ref">↩</a></p></li> <li id="fn:10"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:10" class="footnote-back-ref">↩</a></p></li> <li id="fn:11"><p>"Humalog- insulin lispro injection, solution Humalog Kwikpen- insulin lispro injection, solution Humalog Junior Kwikpen- insulin lispro injection, solution Humalog Tempo Pen- insulin lispro injection, solution". DailyMed. 25 November 2019. Archived from the original on 24 September 2019. Retrieved 23 February 2020. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f</a> <a href="#fnref:11" class="footnote-back-ref">↩</a></p></li> <li id="fn:12"><p>"Humalog approval" (PDF). U.S. Food and Drug Administration (FDA). 14 June 1996. Archived (PDF) from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf</a> <a href="#fnref:12" class="footnote-back-ref">↩</a></p></li> <li id="fn:13"><p>Koivisto VA (June 1998). "The human insulin analogue insulin lispro". Annals of Medicine. 30 (3): 260–6. doi:10.3109/07853899809005853. PMID 9677011. <a href="/wiki/Doi_(identifier)" target="_blank">/wiki/Doi_(identifier)</a> <a href="#fnref:13" class="footnote-back-ref">↩</a></p></li> <li id="fn:14"><p>"The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024. <a href="https://clincalc.com/DrugStats/Top300Drugs.aspx" target="_blank">https://clincalc.com/DrugStats/Top300Drugs.aspx</a> <a href="#fnref:14" class="footnote-back-ref">↩</a></p></li> <li id="fn:15"><p>"Insulin Lispro Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Retrieved 30 August 2024. <a href="https://clincalc.com/DrugStats/Drugs/InsulinLispro" target="_blank">https://clincalc.com/DrugStats/Drugs/InsulinLispro</a> <a href="#fnref:15" class="footnote-back-ref">↩</a></p></li> <li id="fn:16"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:16" class="footnote-back-ref">↩</a></p></li> <li id="fn:17"><p>"Insulin Lispro Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019. <a href="https://www.drugs.com/monograph/insulin-lispro.html" target="_blank">https://www.drugs.com/monograph/insulin-lispro.html</a> <a href="#fnref:17" class="footnote-back-ref">↩</a></p></li> <li id="fn:18"><p>"Humalog- insulin lispro injection, solution Humalog Kwikpen- insulin lispro injection, solution Humalog Junior Kwikpen- insulin lispro injection, solution Humalog Tempo Pen- insulin lispro injection, solution". DailyMed. 25 November 2019. Archived from the original on 24 September 2019. Retrieved 23 February 2020. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f</a> <a href="#fnref:18" class="footnote-back-ref">↩</a></p></li> <li id="fn:19"><p>"Humalog- insulin lispro injection, solution Humalog Kwikpen- insulin lispro injection, solution Humalog Junior Kwikpen- insulin lispro injection, solution Humalog Tempo Pen- insulin lispro injection, solution". DailyMed. 25 November 2019. Archived from the original on 24 September 2019. Retrieved 23 February 2020. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f</a> <a href="#fnref:19" class="footnote-back-ref">↩</a></p></li> <li id="fn:20"><p>Noble SL, Johnston E, Walton B (January 1998). "Insulin lispro: a fast-acting insulin analog". American Family Physician. 57 (2): 279–86, 289–92. PMID 9456992. Archived from the original on 29 September 2007. Retrieved 5 September 2007. <a href="https://web.archive.org/web/20070929095848/http://www.aafp.org/afp/980115ap/noble.html" target="_blank">https://web.archive.org/web/20070929095848/http://www.aafp.org/afp/980115ap/noble.html</a> <a href="#fnref:20" class="footnote-back-ref">↩</a></p></li> <li id="fn:21"><p>Koivisto VA (June 1998). "The human insulin analogue insulin lispro". Annals of Medicine. 30 (3): 260–6. doi:10.3109/07853899809005853. PMID 9677011. <a href="/wiki/Doi_(identifier)" target="_blank">/wiki/Doi_(identifier)</a> <a href="#fnref:21" class="footnote-back-ref">↩</a></p></li> <li id="fn:22"><p>Ratledge, C., & Kristiansen, B. (2007). Basic biotechnology. Cambridge: Cambridge University Press. Page 513 "insulin lispro, where, in analogy to the naturally occur- ring insulin homologue insulin-like growth factor-I (IGF-I), the order of the amino acid residues B28 and B29 was changed;" <a href="#fnref:22" class="footnote-back-ref">↩</a></p></li> <li id="fn:23"><p>"Humalog EPAR". European Medicines Agency (EMA). 11 February 2020. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/humalog" target="_blank">https://www.ema.europa.eu/en/medicines/human/EPAR/humalog</a> <a href="#fnref:23" class="footnote-back-ref">↩</a></p></li> <li id="fn:24"><p>"Humalog approval" (PDF). U.S. Food and Drug Administration (FDA). 14 June 1996. Archived (PDF) from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf</a> <a href="#fnref:24" class="footnote-back-ref">↩</a></p></li> <li id="fn:25"><p>"Humalog: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 November 2020. Retrieved 23 February 2020. <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020563" target="_blank">https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020563</a> <a href="#fnref:25" class="footnote-back-ref">↩</a></p></li> <li id="fn:26"><p>"Liprolog EPAR". European Medicines Agency (EMA). 1 August 2001. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog" target="_blank">https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog</a> <a href="#fnref:26" class="footnote-back-ref">↩</a></p></li> <li id="fn:27"><p>"Liprolog EPAR". European Medicines Agency (EMA). 11 February 2020. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog-0" target="_blank">https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog-0</a> <a href="#fnref:27" class="footnote-back-ref">↩</a></p></li> <li id="fn:28"><p>"Drug Approval Package: Humalog Mix (75/25 & 50/50) NDA# 21-017 & 21-018". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 24 February 2020. 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Retrieved 23 February 2020. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c73da51a-1899-45ad-b6cf-9c52c36a25dd" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c73da51a-1899-45ad-b6cf-9c52c36a25dd</a> <a href="#fnref:30" class="footnote-back-ref">↩</a></p></li> <li id="fn:31"><p>"Insulin lispro Sanofi EPAR". European Medicines Agency (EMA). 17 June 2019. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi" target="_blank">https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi</a> <a href="#fnref:31" class="footnote-back-ref">↩</a></p></li> <li id="fn:32"><p>"Drug Approval Package: Admelog (insulin lispro)". U.S. Food and Drug Administration (FDA). 17 May 2018. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm</a> <a href="#fnref:32" class="footnote-back-ref">↩</a></p></li> <li id="fn:33"><p>"FDA Approves Sanofi's Admelog (insulin lispro injection)". Sanofi (Press release). 11 December 2017. Archived from the original on 24 February 2020. Retrieved 23 February 2020. <a href="http://www.news.sanofi.us/2017-12-11-FDA-Approves-Sanofis-Admelog-R-insulin-lispro-injection" target="_blank">http://www.news.sanofi.us/2017-12-11-FDA-Approves-Sanofis-Admelog-R-insulin-lispro-injection</a> <a href="#fnref:33" class="footnote-back-ref">↩</a></p></li> <li id="fn:34"><p>"FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes". U.S. Food and Drug Administration (FDA) (Press release). 11 December 2017. Archived from the original on 14 June 2019. Retrieved 12 December 2017. <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-admelog-first-short-acting-follow-insulin-product-treat-diabetes" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-approves-admelog-first-short-acting-follow-insulin-product-treat-diabetes</a> <a href="#fnref:34" class="footnote-back-ref">↩</a></p></li> <li id="fn:35"><p>"Lyumjev: Pending EC decision". European Medicines Agency (EMA). 30 January 2020. Archived from the original on 31 January 2020. 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