إنسولين ليسپرو

إنسولين ليسپرو
البيانات السريرية
الأسماء التجاريةHumalog, Liprolog, Admelog, others
أسماء أخرىURLi, LY900014
AHFS/Drugs.comMonograph
MedlinePlusa697021
License data
فئة السلامة
أثناء الحمل
مسارات
الدواء		Subcutaneous
رمز ATC
الحالة القانونية
الحالة القانونية
المعرفات
رقم CAS
PubChem CID
DrugBank
ChemSpider
  • none
UNII
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
التركيبC257H389N65O77S6
الكتلة المولية5813.63 g/mol
 ☒NYesY (what is this?)  (verify)

إنسولين ليسپرو، يُباع تحت الاسم التجاري هومالوگ Humalog، هو نوع من الإنسولين يستخدم لعلاج سكري النمط الأول والثاني.[3] Typically it is taken around the time of eating.[3] It is used by injection under the skin or within an insulin pump.[3][4] Onset of effects typically occurs within 30 minutes and lasts about 5 hours.[3] Often a longer acting insulin like NPH is also needed.[3]

Common side effects include low blood sugar.[3] Other serious side effects may include low blood potassium.[3] Use in pregnancy and breastfeeding is generally safe.[5] It works the same as human insulin by increasing the amount of glucose that tissues take in and decreasing the amount of glucose made by the liver.[3]

Insulin lispro was first approved for use in the United States in 1996.[3][6][7] It is a manufactured form of human insulin where an amino acid has been switched.[8] In the United Kingdom it costs the NHS about GB£1.89 per 100 units as of 2019.[4] In the United States the wholesale cost of this amount is about US$30٫00.[9] In 2016 it was the 100th most prescribed medication in the United States with more than seven million prescriptions.[10]

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الاستخدامات الطبية

Insulin lispro is used to treat people with type 1 diabetes or type 2 diabetes.[3] People doing well on regular insulin should not generally be changed to insulin lispro.[3]


الآثار الجانبية

Common side effects include skin irritation at the site of injection, hypoglycemia, hypokalemia, and lipodystrophy.[6] Other serious side effects include anaphylaxis, and hypersensitivity reactions.[6]

موانع الاستخدام

Do not administer insulin lispro during episodes of hypoglycemia, or if a person has a hypersensitivity to insulin lispro or any of its excipients.[6]

آلية العمل

Through recombinant DNA technology, the final lysine and proline 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 dimers and hexamers. This allows larger amounts of active monomeric insulin to be immediately available for postprandial injections.[11]

الكيمياء

It is a manufactured form of human insulin where the amino acids lysine and proline have been switched at the end of the B chain of the insulin molecule.[8]

تكلفة العلاج

In the United States, in 2015, the cost was between US$10٫06 and US$29٫36 per 100 units.[12] In April 2019, Eli Lilly and Company announced they would produce a version selling for US$137٫35 per vial, about half the then current cost. 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 Patients for Affordable Drugs Now said this was just a public relations move, as "other countries pay US$20 for a vial of insulin."[13]

The cost in the United Kingdom was between GB£1.66 and GB£1.96 per 100 units, in 2017.[14]

التاريخ

insulin lispro (brand name Humalog) was granted marketing authorization in the European Union in April 1996,[15] and it was approved for use in the United States in June 1996.[7][16]

Insulin lispro (brand name Liprolog) was granted marketing authorization in the European Union in May 1997,[17] and again in August 2001.[18]

Combination drugs combining insulin lispro and other forms of insulin were approved for use in the United States in December 1999.[19][20][21]

Insulin lispro Sanofi was granted marketing authorization as a biosimilar in the European Union in July 2017.[22]

Insulin lispro injection (brand name Admelog) was approved for use in the United States in December 2017.[23][24][25]

In January 2020, the Committee for Medicinal Products for Human Use (CHMP) in the European Union recommended granting of a marketing authorization for insulin lispro acid for the treatment of diabetes mellitus in adults.[26][27]

المصادر

  1. ^ أ ب "Insulin lispro Use During Pregnancy". Drugs.com. 7 October 2019. Retrieved 23 February 2020.
  2. ^ "Humalog 100 units/ml, solution for injection in vial - Summary of Product Characteristics (SmPC)". (emc). 30 January 2020. Retrieved 23 February 2020.
  3. ^ أ ب ت ث ج ح خ د ذ ر ز "Insulin Lispro Monograph for Professionals". Drugs.com (in الإنجليزية). American Society of Health-System Pharmacists. Retrieved 3 March 2019.
  4. ^ أ ب British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 698. ISBN 9780857113382.
  5. ^ "Insulin lispro Pregnancy and Breastfeeding Warnings". Drugs.com (in الإنجليزية). Retrieved 3 March 2019.
  6. ^ أ ب ت ث "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. Retrieved 23 February 2020.
  7. ^ أ ب "Humalog approval" (PDF). U.S. Food and Drug Administration (FDA). 14 June 1996. Retrieved 23 February 2020.
  8. ^ أ ب Koivisto VA (June 1998). "The human insulin analogue insulin lispro". Annals of Medicine. 30 (3): 260–6. doi:10.3109/07853899809005853. PMID 9677011.
  9. ^ "NADAC as of 2019-02-27". Centers for Medicare and Medicaid Services (in الإنجليزية). Retrieved 3 March 2019.
  10. ^ "The Top 300 of 2019". clincalc.com. Retrieved 22 December 2018.
  11. ^ 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.
  12. ^ Langreth, Robert (June 29, 2016). "Decoding Big Pharma's Secret Drug Pricing Practices". Bloomberg. Retrieved 15 July 2016. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  13. ^ "Drug company announces new version of insulin at half the price". The Hill. 3 April 2019. Retrieved 15 April 2019.
  14. ^ "Humalog". MIMS. Retrieved 2017-01-12.
  15. ^ "Humalog EPAR". European Medicines Agency (EMA). 11 February 2020. Retrieved 23 February 2020.
  16. ^ "Humalog: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 23 February 2020.
  17. ^ "Liprolog EPAR". European Medicines Agency (EMA). 1 August 2001. Retrieved 23 February 2020.
  18. ^ "Liprolog EPAR". European Medicines Agency (EMA). 11 February 2020. Retrieved 23 February 2020.
  19. ^ "Drug Approval Package: Humalog Mix (75/25 & 50/50) NDA# 21-017 & 21-018". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 23 February 2020.
  20. ^ "Humalog Mix50/50- insulin lispro injection, suspension Humalog Mix50/50 Kwikpen- insulin lispro injection, suspension". DailyMed. 19 November 2019. Retrieved 23 February 2020.
  21. ^ "Humalog Mix75/25- insulin lispro injection, suspension Humalog Mix75/25 Kwikpen- insulin lispro injection, suspension". DailyMed. 3 February 2020. Retrieved 23 February 2020.
  22. ^ "Insulin lispro Sanofi EPAR". European Medicines Agency (EMA). 17 June 2019. Retrieved 23 February 2020.
  23. ^ "Drug Approval Package: Admelog (insulin lispro)". U.S. Food and Drug Administration (FDA). 17 May 2018. Retrieved 23 February 2020.
  24. ^ "FDA Approves Sanofi's Admelog (insulin lispro injection) - Dec 11, 2017". Sanofi (Press release). 11 December 2017. Retrieved 23 February 2020.
  25. ^ "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. Retrieved 12 December 2017.
  26. ^ "Liumjev: Pending EC decision". European Medicines Agency (EMA). 30 January 2020. Retrieved 23 February 2020.
  27. ^ "CHMP Recommends Approval of Lilly's New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes". Eli Lilly and Company (Press release). 31 January 2020. Retrieved 23 February 2020.

وصلات خارجية


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