Wikipedia

Insulin aspart

(Redirected from NovoLog Flexpen Mix)

Insulin aspart, sold under the brand name NovoLog, among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes.[17] It is generally used by injection under the skin but may also be used by injection into a vein.[17] Maximum effect occurs after about 1–3 hours and lasts for 3–5 hours.[17] Generally a longer-acting insulin like insulin NPH is also needed.[17]

Insulin aspart
Clinical data
Trade namesNovoLog, NovoRapid, Fiasp, others
BiosimilarsKirsty,[1] Trurapi,[2] Truvelog[3]
AHFS/Drugs.comMonograph
MedlinePlusa605013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Onset of action15 minutes
Duration of action3–5 hours
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC256H381N65O79S6
Molar mass5825.60 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Common side effects include low blood sugar, allergic reactions, itchiness, and pain at the site of injection.[17] Other serious side effects may include low blood potassium.[17] Use in pregnancy and breastfeeding is generally safe.[4] 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.[17] It is a manufactured form of human insulin; where a single amino acid has been changed, specifically a proline with an aspartic acid at the B28 position.[18]

Insulin aspart was approved for medical use in the United States in 2000.[17] In 2022, it was the 76th most commonly prescribed medication in the United States, with more than 8 million prescriptions.[19][20] Manufacturing involves yeast, which have had the gene for insulin aspart put into their genome.[21] This yeast then makes the insulin, which is harvested from the bioreactor.[22]

Medical uses

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Insulin aspart is indicated to improve glycemic control in people with diabetes.[12][13]

Onset of action

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The onset of action is approximately fifteen minutes, the peak action is reached in 45–90 minutes, and the duration is 3–5 hours.[13]

Side effects

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The safety of insulin aspart in people with diabetes is no different from that of regular insulin. The side effects that are commonly associated with insulin therapy include: allergic reactions, injection site irritation, rashes, and hypoglycemia.[23] The most common side effect is hypoglycemia. Long-term use of insulin, including insulin aspart, can cause lipodystrophy at the site of repeated injections or infusion. To reduce the risk of lipodystrophy, rotate the injection sites within the same region. Weight gain can also occur with the use of insulin aspart and it has been attributed to anabolic effects of insulin and a decrease in glucosuria. Use of insulin aspart has also been associated with sodium retention and edema.[24]

Formulations

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Insulin aspart can be used in an insulin pump and insulin pen for subcutaneous injection. Additionally, it can be used with an injection port such as the I-port.[25]

Insulin aspart has a more rapid onset, and a shorter duration of activity than normal human insulin.[26] Insulin aspart can also be used with external insulin pumps.[13]

 
This is a picture of an insulin aspart injection (NovoLog brand) along with its packaging.

Variations

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NovoLog Mix 70/30 is a product which contains 30% insulin aspart and 70% insulin aspart protamine.[14] The insulin aspart protamine portion is a crystalline form of insulin aspart, which delays the action of the insulin, giving it a prolonged absorption profile after injection.[14] The combination of the fast-acting form and the long-acting form allows the patient to receive fewer injections over the course of the day.[27]

NovoLog Mix is marketed to be used with the Novo Nordisk FlexPen.[28] The onset of action is less than 30 minutes, the peak action is reached in 1–4 hours, and the duration is less than 24 hours.[29] NovoLog Mix is marketed in some countries as NovoMix 30.[30][15]

NovoRapid is produced in Saccharomyces cerevisiae by recombinant DNA technology.[11]

A faster acting version of aspart insulin, known as fast-aspart (Fiasp) insulin, is associated with more efficient control of post-prandial rise in blood glucose, without increasing the risks of hypoglycemia and glycemic variability.[31][32][33]

Biosimilars

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In December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kixelle, intended for the treatment of diabetes.[34] The applicant for this medicinal product is Mylan IRE Healthcare Limited. Kixelle was approved for medical use in the European Union in February 2021.[35] Kixelle was renamed to Kirsty.[1]

Trurapi was approved for medical use in Canada in October 2020.[36]

Truvelog and Truvelog Solostar were approved for medical use in Australia in October 2020.[3][7]

In October 2021, Kirsty was approved for medical use in Canada.[37]

In February 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Truvelog Mix 30, intended for the treatment of diabetes.[38] The applicant for this medicinal product is sanofi-aventis groupe.[38] It was approved for medical use in the European Union in April 2022.[16][39]

Society and culture

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As of 2018, there is a lack of compelling evidence to conclude superiority of insulin aspart over human insulin in type 2 diabetes.[40] It is thus unclear why the shifting of people from human insulin to insulin aspart has occurred.[41] In type 1 diabetes it appears to result in slightly better blood sugar control.[42]

References

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  1. ^ a b c "Kirsty EPAR". European Medicines Agency (EMA). 9 December 2020. Archived from the original on 15 September 2021. Retrieved 14 September 2021.
  2. ^ "Approved in 2020: Drugs for human use". Health Canada. 26 July 2021. Retrieved 27 March 2024.
  3. ^ a b c d "Truvelog". Therapeutic Goods Administration (TGA). 23 October 2020. Archived from the original on 13 June 2021. Retrieved 12 June 2021.
  4. ^ a b "Insulin aspart Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 6 March 2019. Retrieved 3 March 2019.
  5. ^ a b "Australian Public Assessment Report for Insulin aspart" (PDF). Therapeutic Goods Administration (TGA). March 2021. Archived from the original (PDF) on 24 June 2021.
  6. ^ "Australian Public Assessment Report for Insulin aspart (rys)" (PDF). Therapeutic Goods Administration (TGA). August 2021. Archived from the original (PDF) on 5 February 2022.
  7. ^ a b "Truvelog Solostar ARTG". Therapeutic Goods Administration (TGA). Archived from the original on 13 June 2021. Retrieved 12 June 2021.
  8. ^ "Regulatory Decision Summary - Fiasp". Health Canada. 23 October 2014. Archived from the original on 5 June 2022. Retrieved 4 June 2022.
  9. ^ "Regulatory Decision Summary - Trurapi". Health Canada. 23 October 2014. Archived from the original on 5 June 2022. Retrieved 4 June 2022.
  10. ^ "Diabetic health". Health Canada. 8 May 2018. Retrieved 13 April 2024.
  11. ^ a b "NovoRapid 100 units/ml in a vial - Summary of Product Characteristics (SmPC)". (emc). 25 May 2018. Archived from the original on 16 January 2021. Retrieved 9 September 2020.
  12. ^ a b "Fiasp- insulin aspart injection injection, solution". DailyMed. 19 December 2019. Archived from the original on 13 November 2020. Retrieved 12 November 2020.
  13. ^ a b c d "NovoLog- insulin aspart injection, solution Insulin Diluting Medium For NovoLog- water injection injection, solution". DailyMed. 15 November 2019. Archived from the original on 12 November 2020. Retrieved 12 November 2020.
  14. ^ a b c "NovoLog Mix 70/30- insulin aspart injection, suspension". DailyMed. 15 November 2019. Archived from the original on 29 September 2020. Retrieved 12 November 2020.
  15. ^ a b "NovoMix EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 13 April 2020. Retrieved 12 April 2020.
  16. ^ a b "Truvelog Mix 30 EPAR". European Medicines Agency. 23 February 2022. Archived from the original on 17 June 2022. Retrieved 16 June 2022.
  17. ^ a b c d e f g h "Insulin Aspart Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019.
  18. ^ Turner JR (2010). New Drug Development: An Introduction to Clinical Trials: Second Edition. Springer Science & Business Media. p. 32. ISBN 9781441964182. Archived from the original on 20 April 2021. Retrieved 11 September 2020.
  19. ^ "The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  20. ^ "Insulin Aspart Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Retrieved 30 August 2024.
  21. ^ Banga AK (2005). Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Second Edition. CRC Press. p. 13. ISBN 9781420039832. Archived from the original on 20 April 2021. Retrieved 11 September 2020.
  22. ^ Schmid RD, Schmidt-Dannert C (2016). Biotechnology: An Illustrated Primer. John Wiley & Sons. p. 222. ISBN 9783527677566. Archived from the original on 20 April 2021. Retrieved 11 September 2020.
  23. ^ "Novolog: most FAQ". Archived from the original on 3 October 2011. Retrieved 18 April 2011.
  24. ^ "Novolog: insulin aspart (rDNA origin) injection" (PDF). Novo Nordisk. Archived (PDF) from the original on 22 March 2011. Retrieved 18 April 2011.
  25. ^ "Aspart insulin (rDNA origin) injection". Archived from the original on 10 June 2007. Retrieved 8 June 2007.
  26. ^ "Novolog: insulin aspart" (PDF). Food and Drug Administration. Archived (PDF) from the original on 17 May 2017. Retrieved 16 December 2019.
  27. ^ "NovoLog Mix 70/30". Rx List. 6 August 2008. Archived from the original on 20 April 2009.
  28. ^ "NovoLog Mix 70/30". Novo Nordisk. 2008. Archived from the original on 8 May 2009.
  29. ^ Beals JM, DeFelippis MR, Kovach PM (2008). "Insulin". In Crommelin DJ, Sindelar RD, Meibohm B (eds.). Pharmaceutical Biotechnology: Fundamentals and Applications. New York, NY: Informa Healthcare USA, Inc. p. 265–280 (270). ISBN 978-1-4200-4437-9.
  30. ^ "NovoMix 30 FlexPen 100 units/ml - Summary of Product Characteristics (SmPC)". (emc). 27 March 2019. Archived from the original on 13 April 2020. Retrieved 12 April 2020.
  31. ^ Dutta D, Mohindra R, Mahajan K, Sharma M (January 2023). "Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis". Diabetes & Metabolism Journal. 47 (1): 72–81. doi:10.4093/dmj.2022.0035. PMC 9925142. PMID 35746893.
  32. ^ Evans M, Ceriello A, Danne T, De Block C, DeVries JH, Lind M, et al. (September 2019). "Use of fast-acting insulin aspart in insulin pump therapy in clinical practice". Diabetes, Obesity & Metabolism. 21 (9): 2039–2047. doi:10.1111/dom.13798. PMC 6773364. PMID 31144428.
  33. ^ Evans M, Wilkinson M, Giannpolou A (October 2019). "Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin". Diabetes Therapy. 10 (5): 1793–1800. doi:10.1007/s13300-019-00685-0. PMC 6778592. PMID 31485918.
  34. ^ "Kixelle: Pending EC decision". European Medicines Agency (EMA). 10 December 2020. Archived from the original on 12 December 2020. Retrieved 12 December 2020.
  35. ^ "Kixelle EPAR". European Medicines Agency (EMA). 9 December 2020. Archived from the original on 29 June 2021. Retrieved 16 March 2021.
  36. ^ "Summary Basis of Decision (SBD) for Trurapi". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  37. ^ "Summary Basis of Decision (SBD) for Kirsty". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  38. ^ a b "Truvelog Mix 30: Pending EC decision". European Medicines Agency. 24 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  39. ^ "Truvelog Mix 30 Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  40. ^ Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, et al. (December 2018). "Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus". The Cochrane Database of Systematic Reviews. 12 (12): CD013228. doi:10.1002/14651858.CD013228. PMC 6517032. PMID 30556900.
  41. ^ Cohen D, Carter P (December 2010). "How small changes led to big profits for insulin manufacturers". BMJ. 341: c7139. doi:10.1136/bmj.c7139. PMID 21159773. S2CID 30709912.
  42. ^ Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, et al. (June 2016). "Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus". The Cochrane Database of Systematic Reviews. 2016 (6): CD012161. doi:10.1002/14651858.CD012161. PMC 6597145. PMID 27362975.
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