TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 200 U/ML

Insulin Degludec

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Insulin Degludec | Insulin Degludec |

Description

Insulin Degludec is an ultra-long-acting insulin analogue used for glycemic control in Diabetes Mellitus. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake and by preventing hepatic glucose production. Compared to endogenous insulin, this product has an added hexadecanedioic acid to lysine at the B29 position which allows for the formation of multi-hexamers. When injected subcutaneously, these multi-hexamers form a drug depot store from which monomers are slowly and continuously absorbed into the circulation. As a result, Insulin Degludec has a protracted time action profile due to the delayed absorption from subcutaneous tissue depots into the systemic circulation. Compared to available long-acting analogues such as insulin glargine and insulin detemir, which have a duration of action of 20-24 hours, insulin degludec provides a consistent level of basal insulin over 42 hours with a low peak:trough ratio. Limitations of shorter acting analogues include more frequent dosing and less stable pharmacokinetics, which may negatively impact patient adherence and glucose control, particularly nocturnal control. Insulin Degludec was approved by the FDA in September 2015 as the product Tresiba, for use in providing glycemic control to adults with diabetes mellitus.

Indication

Insulin degludec is indicated to improve glycemic control in adults with diabetes mellitus.

Mechanism of Action

Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake and by preventing hepatic glucose production. Compared to endogenous insulin, Insulin Degludec has an added hexadecanedioic acid to lysine at the B29 position which allows for the formation of multi-hexamers in subcutaneous tissues. When injected subcutaneously, these multi-hexamers form a drug depot store that slowly release. As a result, Insulin Degludec has a protracted time action profile due to the delayed absorption from subcutaneous tissue depots into the systemic circulation

Pharmacodynamics

Not Available

Pharmacokinetics

Absorption:

In patients with type 1 diabetes, after 8 days of once daily subcutaneous dosing with 0.4 U/kg, maximum degludec concentrations of 4472 pmol/L were attained at a median of 9 hours (tmax). After the first dose of, median onset of appearance was around one hour. The glucose lowering effect lasted at least 42 hours after the last of 8 once-daily injections. Insulin degludec concentration reach steady state levels after 3-4 days.

Distribution:

Not Available

Metabolism:

All insulin degludec metabolites are inactive.

Elimination:

Not Available

Half-life

The half-life after subcutaneous administration is determined primarily by the rate of absorption from the subcutaneous tissue. On average, the half-life at steady state is approximately 25 hours independent of dose.

Clearance

0.03 L/kg

Toxicity

Observe for signs and symptoms of hypoglycemia, hypokalemia, and fluid retention and heart failure with concomitant use of Thiazolidinediones. Pregnancy Category C

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 200 U/ML was registered with Health Science Authority of Singapore by NOVO NORDISK PHARMA (SINGAPORE) PTE LTD. It is marketed with the registration number of SIN15704P with effective from 2019-05-31.

This product contains 200U/ml of Insulin Degludec in the form of INJECTION, SOLUTION.

The medicine was manufactured by Novo Nordisk A/S (Bagsvaerd) (Bulk production and Primary Packager) in DENMARK

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: A10AE06

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