TRULICITY INJECTION 0.75MG/0.5ML

Product Information

Registration Status: Active

TRULICITY INJECTION 0.75MG/0.5ML is approved to be sold in Singapore with effective from 2016-03-18. It is marketed by ELI LILLY (SINGAPORE) PTE LTD, with the registration number of SIN14968P.

This product contains Dulaglutide 0.75mg/0.5ml in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Eli Lilly and Company in UNITED STATES, andVetter Pharma-Fertigung GmbH & Co KG in GERMANY.

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

Dulaglutide

Description

Dulaglutide is a novel glucagon-like peptide-1 agonist (GLP-1) biologic drug consisting of a dipeptidyl peptidase-IV-protected GLP-1 analogue covalently linked to a human IgG4-Fc heavy chain by a small peptide linker. Dulaglutide is indicated in the treatment of type 2 diabetes and can be used once a week. It was approved by the FDA in September 2014. Dulaglutide is manufactured and marketed by Eli Lily under the brand Trulicity™. It is not known if dulaglutide can increase the risk of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and is thus not recommended for use in populations with a personal or family history of these conditions.

Indication

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Mechanism of Action

Dulaglutide is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

Pharmacokinetics

Absorption
Maximum plasma concentration (Cmax) is achieved in 24–72 h (median 48 h) after a subcutaneous injection administered at a steady state.
Distribution
After subcutaneous administration of 0.75 mg and 1.5 mg to steady state were approximately 19.2 L (range 14.3 to 26.4 L) and 17.4 L (range 9.3 to 33 L), respectively.
Metabolism
Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.
Elimination

Clearance

The mean apparent clearance at steady state of dulaglutide is approximately 0.111 L/h for the 0.75 mg dose, and 0.107 L/h for the 1.5 mg dose.

Toxicity

-RISK OF THYROID C-CELL TUMORS -Dulaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Dulaglutide.

Active Ingredient/Synonyms

Dulaglutide | Dulaglutide |


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.

References

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