Product Information
Registration Status: ActiveTRULICITY 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.
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.