Trelagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

LuciTrelag Tablets Simple Instructions

Please use under the guidance of a physician

Product Name: LuciTrelag

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Trelagliptin tablets

English name: Trelagliptin tablets

Drug approval number: 07 L 1143/24

 

【Indications】

LuciTrelag is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

 

【Usage and Dosage】

For adults, 100 mg of trelagliptin is taken orally once a week.

Do not cut, crush, or chew the tablets.

 

【Specification】

100 mg/tablet, 20 tablets/box.

 

【 Contraindications 】

1. Allergic to trelagliptin or any of its ingredients.

2. Patients with severe renal impairment or end-stage renal failure undergoing dialysis.

 

【 Warnings and Precautions 】

1. Hypoglycemia

Concomitant use of trelagliptin and sulfonylureas or insulin preparations may increase the risk of hypoglycemia. Therefore, a dose reduction of the sulfonylurea or insulin preparation should be considered to reduce the risk of hypoglycemia when used in combination with trelagliptin.

2. Acute pancreatitis

Events of acute pancreatitis have been reported postmarketing with trelagliptin and have been associated with other DPP-4 inhibitors. Patients should be carefully observed for signs and symptoms of pancreatitis after initiation of trelagliptin. If pancreatitis is suspected, trelagliptin should be discontinued immediately and appropriate treatment initiated.

 

【Adverse Reactions】

The following table lists adverse drug reactions occurring ≥0.1% to <5%.

	≥ 0.1% to < 5%
allergy	Itchy rash
Cardiovascular	Atrial fibrillation
liver	ALT elevation Elevated AST Increased γ-GTP
other	Increased lipase Amylase increased CPK increased Urine occult blood positive Nasopharyngitis

【Drug Interactions】

No clinically significant interactions (with drugs and food) were observed, nor was there a need for dose adjustment of trelagliptin or other concomitant medications.

Trelagliptin is primarily excreted via the kidneys. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug interactions were observed with the tested CYP substrates.

Effects of other drugs on trelagliptin.

Results of clinical interaction studies indicate that there are no clinically relevant effects of glimepiride or metformin on the pharmacokinetics of trelagliptin.

Effects of trelagliptin on other medical products

In vitro studies have shown that trelaglipin neither inhibits nor induces CYP 450 isoforms at concentrations achieved at the recommended dose of 100 mg trelagliptin.

Trelagliptin is a substrate of P-glycoprotein. In vitro studies have shown that it has a slight inhibitory effect on the transport of digoxin through P-glycoprotein (IC50 value: 500µmol/L or higher) or inhibits the uptake of metformin, a substrate of organic cation transporter-2 (OCT2) (IC50: 55.9µmol/L).

In clinical studies, trelagliptin had no clinically relevant effects on the pharmacokinetics of caffeine, tolbutamide, dextromethorphan, midazolam, metformin, or glimepiride, thus providing in vivo evidence of a low propensity to interact with CYP1A2, CYP2C9, CYP2D6, CYP3A4, or OCT2 substrates.

【Use by specific groups】

Pregnant

Trelagliptin should not be administered to women who are pregnant or who may become pregnant unless the expected therapeutic effect is considered to outweigh any possible risks to the mother and fetus. To date, no clinical studies have been conducted to evaluate the effects of trelagliptin in pregnant subjects.

Lactation

During treatment with trelagliptin, mothers should avoid breastfeeding if they need to take this drug. To date, no clinical studies have been conducted to evaluate the effects of trelagliptin in breastfeeding subjects.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.