Trulicity Dulaglutide Injection

Brand Name: 度易达 ®(Trulicity®)
Generic Name: Dulaglutide
Strength: 0.75 mg in 0.5 mL per single-use pre-filled pen, 2 pens per box
Manufacturer: Eli Lilly and Company
Marketing Authorization Holder: Eli Lilly Suzhou Pharmaceutical Co., Ltd.
Approval Date in China: February 26, 2019
Registration Number:国药准字 HJ20190007
Storage: Store refrigerated at 2°C to 8°C; avoid freezing. Unopened pens can be stored below 30°C for up to 14 days. Protect from light. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.

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1. Indications and Usage
Dulaglutide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It can be used as monotherapy or in combination with other antidiabetic agents.
2. Dosage and Administration
Recommended Dosage: The recommended starting dosage is 0.75 mg administered once weekly. To further improve glycemic control, the dosage can be increased to 1.5 mg once weekly.
Administration: Administered by subcutaneous injection into the thigh, abdomen, or upper arm. It must not be administered intravenously or intramuscularly. It can be given at any time of day, with or without meals.
Missed Dose: If a dose is missed, it should be administered as soon as possible within 3 days (72 hours) of the scheduled day. If more than 3 days have passed, the missed dose should be skipped, and the next dose administered on the regularly scheduled day.
3. Mechanism of Action
Dulaglutide is a GLP-1 receptor agonist. It activates the GLP-1 receptor, leading to glucose-dependent stimulation of insulin secretion, suppression of glucagon secretion, and slowing of gastric emptying.
4. Safety and Warnings
Thyroid C-Cell Tumor Risk: Rodent studies show dulaglutide causes thyroid C-cell tumors. It is unknown whether this risk is present in humans. Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Pancreatitis: Acute pancreatitis has been reported in patients treated with GLP-1 receptor agonists.
Hypoglycemia: When used in combination with insulin or sulfonylureas, the risk of hypoglycemia is increased, and a dose reduction of the concomitant agent may be necessary.
Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.
Renal Impairment: Acute renal failure and worsening of chronic renal failure have been reported, often in the setting of nausea, vomiting, or diarrhea.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include nausea, diarrhea, vomiting, abdominal pain, and constipation. These are usually mild to moderate and tend to decrease in frequency with continued use.
Clinical Research: Clinical trials have demonstrated that dulaglutide significantly reduces HbA1c and body weight in patients with type 2 diabetes.
6. Drug Interactions
Oral Medications: As dulaglutide slows gastric emptying, it may delay the absorption of concomitantly administered oral medications. Clinical relevance is unknown.
Antidiabetic Agents: When used with sulfonylureas or insulin, dose reduction of these agents may be necessary to reduce the risk of hypoglycemia.
7. Pharmaceutical Information
Composition: Available as a solution for subcutaneous injection in pre-filled pens (0.75 mg/0.5 mL and 1.5 mg/0.5 mL).
Appearance: The solution is clear and colorless to slightly yellow.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. It may be stored at temperatures up to 30°C (86°F) for up to 14 days. Protect from light.

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