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 What is Trulicity and how is it used?

Trulicity (duraglutide) is a human GLP-1 receptor agonist that can be used as an aid to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

What are the side effects of Trulicity?

Common side effects of Trulicity include:

• nausea,
• diarrhea,
• Frequent bowel movements,
• Vomiting
• Abdominal pain or discomfort,
• Decreased appetite,
• indigestion,
• fatigue,
• constipation,
• gas,
• Bloating
• Gastroesophageal reflux disease (GERD),
• Lack of energy/lack,
• Feel unwell (discomfort),
• bel
• Hypoglycemia (hypoglycemia).

Description

TRULICITY contains the human GLP-1 receptor agonist dulaglutide. The molecule is a fusion protein consisting of two identical chains connected by disulfide bonds. Each chain contains an N-terminal GLP-1 similar sequence, which is linked to a modified human immunoglobulin G4 (IgG4) via a small peptide linker. ) The Fc part of the heavy chain is covalently linked. And use mammalian cell culture method to produce. The GLP-1 analog of dulaglutide is 90% homologous to natural human GLP-1 (7-37). A structural modification was introduced in the GLP-1 part of the molecule, which is responsible for the interaction with dipeptidyl peptidase-IV (DPP-4). Other modifications were made in the regions with potential T cell epitopes and the IgG4 Fc part of the molecules responsible for binding high-affinity Fc receptors and half-antibody formation. The total molecular weight of dulaglutide is approximately 63 kilodaltons.

TRULICITY is a transparent, colorless sterile solution. Each 0.5 ml of TRULICITY solution contains 0.75 mg or 1.5 mg dulaglutide. Each single-dose pen contains 0.5 mL solution in water for injection and the following excipients: anhydrous citric acid (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg).

Use restrictions

TRULICITY is not recommended as a first-line treatment for patients with insufficient glycemic control during diet and exercise, because the discovery of rodent C-cell tumors is associated with uncertainty in humans. Only prescribe drugs for patients whose potential benefits outweigh the potential risks [see Warnings and Precautions].

For patients with a history of pancreatitis, TRULICITY has not been studied [see Warnings and Precautions]. Patients with a history of pancreatitis should consider other anti-diabetic treatments.

TRULICITY is not suitable for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRULICITY cannot replace insulin.

For patients with severe gastrointestinal diseases (including severe gastroparesis), TRULICITY has not been studied. TRULICITY is not recommended for patients with pre-existing serious gastrointestinal diseases [see Warnings and Precautions].

The recommended starting dose of TRULICITY is 0.75 mg once a week. The dose can be increased to 1.5 mg once a week for additional blood sugar control. The maximum recommended dose is 1.5 mg once a week.

Once a week, TRULICITY is managed at any time, with or without food. TRULICITY should be injected subcutaneously into the abdomen, thigh or upper arm.

If a dose is missed, if there are at least 3 days (72 hours) until the next scheduled dose, instruct the patient to administer it as soon as possible. If there are less than 3 days left before the next scheduled dose, skip the missed dose and take the next dose on the regularly scheduled day. In each case, patients can resume their regular dosing schedule once a week.

As long as necessary, the weekly dosing date can be changed, as long as the last dose is administered 3 days or more before.

Simultaneous use with insulin secretagogues (such as sulfonylureas) or insulin

When starting TRULICITY, please consider reducing the dose of insulin secretagogues (such as sulfonylureas) or insulin used at the same time to reduce the risk of hypoglycemia [see Warnings and Precautions].

Important management instructions

Before starting TRULICITY, the patient should be properly trained in injection techniques by its healthcare professional. Training can reduce the risk of management errors, such as improper injection site, acupuncture and incomplete administration. Please refer to the accompanying instructions for use for complete management instructions with illustrations. The instructions can also be found on www.trulicity.com.

When using TRULICITY with insulin, instruct patients to inject separately and not to mix products. TRULICITY and insulin can be injected in the same body part, but the injections should not be adjacent to each other.

When injecting in the same body part, it is recommended that the patient use a different injection site every week. TRULICITY should not be injected intravenously or intramuscularly. Before application, the TRULICITY solution should be visually inspected for particles and discoloration.

Supply method

Formulations and advantages

Injection: 0.75 mg/0.5 mL solution in a single-dose pen

Injection: 1.5 mg/0.5 mL solution in a single-dose pen

Each TRULICITY single-dose pen is packaged in a cardboard outer box.

Four single-dose pens in a carton

0.75 mg / 0.5 mL solution in a single-dose pen (NDC 0002-1433-80)

1.5 mg / 0.5 mL solution in a single-dose pen (NDC 0002-1434-80)

Storage and handling

Store TRULICITY in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not use TRULICITY after the expiration date.

If required, each single-dose pen can be kept at room temperature not to exceed 86°F (30°C) for a total of 14 days.

Don't freeze TRULICITY. If it is frozen, please do not use TRULICITY.

TRULICITY must be protected from light. It is recommended to keep TRULICITY in the original carton until before administration.

After use, discard the TRULICITY single-dose pen in a puncture-resistant container.

Manufacturers: Eli Lilly and Company of Indiana 46285 and Indianapolis Corporation. Last revision date: January 2019

Side effects and drug interactions

side effect

The following serious reactions will be described below or in the prescription information:

Risk of thyroid C-cell tumors [see warnings and precautions]

Pancreatitis [see warnings and precautions]

Hypoglycemia with concurrent use of insulin secretagogues or insulin [see Warnings and Precautions]

Allergic reaction [see warnings and precautions]

Acute kidney injury [see warnings and precautions]

Severe gastrointestinal disease [see warnings and precautions]

Clinical research experience

Since clinical research is conducted under widely different conditions, it is impossible to directly compare the adverse reaction rate observed in the clinical study of a certain drug with the adverse reaction rate observed in the clinical study of another drug, and it may Can not reflect the adverse reaction rate observed in drug treatment.

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