Trulicity 1.5mg Pre Filled Pens

TRULICITY 1.5mg Pre-Filled Pens

Name

• Common Name: Dulaglutide
• Brand Name: TRULICITY 1.5mg Pre-Filled Pen

Composition Each pre-filled pen contains 1.5 mg of Dulaglutide in 0.5 mL solution. Dulaglutide is produced in CHO cells by recombinant DNA technology.

Uses TRULICITY is prescribed for adults and children aged 10 years and above with Type 2 Diabetes Mellitus to improve blood sugar (glucose) control. It can be used alone when diet and exercise are insufficient and metformin is not tolerated, or in combination with other diabetes medications, including insulin. Additionally, it helps to reduce the risk of major adverse cardiovascular events in adults with Type 2 Diabetes and established cardiovascular disease or multiple cardiovascular risk factors. It works by increasing insulin release when blood sugar is high, reducing sugar production by the liver, and slowing down stomach emptying, which contributes to a feeling of fullness and can aid in weight management.

Dosage and Administration The typical recommended dose for adults is 1.5 mg injected subcutaneously once weekly. For children aged 10 and above, the starting dose is 0.75 mg once weekly, which can be increased to 1.5 mg once weekly if needed for additional glycemic control. In adults, the dose can be further increased to 3 mg and then to a maximum of 4.5 mg once weekly if additional glycemic control is required. The injection can be administered at any time of day, with or without meals, into the abdomen, thigh, or upper arm. If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain, the missed dose should be skipped.

Side Effects Common side effects include nausea, diarrhea, abdominal pain, decreased appetite, vomiting, constipation, flatulence, and fatigue. More serious side effects can include severe low blood sugar (hypoglycemia), especially when used with sulfonylureas or insulin, pancreatitis (inflammation of the pancreas), gallbladder problems, severe allergic reactions (e.g., rashes, swelling, difficulty breathing), and gastroparesis (delayed stomach emptying). There is also a potential risk of medullary thyroid carcinoma, which has been observed in rodent studies, though the human relevance is unknown.

Precautions TRULICITY is not for use in patients with Type 1 Diabetes or diabetic ketoacidosis. Caution is advised for patients with a history of pancreatitis, kidney or liver disease, or severe gastrointestinal disease such as gastroparesis. When used with insulin or sulfonylureas, blood sugar levels should be monitored closely, and dose adjustments of these concomitant medications may be necessary to reduce the risk of hypoglycemia. Alcohol intake should be limited as it can affect blood glucose levels. Inform your doctor if you are undergoing surgery or taking other medications, as TRULICITY can affect the absorption of oral medications.

Storage TRULICITY pre-filled pens should be stored in a refrigerator at 2°C to 8°C. Do not freeze. Keep the pen in its original package to protect it from light. After initial use or if refrigeration is not possible, the pen can be stored at room temperature (below 30°C) for up to 14 days. Do not use if the solution appears cloudy, discolored, or contains particles. Keep out of sight and reach of children.

Here are frequently asked questions about TRULICITY 1.5MG PRE FILLED PENS:

What is TRULICITY 1.5MG used for?

TRULICITY (dulaglutide) 1.5MG is primarily used to help lower blood sugar levels in adults and children aged 10 years and above who have type 2 diabetes mellitus. It can be used alone when diet and exercise are not sufficient and metformin is unsuitable, or in combination with other diabetes medications. Additionally, it is used to reduce the risk of major cardiovascular events, such as heart attack or stroke, in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.

How does TRULICITY work?

TRULICITY contains the active substance dulaglutide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist. It works by mimicking the action of a natural hormone in the body. Specifically, it helps lower blood sugar by increasing insulin release from the pancreas when blood sugar levels are high, decreasing the amount of sugar the liver produces, and slowing down the rate at which food leaves the stomach. These actions contribute to better blood sugar control and can also lead to a feeling of fullness, which may aid in weight loss.

What is the usual dosage of TRULICITY 1.5MG?

TRULICITY is administered as a subcutaneous injection once weekly. For adults, the usual recommended dose is 1.5 mg once weekly, especially when used with other diabetes medications. If additional blood sugar control is needed, your doctor may increase the dose after at least four weeks to 3 mg or up to a maximum of 4.5 mg once weekly. The injection can be given at any time of day, with or without meals, in the abdomen, thigh, or upper arm.

What are the possible side effects of TRULICITY?

Common side effects often include gastrointestinal issues such as nausea, diarrhea, vomiting, decreased appetite, stomach pain, and constipation. These are usually mild to moderate and tend to lessen over time, particularly in the first few weeks of treatment. Less common but serious side effects can include pancreatitis (inflammation of the pancreas), severe hypoglycemia (low blood sugar) especially when used with insulin or sulfonylureas, gallbladder problems, acute kidney injury, and serious allergic reactions. There is also a rare risk of thyroid C-cell tumors, including medullary thyroid carcinoma.

Is TRULICITY safe during pregnancy or breastfeeding?

TRULICITY is generally not recommended during pregnancy or breastfeeding. There is limited data on its use in pregnant women, and animal studies have shown reproductive toxicity. It is unknown if dulaglutide passes into human breast milk, and a risk to newborns or infants cannot be excluded. Your doctor will weigh the potential benefits against the risks if you are pregnant, planning to become pregnant, or breastfeeding.

Can TRULICITY be taken with other medications?

Yes, TRULICITY can be taken with other diabetes medications, including metformin and insulin. However, caution is advised. If you are also taking insulin or a sulfonylurea (another type of diabetes medication), your doctor may need to reduce the dose of these medications to lower the risk of hypoglycemia (low blood sugar). TRULICITY also slows gastric emptying, which could potentially affect the absorption of other oral medications. It's important to inform your doctor about all medications and supplements you are taking.

What precautions should be taken while using TRULICITY?

TRULICITY is not for people with type 1 diabetes or diabetic ketoacidosis. Inform your doctor if you have a history of pancreatitis, gallbladder disease, kidney or liver problems, or severe gastrointestinal disease (like severe gastroparesis). You should monitor for symptoms of pancreatitis, such as severe, persistent abdominal pain. If taking TRULICITY with insulin or sulfonylureas, always carry glucose or sugary foods to treat potential low blood sugar. Limit alcohol intake, as it can increase the risk of low blood sugar. Do not stop taking TRULICITY without consulting your doctor.

What happens if a dose of TRULICITY is missed?

If you miss a dose of TRULICITY, take it as soon as possible if there are at least three days (72 hours) until your next scheduled dose. If there are less than three days (72 hours) remaining before your next scheduled dose, skip the missed dose and simply take your next dose on your regularly scheduled day. Do not take two doses to make up for a missed one. You can change your weekly injection day if needed, as long as the last dose was given at least three days prior.

How should TRULICITY 1.5MG PRE FILLED PENS be stored?

TRULICITY pre-filled pens should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze the pens. If freezing occurs, the pen should not be used. If necessary, a pen can be kept at room temperature (below 30°C or 86°F) for a maximum of 14 days. Keep the pens in their original carton to protect them from light and out of the reach of children.