Dulaglutide

What is Dulaglutide?

• Dulaglutide (TRULICITY) is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes in combination with diet and exercise.

What are the uses of this medicine?

This medicine is used:

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
• to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with type 2 diabetes mellitus with known heart disease or multiple cardiovascular risk factors.

Limitations of Use:

• Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients .
• Not for treatment of type 1 diabetes mellitus.
• Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis

How does this medicine work?

• Dulaglutide (doo" la gloo' tide) is a glucagon-like peptide-1 (GLP-1) analogue that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion.
• Dulaglutide reproduces the activity of GLP-1, binding to specific receptors on pancreatic beta cells and increasing insulin secretion, which can lead to improvement of glycemic control in patients with type 2 diabetes.
• Dulaglutide, like other GLP-1 analogues, also causes weight loss which may contribute to its clinical effects.
• Dulaglutide is a recombinant DNA produced polypeptide that shares 97% homology to endogenous human GLP-1(7-37), but has an amino acid substitution which makes it resistant to DPP-4 degradation and thus extends its half-life in serum.
• In addition, the GLP-1 like polypeptide is linked to an Fc fragment of human IgG4 which further prolongs its serum half-life and duration of activity. Dulaglutide, like other GLP-1 analogues, must be given parenterally.

Who Should Not Use this medicine ?

This medicine cannot be used in patients if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• you are allergic to dulaglutide or any of the ingredients in TRULICITY.

What drug interactions can this medicine cause?

• TRULICITY delays gastric emptying and has the potential to reduce the rate of absorption of concomitantly administered oral medications.
• When initiating TRULICITY, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended initiating dose of TRULICITY is 0.75 mg injected subcutaneously once weekly.
• Increase the dose to 1.5 mg once weekly for additional glycemic control.
• If additional glycemic control is needed, increase the dose to 3 mg once weekly after at least 4 weeks on the 1.5 mg dose.
• If additional glycemic control is needed, increase the dose to the maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3 mg dose.

Administration

• Use TRULICITY exactly as your healthcare provider tells you to.
• TRULICITY is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use TRULICITY 1 time each week on the same day each week at any time of the day.
• You may change the day of the week as long as your last dose was given 3 or more days before.
• If you miss a dose of TRULICITY, take the missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of TRULICITY within 3 days of each other.
• TRULICITY may be taken with or without food.
• Do not mix insulin and TRULICITY together in the same injection.
• You may give an injection of TRULICITY and insulin in the same body area (such as, your stomach area), but not right next to each other.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much TRULICITY, call your healthcare provider or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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
• Injection: 3 mg/0.5 mL solution in a single-dose pen
• Injection: 4.5 mg/0.5 mL solution in a single-dose pen

This medicine is available in fallowing brand namesː

• TRULICITY

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• diarrhea
• vomiting
• stomach (abdominal) pain
• decreased appetite

TRULICITY may cause serious side effects, including:

• Possible thyroid tumors, including cancer
• Inflammation of your pancreas (pancreatitis)
• Low blood sugar (hypoglycemia)
• Serious allergic reactions
• Kidney problems (kidney failure)
• Severe stomach problems
• Changes in vision

What special precautions should I follow?

• Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.
• TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.
• After initiation of TRULICITY, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, promptly discontinue TRULICITY. If pancreatitis is confirmed, TRULICITY should not be restarted. TRULICITY has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• Patients receiving TRULICITY in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary.
• In patients treated with GLP-1 receptor agonists, including TRULICITY, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
• Use of TRULICITY may be associated with gastrointestinal adverse reactions, sometimes severe. TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
• Diabetic retinopathy complications have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• primarily mild or moderate gastrointestinal events (e.g., nausea, vomiting)
• non-severe hypoglycemia

Management of overdosage:

• In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient's clinical signs and symptoms.

Can this medicine be used in pregnancy?

• Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of TRULICITY have not been established in pediatric patients. TRULICITY is not recommended for use in pediatric patients younger than 18 years.

What are the active and inactive ingredients in this medicine?

• Active ingredient: Dulaglutide
• Inactive ingredients: Citric acid anhydrous, mannitol, polysorbate 80, trisodium citrate dihydrate, in water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA

What should I know about storage and disposal of this medication?

• Store TRULICITY in the refrigerator at 36°F to 46°F (2°C to 8°C).
• If needed, each single-dose pen can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.
• Do not freeze Trulicity. Do not use TRULICITY if it has been frozen.
• Protect TRULICITY from light. Storage of TRULICITY in the original carton is recommended until time of administration.

• Dailymed label info on Dulaglutide
• FDA Dulaglutide

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