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Trulicity® Important Safety Information | WW USA

Important Trulicity® Safety Information

Most Important Safety Information

  • In male and female rats, dulaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and carcinoma) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.
  • 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). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.
  • Do not use Trulicity if you have had a serious allergic reaction to dulaglutide or any of the ingredients in Trulicity.

What is the FDA-approved use of Trulicity?

Trulicity is a glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Trulicity is also approved to reduce the risk of major cardiovascular events in people with type 2 diabetes and cardiovascular disease or multiple risk factors for heart disease.

Limitations of Use:

  • Trulicity has not been studied in patients with a history of pancreatitis.
  • Trulicity should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Trulicity is not a substitute for insulin.
  • Trulicity has not been studied in patients with pre-existing severe gastrointestinal disease and is not recommended for patients with pre-existing severe gastrointestinal disease.
  • Trulicity has not been studied in combination with basal insulin.

What should I tell my provider before using Trulicity?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • you or a member of your family has or has had medullary thyroid carcinoma, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • have type 1 diabetes.
  • have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
  • Pancreatitis.
  • a stomach or intestinal disorder
  • gastroesophageal reflux disease (GERD) or slow digestion
  • eye problems caused by diabetes (retinopathy)
  • liver or kidney disease
  • if you also use insulin or oral diabetes medicine; or
  • if you have been sick with vomiting or diarrhea.

Whether you are pregnant, planning to become pregnant, or breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Insulin
  • Sulfonylureas (these can cause blood sugar levels to drop dangerously low when combined with Trulicity)
  • Other GLP-1 or GLP-1/GIP receptor agonist medications such as liraglutide, semaglutide, or tirzepatide
  • You should not drink alcohol while taking this drug because alcohol can lower blood sugar. Combining alcohol with Trulicity may cause blood sugars to fall too fast, leading to fainting and dizziness.
  • If you’re using other products for weight loss, including dietary supplements

What are the most serious side effects that I or a caregiver should monitor for when taking Trulicity?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Trulicity. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Thyroid C-Cell Tumors: In mice and rats, dulaglutide (the active ingredient in Trulicity) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Trulicity causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Trulicity is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
  • Acute Gallbladder Disease: Trulicity may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
  • Low Blood Sugar (hypoglycemia): Trulicity lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
  • Serious Allergic Reactions: Stop using Trulicity right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
  • Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
  • Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
  • Never Share a Pen: Pen-sharing poses a risk of infection.

These common side effects can occur with Trulicity.

  • Nausea
  • Diarrhea
  • Vomiting
  • Abdominal pain and decreased appetite
  • Indigestion
  • Fatigue

You are encouraged to report negative side effects of prescription products:

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Trulicity® is a registered trademark of Eli Lilly.