![]() Very common (10% or more): Hypoglycemia (up to 85% when combined with prandial insulin)Ĭommon (1% to 10%): Decreased appetite Cardiovascularĭuring clinical trials, a mean increase in heart rate of 2 to 4 beats per minute was observed. As add-on therapy to metformin or metformin plus pioglitazone, symptomatic hypoglycemia occurred in up to 5.6% of patients, with no reports of severe hypoglycemia. In combination with a sulfonylurea, symptomatic hypoglycemia occurred in 39% and 40%. ![]() In combination with prandial insulin, hypoglycemia occurred in 85% and 80% of patients receiving 0.75 mg and 1.5 mg severe hypoglycemia in 2.4% and 3.4% of patients, respectively. Hypoglycemia occurred more frequently when this drug was used in combination with a sulfonylurea or insulin. Prior to receiving treatment, this patient had calcitonin levels approximately 8 times the upper limit of normal. ![]() One case of Medullary Thyroid Carcinoma (MTC) has been reported in a patient treated with this drug. Very rare (less than 0.01%): Medullary Thyroid Carcinoma Postmarketing reports: Anaphylactic reactions, angioedema Oncologic Uncommon (0.1% to 1%): Systemic hypersensitivity including severe urticaria, systemic rash, facial edema, lip swelling Very common (10% or more): Nausea (up to 21.1%), diarrhea (up to 13.7%), vomiting (up to 11.5%)Ĭommon (1% to 10%): Abdominal pain, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation, lipase and/or pancreatic amylase increases from baseline (up to 20%)įrequency not reported: Pancreatitis Hypersensitivity The severity of events was graded by clinical trial investigators. Cases were graded as mild, moderate, or severe in 58% and 48%, 35% and 43%, and 7% and 11%, of patients receiving the 0.75 mg dose and the 1.5 mg dose, respectively. Gastrointestinal events occurred more frequently with the higher dose. ![]() Analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in dulaglutide-exposed patients compared with 1 case in the non-incretin comparator group. Gastrointestinalĭuring clinical trials, a greater number of pancreatitis related adverse reactions were reported in patients exposed to this drug versus non-incretin comparators (12 cases vs 3 cases). The most common adverse reactions included nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. general feeling of discomfort or illnessĪpplies to dulaglutide: subcutaneous solution.bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.Ĭheck with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common These side effects may go away during treatment as your body adjusts to the medicine. Some side effects of dulaglutide may occur that usually do not need medical attention. swelling of the eyes or inside of the nose.reddening of the skin, especially around the ears.pains in the stomach, side, or abdomen, possibly radiating to the back.large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs.difficulty with breathing or swallowing.Although not all of these side effects may occur, if they do occur they may need medical attention.Ĭheck with your doctor immediately if any of the following side effects occur while taking dulaglutide: Less common Serious side effects of TrulicityĪlong with its needed effects, dulaglutide (the active ingredient contained in Trulicity) may cause some unwanted effects. Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with dulaglutide. Counsel patients regarding the potential risk of MTC with use of dulaglutide and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Dulaglutide 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 dulaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. In male and female rats, dulaglutide caused a dose-related and treatment- duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.
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