rators (2.7 cases per 1000 patient years). An analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to TRULICITY (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years).
After initiation of TRULICITY, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue TRULICITY. If pancreatitis is confirmed, TRULICITY should not be restarted. TRULICITY has not been eva luated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
The risk of hypoglycemia is increased when TRULICITY is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting [see Adverse Reactions (6.1)].
5.4 Hypersensitivity Reactions
Systemic hypersensitivity reactions were observed in patients receiving TRULICITY in clinical trials [see Adverse Reactions (6.1)]. If a hypersensitivity reaction occurs, the patient should discontinue TRULICITY and promptly seek medical advice.
5.5 Renal Impairment
In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal function, use caution when initiating or escalating doses of TRULICITY in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions [see Dosage and Administration (2.3), Use in Specific Populations (8.7)].
5.6 Severe Gastrointestinal Disease
Use of TRULICITY may be associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6.1)]. TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
5.7 Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRULICITY or any other antidiabetic drug.
6 ADVERSE REACTIONS
The following serious reactions are described below or elsewhere in the labeling:
Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]
Pancreatitis [see Warnings and Precautions (5.2)]
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions (5.3)]
Hypersensitivity reactions [see Warnings and Precautions (5.4)]
Renal impairment [see Warnings and Precautions (5.5)]
6.1 Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Pool of Placebo-controlled Trials
The data in Table 1 are derived from the placebo-controlled trials [see Cli |
