Trulicity

75 mg once weekly. 5 mg once weekly. 5 mg dose can be increased after at least 4 weeks to 3 mg once weekly. 5 mg once weekly. 5 mg once weekly. 75 mg once weekly. 5 mg once weekly after at least 4 weeks. 5 mg once weekly. Combination therapy When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued.

When Trulicity is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued. 8). 4 The use of Trulicity does not require blood glucose self-monitoring.

Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended. Missed doses 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 (72 hours) remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

2). 73m2). 2). Hepatic impairment No dose adjustment is required in patients with hepatic impairment. 2). Method of administration Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be administered intravenously or intramuscularly.

The dose can be administered at any time of day, with or without meals. The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days (72 hours) before.

5 mg, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products. The most frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, vomiting and diarrhoea.

In general, these reactions were mild or moderate in severity and transient in nature. 4 years were consistent with these findings. Tabulated list of adverse reactions The following adverse reactions have been identified based on evaluation of the full duration of the phase 2 and phase 3 clinical studies, the long-term cardiovascular outcome study and post-marketing reports.

The adverse reactions are listed in Table 1 as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000 and not known: cannot be estimated from available data).

Within each incidence grouping, adverse reactions are presented in order of decreasing frequency. Frequencies for events have been calculated based on their incidence in the phase 2 and phase 3 registration studies. Table 1. The frequency of adverse reactions of dulaglutide System organ class Very common Common Uncommon Rare Not known Immune system disorders Hypersensitivity Anaphylactic reaction# Metabolism and nutrition disorders Hypoglycaemia* (when used in combination with insulin, glimepiride, metformin† or metformin plus glimepiride) Hypoglycaemia* (when used as monotherapy or in combination with metformin plus pioglitazone) Dehydration 9 # From post-marketing reports.

75 mg, adverse reaction met frequency for next lower incidence grouping. 5 mg group and 2 % (1 patient) in the placebo group. All events were mild to moderate in severity. 62 events/patient/year, and no episodes of severe hypoglycaemia were reported.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Type 1 diabetes mellitus or diabetic ketoacidosis 5 Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Dulaglutide is not a substitute for insulin. 2). Severe gastrointestinal disease Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Events related to impaired gastric emptying, including severe gastroparesis, have been reported. Monitor and consider dose modification or discontinuation in patients who develop severe gastrointestinal symptoms while on treatment. Aspiration in association with general anaesthesia or deep sedation Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation.

8) should be considered prior to performing procedures with general anaesthesia or deep sedation. Dehydration Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been reported in patients treated with dulaglutide, especially at the initiation of treatment.

Many of the reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, or dehydration. Patients treated with dulaglutide should be advised of the potential risk of dehydration, particularly in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.

Acute pancreatitis Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. 8). Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, dulaglutide should be discontinued.

1.