1. Name of the medicinal product
Trulicity 0.75 mg solution for injection in pre-filled pen.
Trulicity 0.75 mg solution for injection in pre-filled syringe.
Trulicity 1.5 mg solution for injection in pre-filled pen.
Trulicity 1.5 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Pre-filled pen
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution.
Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml solution.
Pre-filled syringe
Each pre-filled syringe contains 0.75 mg of dulaglutide* in 0.5 ml solution.
Each pre-filled syringe contains 1.5 mg of dulaglutide* in 0.5 ml solution.
*Produced in CHO cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Add-on therapy
In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).
4.2 Posology and method of administration
Posology
Monotherapy
The recommended dose is 0.75 mg once weekly.
Add-on therapy
The recommended dose is 1.5 mg once weekly.
For potentially vulnerable populations, such as patients ≥ 75 years, 0.75 mg once weekly can be considered as a starting dose.
When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When it is added to existing therapy of a sulphonylurea or prandial insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).
The use of Trulicity does not require blood glucose self-monitoring. Self-monitoring may be necessary to adjust the dose of sulphonylurea or prandial insulin.
Elderly patients (> 65 years old)
No dose adjustment is required based on age (see section 5.2). However, the therapeutic experience in patients ≥ 75 years is very limited (see section 5.1), and in these patients 0.75 mg once weekly can be considered as a starting dose.
Patients with renal impairment
No dosage adjustment is required in patients with mild or moderate renal impairment.
There is very limited experience in patients with severe renal impairment (eGFR [by CKD-EPI] < 30 ml/min/1.73 m2) or end stage renal disease, therefore Trulicity is not recommended in this population (see section 5.2).
Patients with hepatic impairment
No dosage adjustment is required in patients with hepatic impairment.
Paediatric population
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established. No data are available.
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.
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.
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function since these events, i.e. nausea, vomiting, and/or diarrhoea, may cause dehydration which could cause a deterioration of renal function. Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Acute pancreatitis
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. In clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8).
Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, dulaglutide should be discontinued. If pancreatitis is confirmed, dulaglutide should not be restarted. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis (see section 4.8).
Hypoglycaemia
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin (see sections 4.2 and 4.8).
Populations not studied
There is limited experience in patients with congestive heart failure.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially 'sodium- free'.
4.5 Interaction with other medicinal products and other forms of interaction
Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Dulaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption. For some prolonged release formulations, an increased release due to an extended gastric residence time may slightly increase drug exposure.