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  • Trulicity 0.75 mg, 1.5 mg
    / Eli Lilly


    Active Ingredient
    Dulaglutide 0.75 mg, 1.5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    4 X 0.75 mg / 0.5 ml

    partial basket chart 32988 20810

    Pre-filled Syringe (solution for injection)

    4 X 1.5 mg / 0.5 ml

    partial basket chart 32989 20811

    Related information


    Dosage

    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 Dulaglutide  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 sulphonylurea or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. The use of Dulaglutide  does not require blood glucose self-monitoring. Self-monitoring may be necessary to adjust the dose of sulphonylurea or insulin.
    Elderly patients (> 65 years old): No dose adjustment is required based on age. However, the therapeutic experience in patients ≥ 75 years is very limited, 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, moderate or sever renal impairment (eGFR <90 to ≥15 mL/min/1.73m²). There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m²), therefore Dulaglutide can not be recommended in this population.
    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: Dulaglutide  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.


    Indications

    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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    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. 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.
    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. Populations not studiedץ 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’.
    See prescribing information for full details.


    Side Effects

    Hypoglycaemia (when used in combination with prandial insulin, metformin or metformin plus glimepiride), nausea, diarrhea, vomiting, abdominal pain.
    See prescribing information for full details.


    Drug interactions

    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.
    Paracetamol: No dose adjustment of paracetamol is necessary when administered with dulaglutide.
    Atorvastatin: No dose adjustment of atorvastatin is necessary when administered with dulaglutide.
    Digoxin:  No dose adjustment is required for digoxin when administered with dulaglutide.
    Anti-hypertensives: Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically relevant changes in the AUC or Cmax of lisinopril. Statistically significant delays in lisinopril tmax of approximately 1 hour were observed on Days 3 and 24 of the study. These changes were not clinically relevant; therefore no dose adjustment of lisinopril or metoprolol is necessary when administered with dulaglutide.
    Warfarin: Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were unaffected, and S-warfarin Cmax decreased by 22 %. AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax). No dose adjustment for warfarin is necessary when given together with dulaglutide.
    Oral contraceptives: Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol. No dose adjustment for oral contraceptives is required when given together with dulaglutide.
    Metformin: Following coadministration of multiple dose dulaglutide with steady state metformin (immediate release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, respectively, with no changes in tmax. No dose adjustment for metformin IR is recommended when given with dulaglutide.
    Sitagliptin: Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide. Following coadministration with 2 consecutive doses of dulaglutide, sitagliptin AUC(0-τ) and Cmax decreased by approximately 7.4 % and 23.1 %, respectively. Sitagliptin tmax increased approximately 0.5 hours following coadministration with dulaglutide compared to sitagliptin alone.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of dulaglutide in pregnant women.
    Lactation: It is unknown whether dulaglutide is excreted in human milk.
    See prescribing information for full details.   


    Overdose

    Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.


    Important notes

    Storage: Store in a refrigerator (2ºC – 8ºC). Do not freeze. Store in original package in order to protect from light.
    In use: Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30ºC. If the pen has been left out of the refrigerator for more than 14 days, the pen must be discarded even if it has not reached the expiration date.


    Manufacturer
    Eli Lilly & Company Ltd. USA
    Licence holder
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