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    / Sanofi


    Active Ingredient
    Lixisenatide 10 mcg, 20 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Pen

    1 X 10 mcg / 0.2 ml

    partial basket chart 55987 12505

    Pre-filled Pen

    2 X 20 mcg / 0.2 ml

    partial basket chart 55988 12506

    Related information


    Dosage

    Starting dose: dosing is initiated at 10 mcg Lixisenatide once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg Lixisenatide once daily is started on Day 15. Lixisenatide 20 micrograms solution for injection is available for the maintenance dose. Lixisenatide is administered once daily, within the hour prior to the first meal of the day or the evening meal. If a dose of Lixisenatide is missed, it should be injected within the hour prior to the next meal. When Lixisenatide is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lixisenatide is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycemia. Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycemia. The use of Lixisenatide does not require specific blood glucose monitoring. However, when used in combination with a sulphonylurea or a basal insulin, blood glucose monitoring or blood glucose selfmonitoring may become necessary to adjust the doses of the sulphonylurea or the basal insulin.
    Special Populations:
    Elderly patients(≥65 years): No dose adjustment is required based on age. The clinical experience in patients ≥75 years is limited.
    Patients with renal impairment: No dose adjustment is required for patients with mild renal impairment (creatinine clearance : 50-80 ml/min). There is limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30-50 ml/min) and Lixisenatide should be used with caution in this population. There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use Lixisenatide in these populations.
    Patients with hepatic impairment: No dose adjustment is needed in patients with hepatic impairment.
    Pediatric population: The safety and efficacy of Lixisenatide in children and adolescents less than 18 years of age have not yet been established. No data are available.


    Indications

    Treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. 


    Contra-Indications

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


    Special Precautions

    There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients. Lixisenatide should not be used for treatment of diabetic ketoacidosis.
    Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established . Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, lixisenatide should be discontinued ;if acute pancreatitis is confirmed, lixisenatide should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
    Severe gastrointestinal disease: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients.
    Renal impairment: There is limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30-50 ml/min) and no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Lixisenatide should be used with caution in patients with moderate renal impairment. Use is not recommended in patients with severe renal impairment or end-stage renal disease. Patients receiving Lixisenatide with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycemia. Reduction of the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycemia. Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycemia.
    Concomitant medicinal products: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Lixisenatide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio. Specific recommendations regarding intake of such medicinal products.
    Populations not studied: Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors. There is limited experience in patients with congestive heart failure.
    Dehydration: Patients treated with Lixisenatide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
    Excipients: This medicinal product contains metacresol, which may cause allergic reactions.
    See prescribing information for full details.


    Side Effects

    Nausea, vomiting, diarrhea, hypoglycemia.
    See prescribing information for full details.


    Drug interactions

    Lixisenatide is a peptide and is not metabolised by cytochrome P450. In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested. The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment. These medicinal products should be taken in a standardised way in relation to lixisenatide. If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when lixisenatide is not administered. For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before or 4 hours after lixisenatide injection. Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Lixisenatide is not recommended in women of childbearing potential not using contraception. There are no adequate data from the use of Lixisenatide in pregnant women.
    Lactation: It is unknown if Lixisenatide is excreted in human milk. Lixisenatide should not be used during breastfeeding.
    See prescribing information for full details.


    Overdose

    During clinical studies, doses up to 30 mcg of Lixisenatide Twice a day were administered to type 2 diabetic patients in a 13-week study. An increased incidence of gastrointestinal disorders was observed.
    In case of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms and the Lixisenatide dose should be reduced to the prescribed dose.


    Important notes

    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Store away from  the freezer compartment. After first use:Store below 30°C. Do not freeze. Do not store with attached needle. Keep the cap on the pen in order to protect from light.
    Shelf life: 2 years.
    After first use: 14 days


    Manufacturer
    Sanofi-Aventis Deutschland GmbH, Germany
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