Approvals/HSA/TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ML

Approved

THERAPEUTIC

TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ML

NOVO NORDISK A/S (BAGSVAERD) (BULK PRODUCTION AND PRIMARY PACKAGER) - DENMARKNOVO NORDISK PRODUCTION SAS (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: May 31, 2019
Approval ID: fb72e353c53254da
Company: NOVO NORDISK A/S (BAGSVAERD) (BULK PRODUCTION AND PRIMARY PACKAGER) - DENMARKNOVO NORDISK PRODUCTION SAS (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: fb72e353c53254da
Drug Name: TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ML
Product Name: TRESIBA® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ML
Approval Number: SIN15703P
Approval Date: 2019-05-31
Registrant: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Licence Holder: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: Posology and method of administration Posology Tresiba® is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) of insulin degludec corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine (100 units/ml) or 1 unit of insulin detemir. In patients with type 2 diabetes mellitus, Tresiba® can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In type 1 diabetes mellitus, Tresiba® must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. Tresiba® is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose (FPG). As with all insulin products, adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Tresiba® 100 units/ml and Tresiba® 200 units/ml Tresiba® is available in two strengths. For both, the needed dose is dialled in units. The dose steps, however, differ between the two strengths of Tresiba®. With Tresiba® 100 units/ml a dose of 1–80 units per injection, in steps of 1 unit, can be administered. With Tresiba® 200 units/ml a dose of 2–160 units per injection, in steps of 2 units, can be administered. The dose is provided in half the volume of 100 units/ml basal insulin products. The dose counter shows the number of units regardless of strength, and no dose conversion should be done when transferring a patient to a new strength. Flexibility in dosing time On occasions when administration at the same time of the day is not possible, Tresiba® allows for flexibility in the timing of insulin administration (see Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of Tresiba® in children and adolescents. Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule. Initiation Patients with type 2 diabetes mellitus The recommended daily starting dose is 10 units followed by individual dosage adjustments. Patients with type 1 diabetes mellitus Tresiba® is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments. Transfer from other insulin medicinal products Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted. Patients with type 2 diabetes mellitus For patients with type 2 diabetes taking once-daily basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to Tresiba® can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments. A dose reduction of 20% based on the previous basal insulin dose followed by individual dosage adjustments should be considered when <ul class="dash"> <li>transferring to Tresiba® from twice-daily basal insulin</li> <li>transferring to Tresiba® from insulin glargine (300 units/ml).</li> </ul> Patients with type 1 diabetes mellitus For patients with type 1 diabetes, a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response. Use of Tresiba® in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus When adding GLP-1 receptor agonists to Tresiba®, it is recommended to reduce the dose of Tresiba® by 20% to minimise the risk of hypoglycaemia. Subsequently, the dosage should be adjusted individually after the optimisation of GLP-1 dose. Special populations Elderly (≥65 years old): Tresiba® can be used in elderly. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal and hepatic impairment: Tresiba® can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population: Tresiba® can be used in adolescents from the age of 12–17 years (see Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When changing basal insulin to Tresiba®, dose reduction of basal and bolus insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Method of administration Tresiba® is for subcutaneous use only. Tresiba® must not be administered intravenously as it may result in severe hypoglycaemia. Tresiba® must not be administered intramuscularly as it may change the absorption. Tresiba® must not be used in insulin infusion pumps. Tresiba® must not be drawn from the cartridge of the pre-filled pen into a syringe (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Tresiba® is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Special warnings and precautions for use and Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying this leaflet (see Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Tresiba® comes in a pre-filled pen (FlexTouch®) designed to be used with NovoFine® or NovoTwist® injection needles. The 100 units/ml pre-filled pen delivers 1–80 units in steps of 1 unit.
Route Of Administration: SUBCUTANEOUS
Indication Info: Therapeutic indications Treatment of diabetes mellitus in adults and adolescents from the age of 12–17 years.
Contraindications: Contraindications Hypersensitivity to the active substance or to any of the excipients listed in List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: A10AE06
Atc Item Name: insulin degludec
Pharma Manufacturer Name: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Active Ingredients

Insulin Degludec

100U/ml

INSULIN DEGLUDEC

100 UNITS/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 31, 2019

Approval ID

fb72e353c53254da

Type

Therapeutic

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