DIAGLUTIDE SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML [SIN17341P]

Product Info

DIAGLUTIDE SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML

[SIN17341P]

Indication

INDICATIONS

DIAGLUTIDE is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

• in addition to other medicinal products for the treatment of diabetes (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES – Clinical efficacy and safety section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Prevention of cardiovascular events
Diaglutide is indicated as an adjunct to diet, exercise and standard care therapy to reduce the risk of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke) in adult patients with type 2 diabetes mellitus and established cardiovascular disease who have inadequate glycaemic control (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES – Clinical efficacy and safety section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

DOSE AND METHOD OF ADMINISTRATION

DIAGLUTIDE is available at the strength of 6mg/ml, 3ml only and may not be suitable for all the dosing recommendations mentioned below. In such cases, other approved strength must be used.

Dose

Adults
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended.

When DIAGLUTIDE is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Combination therapy with sulfonylurea is only valid for adult patients.

Self-monitoring of blood glucose is not needed in order to adjust the dose of DIAGLUTIDE. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when DIAGLUTIDE therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.

No dose adjustment is required during Ramadan when DIAGLUTIDE is added to metformin for treatment of type 2 diabetes mellitus (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic properties: Other clinical data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It is recommended to finalise dose escalation of DIAGLUTIDE before patients start Ramadan fasting.

Children aged 10 years and above
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose may be increased to 1.2 mg daily if additional glycaemic control is required. The dose can be increased to 1.8mg daily if required to further improve glycaemic control after at least one week of treatment with the 1.2mg daily dose.

Special populations

Elderly patients (>65 years old):
No dose adjustment is required based on age (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment:
No dose adjustment is required for patients with mild, moderate or severe renal impairment. There is no therapeutic experience in patients with end-stage renal disease, and DIAGLUTIDE is therefore not recommended for use in these patients (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic properties and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment:
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. DIAGLUTIDE is not recommended for use in patients with severe hepatic impairment (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population: No data are available for children below 10 years of age (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic properties and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

METHOD OF ADMINISTRATION
DIAGLUTIDE must not be administered intravenously or intramuscularly.

DIAGLUTIDE is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that DIAGLUTIDE is injected around the same time of the day, when the most convenient time of the day has been chosen. Injection sites should always be rotated to reduce the risk of injection site amyloid deposits (see UNDESIRABLE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

CONTRAINDICATIONS

Hypersensitivity to liraglutide or to any of the excipients present in the formulation.