Active Ingredient and Strength	VILDAGLIPTIN - 50 MG
Dosage Form	TABLET
Manufacturer and Country	SIEGFRIED BARBERA S.L. - SPAIN NOVARTIS PHARMACEUTICAL MANUFACTURING LLC - SLOVENIA
Registration Number	SIN13407P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	A10BH02

INDICATIONS

Galvus is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM):

as monotherapy.
initial combination with metformin when diabetes is not adequately controlled by diet and exercise alone.
in combination with other medicinal products, including insulin, when these do not provide adequate glycaemic control (see section on Clinical Studies for available data on different combinations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Important limitations of Use

Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE REGIMEN AND ADMINISTRATION

Method of administration

For oral use

Galvus can be administered with or without meals (see section PHARMACOKINETICS, absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening.

If a dose of Galvus is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Dosage Regimen

The management of antidiabetic therapy should be individualized.

The recommended dose of Galvus is 50 mg once or twice daily. The maximum daily dose of Galvus is 100 mg.

For monotherapy, and for combination with metformin or with a thiazolidinedione (TZD), the recommended dose of Galvus is 50 mg or 100 mg daily.

The recommended dose of Galvus is 100mg daily in combination with insulin (with or without metformin).

When used in dual combination with a sulfonylurea (SU), the recommended dose of vildagliptin is 50 mg once daily. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.

For triple combination with metformin and a SU, the recommended dose of Galvus is 100 mg daily.

When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia.

If tighter glycemic control is required on top of the maximum recommended daily dose of vildagliptin, the addition of other antidiabetic drugs such as metformin, an SU, a TZD or insulin may be considered. The safety and efficacy of vildagliptin as triple oral therapy in combination with other antidiabetic drugs has not been established.

Doses higher than 100mg are not recommended.

Initial combination therapy or maintenance of combination therapy should be individualized and are left to the discretion of the health care provider.

General target population

Adults 18 years of age and above

Special populations

Renal impairment

No dosage adjustment of Galvus is required in patients with mild renal impairment (creatinine clearance ≥ 50mL/min). In patients with moderate or severe renal impairment or End Stage Renal Disease (ESRD) on haemodialysis, the recommended dose of Galvus is 50 mg once daily (see section PHARMACOKINETICS under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Galvus is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal (ULN) (see section PHARMACOKINETICS under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients (65 years or above)

In patients treated with Galvus ≥ 65 years of age and ≥ 75 years of age, no differences were observed in the overall safety, tolerability, or efficacy between this elderly population and younger patients. No dosage adjustments are therefore necessary in the elderly patients (see section PHARMACOKINETICS under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

Galvus has not been studied in patients under 18 years of age; therefore, the use of Galvus is not recommended for use in children below 18 years. (see section PHARMACOKINETICS under Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS

Galvus is contraindicated in patients with known hypersensitivity to vildagliptin or to any of the excipients (see section COMPOSITION AND PHARMACEUTICAL FORM under subsection EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).