Galvus® UAE
Galvus® UAE
Regulatory Affairs
GALVUS®
(vildagliptin)
50 mg Tablets
National Succinct Statement (NSS)
Version 4.2
Effective date: 22 Aug 2023
Safety Label Change 2023-PSBGLC-1379-I
(SLC) Tracking Number:
Document status:Final
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without the consent of Novartis
GALVUS®
Important note: Before prescribing, consult full prescribing information
https://www.swissmedicinfo.ch/ This link will contain the most updated product information approved by the reference country
Presentation: ♦Tablets containing 50 mg of vildagliptin.
Indications: Galvus is indicated as an adjunct to diet and exercise in patients with type 2 diabetes mellitus
• as monotherapy, when diet and exercise are not sufficient
• in dual combination
• with metformin when diet, exercise and metformin alone do not result in adequate glycaemic control
• with a sulphonylurea (SU) when diet, exercise and a sulphonylurea alone do not result in adequate glycaemic control
• with a thiazolidinedione (TZD) when diet, exercise and a thiazolidinedione alone do not result in adequate glycaemic control
• in triple combination
• with metformin and a sulphonylurea when diet and exercise plus dual combination with these agents do not result in adequate glycaemic control.
Galvus is also indicated in combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control.
Dosage and administration:
The dosage of antidiabetic therapy should be individualised.
Usual dosage
The recommended dose of Galvus when used as monotherapy is 50 mg once or twice daily.
Combination therapy
The recommended dose of Galvus when used in combination with insulin (with or without metformin) is 50 mg once or twice daily, depending on renal function (see “Patients with renal impairment”).
The recommended dose of Galvus when used in combination with metformin or in combination with metformin and a sulphonylurea is 50 mg twice daily.
The recommended dose of Galvus when used in combination with a sulphonylurea or a thiazolidinedione is 50 mg once daily.
When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
A dosage higher than 50 mg twice daily is not recommended. The tablets can be taken with or without food.
Special dosage instructions
Patients with hepatic impairment
Galvus is not recommended in patients with hepatic impairment, including patients with pretreatment ALT or AST >2.5x ULN.
Patients with renal impairment
No dosage adjustment of Galvus is required in patients with mild renal impairment (creatinine clearance [CrCl] ≥50 ml/min, corresponding to a serum creatinine level of ≤150 µmol/l in men and ≤133 µmol/l in women). The recommended dose in patients with moderate to severe renal impairment is 50 mg Galvus once daily (see “Warnings and precautions”).
Elderly patients
No dosage adjustment is required in elderly patients.
Children and adolescents
The safety and efficacy of Galvus have not been studied in patients under 18 years of age. Therefore, the use of Galvus in paediatric patients is not recommended.
Contraindications: ♦Hypersensitivity to vildagliptin or to any of the excipients.
Warnings and precautions: ♦Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. ♦Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST>2.5X the upper limit of normal. Liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter. Withdrawal of therapy with Galvus recommended if an increase in AST or ALT of 3X the upper limit normal or greater persist. Following withdrawal of treatment with Galvus and LFT normalization, treatment with Galvus should not be reinitiated. ♦Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive. ♦Not recommended in patients with NYHA Class IV.
Pregnancy, lactation, females and males of reproductive potential
Pregnancy: Not to be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Lactation: Should not be used during breast-feeding.
Special excipients: Contains lactose.
Adverse reactions:
♦ Monotherapy - Common: dizziness - Uncommon: headache, constipation, edema peripheral.
Combination with insulin - Common: headache, nausea, gastrooesophageal reflux disease, chills, decreased blood glucose – Uncommon: Diarrhea, flatulence. ♦Combination with metformin and a sulfonylurea - Common: dizziness, tremor, asthenia, hypoglycemia, hyperhidrosis. ♦Post-marketing experience – Unknown: hepatitis (reversible with drug discontinuation), urticaria, bullous and exfoliative skin lesions including bullous pemphigoid, cutaneous vasculitis, pancreatitis.
Interactions: ♦Vildagliptin has a low potential for drug interactions. ♦No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin.