Regulatory Affairs

GALVUSMET®

(vildagliptin and metformin fixed combination)

50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 mg Tablets

National Succinct Statement (NSS)

Version 4.2

Effective date: 22 Aug 2023

Safety Label Change (SLC) 2023-PSB/GLC-1380-I

Tracking Number:

Document status:Final

Property of Novartis

Confidential

May not be used, divulged, published or otherwise disclosed

without the consent of Novartis

GALVUSMET®

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 vildagliptin/metformin hydrochloride fixed dose combination: 50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 mg.

Indications: Patients with type 2 diabetes mellitus (T2DM):

Galvusmet is indicated as an adjunct to diet and exercise in patients whose treatment with metformin hydrochloride or vildagliptin alone does not offer adequate control of blood glucose or in patients already being treated with a free combination of metformin hydrochloride and vildagliptin.

Galvusmet is indicated in combination with a sulphonylurea (i.e. as triple combination therapy) as an adjunct to diet and exercise in patients whose treatment with metformin and a sulphonylurea alone does not offer adequate control of blood glucose.

Galvusmet is indicated in combination with insulin to improve glycaemic control in patients whose blood glucose cannot be adequately controlled by diet, exercise and treatment with a stable dose of insulin and metformin.

Dosage and administration: Antidiabetic treatment should be individualised on the basis of effectiveness and tolerability. When using Galvusmet, the maximum recommended daily dose of 100 mg vildagliptin should not be exceeded.

The recommended starting dose of Galvusmet should be based on the current treatment with vildagliptin and/or metformin. To reduce the adverse gastrointestinal effects of metformin, the total daily dose of metformin should be taken in 2-3 equal doses with meals spread over the course of the day, with Galvusmet being taken twice daily.

Initiation of therapy

Starting dose for patients inadequately controlled on vildagliptin monotherapy

Based on the usual starting dose of metformin (daily dose: 500 mg-1000 mg) Galvusmet should be initiated at the 50 mg/500 mg or 50 mg/850 mg tablet strength twice daily. The dose of metformin should be gradually titrated based on an assessment of the therapeutic response.

Starting dose for patients inadequately controlled on metformin monotherapy

Based on the current dose of metformin Galvusmet should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily.

Starting dose for patients switching to Galvusmet from a free combination of metformin and vildagliptin

Based on the current dose of metformin or vildagliptin Galvusmet should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength.

Combination therapy

Use in combination with insulin or sulphonylurea

Based on the current dose of metformin Galvusmet should be taken at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily.

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

Patients with hepatic impairment

Galvusmet is not recommended for use in patients with hepatic impairment, including patients with pretreatment AST or ALT >2.5x ULN (see “Warnings and precautions”).

Patients with renal impairment

The glomerular filtration rate (GFR) should be assessed before initiation of treatment with metformin-containing products (such as Galvusmet) and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in elderly patients renal function should be assessed more frequently, e.g. every 3 to 6 months.

Factors that may increase the risk of lactic acidosis (see “Warnings and precautions”) should be reviewed before considering treatment with metformin-containing products (such as Galvusmet) in patients with a GFR <60 ml/min. Galvusmet is contraindicated in patients with a GFR <30 ml/min due to the active substance metformin (see “Contraindications”).

Please note the following dose recommendations, which are based on current renal function status:

If the required dose for one of the two active substances is not available with Galvusmet, both individual substances should be used instead of the combination product.

Elderly patients

As Metformin is excreted via the kidneys and elderly patients have a tendency towards decreased renal function, elderly patients taking metformin-containing products (such as Galvusmet) should have their renal function monitored regularly. Galvusmet should only be used in elderly patients with normal renal function (see “Contraindications” and “Warnings and precautions”).

Children and adolescents

The safety and efficacy of Galvusmet have not been established in patients under 18 years of age. Galvusmet is therefore not recommended for use in paediatric patients.

Contraindications:

Known hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients ♦patients with creatinine clearance <30 mL/min ♦congestive heart failure ♦acute or chronic metabolic acidosis including lactic acidosis or diabetic ketoacidosis with or without coma.

Warnings and precautions: ♦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 Galvusmet recommended if an increase in AST or ALT of 3x upper limit normal or greater persist. Following withdrawal of treatment with Galvusmet and LFT normalisation, treatment with Eucreas 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 ♦Risk of lactic acidosis. ♦Monitoring of renal function before treatment initiation and regularly thereafter. ♦Caution with concomitant use of medications that may affect renal function or metformin hydrochloride disposition. ♦Galvusmet should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. ♦Temporary discontinuation in patients undergoing surgical procedure. ♦Excessive alcohol intake to be avoided. ♦Risk of decreased vitamin B12 serum levels. ♦Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. ♦Risk of hypoglycemia. ♦May be temporarily withheld in case of loss of glycemic control. ♦Elderly patients’ renal function should be assessed more frequently.

Pregnancy, lactation, females and males of reproductive potential

Pregnancy: Should not be used in pregnancy.

Lactation: Should not be used during breast-feeding.

Adverse reactions:

♦Vildagliptin monotherapy – Common: dizziness – Uncommon: headache, constipation, oedema peripheral. ♦Metformin monotherapy – Very common: decreased appetite. Common to Very common: nausea, vomiting, diarrhoea, abdominal pain. Common: dysgeusia, decrease of vitamin B12 absorption.. Very rare: lactic acidosis, skin reactions such as erythema, pruritus and urticaria. Isolated Cases: hepatitis, liver function test abnormalities. ♦Other effects with combination of Vildagliptin with insulin (with/without Metformin) – Common: headache, nausea, gastrooesophageal reflux disease, chills, blood glucose decreased – Uncommon: diarrhoea, flatulence. ♦Other effects with combination of vildagliptin and metformin with a sulfonylurea – Common: dizziness, tremor, asthenia, hypoglycemia, hyperhidrosis. ♦Post- marketing experience: Unknown:–hepatitis (reversible upon drug discontinuation), urticaria, bullous and exfoliative skin lesions including bullous pemphigoid, cutaneous vasculitis, pancreatitis.

Interactions: ♦Interactions with vildagliptin: 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.

Interactions with metformin hydrochloride: furosemide, nifedipine, drugs reducing metformin clearance such as ranolazine, vandetanib, dolutegravir, and cimetidine, drugs that can affect renal function such as NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics, drugs tending to cause hyperglycemia, alcohol.

Packs and prices: Country-specific.

Legal classification: Country-specific.

Leaflet revision Date: September 2023

NSS Version: 4.2

Leaflet Presentation Type: R02