GALVUS® and GALVUMET® STILL FULLY FUNDED

GALVUS® and GALVUMET® STILL FULLY FUNDED

Novartis New Zealand
Galvus and Galvumet image
Intensify treatment early with GALVUS & GALVUMET¹

GALVUS and GALVUMET remain an effective, subsidised treatment strategy for your type 2 diabetes patient not reaching their HbA1c target.1-3

GALVUS and GALVUMET have an established safety profile with good tolerability 2,4-7

Treating early with GALVUMET or adding GALVUS to metformin improved HbA1c3 with similar adverse event profiles for both treatment strategies.1

Studies indicate:

  • early glycaemic control (HbA1c <6.5% (48 mmol/mol) brings durable glycaemic control.1
  • 3 out of 4 patients on GALVUS/METFORMIN combination achieved HbA1c <6.5% (48 mmol/mol) at 3 months1
  • early GALVUS/METFORMIN strategy was well tolerated, and well adhered to, over the 5 years.1

Intensify treatment early with GALVUS and GALVUMET to stay on track with powerful HbA1c reduction1,2

https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2020-12-23-decision-to-award-vildagliptin-supply/ 3

References: 1. Matthews DR et al. The Lancet. 2019;394(10208):1519-1529 (and supplementary appendix). 2. Bosi E, et al. Diabetes Care 2007;30(4):890–895. 3. Pharmaceutical Schedule, available at www.pharmac.govt.nz. Last accessed January 2021. 4. Lukashevich V, et al. Diabetes Obes Metab 2014;16:403-409. 5. GALVUS® Data Sheet 1 July 2020. 6. GALVUMET Data Sheet 2 September 2020. 7. Ferrannini E, et al. Diabetes Obes Metab 2009;11(2):157-166.

GALVUS (vildagliptin) 50 mg tablets

Important note: Consult Data Sheet before prescribing, available from www.medsafe.co.nz. Galvus is fully funded with no Special Authority criteria. Presentation: Tablets containing 50 mg of vildagliptin. Indications: Galvus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus as monotherapy; in dual combination with metformin, a sulphonylurea (SU), or a thiazolidinedione (TZD) when diet, exercise and a single antidiabetic agent do not result in adequate glycaemic control; in triple combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; 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: Adults: The recommended dose is 50 mg or 100 mg daily for monotherapy and in combination with metformin, with a TZD or with insulin (with or without metformin); 50 mg daily in combination with a SU; 100 mg daily for triple combination with metformin and a SU. The 50 mg dose is taken once daily in the morning, while the 100 mg dose is taken in two divided doses of 50 mg each in the morning and evening. Children (under 18 years of age): Not recommended. Special populations: In patients with moderate to severe renal impairment or End Stage Renal Disease (ESRD), the recommended dose is 50 mg once daily. Contraindications: Hypersensitivity to vildagliptin or to any of the excipients. Precautions/Warnings: 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 upper limit normal or greater persist. Following withdrawal of treatment with Galvus and LFT normalisation, 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. Women of child-bearing potential, pregnancy: Should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: Should not be used. Special excipients: Contains lactose. 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. Adverse reactions: Rare cases of angioedema. Rare cases of hepatic dysfunction (including hepatitis) Monotherapy - Common: dizziness - Uncommon: headache, constipation, oedema peripheral. Combination with metformin - Common: tremor, dizziness, headache. Combination with a sulphonylurea - Common: tremor, headache, dizziness, asthenia. Combination with a thiazolidinedione - Common: weight increase, oedema peripheral. Combination with insulin - Common: headache, nausea, gastrooesophageal reflux disease, chills, decreased blood glucose - Uncommon: Diarrhoea, flatulence. Combination with metformin and a sulphonylurea - Common: dizziness, tremor, asthesia, hypoglycaemia, hyperhidrosis. Post-marketing experience - Rare: hepatitis (reversible with drug discontinuation) - Unknown: urticaria, pancreatitis, bullous and exfoliative skin lesions, including bullous pemphigoid. Packs Aluminium/aluminium blisters containing 60 film-coated tablets. Novartis New Zealand Limited, Auckland. Phone: 0800 354 335. Reference Data Sheet date: 1 July 2020 PRESCRIPTION MEDICINE

GALVUMET® (vildagliptin/metformin hydrochloride) 50 mg/850 mg and 50 mg/1000 mg tablets

Important note: Before prescribing, consult full prescribing information. Presentation: Tablets containing vildagliptin/metformin hydrochloride fixed dose combination: 50 mg/850 mg, and 50 mg/1,000 mg. Indications: For patients with Type 2 diabetes mellitus (T2DM): • Galvumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. • Galvumet is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea.• Galvumet is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. Dosage and administration: • Do not exceed the maximum recommended daily dose of vildagliptin (100 mg). • Should be given with meals. • Adults: • Starting dose for patients inadequately controlled on vildagliptin monotherapy: Based on the usual starting doses of metformin hydrochloride (850 mg once daily), Galvumet may be initiated at the 50 mg/1000mg tablet strength once daily and gradually titrated after assessing the adequacy of therapeutic response. • Starting dose for patients inadequately controlled on metformin hydrochloride monotherapy: Based on the patient’s current dose of metformin hydrochloride, Galvumet may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily. • Starting dose for patients switching from combination therapy of vildagliptin plus metformin hydrochloride as separate tablets: 50 mg/850 mg or 50 mg/1000 mg based on the dose of vildagliptin or metformin already being taken. • Use in combination with a sulfonylurea or with insulin: the dose of Galvumet should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. • Renal impairment: Dosage adjustment may be required in patients with GFR between 30 and 120 ml/min. • Elderly patients: Dosage should be adjusted based on renal function • Children (under 18 years of age): Not recommended. Contraindications: Hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipientsª Severe renal impairment (GFR <30 ml/min) • Congestive heart failure requiring pharmacological treatment • Metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, with or without coma • Radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. Warnings and precautions: • 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. • Galvumet should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. • Discontinue treatment in case of hypoxemia. • Temporary discontinuation in patients undergoing surgical procedure. • Excessive alcohol intake to be avoided. • 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 Galvumet recommended if an increase in AST or ALT of 3x upper limit normal or greater persist. Following withdrawal of treatment with Galvumet and LFT normalisation, treatment with Galvumet should not be reinitiated. • 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 hypoglycaemia. • May be temporarily withheld in case of loss of glycaemic control. • Elderly patients’ renal function should be assessed more frequently. • Not recommended in paediatric patients. Women of child-bearing potential, pregnancy: Should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: Should not be used during breast-feeding. Adverse reactions: • Vildagliptin: Rare cases of angioedema. Rare cases of hepatic dysfunction (including hepatitis). • Vildagliptin monotherapy – Common: dizziness – Uncommon: headache, constipation, oedema peripheral. • Metformin monotherapy – Very common: loss of appetite, flatulence, nausea, vomiting, diarrhoea, abdominal pain. Common: dysgeusia. Very rare: lactic acidosis, hepatitis, skin reactions such as erythema, pruritus and urticarial, decrease of vitamin B12 absorption, liver function test abnormalities. • Other effects with combination of vildagliptin and metformin - Common: tremor, dizziness, headache. • Other effects with combination of Vildagliptin and Metformin with insulin – 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: – Rare: hepatitis (reversible upon drug discontinuation) – Unknown: urticaria, bullous and exfoliative skin lesions including bullous pemphigoid, pancreatitis, arthralgia, sometimes severe. 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 that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine), drugs tending to produce hyperglycaemia, alcohol. Packs Aluminium/aluminium blisters containing 60 film-coated tablets Novartis New Zealand Limited, Auckland. Phone: 0800 354 335 Date of Preparation: 11 September 2020 Reference Data Sheet date: 02 September 2020 PRESCRIPTION MEDICINE NZ-00862 January 2021 TAPS PP7167 essence NV9922