SAXAGLIPTIN SANDOZ

Posology The recommended dose of Saxagliptin is 5 mg once daily. 4). The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. 2). Renal impairment No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥ 45 mL/min.

5 mg once daily in patients with moderate renal impairment that have GFR < 45 mL/min and in patients with severe renal impairment. 4). 2). 2). 4). Paediatric population The efficacy of Saxagliptin in children aged 10 to < 18 years has not yet been established.

Therefore, treatment of children and adolescents with Saxagliptin is not recommended. 2. Saxagliptin has not been studied in children under 10 years of age. Method of administration The tablets can be taken with or without a meal at any time of the day.

Tablets must not be split or cut. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

5%). There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.

In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin. In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with saxagliptin 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.

8%). Tabulated list of adverse reactions Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo from the pooled analysis of five studies of glycaemic control, plus an additional active-controlled study of initial combination with metformin are shown in Table 1.

The adverse reactions are listed by system organ class and absolute frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to 1/100), rare (≥ 1/10,000 to 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).

Table 1 Frequency of adverse reactions by system organ class from clinical trials and postmarketing experience System organ class Adverse reaction Frequency of adverse reactions by treatment regimen Saxagliptin monotherap y Saxaglipti n with metformin 1 Saxagliptin with a sulphonylurea (glibenclamide ) Saxagliptin with a thia- zolidinedion e Saxagliptin as add-on to metformin plus a sulphonylure a Infections and infestations Upper respiratory infection Common Common Common Common Urinary tract infection Common Common Common Common Gastroenteri tis Common Common Common Common Sinusitis Common Common Common Common Nasopharyn gitis Common2 Immune system disorders Hypersensiti vity reactions†‡ Uncommon Uncommo n Uncommon Uncommon Anaphylacti c reactions including anaphylactic shock†‡ Rare Rare Rare Rare Metabolism and nutrition disorders Hypoglycae mia Very common3 System organ class Adverse reaction Frequency of adverse reactions by treatment regimen Saxagliptin monotherap y Saxaglipti n with metformin 1 Saxagliptin with a sulphonylurea (glibenclamide ) Saxagliptin with a thia- zolidinedion e Saxagliptin as add-on to metformin plus a sulphonylure a Dyslipidaem ia Uncommon Hypertri- glyceridaem ia Uncommon Nervous system disorders Dizziness Common Common Headache Common Common Common Common Gastrointes tinal disorders Abdominal pain† Common Common Common Common Diarrhoea4 Common Common Common Common Dyspepsia Common Flatulence Common Gastritis Common Nausea† Common Common Common Common Vomiting Common Common Common Common Pancreatitis† Uncommon Uncommo n Uncommon Uncommon Constipation † Not known Not known Not known Not known Not known Skin and subcutaneo us tissue disorders Rash† Common Common Common System organ class Adverse reaction Frequency of adverse reactions by treatment regimen Saxagliptin monotherap y Saxaglipti n with metformin 1 Saxagliptin with a sulphonylurea (glibenclamide ) Saxagliptin with a thia- zolidinedion e Saxagliptin as add-on to metformin plus a sulphonylure a Dermatitis† Uncommon Uncommo n Uncommon Uncommon Pruritus† Uncommon Uncommo n Uncommon Uncommon Urticaria† Uncommon Uncommo n Uncommon Uncommon Angioedema †‡ Rare Rare Rare Rare Bullous pemphigoid† Not known Not known Not known Not known Not known Musculo- skeletal and connective tissue disorders Arthralgia* Uncommo n Myalgia5 Common Reproducti ve system and breast disorders Erectile dysfunction Uncommo n General disorders and administrat ion site conditions Fatigue Common Uncommon Common Oedema peripheral Common 1 Includes saxagliptin in add-on to metformin and initial combination with metformin.

2 Only in the initial combination therapy. 3 There was no statistically significant difference compared to placebo. 7%). 1% (49/799) in the placebo group. 5 As initial combination with metformin, myalgia is reported as uncommon. † Adverse reactions were identified through postmarketing surveillance.

4. 4). 5 mg once daily and 8173 patients on placebo. 2%, respectively). 3% in both saxagliptin- treated patients and placebo-treated patients in the intent-to-treat population. 1% in both saxagliptin- treated patients and placebo- treated patients.

8% among patients treated with placebo. The […]

General Saxagliptin should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Saxagliptin is not a substitute for insulin in insulin-requiring patients. Acute pancreatitis Use of DPP4 inhibitors has been associated with a risk of developing acute pancreatitis.

Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain. If pancreatitis is suspected, Saxagliptin should be discontinued; if acute pancreatitis is confirmed, Saxagliptin should not be restarted.

Caution should be exercised in patients with a history of pancreatitis. In post-marketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis. 5 mg once daily. Saxagliptin is not recommended for use in patients with end-stage renal disease (ESRD) requiring haemodialysis.

2). 2). Use with medicinal products known to cause hypoglycaemia Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Saxagliptin.

3). During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.

8). 3). Skin lesions were not observed at an increased incidence in clinical trials. Postmarketing reports of rash have been described in the DPP4 inhibitor class. 8). Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.

Bullous pemphigoid Postmarketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP4 inhibitor use, including saxagliptin. In reported cases, patients typically responded to topical or systemic immunosuppressive treatment and discontinuation of the DPP4 inhibitor.

8). Cardiac failure Experience in NYHA class III-IV is still limited. 1). Additional analysis did not indicate a differential effect among NYHA classes. Caution is warranted if Saxagliptin is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.

Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms. 8). Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.

Onset of symptoms following initiation of drug therapy may be rapid or may occur after longer periods of treatment. If a patient presents with severe joint pain, continuation of drug therapy should be individually assessed. Immunocompromised patients Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Saxagliptin clinical program.

Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established. 5). Saxagliptin contains lactose and sodium The film-coated tablets contain lactose monohydrate and lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per film- coated tablet, that is to say essentially ‘sodium-free’.

8).