QTERN Special Precautions

Use in patients with renal impairment: The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients where eGFR is < 45 mL/min/1.73 m².
Saxagliptin/Dapagliflozin (QTERN) should not be used in patients with an eGFR persistently < 45 mL/min/1.73 m² by MDRD or end-stage renal disease (ESRD). Saxagliptin/Dapagliflozin (QTERN) has not been studied in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m² by MDRD or end-stage renal disease (ESRD) and, therefore, should not be used in these populations. Renal function should be evaluated prior to initiation of Saxagliptin/Dapagliflozin (QTERN) and periodically thereafter (see Dosage & Administration).
Ketoacidosis: There have been reports of ketoacidosis, including diabetic ketoacidosis, in patients with type 1 and type 2 diabetes mellitus taking dapagliflozin and other SGLT2 inhibitors.
Saxagliptin/Dapagliflozin (QTERN) is not indicated for the treatment of patients with type 1 diabetes mellitus.
Patients treated with Saxagliptin/Dapagliflozin (QTERN) who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise and shortness of breath, should be assessed for ketoacidosis, even if blood glucose levels are below 14 mmol/L (250 mg/dL). If ketoacidosis is suspected, discontinuation or temporary interruption of Saxagliptin/Dapagliflozin (QTERN) should be considered and the patient should be promptly evaluated.
Predisposing factors to ketoacidosis include a low beta-cell function reserve resulting from pancreatic disorders (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness, or surgery and alcohol abuse. Saxagliptin/Dapagliflozin (QTERN) should be used with caution in these patients.
Use with medications known to cause hypoglycaemia: Saxagliptin/Dapagliflozin (QTERN) has not been studied in combination with insulin. Insulin and insulin secretagogues, such as sulfonylureas, are known to cause hypoglycaemia. Both saxagliptin and dapagliflozin can individually increase the risk of hypoglycaemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycaemia if used in combination with Saxagliptin/Dapagliflozin (QTERN) (see Pharmacology: Pharmacodynamics under Actions).
Hypersensitivity reactions: During postmarketing experience, the following adverse reactions have been reported with use of saxagliptin, serious hypersensitivity reactions, including anaphylaxis and angioedema. If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue Saxagliptin/Dapagliflozin (QTERN), assess for other potential causes for the event, and institute alternative treatment for diabetes (see Contraindications and Adverse Reactions).
Pancreatitis: During postmarketing experience for saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, Saxagliptin/Dapagliflozin (QTERN) should be discontinued (see Adverse Reactions).
In the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction (SAVOR) Trial, the incidence of adjudicated pancreatitis events was 0.3% in both saxagliptin-treated patients and placebo-treated patients in the intent-to-treat population (see Adverse Reactions).
Cardiac Failure: In the SAVOR trial an increase in the rate of hospitalisation for heart failure was observed in the saxagliptin-treated patients compared to placebo, although a causal relationship has not been established. 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 (see Pharmacology: Pharmacodynamics under Actions).
Arthralgia: Joint pain, which may be severe, has been reported in postmarketing reports for DPP4 inhibitors. Patients experienced relief of symptoms after discontinuation of the medication 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 (see Adverse Reactions).
Necrotizing fasciitis of the perineum (Fournier's gangrene): Post-marketing cases of necrotizing fasciitis of the perineum (also known as Fournier's gangrene) have been reported in female and male patients taking SGLT2 inhibitors. This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis. If Fournier's gangrene is suspected, Saxagliptin/Dapagliflozin (QTERN) should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
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. If a patient develops blisters or erosions while receiving Saxagliptin/Dapagliflozin (QTERN) and bullous pemphigoid is suspected, Saxagliptin/Dapagliflozin (QTERN) should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment (see Adverse Reactions).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.