Sidapvia Special Precautions

Use in patients with renal impairment: SIDAPVIA should not be used in patients with an eGFR <45 mL/min/1.73 m². Renal function should be evaluated prior to initiation of SIDAPVIA and periodically thereafter.
Ketoacidosis in patients with diabetes mellitus: There have been reports of ketoacidosis, including diabetic ketoacidosis, in patients with type 1 and type 2 diabetes mellitus taking dapagliflozin and other sodium glucose cotransporter 2 (SGLT2) inhibitors. SIDAPVIA is not indicated for the treatment of patients with type 1 diabetes mellitus.
Patients treated with SIDAPVIA 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 SIDAPVIA should be considered and the patient should be promptly evaluated.
Treatment should be interrupted in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. Consider monitoring for ketoacidosis and temporarily discontinuing SIDAPVIA in other clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Ensure risk factors for ketoacidosis are resolved prior to restarting SIDAPVIA.
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. SIDAPVIA should be used with caution in these patients.
Use with medications known to cause hypoglycaemia: Insulin and insulin secretagogues, such as sulfonylureas, cause hypoglycaemia. Hypoglycaemia has been observed when dapagliflozin or sitagliptin was used in combination with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with SIDAPVIA.
Hypersensitivity reactions: Post marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, SIDAPVIA should be discontinued. Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated (see Contraindications and Adverse Reactions).
Acute pancreatitis: Use of dipeptidyl peptidase 4 (DPP4) inhibitors, including sitagliptin, has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, SIDAPVIA should be discontinued; if acute pancreatitis is confirmed, SIDAPVIA should not be restarted. Caution should be exercised in patients with a history of pancreatitis (see Adverse Reactions).
Arthralgia: Joint pain, which may be severe, has been reported in post-marketing 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).
Bullous Pemphigoid: Post-marketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP4 inhibitor use, including sitagliptin. 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 SIDAPVIA and bullous pemphigoid is suspected, SIDAPVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment (see Adverse Reactions).
Use in patients at risk for volume depletion: Due to its mechanism of action, dapagliflozin induces osmotic diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see Pharmacology: Pharmacodynamics under Actions).
Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
For patients receiving SIDAPVIA, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Temporary interruption of SIDAPVIA should be considered for patients who develop volume depletion.
Necrotising Fasciitis of the Perineum (Fournier's gangrene): Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors (see Adverse Reactions). 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 urogenital infection or perineal abscess may precede necrotising fasciitis. If Fournier's gangrene is suspected, SIDAPVIA should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. SIDAPVIA is anticipated to have no or negligible influence on the ability to drive and use machines. However, when driving or operating machines, it should be taken into account that dizziness has been reported with sitagliptin. In addition, patients should be alerted to the risk of hypoglycaemia when SIDAPVIA is used in combination with insulin or an insulin secretagogue, such as a sulfonylurea.