Sidapvia Special Precautions

General: Sidapvia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Urinary tract infections: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.
Use in patients at risk for volume depletion and/or hypotension: For patients receiving dapagliflozin, In case of intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including electrolytes) is recommended. Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected.
Ketoacidosis: 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.
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. 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.
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).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
However, when driving or operating machines, it should be taken into account that dizziness has been reported with sitagliptin.
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.