What medical diagnoses are contraindicated for steglujan?

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: May 3, 2024.

Contraindications And Precautions Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as acute febrile illness, infection, reduced caloric intake, ketogenic diet, surgery, reduction in dose of exogenous insulin or discontinuation of exogenous insulin or insulin secretagogue, volume depletion, and alcohol abuse were identified. Before initiating steglujan, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. For patients who undergo scheduled surgery, temporarily discontinue steglujan at least 3 days before surgery or procedures associated with prolonged fasting. Consider monitoring for ketoacidosis in patients with type 1 diabetes mellitus and for others in clinical situations known to predispose to ketoacidosis. If possible, withhold steglujan in temporary clinical situations that could predispose patients to ketoacidosis. Steglujan can be resumed once the patient is clinical stable and able to receive oral medications. Ensure risk factors for ketoacidosis are resolved before restarting steglujan. Urinary glucose excretion may persist for 3 days after discontinuing steglujan, but there are some postmarketing reports of ketoacidosis and/or glucosuria lasting longer than 6 days and up to 2 weeks after steglujan discontinuation. Educate patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue this product and seek medical attention immediately if signs and symptoms occur.

Contraindications And Precautions Steglujan is contraindicated in patients with a serious hypersensitivity reaction to ertugliflozin or a known sitagliptin hypersensitivity , such as anaphylaxis , urticaria , history of angioedema to the drug , or exfoliative dermatitis or other serious skin conditions ( serious rash ), including Stevens-Johnson syndrome. A risk of serious hypersensitivity reactions or anaphylaxis has been reported in patients during the first 3 months of therapy with sitagliptin; some reports occurred after the first dose. Use caution in patients with a history of serious hypersensitivity to another dipeptidyl peptidase-4 (DPP4) inhibitor, because it is unknown whether such patients will be predisposed to serious reactions with sitagliptin. Postmarketing cases of serious rash, specifically bullous pemphigoid, requiring hospitalization, have been reported with DPP-4 inhibitor use. Hypersensitivity reactions such as angioedema have also occurred during postmarketing use of ertugliflozin. Inform patients of the risk of serious rash with sitagliptin. If a serious skin reaction is suspected, discontinue steglujan and refer the patient to a dermatologist for diagnosis and appropriate treatment. For example, treatment with topical or systemic immunosuppressives and discontinuation of the DPP-4 inhibitor has typically resulted in resolution of the rash.

Contraindications And Precautions Ertugliflozin is not indicated to improve glycemic control of patients with type 1 diabetes mellitus and should not be used for the treatment of diabetic ketoacidosis (DKA). Reports of ketoacidosis, a serious, life-threatening condition requiring urgent hospitalization have been identified in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including ertugliflozin. In clinical trials in patients with type 1 diabetes mellitus, the risk of DKA was significantly increased in patients who received SGLT2 inhibitors compared to patients who received placebo. Risk factors for ketoacidosis also include patients with type 2 diabetes mellitus and pancreatic disorders such as, a history of pancreatitis, pancreatic insufficiency, or pancreatic surgery. Assess patients treated with ertugliflozin who present with signs and symptoms consistent with severe metabolic acidosis for ketoacidosis regardless of presenting blood glucose concentrations, as ketoacidosis may be present even if blood glucose concentrations are less than 250 mg/dL. If ketoacidosis is suspected, discontinue steglujan, evaluate the patient, and institute prompt treatment. Treatment of ketoacidosis may require insulin, fluids, and carbohydrate replacement. In many of the postmarketing reports, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized, and the institution of treatment was delayed because presenting blood glucose concentrations were below those typically expected for DKA (often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath.

2.

Food and Drug Administration (DailyMed).

Publish date: October 5, 2023.

Contraindications 4 CONTRAINDICATIONS Patients with severe renal impairment (<30 mL/min/1.73 m 2 ), end-stage renal disease (ESRD), or on dialysis [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ]. Hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in STEGLUJAN (ertugliflozin and sitagliptin), reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precautions (5.11) and Adverse Reactions (6.2) ]. Severe renal impairment (<30 mL/min/1.73 m 2 ), end-stage renal disease, or dialysis. ( 4 ) Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in STEGLUJAN (ertugliflozin and sitagliptin). ( 4, 5.11, 6.2 )

Warnings And Cautions 5 WARNINGS AND PRECAUTIONS Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue STEGLUJAN (ertugliflozin and sitagliptin) if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking sitagliptin, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue. ( 5.2 ) Lower Limb Amputation: Consider factors that may increase the risk of amputation before initiating STEGLUJAN (ertugliflozin and sitagliptin). Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur. ( 5.3 ) Acute Renal Failure: There have been postmarketing reports of acute renal failure in patients taking sitagliptin, sometimes requiring dialysis. Monitor renal function. ( 5.4 ) Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment, or low systolic blood pressure elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.5 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. ( 5.6 ) Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.7 ) Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. ( 5.8 )

Warnings And Cautions ( 5.7 ) Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. ( 5.8 ) Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment. ( 5.9 ) Genital Mycotic Infections: Monitor and treat if indicated. ( 5.10 ) Hypersensitivity: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly discontinue, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. ( 5.11 ) Severe and Disabling Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue if appropriate. ( 5.12 ) Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue. ( 5.13 ) 5.1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, STEGLUJAN (ertugliflozin and sitagliptin) significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate.