País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP), SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)
Merck Sharp & Dohme LLC
ERTUGLIFLOZIN PIDOLATE
ERTUGLIFLOZIN 5 mg
ORAL
PRESCRIPTION DRUG
STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use - Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. - Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)] . - Patients with severe renal impairment (<30 mL/min/1.73 m2 ), 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, reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precautions (5.11) and Adverse Reactions (6.2)]. Risk Summary Based on animal data showing adverse renal effects, from ertugliflozin, STEGLUJAN is
STEGLUJAN (ertugliflozin and sitagliptin) tablets are available in the strengths listed below: Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (between 59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.
New Drug Application
Merck Sharp & Dohme LLC ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2023 Medication Guide STEGLUJAN® [STEG-loo-jan] (ertugliflozin and sitagliptin) tablets, for oral use Read this Medication Guide carefully before you start taking STEGLUJAN and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about STEGLUJAN? STEGLUJAN may cause serious side effects, including: • Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. STEGLUJAN can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking STEGLUJAN and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: • nausea • vomiting • stomach-area (abdominal) pain • tiredness • trouble breathing • ketones in your urine or blood • Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make Leia o documento completo
STEGLUJAN- ERTUGLIFLOZIN AND SITAGLIPTIN TABLET, FILM COATED MERCK SHARP & DOHME LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE STEGLUJAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STEGLUJAN. STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2017 RECENT MAJOR CHANGES Indications and Usage (1) 09/2023 Dosage and Administration (2.1, 2.3) 09/2023 Warnings and Precautions (5.1) 09/2023 INDICATIONS AND USAGE STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. (1) Has not been studied in patients with a history of pancreatitis. (1, 5.2) DOSAGE AND ADMINISTRATION Assess renal function before initiating and as clinically indicated. (2.1) Correct volume depletion before initiating. (2.1) Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. (2.2) Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in those tolerating STEGLUJAN and needing additional glycemic control. (2.2) Use is not recommended in patients with an eGFR less than 45 mL/min/1.73 m . (2.2) Withhold STEGLUJAN for at least 4 days, if possible, prior to major surgery or procedures associated with prolonged fasting. (2.3) DOSAGE FORMS AND STRENGTHS Tablets: Ertugliflozin 5 mg and sitagliptin 100 mg (3) Ertugliflozin 15 mg and sitagliptin 100 mg (3) CONTRAINDICATIONS Severe renal impairment (<30 mL/min/1.73 m ), end-stage renal disease, or dialysis. (4) Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in STEGLUJAN. (4, 5.11, 6.2) WARNINGS AND PRECAUTIONS _Diabetic Ketoacidosis in Patients with Type 1 Diabe Leia o documento completo