STEGLUJAN 15 mg/1
ertugliflozin and sitagliptin · TABLET, FILM COATED · Merck Sharp & Dohme LLC
STEGLUJAN is a tablet, film coated containing ertugliflozin and sitagliptin at 15 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- STEGLUJAN
- Generic Name
- ertugliflozin and sitagliptin
- NDC Code (Product)
0006-5368- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 15 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA209805
- Marketing Start
- 12/19/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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) ] . 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 & Administration
2 DOSAGE AND ADMINISTRATION Assess renal function before initiating and as clinically indicated. ( 2.1 ) Correct volume depletion before initiating. ( 2.1 ) Recommended starting dosage is 5 mg ertugliflozin/100 mg sitagliptin orally once daily, taken in the morning, with or without food. ( 2.2 ) Increase dosage to 15 mg ertugliflozin/100 mg sitagliptin orally once daily in those tolerating STEGLUJAN and needing additional glycemic control. ( 2.2 ) Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2 . ( 2.2 ) Withhold STEGLUJAN for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.3 ) 2.1 Prior to Initiation of STEGLUJAN Assess renal function before initiating STEGLUJAN and as clinically indicated [see Warnings and Precautions (5.4) ] . Assess volume status. In patients with volume depletion, correct this condition before initiating STEGLUJAN [see Warnings and Precautions (5.5) and Use in Specific Populations (8.5 , 8.6) ]. 2.2 Recommended Dosage The recommended starting dosage of STEGLUJAN is 5 mg ertugliflozin/100 mg sitagliptin orally once daily, taken in the morning,…
Contraindications
4 CONTRAINDICATIONS STEGLUJAN is contraindicated in patients with: Severe renal impairment (eGFR less than 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. Reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precautions (5.11) and Adverse Reactions (6.2) ]. Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end-stage renal disease, or dialysis. ( 4 ) Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in STEGLUJAN. ( 4 , 5.11 , 6.2 )
Drug Interactions
7 DRUG INTERACTIONS Table 3: Clinically Significant Drug Interactions with STEGLUJAN Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when STEGLUJAN is used in combination with insulin or an insulin secretagogue. Intervention: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLUJAN. Lithium Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during STEGLUJAN initiation and dosage changes. Positive Urine Glucose Test Clinical Impact: SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact: Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention: Monitoring glycemic control with 1,5-AG assay is n…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Lower Limb Amputation [see Warnings and Precautions (5.3) ] Acute Renal Failure [see Warnings and Precautions (5.4) ] Volume Depletion [see Warnings and Precautions (5.5) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.6) ] Heart Failure [see Warnings and Precautions (5.7) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.8) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.9) ] Genital Mycotic Infections [see Warnings and Precautions (5.10) ] Hypersensitivity Reactions [see Warnings and Precautions (5.11) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.12) ] Bullous Pemphigoid [see Warnings and Precautions (5.13) ] Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections. ( 6.1 ) Most common adverse reactions associated with sit…
Frequently Asked Questions
What is STEGLUJAN used for?
STEGLUJAN contains ertugliflozin and sitagliptin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is STEGLUJAN a controlled substance?
STEGLUJAN is not classified as a controlled substance by the DEA.
What is the generic name for STEGLUJAN?
The generic name for STEGLUJAN is ertugliflozin and sitagliptin. There are no other listed brand versions of ertugliflozin and sitagliptin.
What is the NDC code for STEGLUJAN 15 mg/1?
The NDC (National Drug Code) for STEGLUJAN 15 mg/1 is 0006-5368, listed by Merck Sharp & Dohme LLC.
Other STEGLUJAN Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)