Steglujan Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
Mechanism of Action
Steglujan Indications
Indications
Limitations of Use
Not for improving glycemic control in patients with type 1 diabetes. Not studied in patients with a history of pancreatitis.
Steglujan Dosage and Administration
Adult
Children
Steglujan Contraindications
Contraindications
Steglujan Boxed Warnings
Not Applicable
Steglujan Warnings/Precautions
Warnings/Precautions
Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on loop diuretics. Assess volume status, renal function before and after initiating therapy. Correct volume depletion before initiating. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected; evaluate and treat if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 4 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections, UTIs (including urosepsis, pyelonephritis); monitor and treat appropriately. Prior to initiation, consider factors that may predispose the need for amputations (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infection (including osteomyelitis), new pain/tenderness, sores or ulcers of the lower limbs; discontinue if occur. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
Steglujan Pharmacokinetics
Absorption
Peak plasma concentration: 1 hour postdose under fasted conditions (ertugliflozin). Absolute bioavailability: ~100% (ertugliflozin); ~87% (sitagliptin).
Distribution
Mean steady-state volume of distribution: 85.5 L (ertugliflozin); 198 L (sitagliptin). Plasma protein bound: 93.6% (ertugliflozin).
Elimination
Sitagliptin: renal (87%), fecal (13%). Ertugliflozin: renal (50.2%), fecal (40.9%). Half-life: 12.4 hours (sitagliptin), 16.6 hours (ertugliflozin).
Steglujan Interactions
Interactions
Greater potential for volume depletion or hypotension with concomitant diuretics. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Ertugliflozin may antagonize serum lithium concentrations; monitor levels more frequently. Ertugliflozin will lead to false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Steglujan Adverse Reactions
Adverse Reactions
Genital mycotic infections (esp. females), upper RTIs, nasopharyngitis, headache, UTIs, vaginal pruritus, increased urination, back pain, weight decrease, thirst; hypoglycemia, pancreatitis, ketoacidosis, renal impairment, severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.
Steglujan Clinical Trials
See Literature
Steglujan Note
Not Applicable
Steglujan Patient Counseling
See Literature