Steglatro

— THERAPEUTIC CATEGORIES —
  • Diabetes

Steglatro Generic Name & Formulations

General Description

Ertugliflozin 5mg, 15mg; tabs.

Pharmacological Class

Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

How Supplied

Tabs—30, 90

Manufacturer

Generic Availability

NO

Mechanism of Action

Ertugliflozin inhibits SGLT2 reducing renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Steglatro Indications

Indications

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

Not for improving glycemic control in patients with type 1 diabetes.

Steglatro Dosage and Administration

Adult

Take in the AM (with or without food). Initially 5mg once daily; if tolerated and need additional glycemic control; may increase to max 15mg once daily. Renal impairment (eGFR <45mL/min/1.73m2): not recommended.

Children

<18yrs: not established.

Steglatro Contraindications

Not Applicable

Steglatro Boxed Warnings

Not Applicable

Steglatro 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. Risk for lower limb amputations. 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 foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers in lower limbs; discontinue if occur. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs (including urosepsis, pyelonephritis); monitor and treat appropriately. Severe hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

Steglatro Pharmacokinetics

Absorption

Peak plasma concentrations (median Tmax): 1 hour postdose (under fasted conditions).

Distribution

Plasma protein bound: 93.6%.

Metabolism

Glucuronidation by UGT2B7, UGT1A9.

Elimination

Renal (50.2%), fecal (40.9%). Half-life: 16.6 hours.

Steglatro 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. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Steglatro Adverse Reactions

Adverse Reactions

Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decreased, thirst; ketoacidosis, renal impairment, angioedema; rare: Fournier's gangrene.

Steglatro Clinical Trials

See Literature

Steglatro Note

Not Applicable

Steglatro Patient Counseling

See Literature