How should I take Ertugliflozin?

Ertugliflozin comes as a tablet to take by mouth. It is usually taken once a day in the morning with or without food. Take this medicine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take it exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of ertugliflozin and gradually increase your dose.

Ertugliflozin controls type 2 diabetes but does not cure it. Continue to take it even if you feel well. Do not stop taking this drug without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with ertugliflozin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Ertugliflozin Side Effects

The common side effects don’t need medical attention and will disappear as your body adjusts to the dosage. But if you are facing any serious or rare side effects, then immediately seek medical attention.

• Female genital mycotic infections (9.1-12.2%)
• Volume depletion adverse effects (1.9-4.4%)
• Male genital mycotic infections (3.7-4.2%)
• Urinary tract infections (4-4.1%)
• Headache (2.9-3.5%)
• Vaginal pruritus (2.4-2.8%)
• Increased urination (2.4-2.7%)
• Nasopharyngitis (2-2.5%)
• Back pain (1.7-2.5%)
• Renal adverse effects (1.3-2.5%)
• Weight decreased (1.2-2.4%)
• Thirst (1.4-2.7%)
• Adverse Effects
• Necrotizing fasciitis of the perineum (Fournier’s Gangrene)
• Angioedema

What Are Warnings and Precautions for Ertugliflozin?

Warnings

Causes intravascular volume contraction; symptomatic hypotension may occur after initiating, particularly in patients with renal impairment, with low systolic blood pressure, on diuretics, or who are older people,; before initiating treatment in patients with one or more of risk factors, assess volume status and renal function

Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients to acute kidney injury, including hypovolemia, chronic renal insufficiency, CHF, and concomitant medications (eg, diuretics, ACE inhibitors, ARBs, NSAIDs); consider temporarily discontinuing ertugliflozin in any setting of reduced oral intake or fluid loss; monitor for signs and symptoms of acute kidney injury, and, if evident, discontinue drug promptly and institute treatment

Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors

Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4°F or a general feeling of being unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

Dose-related increases in LDL-C reported

No conclusive evidence of macrovascular risk reduction with empagliflozin or any other antidiabetic agent

Before taking Ertugliflozin, Cautions

Hypersensitivity to ertugliflozin or any excipient; reactions such as angioedema have occurred

Patients on dialysis

Pregnancy and Lactation

Pregnancy

• Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy

  Data are limited in pregnant women and are not sufficient to determine a drug-associated risk of adverse developmental outcomes; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy

Lactation

• Not recommended while breastfeeding

  Unknown if distributed in human breast milk

  Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney

What Are Dosages of Ertugliflozin?

Dosage Forms & Strengths

Ertugliflozin Tablet 5mg, 15mg

15 mg/day PO.

15 mg/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Not indicated.

Not indicated.

Ertugliflozin brand name

Ertugliflozin brand name : Steglatro Tablet 5mg, 15mg

Brand names of Ertugliflozin combination products

• Segluromet^® (containing Ertugliflozin, Metformin)
• Steglujan^® (containing Ertugliflozin, Sitagliptin)