Ertugliflozin

Ertugliflozin is a prescription medication used to treat the symptoms of Type 2 Diabetes Mellitus. 

• Ertugliflozin is available under the following different brand names: Steglatro

Adult dosage

Tablet

• 5mg
• 15mg

Type 2 Diabetes Mellitus

Adult dosage

• Recommended starting dose is 5 mg orally once a day in the morning
• If starting dose is tolerated and additional glycemic control is needed, increase the dose to a maximum of 15 mg once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ertugliflozin include:

• genital yeast infections,
• urinary tract infections (UTIs),
• headache,
• vaginal itching,
• increased urination,
• runny or stuffy nose,
• weight loss, and
• thirst.

Serious side effects of Ertugliflozin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area,
• fever,
• feeling unwell,
• new pain,
• tenderness,
• sores,
• ulcers,
• infections in the legs or feet,
• little or no urination,
• nausea,
• vomiting,
• stomach pain,
• confusion,
• unusual drowsiness,
• trouble breathing,
• dizziness,
• weakness,
• light-headedness,
• pain or burning while urinating,
• increased urination,
• blood in the urine, and
• pain in the pelvis or back

Rare side effects of Ertugliflozin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ertugliflozin has severe interactions with no other drugs
• Ertugliflozin has serious interactions with no other drugs
• Ertugliflozin has moderate interactions with at least 23 other drugs.
• Ertugliflozin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to ertugliflozin or any excipient; reactions such as angioedema have occurred
• Patients on dialysis 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ertugliflozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ertugliflozin?”

Cautions

• 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 elderly; before initiating treatment in patients with one or more 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 (e.g.zx, 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 a 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) was 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
• Lower limb amputations
  • An increased risk for lower limb amputation (primarily of the toe) has been observed in clinical studies with another SGLT2 inhibitor; before initiating, consider factors that may predispose the patient to increased risk of amputations (.g, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers)
  • Counsel patients about the importance of routine preventative foot care; monitor patients receiving drugs for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue therapy if these complications occur
• Ketoacidosis
  • Not indicated for patients with type 1 diabetes mellitus (T1DM); in placebo-controlled trials, the risk of ketoacidosis was increased in patients with T1DM who received SGLT2 inhibitors
  • The risk of ketoacidosis may be greater with higher doses
  • Before initiating therapy, consider factors in inpatient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
  • Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
  • Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (.g, prolonged fasting due to acute illness or post-surgery); ensure risk factors for ketoacidosis are resolved before restarting therapy
  • Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved
• Drug interactions overview
  • Hypoglycemia risk increased with insulin and insulin secretagogues (e.g., sulfonylureas); a lower dose of insulin or insulin secretagogue may be required
• Laboratory testing
  • Urine glucose tests are not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
  • The 1,5-AG assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control

Pregnancy & Lactation

• 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 a risk to the developing human kidney
  • Because of the potential for serious adverse reactions in a breastfed infant, advise women that ertugliflozin is not recommended while breastfeeding