WARNINGS AND PRECAUTIONS 

 

Lactic Acidosis: See boxed warning. (5.1)

Hypotension: May occur particularly in patients with renal impairment, the elderly, or patients on diuretics. Before initiating, assess and correct volume status. Monitor for signs and symptoms during therapy. (5.2)

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, eva luate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. (5.3)

Acute Kidney Injury and Impairment in Renal Function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. Monitor renal function. (5.4)

Urosepsis and Pyelonephritis: eva luate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.5)

Lower Limb Amputation: Before initiating, consider factors that may increase risk of amputation. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur. (5.6)

Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. (5.7)

Genital Mycotic Infections: Monitor and treat if indicated. (5.8)

Vitamin B12 Deficiency: Metformin may lower vitamin B12 levels. Measure hematological parameters annually. (5.9)

Increased LDL-C: Monitor and treat as appropriate. (5.10)

 

ADVERSE REACTIONS 

 

The most common adverse reactions associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. (6.1)

Most common adverse reactions associated with metformin (incidence ≥5%): diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. (6.1)

 

 

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

 

DRUG INTERACTIONS 

 

Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring. (7.2)

Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. (7.2)

Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake. (7.2)

 

USE IN SPECIFIC POPULATIONS 

 

Pregnancy: Advise females of the potential risk to a fetus, especially during the second and third trimesters. (8.1)

Lactation: Breastfeeding not recommended. (8.2)

Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3)

Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. (5.2, 8.5)