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)

Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. (5.7) 

Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. (5.8) 

Genital Mycotic Infections: Monitor and treat if indicated. (5.9) 

Hypersensitivity: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly discontinue, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. (5.10)

Increased LDL-C: Monitor and treat as appropriate. (5.11) 

Severe and Disabling Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue if appropriate. (5.12)

Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue. (5.13)

ADVERSE REACTIONS 

Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections. (6.1) 

Most common adverse reactions associated with sitagliptin (incidence ≥5%): upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. (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. 

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)

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

Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. (5.2, 5.4, 8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 2/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE 

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Recommended Dosage 

 

2.2 Patients with Renal Impairment 

 

3 DOSAGE FORMS AND STRENGTHS 

 

4 CONTRAINDICATIONS 

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Pancreatitis 

 

5.2 Hypotension 

 

5.3 Ketoacidosis