STEGLATRO (ertugliflozin pidolate)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Diabetic foot infection
History of diabetes-related lower-extremity amputation
Invasive surgical procedure
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Necrotizing fasciitis of perineum or genital area
Peripheral vascular disease
Pregnancy

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetic peripheral neuropathy
Hypercholesterolemia
Hypotension

There are 9 severe adverse reactions.

More Frequent	Less Frequent
None.	Dehydration

Rare/Very Rare
Acute kidney injury Angioedema Diabetic ketoacidosis Hypovolemia Ketoacidosis Necrotizing fasciitis of perineum or genital area Pyelonephritis Urosepsis

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Vulvovaginal candidiasis	Back pain Candidal balanitis Genital organ pruritus Headache disorder Hypercholesterolemia Hyperphosphatemia Hypoglycemic disorder Increased hemoglobin Increased urinary frequency Pharyngitis Polydipsia Polyuria Urinary tract infection Vaginitis Weight loss Xerostomia

Rare/Very Rare
Hypotension Skin rash

There is insufficient evidence with ertugliflozin in pregnant women to evaluate a drug-associated risk of adverse developmental outcomes. Based on the results of reproductive and developmental toxicity studies in animals, ertugliflozin use during pregnancy may affect renal development and maturation, especially during the second and third trimesters of pregnancy. Poorly controlled diabetes mellitus during pregnancy carries risks to the mother and fetus, including diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, delivery complications, major birth defects, stillbirth, and macrosomia-related morbidity. Ertugliflozin therapy is not recommended in pregnant women during the second and third trimesters of pregnancy.

There is no information regarding the presence of ertugliflozin in human milk, the effects on the breast-fed infant, or the effects on milk production. Ertugliflozin is distributed into milk in rats. 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. Because of the potential risk for serious adverse reactions in a breast-fed infant, ertugliflozin is not recommended for use while breastfeeding.

In clinical trials in patients treated with ertugliflozin, 25.7% of patients were 65 years of age or older and 4.5% were 75 years of age or older.

Patients 65 years of age and older who received ertugliflozin had a higher incidence of adverse reactions related to volume depletion compared with younger patients; events were reported in 1.1%, 2.2%, and 2.6%

of patients treated with comparator, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. In the VERTIS CV trial, 50.5% of patients treated with ertugliflozin were 65 years of age and older, and 10.8%

of patients were 75 years of age and older. Safety and efficacy were generally similar for patients aged 65 years and older compared to patients younger than 65 years.