ertugliflozin

BEERS REMS

Type 2 diabetes mellitus (as adjunct to diet and exercise).

Contraindicated in:

Hypersensitivity
eGFR <45 mL/min/1.73 m² or on dialysis
Type 1 diabetes
Diabetic ketoacidosis
Severe hepatic impairment
OB: Avoid use during 2nd and 3rd trimesters (↑ risk of renal impairment in fetus)
Lactation: Lactation.

Use Cautiously in:

Renal impairment (eGFR <60 mL/min/1.73 m²), age 65 yr, low systolic BP, or concurrent use of diuretics (↑ risk of hypotension)
Acute febrile illness, reduced caloric intake due to illness or surgery, history of pancreatitis or pancreatic surgery, or alcohol abuse (↑ risk of ketoacidosis)
Hypovolemia, chronic kidney disease, HF, or concurrent use of diuretics, NSAIDs, ACE inhibitors, or angiotensin receptor blockers (↑ risk of acute kidney injury)
Previous amputation, peripheral vascular disease, neuropathy, or diabetic foot infection (↑ risk of lower limb amputation)
History of genital mycotic infections or uncircumcised (↑ risk of genital mycotic infections)
OB: Use during 1st trimester only if potential maternal benefit justifies potential fetal risk
Pedi: Safety and effectiveness not established in children
Geri: Appears on Beers list. Older adults may have ↑ risk of urogenital infections (especially women in the 1st mo of treatment) and euglycemic diabetic ketoacidosis. Use with caution in older adults.

CV: hypotension.

Endo: hypoglycemia (↑ with other medications).

F and E: dehydration, KETOACIDOSIS, polydipsia.

GI: ↓weight.

GU: genital mycotic infection, acute kidney injury, NECROTIZING FASCIITIS OF PERINEUM (FOURNIER'S GANGRENE), polyuria, urinary tract infection (including pyelonephritis), UROSEPSIS, vaginal pruritus.

Metab: hyperlipidemia.

MS: back pain, lower limb amputation (primarily toe and foot).

Neuro: dizziness, headache, syncope.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA).

Drug-Drug:

↑risk of hypoglycemia with insulin or insulin secretagogues; dose adjustments may be required.
Concurrent use with NSAIDs, diuretics, ACE inhibitors, or angiotensin receptor blockers may ↑ risk of acute kidney injury.
May ↓ lithium levels and effectiveness.

(Generic available)

Tablets: 5 mg; 15 mg;
In combination with: metformin (Segluromet); sitagliptin (Steglujan). See Appendix [not included in this PDA edition]

PO (Adults): 5 mg once daily initially; may ↑ to 15 mg once daily if needed.

Inhibits proximal renal tubular sodium-glucose co-transporter 2 (SGLT2), which reduces reabsorption of glucose and lowers renal threshold for glucose, and ultimately increases excretion of glucose in urine.

Therapeutic Effects:

Improved glycemic control.

Therapeutic Classification: antidiabetics

Pharmacologic Classification: sodium-glucose co-transporter 2 (SGLT2) inhibitors

Absorption: Completely absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Mostly metabolized by UDP-glucuronyl transferases (UGT) to inactive metabolites; minimal metabolism by CYP isoenzymes (12%). 41% excreted in feces (33.8% as unchanged drug), 50.2% excreted in urine (1.5% as unchanged drug).

Half-life: 16.6 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	24 hr

Instruct patient to take ertugliflozin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read the Medication Guide before starting and with each Rx refill in case of changes.
Explain to patient that ertugliflozin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
Instruct patient in proper testing of blood glucose and urine ketones. Inform patient that ertugliflozin will cause a positive test result when testing for urine glucose. Advise patient to monitor ketones, even if blood glucose is not elevated and blood glucose during periods of stress or illness. Notify health care professional if signs and symptoms of ketoses or significant changes occur.
Inform patient that ertugliflozin may cause yeast infections. Women may have signs and symptoms of a vaginal yeast infection (vaginal odor, white or yellow vaginal discharge [may be lumpy or look like cottage cheese], vaginal itching). Men may have signs and symptoms of a yeast infection of the penis (redness, itching, or swelling of penis; rash on penis; foul smelling discharge from penis; pain in skin around penis). Advise patient to notify health care professional if yeast infection occurs.
Advise patient to notify health care professional promptly if rash; hives; or swelling of face, lips, or throat occur.
Advise patient to notify health care professional if signs and symptoms of urinary tract infections (painful urination, flank pain, fever), hypotension, or perineal necrotizing fasciitis (pain or tenderness, redness, or swelling of genitals or area from genitals back to the rectum, with a fever above 100.4°F; malaise) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially other oral hypoglycemic medications.
Rep: Advise females of reproductive potential to use effective contraception, especially during the 2nd and 3rd trimesters and to avoid breastfeeding during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected.

NDC Code^*

0006- Merck Sharp and Dohme Corp.
0006-5363- STEGLATRO 0006-5363-03- 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)

0006- Merck Sharp and Dohme Corp.
0006-5363- STEGLATRO 0006-5363-06- 90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)

0006- Merck Sharp and Dohme Corp.
0006-5363- STEGLATRO 0006-5363-07- 500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07)

0006- Merck Sharp and Dohme Corp.
0006-5363- STEGLATRO 0006-5363-09- 2 BOTTLE in 1 CARTON (0006-5363-09) > 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)

0006- Merck Sharp and Dohme Corp.
0006-5363- STEGLATRO 0006-5363-10- 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10)

0006- Merck Sharp and Dohme Corp.
0006-5364- STEGLATRO 0006-5364-03- 30 TABLET, FILM COATED in 1 BOTTLE (0006-5364-03)

0006- Merck Sharp and Dohme Corp.
0006-5364- STEGLATRO 0006-5364-06- 90 TABLET, FILM COATED in 1 BOTTLE (0006-5364-06)

0006- Merck Sharp and Dohme Corp.
0006-5364- STEGLATRO 0006-5364-07- 500 TABLET, FILM COATED in 1 BOTTLE (0006-5364-07)

0006- Merck Sharp and Dohme Corp.
0006-5364- STEGLATRO 0006-5364-09- 2 BOTTLE in 1 CARTON (0006-5364-09) > 7 TABLET, FILM COATED in 1 BOTTLE (0006-5364-08)

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