Ertugliflozin and metformin

(er too gli FLOE zin & met FOR min)

Diabetes mellitus, type 2: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin or who are already treated with both ertugliflozin and metformin

History of serious hypersensitivity to ertugliflozin, metformin, or any component of the formulation; severe renal impairment (eGFR <30 mL/minute/1.73 m2), ESRD, or dialysis; acute or chronic metabolic acidosis (including diabetic ketoacidosis, with or without coma)

Note: If present, correct volume depletion prior to initiation.

Diabetes mellitus, type 2: Oral:

Initial: Individualize initial dose based on patient's current antidiabetic regimen. May gradually increase dose based on effectiveness and tolerability.

Patients initiating ertugliflozin and already taking metformin: Ertugliflozin 5 mg/day plus a similar total daily dose of metformin, administered in 2 divided doses

Patients initiating metformin and already taking ertugliflozin: Metformin 1,000 mg/day plus a similar total daily dose of ertugliflozin, administered in 2 divided doses.

Patients already taking ertugliflozin and metformin: Administer the same total daily dose of ertugliflozin and a similar total daily dose of metformin in 2 divided doses

Maximum: Ertugliflozin 15 mg/metformin 2,000 mg per day

Refer to adult dosing. Metformin initial and maintenance dosing should be conservative, due to the potential for decreased renal function (monitor).

Positive test for glucosuria; ertugliflozin may interfere with 1,5-anhydroglucitol (1,5-AG) assay; use alternative methods to monitor glycemic control.

Urine for glucose and ketones, fasting blood glucose, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017c]). Initial and periodic monitoring of hematologic parameters (eg, hemoglobin/hematocrit and red blood cell indices); renal function (eGFR) prior to therapy initiation and at least annually (more often in patients at risk of developing renal impairment; every 3 to 6 months if eGFR 45 to <60 mL/minute/1.73 m2; every 3 months if eGFR 30 to <45 mL/minute/1.73 m2 [Lipska 2011]). Monitor vitamin B12 serum concentrations periodically with long-term therapy; folate (if megaloblastic anemia is suspected); volume status (eg, blood pressure, hematocrit, electrolytes); LDL-C; signs and symptoms of genital mycotic infections and urinary tract infection; signs and symptoms of metabolic acidosis; lower limb and feet (sores, ulcers, infection).

Animal reproduction studies have not been conducted with this combination. Refer to individual agents.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat the does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• For females, vaginal yeast infection. Report itching or discharge.
• For men, yeast infection of the penis. Report pain, swelling, rash, or discharge.
• Low blood sugar can happen. The chance of low blood sugar may be raised when ertugliflozin and metformin is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ertugliflozin and metformin is refilled. If you have any questions about ertugliflozin and metformin, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.