Steglatro

In the U.S.

• Steglatro

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Sodium Glucose Co-Transporter 2 Inhibitor

Ertugliflozin is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. It works in the kidney to prevent the absorption of glucose (blood sugar). This helps lower the blood sugar level. This medicine does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ertugliflozin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ertugliflozin in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in the dose for patients receiving ertugliflozin.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Lanreotide
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Esmolol
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Dehydration, severe or
• Pancreatic insulin deficiency, history of or
• Decrease in eating due to surgery or illness or
• Weakened physical condition (due to illness or surgery)—Use with caution. May cause side effects to become worse.

• Blood vessel disease or
• Diabetic foot ulcer or
• Leg amputation (leg removal surgery), history of or
• Neuropathy (nerve problem) of the leg—May increase the risk of leg amputations.

• Dehydration or
• Genital yeast (fungus) infection (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
• Hypercholesteremia (high levels of cholesterol) or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Kidney disease or
• Urinary tract infections (eg, pyelonephritis, urosepsis), history of—Use with caution. May make these conditions worse.

• Diabetic ketoacidosis or metabolic acidosis (high ketones and acid in the blood) or
• Kidney disease, moderate to severe or
• Liver disease, severe or
• Patients receiving dialysis or
• Type I diabetes—Should not be used in patients with these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause problems with blood sugar control.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Tell your doctor if you are on a low-salt or sodium diet.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and check your blood sugar as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Adults—At first, 1 tablet once a day, in the morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 15 milligrams (mg) of ertugliflozin once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine during the second and later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

It is very important to follow carefully any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe high blood sugar. Discuss this with your doctor.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Drinking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.

Check with your doctor right away if you have bloody urine, decrease in how much or how often you urinate, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may increase your risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may increase your risk of having lower leg or toe amputation (leg removal surgery). Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

You should not use Steglatro if you are allergic to ertugliflozin, or if you have:

• severe kidney disease (or if you are on dialysis); or

• diabetic ketoacidosis (call your doctor for treatment).

To make sure Steglatro is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• a bladder infection or urination problems;

• low blood pressure;

• blood circulation problems, especially in your legs;

• nerve damage in your legs;

• a diabetic foot ulcer or amputation;

• heart problems;

• problems with your pancreas, including surgery;

• if you drink alcohol often; or

• if you are on a low salt diet.

Follow your doctor's instructions about using Steglatro if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of your pregnancy.

Ertugliflozin may harm an unborn baby if you take the medicine during your second or third trimester. Tell your doctor if you become pregnant while using this medicine.

You should not breast-feed while using this medicine.

Steglatro is not approved for use by anyone younger than 18 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

When you start or stop taking Steglatro, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.

Other drugs may interact with ertugliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Applies to ertugliflozin: oral tablet

Along with its needed effects, ertugliflozin (the active ingredient contained in Steglatro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ertugliflozin:

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• itching of the vagina or outside of the genitals
• loss of consciousness
• nausea
• nervousness
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness
• vaginal discharge without odor or with mild odor

• Bladder pain
• bloody or cloudy urine
• blurred vision
• decreased frequency or amount of urine
• difficult, burning, or painful urination
• discharge with a strong odor from the penis
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• frequent urge to urinate
• increase in heart rate
• increased blood pressure
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• pain in the skin around the penis
• rapid breathing
• redness, itching, or swelling of the penis
• sunken eyes
• swelling of face, fingers, or lower legs
• troubled breathing
• vomiting
• weight gain

• Flushed, dry skin
• fruit-like breath odor
• stomach pain
• unexplained weight loss

Some side effects of ertugliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• decreased weight
• stuffy or runny nose

For Healthcare Professionals

Applies to ertugliflozin: oral tablet

General

The most commonly reported adverse events have included genital mycotic infections, more common in females, but also occurring in males.[Ref]

Genitourinary

Very common (10% or more): Female genital mycotic infections (up to 12.2%)
Common (1% to 10%): Male genital mycotic infections, urinary tract infections, vaginal pruritus, increased urination
Frequency not reported: Pyelonephritis

SGLT2 Inhibitors:
Postmarketing reports: Serious urinary tract infections including urosepsis and pyelonephritis

Female genital mycotic infections include genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Male genital mycotic infections balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Urinary tract infections include cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection. Vaginal pruritus includes vulvovaginal pruritus and pruritus genital. Increased urination includes pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.

Musculoskeletal

Nontraumatic lower limb amputation was reported in 3 (0.2%) patients receiving 5 mg and 8 patients (0.5%) receiving 15 mg; there was 1 report (0.1%) in the comparator group. A causal association between this drug and lower limb amputation has not been definitively established.

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Nontraumatic lower limb amputation

Metabolic

Very common (10% or more): Hypoglycemia (in combination with insulin and/or insulin secretagogue in patients with moderate renal impairment; up to 27%)
Common (1% to 10%): Decreased weight, hypoglycemia
Rare (0.01% to 0.1%): Ketoacidosis
Frequency not reported: Increases in low-density lipoprotein cholesterol (LDL-C), increased serum phosphate

Ketoacidosis was reported in 3 of 3409 (0.1%) patients treated with this drug during clinical trials; no cases were identified in comparator-treated patients. Mean increases in low-density lipoprotein cholesterol (LDL-C) relative to placebo were 2.6% and 5.4%, in the 5 mg and 15 mg groups, respectively.

Renal

Renal related adverse reactions included acute kidney injury, renal impairment, acute prerenal failure. The incidence of renal related adverse reactions was 0.6%, 2.5%, and 1.3% in patients receiving placebo, 5 mg, and 15 mg, respectively.

Common (1% to 10%): Renal related adverse reactions
Frequency not reported: Increased serum creatinine, decreased eGFR

SGLT2 Inhibitors:
Postmarketing reports: Acute Kidney Injury

Nervous system

Common (1% to 10%): Headache

Cardiovascular

Adverse reactions related to volume depletion include dehydration, dizziness, postural, presyncope, syncope, hypotension, and orthostatic hypotension.

Common (1% to 10%): Adverse reactions related to volume depletion

Gastrointestinal

Thirst includes thirst, dry mouth, polydipsia, and dry throat

Common (1% to 10%): Thirst

Respiratory

Common (1% to 10%): Nasopharyngitis

Hematologic

Rare (0.01% to 0.1%): Hemoglobin increased greater than 2 g/dL and above the upper limit of normal

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Women should be advised to avoid breastfeeding because of the potential for this drug to affect postnatal renal development.

While it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs in utero during the first 2 years of life. This drug was found in rat milk. Juvenile rats directly exposed to this drug during a developmental period corresponding to human kidney maturation showed an increased risk to the developing kidney (persistent increased organ weight, renal mineralization, renal pelvic and tubular dilations).