Steglujan

In the U.S.

• Steglujan

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Sodium Glucose Co-Transporter 2 Inhibitor

Ertugliflozin and sitagliptin combination is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes.

Ertugliflozin works in the kidney to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. 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.

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 and 100 mg of sitagliptin 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

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.

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

Keep the medicine dry and in its original container.

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, diet, and illness. 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.

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

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.

Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be signs of heart failure.

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.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

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).

Limit the amount of alcohol you drink while you are using this medicine. Heavy alcohol use or binge drinking can increase your chances of serious side effects.

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.

Along with its needed effects, a medicine 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:

• 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

• Agitation
• blistering, peeling, or loosening of skin
• bloating
• constipation
• cough
• darkened urine
• decreased awareness or responsiveness
• decreased urine output
• diarrhea
• difficulty in moving
• difficulty swallowing
• fever
• hives, itching, skin rash
• indigestion
• irritability
• joint or muscle pain
• large, hard skin blisters
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aching or cramping
• muscle pain, stiffness, or twitching
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red, irritated eyes
• red skin lesions, often with a purple center
• severe joint pain
• severe sleepiness
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the face, ankles, or hands
• swollen joints
• tightness in the chest
• unusual drowsiness, dullness, or feeling of sluggishness
• yellow eyes or skin

Some side effects 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

• Pain in the arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Steglujan™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

Limitations of Use

Steglujan is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Steglujan has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Steglujan. [See Warnings and Precautions (5.1).]

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sitagliptin during pregnancy. Health care providers are encouraged to report any prenatal exposure to Steglujan by calling the Pregnancy Registry at 1-800-986-8999.

Risk Summary

Based on animal data showing adverse renal effects, from ertugliflozin, Steglujan is not recommended during the second and third trimesters of pregnancy.

The limited available data with ertugliflozin and sitagliptin use during pregnancy are not sufficient to determine a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).

In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible. There was no evidence of fetal harm in rats or rabbits at exposures of ertugliflozin approximately 300 times higher than the maximal clinical dose of 15 mg/day when administered during organogenesis (see Data).

In rats and rabbits, sitagliptin doses of 250 and 125 mg/kg, respectively (approximately 30 and 20 times the human exposure at the maximum recommended human dose) did not adversely affect development outcomes of either species.

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

Data

Animal Data

Ertugliflozin

When ertugliflozin was orally administered to juvenile rats from PND 21 to PND 90, increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization occurred at doses greater than or equal to 5 mg/kg (13-fold human exposures, based on AUC). These effects occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period.

In embryo-fetal development studies, ertugliflozin (50, 100 and 250 mg/kg/day) was administered orally to rats on gestation days 6 to 17 and to rabbits on gestation days 7 to 19. Ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at maternal exposures that were approximately 300 times the human exposure at the maximum clinical dose of 15 mg/day, based on AUC. A maternally toxic dose (250 mg/kg/day) in rats (707 times the clinical dose) was associated with reduced fetal viability, and a higher incidence of a visceral malformation (membranous ventricular septal defect). In the pre- and post-natal development study in pregnant rats, ertugliflozin was administered to the dams from gestation day 6 through lactation day 21 (weaning). Decreased post-natal growth (weight gain) was observed at maternal doses ≥100 mg/kg/day (greater than or equal to 331 times the human exposure at the maximum clinical dose of 15 mg/day, based on AUC).

Sitagliptin

Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (rats) and 125 mg/kg (rabbits), or approximately 30 and 20 times human exposure at the maximum recommended human dose (MRHD) of 100 mg/day based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1,000 mg/kg, or approximately 100 times human exposure at the MRHD.

Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1,000 mg/kg. No functional or behavioral toxicity was observed in offspring of rats.

Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours.

Lactation

Risk Summary

There is no information regarding the presence of Steglujan, in human milk, the effects on the breastfed infant, or the effects on milk production. Ertugliflozin and sitagliptin are present in the milk of lactating rats (see Data). 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, based on data with ertugliflozin. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of Steglujan is not recommended while breastfeeding.

Data

Animal Data

Ertugliflozin

The lacteal excretion of radiolabeled ertugliflozin in lactating rats was evaluated 10 to 12 days after parturition. Ertugliflozin derived radioactivity exposure in milk and plasma were similar, with a milk/plasma ratio of 1.07, based on AUC. Juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations).

Sitagliptin

Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1.

Pediatric Use

Safety and effectiveness of Steglujan in pediatric patients under 18 years of age have not been established.

Geriatric Use

Steglujan

No dosage adjustment of Steglujan is recommended based on age. Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)]. Steglujan is expected to have diminished efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)].

Ertugliflozin

Across the clinical program, a total of 876 (25.7%) patients treated with ertugliflozin were 65 years and older, and 152 (4.5%) patients treated with ertugliflozin were 75 years and older. Patients 65 years and older had a higher incidence of adverse reactions related to volume depletion compared to 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 [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

Sitagliptin

Of the total number of subjects (N=3,884) in pre-approval clinical safety and efficacy studies of sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

The safety and efficacy of ertugliflozin have not been established in patients with type 2 diabetes mellitus and moderate renal impairment. Compared to placebo-treated patients, patients with moderate renal impairment treated with ertugliflozin did not have improvement in glycemic control, and had increased risks for renal impairment, renal-related adverse reactions and volume depletion adverse reactions [see Dosage and Administration (2.2), Warnings and Precautions (5.4), and Adverse Reactions (6.1)]. Therefore, Steglujan is not recommended in this population.

Steglujan is contraindicated in patients with severe renal impairment, ESRD, or receiving dialysis. Steglujan is not expected to be effective in these patient populations [see Contraindications (4)].

No dosage adjustment or increased monitoring is needed in patients with mild renal impairment.

Hepatic Impairment

No dosage adjustment of Steglujan is necessary in patients with mild or moderate hepatic impairment. Steglujan has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population [see Clinical Pharmacology (12.3)].

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Steglujan only for the indication prescribed.

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

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

Applies to ertugliflozin / sitagliptin: oral tablet

General

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

Gastrointestinal

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

In pooled analysis of clinical trials including data from 5429 patients receiving sitagliptin 100 mg daily and 4817 patients receiving comparator or placebo, the incidence of non-adjudicated acute pancreatitis was 0. Per 100 patient-years in each group.

Ertugliflozin:
Common (1% to 10%): Thirst

Sitagliptin:
Frequency not reported: Abdominal pain, nausea, diarrhea
Postmarketing reports: Acute pancreatitis (including fatal and non-fatal hemorrhagic and necrotizing pancreatitis), constipation, vomiting

Genitourinary

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.

Ertugliflozin:
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

Hypersensitivity

Sitagliptin:
Postmarketing reports: Anaphylaxis, angioedema

Dermatologic

Sitagliptin:
Postmarketing reports: Angioedema, rash urticaria, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome, bullous pemphigoid, pruritus

Renal

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

SGLT2 Inhibitors:
Postmarketing reports: Acute Kidney Injury

Sitagliptin:
Postmarketing reports: Worsening renal function

During clinical trials with ertugliflozin, 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, ertugliflozin 5 mg, and 15 mg, respectively. There have been postmarketing reports of worsening renal function including acute renal failure, sometimes requiring dialysis with sitagliptin use. A subset of these reports involved patients with renal insufficiency, some of who received inappropriate doses.

Musculoskeletal

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

Sitagliptin:
Postmarketing reports: Severe and disabling arthralgia, extremity pain, back pain

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.

Cardiovascular

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

DPP-4 inhibitors
Frequency not reported: Heart failure

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

In a cardiovascular outcomes trials with 2 other dipeptidyl peptidase-4 (DPP-4) inhibitors, an association was observed with the use of DPP-4 inhibitors and heart failure. Subjects had type 2 diabetes and atherosclerotic cardiovascular disease.

Hepatic

Sitagliptin:
Postmarketing reports: Hepatic enzyme elevations

Nervous system

Common (1% to 10%): Headache

Hematologic

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

Respiratory

Common (1% to 10%): Nasopharyngitis

Sitagliptin:
Frequency not reported: Upper respiratory infection

Metabolic

Ertugliflozin:
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 ertugliflozin 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.

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. Ertugliflozin has been found in rat milk. Juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation showed and increased risk to the developing kidney (persistent increased organ weight, renal mineralization, renal pelvic and tubular dilations). Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1.

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.