Steglujan 5-100mg Tablets

Manufacturer MERCK SHARP & DOHME Active Ingredient Ertugliflozin and Sitagliptin(er too gli FLOE zin & sit a GLIP tin) Pronunciation er-too-gli-FLOE-zin & sit-a-GLIP-tin
It is used to help control blood sugar in people with type 2 diabetes.
🏷️
Drug Class
Antidiabetic, combination
🧬
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor and Dipeptidyl peptidase-4 (DPP-4) inhibitor
🤰
Pregnancy Category
Category D
FDA Approved
Dec 2017
⚖️
DEA Schedule
Not Controlled

Overview

ℹ️

What is this medicine?

Steglujan is a medication that combines two different types of diabetes medicines (ertugliflozin and sitagliptin) to help lower your blood sugar. Ertugliflozin works by helping your kidneys remove more sugar from your body through your urine. Sitagliptin works by increasing the levels of natural substances in your body that help control blood sugar, especially after meals.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's recommended to take it in the morning. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
💡

Lifestyle & Tips

  • Follow a healthy diet plan as recommended by your doctor or dietitian.
  • Engage in regular physical activity.
  • Stay well-hydrated to prevent dehydration, especially when sick or in hot weather.
  • Practice good personal hygiene, especially in the genital area, to reduce the risk of infections.
  • Monitor your blood sugar regularly as advised by your healthcare provider.
  • Inform your doctor if you are scheduled for surgery or medical procedures, as you may need to temporarily stop this medication.
💊

Available Forms & Alternatives

Dosing & Administration

👨‍⚕️

Adult Dosing

Standard Dose: Initial: 5 mg ertugliflozin/100 mg sitagliptin orally once daily in the morning. May increase to 15 mg ertugliflozin/100 mg sitagliptin orally once daily if additional glycemic control is needed and tolerated.
Dose Range: 5 - 15 mg

Condition-Specific Dosing:

type 2 diabetes mellitus: Initial: 5 mg ertugliflozin/100 mg sitagliptin orally once daily. Max: 15 mg ertugliflozin/100 mg sitagliptin orally once daily.
👶

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
⚕️

Dose Adjustments

Renal Impairment:

Mild: eGFR ≥ 60 mL/min/1.73 m²: No dose adjustment.
Moderate: eGFR < 60 mL/min/1.73 m² but ≥ 45 mL/min/1.73 m²: Initiate with 5 mg ertugliflozin/100 mg sitagliptin. Do not increase to 15 mg/100 mg. eGFR < 45 mL/min/1.73 m²: Not recommended.
Severe: eGFR < 30 mL/min/1.73 m²: Contraindicated.
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: No dose adjustment.
Moderate: No dose adjustment.
Severe: Not studied; use with caution.

Pharmacology

🔬

Mechanism of Action

Ertugliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion and lowering blood glucose concentrations. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It slows the inactivation of incretin hormones (GLP-1 and GIP), which are released in response to meals. By increasing active incretin levels, sitagliptin enhances glucose-dependent insulin release from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells, leading to improved glycemic control.
📊

Pharmacokinetics

Absorption:

Bioavailability: Ertugliflozin: ~100%; Sitagliptin: ~87%
Tmax: Ertugliflozin: 1 hour; Sitagliptin: 1-4 hours
FoodEffect: Ertugliflozin: No clinically meaningful effect; Sitagliptin: No clinically meaningful effect. Can be taken with or without food.

Distribution:

Vd: Ertugliflozin: 174 L; Sitagliptin: 198 L
ProteinBinding: Ertugliflozin: 93.6%; Sitagliptin: 38%
CnssPenetration: Limited

Elimination:

HalfLife: Ertugliflozin: ~17 hours; Sitagliptin: ~12.4 hours
Clearance: Ertugliflozin: 11.2 L/hr; Sitagliptin: 350 mL/min
ExcretionRoute: Ertugliflozin: Renal (40.6%), Fecal (50.2%); Sitagliptin: Renal (79% unchanged), Fecal (13%)
Unchanged: Ertugliflozin: <1%; Sitagliptin: 79%
⏱️

Pharmacodynamics

OnsetOfAction: Ertugliflozin: Within hours (glucose excretion); Sitagliptin: Within 24 hours (DPP-4 inhibition)
PeakEffect: Ertugliflozin: 1-2 hours; Sitagliptin: 1-4 hours
DurationOfAction: Ertugliflozin: 24 hours; Sitagliptin: 24 hours

Safety & Warnings

⚠️

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic Reaction: 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.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, or vomiting, feeling very sleepy, shortness of breath, or feeling very tired or weak.
Urinary Tract Infection (UTI): 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.
Vaginal Yeast Infection: Itching, bad odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Pancreatitis (Severe and Potentially Deadly Pancreas Problems): Severe stomach pain, severe back pain, or severe upset stomach or vomiting. Contact your doctor immediately if you experience any of these symptoms.
Heart Failure: If you have a history of heart failure or kidney problems, inform your doctor. Contact your doctor right away if you feel very tired, experience shortness of breath, significant weight gain, or swelling in the arms or legs.
Increased Risk of Lower Limb Amputations: Toe and foot amputations have occurred most frequently. Discuss foot care with your doctor, and report any history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. Contact your doctor immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.
Severe Joint Pain: Contact your doctor right away if you experience severe joint pain or any joint pain that does not subside.
Bullous Pemphigoid (Skin Reaction): Blisters or skin breakdown. Contact your doctor immediately if you experience these symptoms.
Fournier's Gangrene (Rare but Potentially Deadly Infection): Tender, red, or swollen genitals or the area between your genitals and rectum, accompanied by fever or feeling unwell. Seek medical help right away if you experience these symptoms.
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (Severe Skin Reaction): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes. Seek medical help immediately if you experience these symptoms.

Other Side Effects

Most people do not experience side effects or only have minor side effects. However, if you are concerned about any of the following side effects or if they persist, contact your doctor or seek medical attention:

Common cold symptoms
Nose or throat irritation
Headache
Upset stomach
Diarrhea

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of low blood sugar (hypoglycemia): shakiness, sweating, confusion, dizziness, hunger, fast heartbeat. (More likely if also taking insulin or sulfonylureas).
  • Signs of dehydration: dizziness, lightheadedness, feeling faint, especially when standing up.
  • Signs of urinary tract infection: burning or pain when urinating, cloudy urine, strong-smelling urine, fever, back pain.
  • Signs of genital yeast infection: itching, redness, swelling, or rash in the genital area, unusual discharge.
  • Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, excessive thirst, frequent urination, fruity-smelling breath, confusion, unusual tiredness.
  • Signs of Fournier's gangrene (a serious genital infection): pain, tenderness, redness, or swelling in the genital or perineal area, fever, feeling unwell.
  • Signs of severe allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing.
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you have liver disease.
If you are dehydrated, as this may require special consideration.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
⚠️

Precautions & Cautions

Important Warnings and Precautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may instruct you to stop taking this drug before certain surgical procedures. If you are required to stop taking this medication, your doctor will advise you on when to resume taking it after your surgery or procedure.

Monitoring and Lab Tests

Regularly have your blood work and other laboratory tests checked as directed by your doctor. This medication may affect the results of certain lab tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this drug.

Blood Sugar Control

Stressful events, such as fever, infection, injury, or surgery, can make it more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels. Monitor your blood sugar levels as instructed by your doctor and discuss with your doctor which glucose tests are best for you to use.

Safety Precautions

Do not drive if your blood sugar levels are low, as this can increase your risk of being involved in an accident. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position and exercise caution when climbing stairs.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor. Additionally, discuss with your doctor before consuming alcohol. If you are unable to eat or drink normally, such as when you are sick, fasting, or undergoing certain procedures or surgery, consult with your doctor for guidance.

Hydration and Dehydration

Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you are unable to consume liquids orally or experience persistent upset stomach, vomiting, or diarrhea, contact your doctor for advice on how to avoid dehydration. Dehydration can lead to low blood pressure or worsen kidney problems.

Potential Side Effects

High cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor. Ketoacidosis, a condition characterized by excessive acid in the blood or urine, has also occurred in patients taking this drug. This condition can be life-threatening and may require hospitalization. People with diabetes or pancreas problems are at higher risk of developing ketoacidosis, as are those who are sick, dehydrated, or cannot eat or drink normally. The risk of ketoacidosis is also increased in individuals who skip meals, follow a ketogenic diet, or undergo surgery. If you use insulin and take less than the prescribed dose or miss a dose, your risk of ketoacidosis may also be higher. Monitor your ketone levels as directed by your doctor and consult with your doctor if you have any questions or concerns.

Urinary Tract Infections and Kidney Problems

Severe urinary tract infections (UTIs) have been reported in patients taking this medication, and in some cases, hospitalization was required. Kidney problems have also occurred, and in some instances, hospitalization or dialysis was necessary.

Special Populations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.
🆘

Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (if co-administered with insulin/sulfonylureas)
  • Volume depletion/dehydration
  • Diabetic ketoacidosis (rare, but possible with SGLT2 inhibitors)
  • Hypotension

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and based on symptoms. For hypoglycemia, administer glucose. For dehydration, administer fluids.

Drug Interactions

🔴

Major Interactions

  • Loop diuretics (e.g., furosemide): Increased risk of volume depletion and hypotension due to additive diuretic effect of ertugliflozin.
  • Insulin and insulin secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia when co-administered with sitagliptin. Dose reduction of insulin or sulfonylurea may be required.
🟡

Moderate Interactions

  • Digoxin: Sitagliptin can slightly increase digoxin plasma concentrations. Monitor digoxin levels.
  • UGT enzyme inducers (e.g., rifampin): May decrease ertugliflozin exposure. Monitor glycemic control.
  • Lithium: SGLT2 inhibitors may decrease lithium levels. Monitor lithium levels.

Monitoring

🔬

Baseline Monitoring

Renal function (eGFR)

Rationale: To assess eligibility for treatment and guide dosing, as the drug is contraindicated in severe renal impairment and not recommended in moderate impairment.

Timing: Prior to initiation

HbA1c

Rationale: To establish baseline glycemic control and guide treatment goals.

Timing: Prior to initiation

Blood glucose (fasting and postprandial)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation

Blood pressure

Rationale: To establish baseline and monitor for potential hypotension due to volume depletion.

Timing: Prior to initiation

📊

Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7%

Action Threshold: If target not met, consider dose adjustment or additional therapy.

Renal function (eGFR)

Frequency: At least annually, or more frequently in patients with impaired renal function or risk factors for renal decline.

Target: Maintain above 45 mL/min/1.73 m² for continued use, above 30 mL/min/1.73 m² for contraindication.

Action Threshold: Discontinue if eGFR falls below 45 mL/min/1.73 m² (not recommended) or 30 mL/min/1.73 m² (contraindicated).

Blood pressure

Frequency: Regularly, as clinically indicated.

Target: Individualized, typically <130/80 mmHg.

Action Threshold: Manage hypotension or hypertension as appropriate.

Signs and symptoms of volume depletion

Frequency: Regularly, especially in elderly or those on diuretics.

Target: N/A

Action Threshold: Address dehydration, consider dose adjustment of diuretics or Steglujan.

Signs and symptoms of urinary tract infections (UTIs) and genital mycotic infections

Frequency: Patient education for self-monitoring.

Target: N/A

Action Threshold: Promptly treat infections.

Signs and symptoms of diabetic ketoacidosis (DKA)

Frequency: Patient education for self-monitoring.

Target: N/A

Action Threshold: Seek immediate medical attention if symptoms occur.

👁️

Symptom Monitoring

  • Symptoms of hypoglycemia (if used with insulin/sulfonylureas): sweating, tremor, dizziness, confusion, hunger.
  • Symptoms of volume depletion: dizziness, lightheadedness, orthostatic hypotension.
  • Symptoms of urinary tract infection: painful urination, frequent urination, urgency, fever, back pain.
  • Symptoms of genital mycotic infection: itching, redness, discharge.
  • Symptoms of diabetic ketoacidosis: nausea, vomiting, abdominal pain, rapid deep breathing, unusual thirst, fruity breath odor, confusion, fatigue.
  • Symptoms of Fournier's gangrene: tenderness, redness, or swelling in the genital or perineal area, fever, malaise.
  • Symptoms of hypersensitivity reactions: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing/swallowing.

Special Patient Groups

🤰

Pregnancy

Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development in the fetus from ertugliflozin. Limited human data for sitagliptin.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies for ertugliflozin show renal pelvic and ureter dilation at high doses. Sitagliptin animal studies show no teratogenicity.
Second Trimester: Ertugliflozin is not recommended due to potential for adverse renal effects in the developing fetus.
Third Trimester: Ertugliflozin is not recommended due to potential for adverse renal effects in the developing fetus.
🤱

Lactation

Not recommended during breastfeeding. Both ertugliflozin and sitagliptin are excreted in the milk of lactating rats. It is unknown if they are excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Potential for serious adverse reactions (e.g., renal effects, hypoglycemia) in breastfed infant.
👶

Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

👴

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion and renal impairment. Monitor renal function and hydration status more frequently.

Clinical Information

💎

Clinical Pearls

  • Advise patients to maintain adequate hydration to minimize the risk of volume depletion, especially during illness or in hot weather.
  • Educate patients on the signs and symptoms of diabetic ketoacidosis (DKA), even if blood glucose levels are not severely elevated (euglycemic DKA), and to seek immediate medical attention if these occur.
  • Emphasize the importance of genital hygiene to reduce the risk of mycotic infections, which are more common with SGLT2 inhibitors.
  • Caution patients about the increased risk of hypoglycemia if Steglujan is used in combination with insulin or insulin secretagogues (e.g., sulfonylureas); dose adjustments of these concomitant medications may be necessary.
  • Steglujan is not indicated for the treatment of type 1 diabetes mellitus or for diabetic ketoacidosis.
  • Discontinue Steglujan if eGFR falls below 45 mL/min/1.73 m² (not recommended) or 30 mL/min/1.73 m² (contraindicated).
🔄

Alternative Therapies

  • Metformin
  • Sulfonylureas (e.g., glipizide, glyburide)
  • GLP-1 Receptor Agonists (e.g., liraglutide, semaglutide)
  • Insulin
  • Thiazolidinediones (e.g., pioglitazone)
  • Alpha-glucosidase inhibitors (e.g., acarbose)
  • Other SGLT2 inhibitors (e.g., Invokana, Farxiga, Jardiance)
  • Other DPP-4 inhibitors (e.g., Januvia, Onglyza, Tradjenta)
💰

Cost & Coverage

Average Cost: $500 - $700 per 30 tablets
Insurance Coverage: Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.