Segluromet 7.5-1000mg Tablets
WARNING: Rarely, metformin may cause too much lactic acid in the blood (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take certain other drugs, including topiramate. The risk is also higher in people who are 65 or older and in people who are having surgery, an exam or test with contrast, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this drug.Do not take this drug if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration).Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like confusion; fast breathing; fast or slow heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; feeling very tired or weak; very bad dizziness; feeling cold; or muscle pain or cramps. @ COMMON USES: It is used to help control blood sugar in people with type 2 diabetes.
Drug Class
Antidiabetic, SGLT2 inhibitor/Biguanide combination
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor; Biguanide
Pregnancy Category
Not available
FDA Approved
Dec 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Segluromet is a combination medicine used to treat type 2 diabetes. It contains two active ingredients: ertugliflozin and metformin. Ertugliflozin works by helping your kidneys remove more sugar from your blood through your urine. Metformin works by reducing the amount of sugar your liver makes and by improving how your body uses insulin. Together, they help lower your blood sugar levels.
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. Take your medication with meals as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel 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 effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has 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 the best way to dispose of your medication, consult with your pharmacist. 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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. Take your medication with meals as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel 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 effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has 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 the best way to dispose of your medication, consult with your pharmacist. 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a healthy diet plan as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Stay well-hydrated by drinking plenty of fluids, especially when starting the medication or in hot weather.
- Limit or avoid excessive alcohol intake, as it can increase the risk of lactic acidosis with metformin.
- Monitor your blood sugar levels regularly as instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (7.5 mg ertugliflozin/1000 mg metformin) orally twice daily with meals. Maximum daily dose is 15 mg ertugliflozin and 2000 mg metformin.
Dose Range:
7.5 - 15 mg
Condition-Specific Dosing:
initial_therapy:
Initial dose should be individualized based on patient's current regimen, effectiveness, and tolerability, not exceeding 7.5 mg ertugliflozin and 1000 mg metformin per day if not already on these doses.
renal_function_eGFR_ge_60:
No dose adjustment needed.
renal_function_eGFR_45_to_lt_60:
Initiation of Segluromet is not recommended. If eGFR falls to <60 mL/min/1.73m2 while on Segluromet, assess renal function more frequently. If eGFR falls to <45 mL/min/1.73m2, discontinue Segluromet.
renal_function_eGFR_30_to_lt_45:
Contraindicated for initiation. If eGFR falls to <45 mL/min/1.73m2 while on Segluromet, discontinue.
renal_function_eGFR_lt_30:
Contraindicated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
eGFR 60 to <90 mL/min/1.73m2: No dose adjustment needed. Monitor renal function.
Moderate:
eGFR 45 to <60 mL/min/1.73m2: Initiation is not recommended. If eGFR falls to <60 mL/min/1.73m2 while on Segluromet, assess renal function more frequently. If eGFR falls to <45 mL/min/1.73m2, discontinue Segluromet.
eGFR 30 to <45 mL/min/1.73m2: Contraindicated for initiation. If eGFR falls to <45 mL/min/1.73m2 while on Segluromet, discontinue.
Severe:
eGFR <30 mL/min/1.73m2: Contraindicated.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
No dose adjustment for ertugliflozin. Metformin: Use with caution.
Moderate:
No dose adjustment for ertugliflozin. Metformin: Use with caution.
Severe:
Ertugliflozin: Not studied. Metformin: Contraindicated due to increased risk of lactic acidosis.
Pharmacology
Mechanism of Action
Segluromet combines two antihyperglycemic agents with different mechanisms of action: ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide. Ertugliflozin reduces renal glucose reabsorption and increases urinary glucose excretion, thereby lowering blood glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Ertugliflozin: ~60%; Metformin: ~50-60% (absolute oral bioavailability of a 500 mg metformin tablet given under fasting conditions)
Tmax:
Ertugliflozin: ~1 hour; Metformin: 2-3 hours (IR), 4-8 hours (ER)
FoodEffect:
Ertugliflozin: Minimal effect on exposure; Metformin: Food decreases the extent and slightly delays the absorption.
Distribution:
Vd:
Ertugliflozin: ~85.5 L; Metformin: 654 L
ProteinBinding:
Ertugliflozin: ~93.6%; Metformin: Negligible
CnssPenetration:
Limited for both
Elimination:
HalfLife:
Ertugliflozin: ~17 hours; Metformin: ~6.2 hours (plasma), ~17.6 hours (blood)
Clearance:
Ertugliflozin: ~11.1 L/hr (renal and non-renal); Metformin: Renal clearance is ~3.5 times greater than creatinine clearance
ExcretionRoute:
Ertugliflozin: Renal (unchanged) and fecal (metabolites); Metformin: Renal (unchanged)
Unchanged:
Ertugliflozin: ~1% (renal); Metformin: ~90% (renal)
Pharmacodynamics
OnsetOfAction:
Ertugliflozin: Within hours (glucose lowering); Metformin: Within days (glucose lowering)
PeakEffect:
Ertugliflozin: Within hours; Metformin: Days to weeks for full glucose-lowering effect
DurationOfAction:
Ertugliflozin: 24 hours; Metformin: 12-24 hours (depending on formulation)
Safety & Warnings
BLACK BOX WARNING
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate/pyruvate ratio; metformin plasma levels were generally >5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. If metformin-associated lactic acidosis is suspected, discontinue Segluromet and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
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 immediately or seek emergency medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Fluid and Electrolyte Imbalance: Mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Urinary Tract Infection (UTI): Blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Vaginal Yeast Infection: Itching, unpleasant 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, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it is essential to properly care for your feet. Inform your doctor if you have a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. If you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet, contact your doctor immediately.
Rare but Serious Infection: A potentially life-threatening infection can occur with this type of medication. Seek medical attention immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Stomach Problems: Although common, stomach problems like nausea, vomiting, or diarrhea can sometimes be a sign of a more serious condition called lactic acidosis. If you experience stomach problems during treatment, contact your doctor right away.
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:
Diarrhea
Nausea or vomiting
Gas
Headache
Stomach pain or heartburn
Feeling tired or weak
If any of these side effects or other symptoms bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediately or seek emergency medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Fluid and Electrolyte Imbalance: Mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Urinary Tract Infection (UTI): Blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Vaginal Yeast Infection: Itching, unpleasant 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, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it is essential to properly care for your feet. Inform your doctor if you have a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. If you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet, contact your doctor immediately.
Rare but Serious Infection: A potentially life-threatening infection can occur with this type of medication. Seek medical attention immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Stomach Problems: Although common, stomach problems like nausea, vomiting, or diarrhea can sometimes be a sign of a more serious condition called lactic acidosis. If you experience stomach problems during treatment, contact your doctor right away.
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:
Diarrhea
Nausea or vomiting
Gas
Headache
Stomach pain or heartburn
Feeling tired or weak
If any of these side effects or other symptoms bother you or do not go away, contact your doctor for advice. 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 lactic acidosis: unusual muscle pain, trouble breathing, stomach pain, dizziness, lightheadedness, feeling cold, or a slow or irregular heartbeat. Seek immediate medical attention.
- Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, excessive thirst, frequent urination, unusual tiredness, or fruity-smelling breath. Seek immediate medical attention.
- Signs of dehydration: dizziness, lightheadedness, or feeling faint, especially when standing up.
- Signs of urinary tract infection (UTI): burning sensation when urinating, frequent urination, cloudy urine, or pain in the pelvis or back.
- Signs of genital yeast infection: itching or irritation in the genital area, unusual discharge.
- Signs of hypoglycemia (low blood sugar): sweating, shaking, fast heartbeat, hunger, confusion, dizziness, or irritability. Carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat mild hypoglycemia.
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 have recently experienced a heart attack or stroke.
If you are unable to eat or drink normally, including situations before certain procedures or surgery.
If you are scheduled to undergo an exam or test that involves contrast agents, or if you have had such a test within the past 48 hours, consult with your doctor.
If you are pregnant or think you may be pregnant. Do not take this medication during the second or third trimester of pregnancy.
If you are breastfeeding. It is recommended that you do 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting 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 have recently experienced a heart attack or stroke.
If you are unable to eat or drink normally, including situations before certain procedures or surgery.
If you are scheduled to undergo an exam or test that involves contrast agents, or if you have had such a test within the past 48 hours, consult with your doctor.
If you are pregnant or think you may be pregnant. Do not take this medication during the second or third trimester of pregnancy.
If you are breastfeeding. It is recommended that you do 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
Monitoring and Testing
Regularly check your blood work and other lab tests as directed by your doctor. Additionally, monitor your blood sugar levels as instructed by your doctor, and discuss with your doctor which glucose tests are most suitable for you.
Safety Precautions
Avoid driving if your blood sugar levels are low, as this can increase the risk of accidents. 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
Adhere to the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe and effective management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
Blood Sugar Control
During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.
Dehydration and Fluid Loss
If you are unable to drink liquids or experience persistent upset stomach, vomiting, or diarrhea, it is crucial to avoid dehydration. Contact your doctor for guidance on managing these symptoms, as dehydration can lead to low blood pressure or worsen kidney problems.
Alcohol Consumption
Consult with your doctor before consuming alcohol while taking this medication.
Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss.
Potential Side Effects
High cholesterol has been reported in some individuals taking this medication. If you have concerns, discuss them with your doctor.
Long-term Treatment
Prolonged treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, inform your doctor.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a potentially life-threatening condition. This risk is higher in individuals with diabetes or pancreas problems, as well as those who are sick, dehydrated, or have undergone surgery. Check your ketone levels as directed by your doctor, and seek medical attention if you have any concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) and kidney problems have been reported in some individuals taking this medication. In some cases, hospitalization or dialysis may be necessary.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Birth Control
There is a risk of pregnancy in individuals of childbearing age who have not been ovulating. If you wish to avoid pregnancy, use birth control while taking this medication. Additionally, this medication may harm the unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant, contact your doctor immediately.
It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
Monitoring and Testing
Regularly check your blood work and other lab tests as directed by your doctor. Additionally, monitor your blood sugar levels as instructed by your doctor, and discuss with your doctor which glucose tests are most suitable for you.
Safety Precautions
Avoid driving if your blood sugar levels are low, as this can increase the risk of accidents. 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
Adhere to the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe and effective management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
Blood Sugar Control
During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.
Dehydration and Fluid Loss
If you are unable to drink liquids or experience persistent upset stomach, vomiting, or diarrhea, it is crucial to avoid dehydration. Contact your doctor for guidance on managing these symptoms, as dehydration can lead to low blood pressure or worsen kidney problems.
Alcohol Consumption
Consult with your doctor before consuming alcohol while taking this medication.
Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss.
Potential Side Effects
High cholesterol has been reported in some individuals taking this medication. If you have concerns, discuss them with your doctor.
Long-term Treatment
Prolonged treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, inform your doctor.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a potentially life-threatening condition. This risk is higher in individuals with diabetes or pancreas problems, as well as those who are sick, dehydrated, or have undergone surgery. Check your ketone levels as directed by your doctor, and seek medical attention if you have any concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) and kidney problems have been reported in some individuals taking this medication. In some cases, hospitalization or dialysis may be necessary.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Birth Control
There is a risk of pregnancy in individuals of childbearing age who have not been ovulating. If you wish to avoid pregnancy, use birth control while taking this medication. Additionally, this medication may harm the unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Lactic acidosis (severe metabolic acidosis)
- Hypoglycemia (especially if taken with other antidiabetic agents)
- Volume depletion/dehydration
- Renal dysfunction
What to Do:
In case of suspected overdose, seek immediate emergency medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Iodinated contrast (for metformin, temporarily discontinue Segluromet at the time of or prior to the procedure)
- Severe renal impairment (eGFR <30 mL/min/1.73m2)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis (DKA)
- Severe hepatic impairment
Major Interactions
- Alcohol (increased risk of lactic acidosis with metformin)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - increased risk of lactic acidosis with metformin
- Loop diuretics (e.g., furosemide) - increased risk of volume depletion and hypotension with ertugliflozin
- Drugs affecting renal function (e.g., NSAIDs, ACE inhibitors, ARBs) - increased risk of renal impairment and lactic acidosis with metformin
Moderate Interactions
- Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) eliminated by renal tubular secretion - may increase metformin levels
- UGT inducers (e.g., rifampin) - may decrease ertugliflozin exposure
- Insulin and insulin secretagogues (e.g., sulfonylureas) - increased risk of hypoglycemia
Minor Interactions
- Not many specific minor interactions listed for this combination beyond those affecting glucose levels.
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess eligibility for treatment and establish baseline for monitoring due to risk of lactic acidosis with metformin and renal effects of ertugliflozin.
Timing: Prior to initiation
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Blood glucose
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Metformin is contraindicated in severe hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
HbA1c
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: >7% (or individualized target) may require therapy adjustment
Blood glucose (fasting and postprandial)
Frequency: Daily (self-monitoring) or as directed by physician
Target: Fasting: 80-130 mg/dL; Postprandial: <180 mg/dL (individualized)
Action Threshold: Persistently high or low readings may require therapy adjustment
Renal function (eGFR)
Frequency: At least annually; more frequently in patients with risk factors for renal impairment (e.g., elderly, concomitant medications)
Target: >60 mL/min/1.73m2 for continued use
Action Threshold: Discontinue if eGFR falls below 45 mL/min/1.73m2
Signs and symptoms of lactic acidosis
Frequency: Ongoing patient education and monitoring
Target: N/A
Action Threshold: Immediate medical evaluation if suspected
Signs and symptoms of volume depletion
Frequency: Ongoing patient education and monitoring
Target: N/A
Action Threshold: Immediate medical evaluation if suspected
Symptom Monitoring
- Signs of lactic acidosis (malaise, myalgias, respiratory distress, somnolence, abdominal pain)
- Signs of diabetic ketoacidosis (nausea, vomiting, abdominal pain, rapid weight loss, thirst, polyuria, fatigue, fruity breath)
- Signs of urinary tract infection (dysuria, frequent urination, urgency, fever, flank pain)
- Signs of genital mycotic infection (itching, redness, discharge)
- Signs of volume depletion/dehydration (dizziness, lightheadedness, orthostatic hypotension)
- Signs of hypoglycemia (sweating, tremor, confusion, hunger, irritability)
Special Patient Groups
Pregnancy
Segluromet is not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects on the developing fetus from ertugliflozin. Metformin use during pregnancy has been more extensively studied and is often continued under medical supervision, but the combination product is generally avoided in later pregnancy. Discuss with your healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data for ertugliflozin. Metformin generally considered low risk.
Second Trimester:
Ertugliflozin: Not recommended due to potential for adverse renal effects (e.g., renal tubular immaturity and impaired renal function) in the developing fetus.
Third Trimester:
Ertugliflozin: Not recommended due to potential for adverse renal effects (e.g., renal tubular immaturity and impaired renal function) in the developing fetus.
Lactation
Both ertugliflozin and metformin are present in human milk. Due to the potential for serious adverse reactions in a breastfed infant (e.g., renal immaturity effects from ertugliflozin, lactic acidosis from metformin), breastfeeding is not recommended while taking Segluromet.
Infant Risk:
L3 (Moderate risk - possible adverse effects on infant)
Pediatric Use
The safety and effectiveness of Segluromet have not been established in pediatric patients. Not recommended for use in this population.
Geriatric Use
Elderly patients (âĨ65 years of age) may be at increased risk for volume depletion, renal impairment, and lactic acidosis. Renal function should be assessed more frequently in this population. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Counsel patients on the importance of adequate hydration to minimize the risk of volume depletion, especially during illness or in hot weather.
- Educate patients on the signs and symptoms of lactic acidosis and diabetic ketoacidosis (even with normal glucose levels, euglycemic DKA can occur with SGLT2 inhibitors) and to seek immediate medical attention if these occur.
- Instruct patients to temporarily discontinue Segluromet prior to any radiological study involving iodinated contrast or any surgical procedure, and to restart only after renal function has been re-evaluated and found to be stable.
- Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
- Monitor for signs of urinary tract infections and genital mycotic infections, which are common side effects of SGLT2 inhibitors.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., Invokana, Farxiga, Jardiance)
- Other biguanides (e.g., metformin monotherapy)
- GLP-1 receptor agonists (e.g., Ozempic, Trulicity, Victoza)
- DPP-4 inhibitors (e.g., Januvia, Tradjenta, Onglyza)
- Sulfonylureas (e.g., glipizide, glyburide)
- Thiazolidinediones (TZDs) (e.g., pioglitazone, rosiglitazone)
- Insulin
Cost & Coverage
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 promptly. 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 receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.