Segluromet 2.5-1000mg 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 cotransporter 2 (SGLT2) inhibitor; Biguanide
Pregnancy Category
Category D
FDA Approved
Nov 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Segluromet is a combination medicine used to help control blood sugar levels in adults with type 2 diabetes. It contains two different medicines: ertugliflozin, which helps your kidneys remove more sugar from your blood, and metformin, which helps your body use insulin better and reduces the amount of sugar your liver makes.
How to Use This Medicine
Taking Your Medication
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines. Take this medication with meals as directed. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It is essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines. Take this medication with meals as directed. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It is essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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, especially when starting treatment or during illness, to reduce the risk of dehydration.
- Limit alcohol intake, as it can increase the risk of lactic acidosis with metformin.
- Monitor blood sugar levels regularly as instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: Ertugliflozin 2.5 mg/Metformin 500 mg orally twice daily. Titrate based on efficacy and tolerability. Max: Ertugliflozin 15 mg/day, Metformin 2000 mg/day.
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial: Ertugliflozin 2.5 mg/Metformin 500 mg orally twice daily. May increase Ertugliflozin to 7.5 mg or 15 mg, and Metformin to 1000 mg, based on glycemic response and tolerability. Administer with meals to reduce gastrointestinal side effects of metformin.
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.
Moderate:
eGFR 45 to <60 mL/min/1.73m2: Max Metformin 1000 mg/day. Do not initiate Ertugliflozin. If already on Ertugliflozin, continue at current dose. eGFR 30 to <45 mL/min/1.73m2: Max Metformin 1000 mg/day. Discontinue Ertugliflozin.
Severe:
eGFR <30 mL/min/1.73m2: Contraindicated.
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No specific adjustment for Ertugliflozin. Metformin: Use with caution.
Moderate:
No specific adjustment for Ertugliflozin. Metformin: Use with caution.
Severe:
Metformin is contraindicated in severe hepatic impairment. Ertugliflozin: Not studied, use with caution.
Pharmacology
Mechanism of Action
Ertugliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces renal glucose reabsorption and increases urinary glucose excretion. Metformin is a biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Ertugliflozin: ~100%; Metformin: 50-60%
Tmax:
Ertugliflozin: ~1 hour; Metformin: 2-3 hours (immediate release)
FoodEffect:
Ertugliflozin: No clinically meaningful effect; Metformin: Decreases absorption rate and extent.
Distribution:
Vd:
Ertugliflozin: ~85.3 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:
Not available for specific rate, primarily renal for metformin, renal/fecal for ertugliflozin
ExcretionRoute:
Ertugliflozin: Renal (50.2%), Fecal (40.9%); Metformin: Renal (primarily unchanged)
Unchanged:
Ertugliflozin: ~34% in urine; Metformin: >90% in urine
Pharmacodynamics
OnsetOfAction:
Ertugliflozin: Within hours; Metformin: Within days
PeakEffect:
Ertugliflozin: Within 1-2 days; Metformin: 2-4 weeks for full effect
DurationOfAction:
Ertugliflozin: 24 hours; Metformin: 12-24 hours
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 distress. 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 generally >5 mcg/mL. If acidosis is suspected, discontinue Segluromet and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Risk factors include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors), age 65 years or greater, radiological studies with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following signs or 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.
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.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
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, call your doctor right away and follow your prescribed plan for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Increased Risk of Lower Limb Amputations: Toe and foot amputations have occurred most often. To minimize this risk, talk to your doctor about proper foot care. If you have a history of amputation, blood vessel disease, nerve disease, or a foot ulcer caused by diabetes, inform your doctor. Seek medical attention immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum become tender, red, or swollen, and you have a fever or do not feel well, seek medical help right away.
Common Side Effects
When starting this medication, it's common to experience stomach problems like upset stomach, vomiting, or diarrhea. If you develop stomach problems later during treatment, contact your doctor right away, as this may be a sign of a serious condition called lactic acidosis.
Other common side effects may include:
Diarrhea
Upset stomach 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.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for medical advice.
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following signs or 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.
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.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
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, call your doctor right away and follow your prescribed plan for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Increased Risk of Lower Limb Amputations: Toe and foot amputations have occurred most often. To minimize this risk, talk to your doctor about proper foot care. If you have a history of amputation, blood vessel disease, nerve disease, or a foot ulcer caused by diabetes, inform your doctor. Seek medical attention immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum become tender, red, or swollen, and you have a fever or do not feel well, seek medical help right away.
Common Side Effects
When starting this medication, it's common to experience stomach problems like upset stomach, vomiting, or diarrhea. If you develop stomach problems later during treatment, contact your doctor right away, as this may be a sign of a serious condition called lactic acidosis.
Other common side effects may include:
Diarrhea
Upset stomach 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.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Signs of lactic acidosis: unusual muscle pain, trouble breathing, unusual stomach discomfort, dizziness, lightheadedness, feeling cold, irregular heartbeat, or unusual tiredness.
- Signs of diabetic ketoacidosis: nausea, vomiting, stomach pain, excessive thirst, rapid deep breathing, unusual sleepiness, or a fruity smell to your breath.
- Signs of dehydration: dizziness, lightheadedness, or feeling faint, especially when standing up.
- Signs of urinary tract infection: burning sensation when urinating, frequent urination, urgency, pain in the lower abdomen or pelvis, or blood in urine.
- Signs of genital yeast infection: itching, redness, swelling, or discharge in the genital area.
- Signs of Fournier's gangrene: tenderness, redness, or swelling in the genital or perineal area, accompanied by fever or general malaise. Seek immediate medical attention.
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 where you are preparing for a procedure 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 you 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 where you are preparing for a procedure 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 you 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 essential to 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, and will advise you 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 best for you to use.
Safety Precautions
Do not drive 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
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 to ensure safe management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is crucial 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
If you are unable to drink liquids or experience persistent upset stomach, vomiting, or diarrhea, it is essential 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.
Heat 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 questions or concerns.
Urinary Tract Infections
Severe urinary tract infections (UTIs) have been reported in some individuals taking this medication, and may require hospitalization.
Kidney Problems
Kidney problems can occur, and in some cases, may require hospitalization or dialysis.
Age-Related Precautions
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 essential to 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, and will advise you 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 best for you to use.
Safety Precautions
Do not drive 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
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 to ensure safe management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is crucial 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
If you are unable to drink liquids or experience persistent upset stomach, vomiting, or diarrhea, it is essential 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.
Heat 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 questions or concerns.
Urinary Tract Infections
Severe urinary tract infections (UTIs) have been reported in some individuals taking this medication, and may require hospitalization.
Kidney Problems
Kidney problems can occur, and in some cases, may require hospitalization or dialysis.
Age-Related Precautions
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)
- Hypoglycemia (if co-administered with insulin or sulfonylureas)
- Severe volume depletion
- Renal failure
What to Do:
Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. Management is supportive and symptomatic. Hemodialysis can remove metformin and ertugliflozin from the blood.
Drug Interactions
Contraindicated Interactions
- Iodinated contrast media (withhold metformin at time of or prior to procedure, restart 48 hours after if renal function stable)
- Severe renal impairment (eGFR <30 mL/min/1.73m2)
- Metabolic acidosis (acute or chronic, including diabetic ketoacidosis)
Major Interactions
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - increased risk of lactic acidosis with metformin
- Alcohol (excessive intake) - potentiates metformin's effect on lactate metabolism, increased risk of lactic acidosis
- Diuretics (loop or thiazide) - increased risk of volume depletion and hypotension with ertugliflozin
- Drugs that affect renal function (e.g., NSAIDs, ACE inhibitors, ARBs) - increased risk of metformin accumulation and lactic acidosis
Moderate Interactions
- Cimetidine - increases metformin plasma concentration
- Digoxin - ertugliflozin may slightly increase digoxin exposure
- Insulin and insulin secretagogues (e.g., sulfonylureas) - increased risk of hypoglycemia when co-administered with ertugliflozin or metformin
- UGT enzyme inducers (e.g., rifampin) - may decrease ertugliflozin exposure (minor effect)
- UGT enzyme inhibitors (e.g., mefenamic acid) - may increase ertugliflozin exposure (minor effect)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess eligibility and guide dosing due to renal excretion of both components and risk of lactic acidosis with metformin.
Timing: Prior to initiation
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Vitamin B12 levels
Rationale: Metformin can decrease B12 absorption.
Timing: Prior to initiation (consider, especially in at-risk patients)
Volume status/Blood pressure
Rationale: To assess risk of hypotension/volume depletion with ertugliflozin.
Timing: Prior to initiation
Routine Monitoring
HbA1c
Frequency: Every 3-6 months
Target: Individualized, typically <7%
Action Threshold: Above target range, consider dose adjustment or additional therapy
Renal function (eGFR)
Frequency: At least annually; more frequently in elderly, renally impaired, or with concomitant nephrotoxic drugs
Target: Maintain eGFR >30 mL/min/1.73m2
Action Threshold: eGFR <45 mL/min/1.73m2 requires dose adjustment/discontinuation of ertugliflozin; eGFR <30 mL/min/1.73m2 requires discontinuation of both components
Fasting Plasma Glucose (FPG)
Frequency: Periodically, as needed
Target: Individualized
Action Threshold: Above target range, consider dose adjustment
Vitamin B12 levels
Frequency: Annually for long-term metformin use
Target: Normal range
Action Threshold: Low levels, consider supplementation
Signs/symptoms of lactic acidosis
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Presence of symptoms (e.g., malaise, myalgia, somnolence, abdominal distress, respiratory distress) requires immediate medical evaluation
Signs/symptoms of volume depletion
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Presence of symptoms (e.g., dizziness, orthostasis) requires fluid intake adjustment or dose modification
Signs/symptoms of UTIs or genital mycotic infections
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires appropriate treatment
Symptom Monitoring
- Symptoms of lactic acidosis (unusual muscle pain, trouble breathing, unusual stomach discomfort, dizziness, lightheadedness, feeling cold, irregular heartbeat)
- Symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, excessive thirst, rapid deep breathing, unusual sleepiness, fruity breath odor)
- Symptoms of volume depletion (dizziness, lightheadedness, orthostatic hypotension)
- Symptoms of urinary tract infection (burning sensation when urinating, frequent urination, urgency, pain in the lower abdomen or pelvis, blood in urine)
- Symptoms of genital mycotic infections (itching, redness, swelling, discharge)
- Symptoms of hypoglycemia (sweating, tremor, fast heartbeat, hunger, blurred vision, dizziness, confusion)
- Symptoms of Fournier's gangrene (tenderness, redness, or swelling in the genital or perineal area, fever, malaise)
Special Patient Groups
Pregnancy
Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects on the developing fetus from ertugliflozin. Metformin is generally considered safer in pregnancy for type 2 diabetes or gestational diabetes, but the combination product should be avoided.
Trimester-Specific Risks:
First Trimester:
Limited data for ertugliflozin. Metformin generally considered low risk.
Second Trimester:
Ertugliflozin: Potential for adverse renal effects (e.g., renal tubular immaturity, hydronephrosis) based on animal data.
Third Trimester:
Ertugliflozin: Potential for adverse renal effects (e.g., renal tubular immaturity, hydronephrosis) based on animal data.
Lactation
Not recommended. Ertugliflozin is present in the milk of lactating rats, and there is a potential for serious adverse reactions in a breastfed infant. Metformin is excreted in human milk, but generally considered compatible with breastfeeding by some sources; however, the combination product is not advised.
Infant Risk:
Potential for serious adverse reactions (e.g., renal effects) from ertugliflozin. Low risk from metformin alone.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
Geriatric Use
Increased risk of volume depletion, renal impairment, and lactic acidosis. Start with lower doses and titrate slowly. Monitor renal function more frequently. Assess volume status regularly.
Clinical Information
Clinical Pearls
- Educate patients on the signs and symptoms of lactic acidosis and diabetic ketoacidosis, and instruct them to seek immediate medical attention if these occur.
- Advise patients to maintain adequate hydration to reduce the risk of volume depletion and acute kidney injury.
- Temporarily discontinue Segluromet before any surgical procedures or radiological studies involving iodinated contrast media.
- Be aware of the increased risk of genital mycotic infections and urinary tract infections with SGLT2 inhibitors. Counsel patients on hygiene.
- Consider vitamin B12 supplementation for patients on long-term metformin therapy, especially if they develop symptoms of deficiency.
- Monitor for signs of Fournier's gangrene, a rare but serious necrotizing fasciitis of the perineum, and discontinue the drug immediately if suspected.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., Invokana, Farxiga, Jardiance)
- Other biguanides (Metformin monotherapy)
- DPP-4 inhibitors (e.g., Januvia, Tradjenta)
- GLP-1 receptor agonists (e.g., Ozempic, Trulicity)
- Sulfonylureas (e.g., Glipizide, Glyburide)
- Thiazolidinediones (e.g., Pioglitazone)
- Insulin
Cost & Coverage
Average Cost:
Highly variable, typically $400-$600 per 60 tablets (1 month supply)
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.