Segluromet 7.5-500mg 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 and Biguanide Combination
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor; Biguanide
Pregnancy Category
Not recommended in 2nd and 3rd trimesters (due to ertugliflozin)
FDA Approved
Dec 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Segluromet is a combination medicine used to help adults with type 2 diabetes control their blood sugar. It contains two active ingredients: ertugliflozin, which helps your kidneys remove more sugar from your body through your urine, 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 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 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 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 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 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 exercising or in hot weather, to reduce the risk of dehydration.
- Limit alcohol intake, as it can increase the risk of lactic acidosis with metformin.
- Monitor your blood sugar levels regularly as instructed by your doctor.
- Carry a source of sugar (e.g., glucose tablets, juice) to treat mild hypoglycemia if you are also taking insulin or a sulfonylurea.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: Ertugliflozin 2.5 mg/Metformin 500 mg orally once daily. Titrate based on efficacy and tolerability. Segluromet 7.5-500mg is a specific strength for maintenance.
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
type2Diabetes:
Initial: Ertugliflozin 2.5 mg/Metformin 500 mg orally once daily. May increase to Ertugliflozin 7.5 mg/Metformin 1000 mg or Ertugliflozin 15 mg/Metformin 1000 mg once daily, based on individual response and tolerability. Take with the evening meal.
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. Continue to monitor renal function.
Moderate:
eGFR 45 to <60 mL/min/1.73m2: Do not initiate Segluromet. If already on Segluromet, assess benefits and risks. Max dose of metformin component should not exceed 1000 mg/day. eGFR 30 to <45 mL/min/1.73m2: Do not initiate Segluromet. If already 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:
Metformin is contraindicated. Segluromet is contraindicated.
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, leading to increased urinary glucose excretion (glucosuria) and reduced plasma glucose concentrations. 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. It does not produce hypoglycemia in patients with type 2 diabetes.
Pharmacokinetics
Absorption:
Bioavailability:
Ertugliflozin: ~60%; Metformin: ~50-60% (oral)
Tmax:
Ertugliflozin: ~1 hour; Metformin: ~2-3 hours (IR), ~7 hours (ER)
FoodEffect:
Ertugliflozin: No clinically meaningful effect; Metformin: Decreases Cmax and AUC slightly, but absorption is prolonged with food (ER formulation).
Distribution:
Vd:
Ertugliflozin: ~85.5 L; Metformin: ~654 L
ProteinBinding:
Ertugliflozin: ~93.6%; Metformin: Negligible
CnssPenetration:
Ertugliflozin: Limited; Metformin: Limited
Elimination:
HalfLife:
Ertugliflozin: ~17 hours; Metformin: ~6.2 hours (plasma), ~17.6 hours (blood)
Clearance:
Ertugliflozin: ~11.2 L/hr; Metformin: Renal clearance is ~3.5 times greater than creatinine clearance
ExcretionRoute:
Ertugliflozin: Fecal (~40% unchanged), Renal (~1% unchanged); Metformin: Renal (unchanged)
Unchanged:
Ertugliflozin: ~40% (feces), ~1% (urine); Metformin: ~100% (urine)
Pharmacodynamics
OnsetOfAction:
Ertugliflozin: Within hours; Metformin: Within days
PeakEffect:
Ertugliflozin: Within hours; Metformin: 2-3 weeks for full effect
DurationOfAction:
Ertugliflozin: 24 hours; Metformin: 12-24 hours (ER)
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. If acidosis is suspected, discontinue Segluromet and institute general supportive measures in a hospital setting along with prompt hemodialysis.
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, abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating 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, drowsiness, weakness, 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 certain fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it's essential to properly care for your feet. Inform your doctor if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers related to diabetes. 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: A potentially life-threatening infection can occur with this type of medication. Seek medical help immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or general feeling of illness.
Stomach Problems: Although common when starting this medication, stomach problems like nausea, vomiting, or diarrhea can be a sign of a more serious condition (lactic acidosis) if they occur later during treatment. Contact your doctor immediately if you experience stomach problems.
Other Possible Side Effects
Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Diarrhea
Nausea or vomiting
Gas
Headache
Stomach pain or heartburn
Fatigue or weakness
This is not an exhaustive list of possible side effects. If you have concerns about side effects, consult your doctor. 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, abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating 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, drowsiness, weakness, 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 certain fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it's essential to properly care for your feet. Inform your doctor if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers related to diabetes. 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: A potentially life-threatening infection can occur with this type of medication. Seek medical help immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or general feeling of illness.
Stomach Problems: Although common when starting this medication, stomach problems like nausea, vomiting, or diarrhea can be a sign of a more serious condition (lactic acidosis) if they occur later during treatment. Contact your doctor immediately if you experience stomach problems.
Other Possible Side Effects
Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Diarrhea
Nausea or vomiting
Gas
Headache
Stomach pain or heartburn
Fatigue or weakness
This is not an exhaustive list of possible side effects. If you have concerns about side effects, consult 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:
- Symptoms of lactic acidosis: unusual muscle pain, stomach discomfort, diarrhea, nausea, vomiting, unusual tiredness or weakness, difficulty breathing, dizziness, lightheadedness, decreased appetite, feeling cold.
- Symptoms of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, excessive thirst, frequent urination, unusual tiredness, difficulty breathing, fruity-smelling breath.
- Symptoms of dehydration: dizziness, lightheadedness, feeling faint, especially when standing up.
- Symptoms of urinary tract infection (UTI): burning sensation when urinating, frequent urination, urgent need to urinate, pain in the lower abdomen or back, fever.
- Symptoms of genital yeast infection: itching or irritation in the genital area, rash, unusual discharge.
- Symptoms of hypoglycemia (low blood sugar): sweating, shaking, fast heartbeat, hunger, confusion, dizziness, blurred vision (especially if taken with insulin or sulfonylureas).
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 medical 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 might 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 (including 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 medical 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 might 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 (including 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 essential 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
Do not drive if you have experienced low blood sugar, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying 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
Stressful events, such as fever, infection, injury, or surgery, can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar control.
Dehydration and Fluid Management
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 Fluid Loss
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 patients 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 patients 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 patients taking this medication, and may require hospitalization.
Kidney Problems
Kidney problems, including those requiring hospitalization or dialysis, have been reported in patients taking this medication.
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 women 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 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
Do not drive if you have experienced low blood sugar, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying 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
Stressful events, such as fever, infection, injury, or surgery, can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar control.
Dehydration and Fluid Management
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 Fluid Loss
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 patients 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 patients 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 patients taking this medication, and may require hospitalization.
Kidney Problems
Kidney problems, including those requiring hospitalization or dialysis, have been reported in patients taking this medication.
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 women 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, hypothermia, hypotension, resistant bradyarrhythmias)
- Hypoglycemia (if co-administered with insulin or sulfonylureas)
- Renal dysfunction
- Dehydration
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately. Seek emergency medical attention. Hemodialysis can be used to remove metformin. Ertugliflozin is minimally dialyzable.
Drug Interactions
Contraindicated Interactions
- Iodinated contrast media (for metformin component, temporarily discontinue)
- Severe renal impairment (eGFR <30 mL/min/1.73m2)
- Metabolic acidosis (including diabetic ketoacidosis)
Major Interactions
- Alcohol (increases risk of lactic acidosis)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - increase risk of lactic acidosis)
- Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, isavuconazonium, trimethoprim, vandetanib - increase metformin levels)
- Diuretics (loop or thiazide - increase risk of dehydration and renal impairment, may increase risk of lactic acidosis)
- Insulin and insulin secretagogues (e.g., sulfonylureas - increased risk of hypoglycemia)
Moderate Interactions
- Digoxin (may increase digoxin levels)
- Lithium (may decrease lithium levels)
- Rifampin (may decrease ertugliflozin exposure)
- Phenytoin (may decrease ertugliflozin exposure)
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess eligibility and guide dosing, as both components are renally cleared and metformin is contraindicated in severe renal impairment.
Timing: Prior to initiation
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Vitamin B12 levels
Rationale: Metformin can decrease Vitamin B12 levels.
Timing: Prior to initiation, especially in patients with risk factors for B12 deficiency
Volume status/hydration
Rationale: Ertugliflozin can cause intravascular volume depletion.
Timing: Prior to initiation
Routine Monitoring
HbA1c
Frequency: Every 3-6 months
Target: Individualized, typically <7%
Action Threshold: If above target, consider dose adjustment or additional therapy.
Renal function (eGFR)
Frequency: At least annually, more frequently in elderly or those with risk factors for renal impairment
Target: >60 mL/min/1.73m2 (ideally)
Action Threshold: If eGFR falls below 45 mL/min/1.73m2, discontinue. If eGFR falls below 60 mL/min/1.73m2, assess benefits/risks and consider dose reduction for metformin component.
Signs/symptoms of lactic acidosis
Frequency: Ongoing clinical assessment
Target: N/A
Action Threshold: If suspected, discontinue immediately and seek emergency medical attention.
Signs/symptoms of diabetic ketoacidosis (DKA)
Frequency: Ongoing clinical assessment
Target: N/A
Action Threshold: If suspected, discontinue immediately and seek emergency medical attention.
Signs/symptoms of urinary tract infections (UTIs) and genital mycotic infections
Frequency: Ongoing clinical assessment
Target: N/A
Action Threshold: If suspected, treat promptly.
Volume status/blood pressure
Frequency: Regularly, especially in patients prone to hypotension or on diuretics
Target: N/A
Action Threshold: If symptomatic hypotension or dehydration occurs, manage appropriately.
Vitamin B12 levels
Frequency: Periodically (e.g., every 1-2 years) in long-term metformin users or those with risk factors
Target: Normal range
Action Threshold: If low, consider supplementation.
Symptom Monitoring
- Unusual muscle pain
- Stomach discomfort
- Diarrhea
- Nausea
- Vomiting
- Unusual tiredness or weakness
- Difficulty breathing
- Dizziness
- Lightheadedness
- Decreased appetite
- Fruity-smelling breath
- Increased thirst
- Increased urination
- Weight loss
- Genital itching or discharge
- Painful urination
- Frequent urination
- Back pain
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 gestational diabetes, but the combination is not advised.
Trimester-Specific Risks:
First Trimester:
Limited data for ertugliflozin. Metformin generally considered low risk.
Second Trimester:
Ertugliflozin: Potential for adverse renal effects on the developing fetus (renal tubular dilation and renal pelvic dilation) observed in animal studies. Not recommended.
Third Trimester:
Ertugliflozin: Potential for adverse renal effects on the developing fetus. Not recommended.
Lactation
Not recommended during breastfeeding. Both ertugliflozin and metformin are excreted into breast milk. Potential for serious adverse reactions in a breastfed infant.
Infant Risk:
L3 (Moderate risk) for metformin alone, but combination with ertugliflozin (unknown risk, but SGLT2 inhibitors generally not recommended) makes overall risk higher. Potential for renal effects in infant from ertugliflozin, and hypoglycemia from metformin.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 18 years of age.
Geriatric Use
Increased risk of adverse reactions, particularly dehydration, hypotension, and renal impairment, especially in patients âĨ65 years of age. Renal function should be assessed more frequently. Metformin-associated lactic acidosis risk increases with age. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Always assess renal function (eGFR) before initiating Segluromet and periodically thereafter. Discontinue if eGFR falls below 30 mL/min/1.73m2.
- Temporarily discontinue Segluromet before or at the time of an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73m2, in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Segluromet if renal function is stable.
- Educate patients on the signs and symptoms of lactic acidosis and DKA, and instruct them to seek immediate medical attention if these occur.
- Advise patients to maintain adequate hydration to reduce the risk of volume depletion, especially during illness, prolonged fasting, or strenuous exercise.
- Be aware of the increased risk of genital mycotic infections and urinary tract infections with SGLT2 inhibitors; educate patients on hygiene and symptoms.
- Consider vitamin B12 monitoring in patients on long-term metformin therapy, especially those with risk factors for deficiency.
- Segluromet should be taken with the evening meal to minimize gastrointestinal side effects of metformin.
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, Victoza)
- Sulfonylureas (e.g., Glipizide, Glyburide)
- Thiazolidinediones (e.g., Pioglitazone)
- Insulin
Cost & Coverage
Average Cost:
$400 - $600 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand 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 about its use. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.