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Segluromet contains a combination of ertugliflozin and metformin which help control blood sugar levels. Ertugliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin works by helping your liver release lower amounts of sugar into your blood.
Segluromet is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Segluromet is not for treating type 1 diabetes.
You should not use Segluromet if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis.
Ertugliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Segluromet.
Ertugliflozin can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Get emergency medical help if you have even mild symptoms such as: unusual muscle pain, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, irregular heart rate, dizziness, or feeling very weak or tired.
You should not use Segluromet if you are allergic to ertugliflozin or metformin, or if you have:
severe kidney disease (or if you are on dialysis); or
diabetic ketoacidosis (call your doctor for treatment).
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine.
Ertugliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.
To make sure Segluromet is safe for you, tell your doctor if you have ever had:
heart problems;
a diabetic foot ulcer or amputation;
circulation problems or nerve problems in your legs or feet;
liver or kidney disease;
high ketone levels in your blood or urine;
bladder infections or other urination problems;
low blood pressure;
problems with your pancreas, including surgery;
if you drink alcohol often; or
if you are on a low salt diet.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.
Follow your doctor's instructions about using Segluromet if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.
You should not use Segluromet during the second or third trimester of pregnancy.
Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.
You should not breastfeed while using this medicine.
Segluromet is not approved for use by anyone younger than 18 years old.
Segluromet is usually taken twice per day with meals. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Segluromet works best if you take it with food.
Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Segluromet can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
This medicine can cause unusual results with certain lab tests. Tell any doctor who treats you that you are using Segluromet.
Segluromet is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Your doctor may have you take extra vitamin B12. Take only the amount of vitamin B12 that your doctor has prescribed.
Store Segluromet at room temperature away from moisture and heat.
Usual Adult Dose of Segluromet for Diabetes Type 2:
Individualize dose based on current regimen:
Initial dose: 1 tablet orally twice a day
-For patients on metformin: Start with tablet containing ertugliflozin 2.5 mg and one-half total daily dose of metformin
-For patients on ertugliflozin: Start with tablet containing one-half daily dose of ertugliflozin and metformin 500 mg
-For patients already treated with ertugliflozin and metformin: Start with tablet that provides one-half total daily dose of ertugliflozin and one-half of similar daily dose of metformin
Adjust dose based on effectiveness and tolerability
Maximum daily dose: Ertugliflozin 15 mg; Metformin 2000 mg
Comments:
-Volume depletion should be corrected prior to therapy initiation.
-Metformin dose should be gradually increased to reduce gastrointestinal side effects; taking with meals will also reduce gastrointestinal effects.
-This drug is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can cause lactic acidosis.
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Get emergency medical help if you have signs of an allergic reaction to Segluromet: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
new pain, tenderness, sores, ulcers, or infections in your legs or feet;
little or no urination;
lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out); or
signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.
Some side effects may be more likely to occur in older adults.
Common Segluromet side effects may include:
genital yeast infection;
stomach discomfort;
nausea, vomiting, diarrhea, gas;
headache, weakness; or
urinating more than usual.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
When you start or stop taking Segluromet, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.
Other drugs may interact with ertugliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Segluromet only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Segluromet (www.drugs.com/segluromet.html).
Note: This document contains side effect information about ertugliflozin / metformin. Some of the dosage forms listed on this page may not apply to the brand name Segluromet.
Applies to ertugliflozin/metformin: oral tablet
Oral route (Tablet)
Death, hypothermia, hypotension, and resistant bradyarrhythmias have been reported due to metformin-associated lactic acidosis. Onset may be subtle and include nonspecific symptoms such as malaise, myalgia, respiratory distress, somnolence, and abdominal distress; laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. The risk of lactic acidosis increases with renal or hepatic impairment, aged 65 years or older, having a radiological study with contrast, surgery, or other procedures, hypoxic states, and excessive alcohol intake. If lactic acidosis is suspected, ertugliflozin and metformin hydrochloride should be discontinued, supportive measures started in a hospital setting. Prompt hemodialysis is recommended.
Along with its needed effects, ertugliflozin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ertugliflozin / metformin:
More common
Less common
Rare
Incidence not known
Some side effects of ertugliflozin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to ertugliflozin / metformin: oral tablet
The most commonly reported adverse events with ertugliflozin have included genital mycotic infections, more common in females, but also occurring in males; the most commonly reported adverse events with metformin have included diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.
Ketoacidosis was reported in 3 of 3409 (0.1%) patients treated with this drug during clinical trials; no cases were identified in comparator-treated patients. Mean increases in low-density lipoprotein cholesterol (LDL-C) relative to placebo were 2.6% and 5.4%, in the 5 mg and 15 mg groups, respectively
Ertugliflozin:
Very common (10% or more): Hypoglycemia (in combination with insulin and/or insulin secretagogue in patients with moderate renal impairment; up to 27%)
Common (1% to 10%): Decreased weight, hypoglycemia
Rare (0.01% to 0.1%): Ketoacidosis
Frequency not reported: Increases in low-density lipoprotein cholesterol (LDL-C), increased serum phosphate
Metformin:
Common (1% to 10%): Hypoglycemia
Very rare (less than 0.01%): Lactic acidosis
Ertugliflozin:
Very common (10% or more): Female genital mycotic infections (up to 12.2%)
Common (1% to 10%): Male genital mycotic infections, urinary tract infections, vaginal pruritus, increased urination
Frequency not reported: Pyelonephritis
SGLT2 Inhibitors:
Postmarketing reports: Serious urinary tract infections including urosepsis and pyelonephritis, Fournier's gangrene
Female genital mycotic infections include genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Male genital mycotic infections balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Urinary tract infections include cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection. Vaginal pruritus includes vulvovaginal pruritus and pruritus genital. Increased urination includes pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Renal related adverse reactions included acute kidney injury, renal impairment, acute prerenal failure. The incidence of renal related adverse reactions was 0.6%, 2.5%, and 1.3% in patients receiving placebo, 5 mg, and 15 mg, respectively.
Ertugliflozin:
Common (1% to 10%): Renal related adverse reactions
Frequency not reported: Increased serum creatinine, decreased eGFR
SGLT2 Inhibitors:
Postmarketing reports: Acute Kidney Injury
Ertugliflozin:
Common (1% to 10%): Thirst
Metformin:
Common (1% to 10%): Diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion
Thirst includes thirst, dry mouth, polydipsia, and dry throat.
Ertugliflozin:
Frequency not reported: Increased serum phosphate
Adverse reactions related to volume depletion include dehydration, dizziness, postural, presyncope, syncope, hypotension, and orthostatic hypotension.
Ertugliflozin:
Common (1% to 10%): Adverse reactions related to volume depletion
Ertugliflozin:
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Nontraumatic lower limb amputation
Nontraumatic lower limb amputation was reported in 3 (0.2%) patients receiving 5 mg and 8 patients (0.5%) receiving 15 mg; there was 1 report (0.1%) in the comparator group. A causal association between this drug and lower limb amputation has not been definitively established.
Ertugliflozin:
Rare (0.01% to 0.1%): Hemoglobin increased greater than 2 g/dL and above the upper limit of normal
Metformin:
Frequency not reported: Vitamin B12 deficiency
Ertugliflozin:
Common (1% to 10%): Nasopharyngitis
Metformin:
Common (1% to 10%): Asthenia
Ertugliflozin:
Common (1% to 10%): Headache
Metformin:
Common (1% to 10%): Headache
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Segluromet (www.drugs.com/segluromet.html).
March 28, 2020
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