Segluromet

Segluromet is a prescription medication used to lower blood sugar in adults with type 2 diabetes mellitus. 

It is a single product containing 2 medications: ertugliflozin and metformin. 

Ertugliflozin belongs to a group of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. These work to lower blood sugar by stopping the reabsorption of sugar by the kidney and causing the kidneys to get rid of more sugar in the urine. Metformin belongs to a group of drugs called biguanides. These help to lower blood sugar by decreasing the amount of sugar you absorb from your food and the amount of sugar produced by the liver. Metformin also increases your body's response to insulin. 

This medication comes in tablet form and is taken 2 times a day, with meals. 

Common side effects of Segluromet include diarrhea, nausea, vomiting, and gas. Segluromet may also cause vaginal yeast infections and yeast infections of the penis. 

Segluromet is a prescription medication used with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Segluromet. See the “Segluromet Precautions” section.

Common side effects of Segluromet include the following:

• Genital mycotic infections (yeast infections)
• Diarrhea
• Nausea
• Vomiting
• Flatulence (gas)
• Stomach discomfort
• Indigestion
• Weakness
• Headache

This is not a complete list of Segluromet side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Alcohol
• Insulins such as:
  • insulin lispro (Humalog)
  • insulin aspart (Novolog)
  • insulin glulisine (Apidra)
  • insulin oral inhalation (Afrezza)
  • insulin regular (Humulin R, Novolin R)
  • insulin NPH (Humulin N, Novolin N)
  • insulin degludec (Tresiba)
  • insulin detemir (Levemir)
  • insulin glargine (Basaglar, Lantus, Toujeo)
• Insulin secretagogues such as;
  • Chlorpropamide
  • Glimepiride (Amaryl)
  • Glipizide (Glucotrol)
  • Glyburide (Diabeta)
  • Tolazamide
  • Tolbutamide
• Carbonic anhydrase inhibitors such as acetazolamide (Diamox), methazolamide (Neptazane)
• Diuretics such as:
  • Acetazolamide (Diamox)
  • Amiloride (Midamor)
  • Bumetanide (Bumex)
  • Chlorothiazide (Diuril)
  • Chlorthalidone (Thalitone)
  • Ethacrynic acid (Edecrin)
  • Furosemide (Lasix)
  • Hydrochlorothiazide (Microzide, HCTZ)
  • Metolazone (Zaroxolyn)
  • Spironolactone (Aldactone)
  • Torsemide (Demadex)
  • Triamterene (Dyrenium, Dyazide, Maxzide)
• Corticosteroids such as:
  • Betamethasone (Celestone Soluspan)
  • Dexamethasone (Decadron)
  • Fludrocortisone
  • Hydrocortisone (Cortef, Solu-Cortef)
  • Methylprednisolone (Medrol, Depo-Medrol)
  • Prednisone (Deltasone)
  • Prednisolone (Orapred, Millipred, Veripred)
  • Triamcinolone (Kenalog)
• Phenothiazines such as:
  • Chlorpromazine
  • Fluphenazine
  • Perphenazine
  • Prochlorperazine (Compazine)
  • Thioridazine
  • Trifluoperazine
• Calcium channel blockers such as:
  • Nifedipine (Adalat, Nifedical, Procardia)
  • Amlodipine (Norvasc)
  • Verapamil (Calan, Isoptin, Covera, Verelan)
  • Diltiazem (Cardizem)
• Ranolazine (Ranexa)
• Vandetanib (Caprelsa)
• Dolutegravir (Tivicay)
• Cimetidine (Tagamet)
• Phenytoin (Dilantin)
• Isoniazid

This is not a complete list of Segluromet drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Segluromet including the following: 

• Lactic acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis:

  • Feeling very weak, tired, or uncomfortable
  • Unusual muscle pain
  • Trouble breathing
  • Unusual or unexpected stomach discomfort
  • Feeling cold
  • Feeling dizzy or lightheaded
  • Suddenly developing a slow or irregular heartbeat
• Hypotension (low blood pressure). This may occur after starting Segluromet. Talk to your doctor right away if you have some or all of the following symptoms of low blood pressure:
  • Dizziness
  • Fatigue
  • Lightheadedness
• Ketoacidosis (increased ketones in your blood or urine).  Ketoacidosis is a serious, life-threatening condition. Talk to your doctor right away if you have some or all of the following symptoms of ketoacidosis:
  • Nausea
  • Vomiting
  • Stomach pain
  • Shortness of breath 
• Kidney problems. Talk to your doctor right away if you:
  • reduce the amount of food or liquid you drink for example if you are sick or cannot eat or
  • you start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long.
• Serious urinary tract infections. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting.
• Lower limb amputation. An increased risk of amputation (primarily of the toe) was observed in trials with another medication similar to one of the components in Segluromet. Talk to your doctor if you have risk factors that may increase your risk of amputation, such as a history of prior amputation, diabetic foot ulcers, and peripheral neuropathy. Tell your doctor right away if you notice new pain, tenderness, or sores or ulcers on your feet or lower limbs. 
• Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugar:
  • Feeling shaky
  • Feeling nervous
  • Sweating
  • Feeling cold or clammy
  • Confusion
  • Fast or irregular heart rate
• Vaginal yeast infection. Women who take this medication may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis. Men who take this medication may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • pain in the skin around the penis
• Vitamin B12 deficiency. Your healthcare provider will do blood tests to check your vitamin B12 levels.
• Increased LDL cholesterol. Your healthcare provider will monitor for this.
• dehydration. You may cause you to feel dizzy, weak or like you are going to faint. This can happen especially when you stand up (orthostatic hypotension). You may be at risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, are on a low salt diet, or are 65 years of age or older. 

When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions. 

Do not take Segluromet if you:

• are allergic to Segluromet or to any of its ingredients 
• have kidney damage
• have acute or chronic metabolic acidosis
• are undergoing radiologic exams where contrast dye is used

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Invokamet XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Alcohol in combination with metformin may increase the risk of developing lactic acidosis. Avoid excessive alcohol use while taking Segluromet. Contact your doctor or pharmacist if you have any questions regarding alcohol use and Segluromet. 

Before taking Segluromet, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Segluromet or to any of its ingredients
• have kidney problems
• have a history of urinary tract infections or problems with urination.
• are on a low sodium (salt) diet.
• are going to get an injection of dye or contrast agents for an x-ray procedure.
• have heart problems, including heart failure.
• are going to have surgery.
• are eating less due to illness, surgery, or a change in your diet.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• are a premenopausal woman who does not have periods regularly or at all and who are not planning to become pregnant. 
• have liver problems
• drink alcohol frequently 
• are dehydrated
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. There is limited data with the use of Segluromet in pregnant women. Based on animal data that showed kidney problems in babies from ertugliflozin, one of the medicines in Segluromet, it is not recommended to use Segluromet during the second and third trimesters of pregnancy.

High blood sugar during pregnancy can be associated with harm to the baby. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

There is no information regarding the presence of Segluromet or ertugliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Limited published studies report that metformin is present in human milk

Because of the possibility for adverse reactions in nursing infants from Segluromet, a choice should be made whether to stop nursing or to stop the use of this medication. Segluromet is not recommended when breastfeeding. 

Take Segluromet exactly as prescribed.

Segluromet comes in a tablet form and is taken twice daily. 

Take this medication with food to lower the chance of having an upset stomach. 

Your doctor may gradually increase the dose of this medication which helps to lessen stomach upset. 

Stay on your prescribed diet and exercise program while taking this medication.

Be sure to check your blood sugar as your doctor tells you to.

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Segluromet at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The starting dose will be based on the current medication regimen. 

The maximum dose of Segluromet (ertugliflozin and metformin) for the treatment of type 2 diabetes mellitus is 7.5 mg of ertugliflozin and 1,000 mg of metformin twice a day.  

If you take too much Segluromet, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Segluromet at room temperature. 
• Keep this and all medicines out of the reach of children.

Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio, and metformin plasma levels generally higher than 5mcg/mL. 

Risk factors include renal impairment, concomitant use of certain drugs, age ≥ 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full PrescribingInformation.

If lactic acidosis is suspected, discontinue Segluromet and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.