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Generic Name: ertugliflozin and metformin hydrochloride
Dosage Form: Tablets
Date of Approval: December 19, 2017
Company: Merck & Co., Inc.

Treatment for: Type 2 Diabetes

FDA Approves Segluromet

The U.S. Food and Drug Administration (FDA) has approved Segluromet (ertugliflozin and metformin hydrochloride), a sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination used to improve glycemic control in adults with type 2 diabetes.

Medication Guide

Read this Medication Guide carefully before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Important information

Segluromet may cause serious side effects, including:

  • Lactic Acidosis. Metformin, one of the medicines in Segluromet, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
    Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:
    • you feel cold in your hands or feet
    • you feel very weak or tired
    • you have trouble breathing
    • you have stomach pains, nausea or vomiting
    • you have a slow or irregular heartbeat
    • you have unusual (not normal) muscle pain
    • you have unusual sleepiness or sleep longer than usual
    • you feel dizzy or lightheaded
    Most people who have had lactic acidosis had other conditions that, in combination with metformin use, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with Segluromet if you:
    • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye.
    • have liver problems.
    • drink alcohol very often, or drink a lot of alcohol in the short term “binge” drinking.
    • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
    • have surgery.
    • have a heart attack, severe infection, or stroke.
    The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your treatment for a while if you have any of these things.

Segluromet can have other serious side effects. See Segluromet side effects.

What is Segluromet?

  • Segluromet contains two prescription medicines called ertugliflozin (Steglatro) and metformin hydrochloride. Segluromet can be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes who are already using ertugliflozin and metformin for treatment or who do not have control of their blood sugar on ertugliflozin or metformin alone.
  • Segluromet is not for:
    • people with type 1 diabetes.
    • people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • It is not known if this medicine is safe and effective in children under 18 years of age.

Who should not take Segluromet?

Do not take Segluromet if you:

  • have severe kidney problems or are on dialysis.
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
  • are allergic to ertugliflozin, metformin, or any of the other ingredients. See the end of this Medication Guide for a list of ingredients. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

Before taking Segluromet

Before you take Segluromet, tell your doctor about all of your medical conditions, including if you:

  • have type 1 diabetes or have had diabetic ketoacidosis.
  • have kidney problems.
  • have liver problems.
  • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
  • have heart problems, including congestive heart failure.
  • have a history of urinary tract infections or problems with urination.
  • are going to get an injection of dye or contrast agents for an x-ray procedure. Segluromet may need to be stopped for a short time. Talk to your doctor about when you should stop Segluromet and when you should start again. See Important information.
  • are eating less due to illness, surgery, or a change in your diet.
  • have a history of amputation.
  • have had blocked or narrowed blood vessels, usually in the leg.
  • have damage to the nerves (neuropathy) in your leg.
  • have had diabetic foot ulcers or sores.
  • are going to have surgery.
  • drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking).
  • are pregnant or plan to become pregnant. Segluromet may harm your unborn baby. If you become pregnant while taking Segluromet, your doctor may switch you to a different medicine to control your blood sugar. Talk to your doctor about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
  • are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all. Talk to your doctor about birth control choices during treatment if you are not planning to become pregnant since Segluromet may increase your chance of becoming pregnant. Tell your doctor right away if you become pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Segluromet passes into your breast milk. You should not breastfeed if you take Segluromet.

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

How should I take Segluromet?

  • Take Segluromet exactly as your doctor tells you to take it.
  • Your doctor may do certain blood tests before you start treatment.
  • Take the tablets by mouth two times a day with meals. Taking the tablets with meals may lower your chance of having an upset stomach.
  • Your doctor may change your dose if needed.
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses at the same time.
  • Your doctor may tell you to take Segluromet along with other diabetes medicines. Low blood sugar can happen more often when Segluromet is taken with certain other diabetes medicines. See Segluromet side effects.
  • Stay on your prescribed diet and exercise program during treatment.
  • 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.
  • Talk to your doctor about how to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), complications of diabetes.
  • Your doctor will do blood tests to check how well your kidneys are working before and during your treatment.
  • 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.
  • When taking Segluromet, you may have sugar in your urine, which will show up on a urine test.
  • If you take too much, or overdose, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Segluromet?

  • Avoid drinking alcohol very often, or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

Segluromet side effects

Segluromet may cause serious side effects, including:

  • See Important information.
  • dehydration. Segluromet can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, 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, including water pills (diuretics)
    • have kidney problems
    • are on a low sodium (salt) diet
    • are 65 years of age or older
    Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
  • ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes during treatment with Segluromet.
    Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Stop taking Segluromet and call your doctor right away if you get any of the following symptoms:
    • nausea
    • vomiting
    • stomach-area (abdominal) pain
    • tiredness
    • trouble breathing
    If you get any of these symptoms during treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
  • kidney problems. Sudden kidney injury has happened to people treated with Segluromet.
    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. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking Segluromet. 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.
  • amputations. Segluromet may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe.
    You may be at a higher risk of lower limb amputation if you:
    • have a history of amputation
    • have had blocked or narrowed blood vessels, usually in your leg
    • have damage to the nerves (neuropathy) in your leg
    • have had diabetic foot ulcers or sores
    Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop treatment for a while if you have any of these signs or symptoms.
  • Talk to your doctor about proper foot care.
  • low blood sugar (hypoglycemia). If you take Segluromet with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take Segluromet. Signs and symptoms of low blood sugar may include:
    • headache
    • drowsiness
    • hunger
    • irritability
    • dizziness
    • confusion
    • sweating
    • feeling jittery or shaky
    • weakness
    • fast heartbeat
  • vaginal yeast infection. Women may get vaginal yeast infections during treatment. 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 (balanitis or balanoposthitis). Men may get a yeast infection of the skin around the penis during treatment. 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 your penis. Other symptoms of yeast infection of the penis include:
    • redness, itching, or swelling of the penis
    • foul smelling discharge from the penis
    • rash of the penis
    • pain in the skin around your penis
    Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
  • low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.
  • increased fats in your blood (bad cholesterol or LDL).

The most common side effects of ertugliflozin include:

  • vaginal yeast infections and yeast infections of the penis (See Important information.
  • changes in urination, including urgent need to urinate more often, in larger amounts, or at night

The most common side effects of metformin hydrochloride include:

  • diarrhea
  • nausea
  • vomiting
  • gas
  • stomach discomfort
  • indigestion
  • weakness
  • headache

These are not all the possible side effects.

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

See also: Side effects (in more detail)

How should I store Segluromet?

  • Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets dry.
  • Store blister packs in the original package.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Segluromet.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information that is written for health professionals.

What are the ingredients?

Active ingredients: ertugliflozin and metformin hydrochloride.

Inactive ingredients: povidone, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, and magnesium stearate.

The tablet film coating contains the following inactive ingredients: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, and carnauba wax.