Segluromet

What is Segluromet?

Segluromet contains 2 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.

Segluromet is not for people with diabetic ketoacidosis (increased ketones in your blood or urine). It is not known if Segluromet is safe and effective in children under 18 years of age.

Description

SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.

What is the most important information I should know about Segluromet?

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 Segluromet for a while if you have any of these things.
Segluromet can have other serious side effects. See “What are the possible side effects of Segluromet?”

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 ingredients in Segluromet. See the end of this Medication Guide for a list of ingredients in Segluromet. Symptoms of a serious allergic reaction to Segluromet 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.

What should I tell my healthcare provider 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 Segluromet again. See “What is the most important information I should know about Segluromet?”.
• 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. Your doctor may stop your Segluromet before you have surgery. Talk to your doctor if you are having surgery about when to stop taking Segluromet and when to start it again.
• are eating less or there is a change in your diet.
• 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 while taking Segluromet 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 while taking Segluromet.
• 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-the-counter 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 Segluromet.
• Take Segluromet by mouth 2 times a day with meals. Taking Segluromet 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 2 doses of Segluromet 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 “What are the possible side effects of Segluromet?”.
• Stay on your prescribed diet and exercise program while taking Segluromet.
• 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 with Segluromet.
• 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 Segluromet, 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.

What are the possible side effects of Segluromet?

Segluromet may cause serious side effects, including:
See “What is the most important information I should know about Segluromet?”

• 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 olderTalk 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 has also happened in people with diabetes who were sick or who had surgery 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 breathingIf you get any of these symptoms during treatment with Segluromet, 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 soresCall 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 your Segluromet 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
• a rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take medicines that lower blood sugar in the same way as one of the medicines in Segluromet. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
• vaginal yeast infection. Women who take Segluromet 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 (balanitis or balanoposthitis). Men who take Segluromet 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 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 penisTalk 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 “What is the most important information I should know about Segluromet?”)
• 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 of Segluromet.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 Segluromet for a condition for which it was not prescribed. Do not give Segluromet 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 about Segluromet that is written for health professionals.

For more information about Segluromet, go to www.segluromet.com or call 1-800-622-4477.

How should I store Segluromet?

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

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

What are the ingredients in Segluromet?

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.

Label

PRINCIPAL DISPLAY PANEL – 2.5 MG/500 MG TABLET BOTTLE LABEL

• NDC 0006-5369-03
• Segluromet®
• (ertugliflozin and
  metformin HCl) tablets
• 2.5 mg / 500 mg
• Dispense the accompanying Medication Guide
  to each patient.
• Each tablet contains 3.24 mg ertugliflozin L-pyroglutamic
  acid (equivalent to 2.5 mg ertugliflozin) and
  500 mg of metformin hydrochloride.
• Rx only
• 60 Tablets

PRINCIPAL DISPLAY PANEL – 2.5 MG/1,000 MG TABLET BOTTLE LABEL

• NDC 0006-5373-03
• Segluromet®
  (ertugliflozin and
  metformin HCl) tablets
• 2.5 mg / 1,000 mg
• Dispense the accompanying Medication Guide
  to each patient.
• Each tablet contains 3.24 mg ertugliflozin
  L-pyroglutamic acid (equivalent
  to 2.5 mg ertugliflozin) and
  1,000 mg of metformin
  hydrochloride.
• 60 Tablets
  Rx only

SRC: NLM .