Steglujan

Name: Steglujan

Overdosage

Steglujan

In the event of an overdose with Steglujan, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient's clinical status.

Ertugliflozin

Removal of ertugliflozin by hemodialysis has not been studied.

Sitagliptin

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status.

Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.

Steglujan Description

Steglujan (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor.

Ertugliflozin

The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00.

The chemical structure is:

Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.

Sitagliptin

Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.

The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is:

Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.

Steglujan is available for oral use as film-coated tablets containing:

  • 6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (Steglujan 5/100)
  • 19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (Steglujan 15/100)

Inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, sodium stearyl fumarate, and magnesium stearate.

The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide/black iron oxide, and carnauba wax.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Ertugliflozin

Carcinogenicity was evaluated in CD-1 mice and Sprague-Dawley rats. In the mouse study, ertugliflozin was administered by oral gavage at doses of 5, 15, and 40 mg/kg/day for up to 97 weeks in males and 102 weeks in females. There were no ertugliflozin-related neoplastic findings at doses up to 40 mg/kg/day (approximately 50 times human exposure at the maximum recommended human dose [MHRD] of 15 mg/day based on AUC). In the rat study, ertugliflozin was administered by oral gavage at doses of 1.5, 5, and 15 mg/kg/day for up to 92 weeks in females and 104 weeks in males. Ertugliflozin-related neoplastic findings included an increased incidence of adrenal medullary pheochromocytoma (PCC) in male rats at 15 mg/kg/day. Although the molecular mechanism remains unknown, this finding may be related to carbohydrate malabsorption leading to altered calcium homeostasis, which has been associated with PCC development in rats and has unclear relevance to human risk. The no-observed-effect level (NOEL) for neoplasia was 5 mg/kg/day (approximately 16 times human exposure at the MRHD of 15 mg/day, based on AUC).

Sitagliptin

A two year carcinogenicity study was conducted in male and female rats given oral doses of sitagliptin of 50, 150, and 500 mg/kg/day. There was an increased incidence of combined liver adenoma/carcinoma in males and females and of liver carcinoma in females at 500 mg/kg. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100 mg/day based on AUC comparisons. Liver tumors were not observed at 150 mg/kg, approximately 20 times the human exposure at the MRHD.

A two year carcinogenicity study was conducted in male and female mice given oral doses of sitagliptin of 50, 125, 250, and 500 mg/kg/day. There was no increase in the incidence of tumors in any organ up to 500 mg/kg, approximately 70 times human exposure at the MRHD.

Mutagenesis

Ertugliflozin

Ertugliflozin was not mutagenic or clastogenic with or without metabolic activation in the microbial reverse mutation, in vitro cytogenetic (human lymphocytes), and in vivo rat micronucleus assays.

Sitagliptin

Sitagliptin was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a Chinese hamster ovary (CHO) chromosome aberration assay, an in vitro cytogenetics assay in CHO, an in vitro rat hepatocyte DNA alkaline elution assay, and an in vivo micronucleus assay.

Impairment of Fertility

Ertugliflozin

In the rat fertility and embryonic development study, male and female rats were administered ertugliflozin at 5, 25, and 250 mg/kg/day. No effects on fertility were observed at 250 mg/kg/day (approximately 480 and 570 times male and female human exposures, respectively, at the MRHD of 15 mg/day based on AUC comparison).

Sitagliptin

In rat fertility studies with oral gavage doses of 125, 250, and 1,000 mg/kg, males were treated for 4 weeks prior to mating, during mating, up to scheduled termination (approximately 8 weeks total) and females were treated 2 weeks prior to mating through gestation day 7. No adverse effect on fertility was observed at 125 mg/kg (approximately 12 times human exposure at the MRHD of 100 mg/day based on AUC comparisons). At higher doses, nondose-related increased resorptions in females were observed (approximately 25 and 100 times human exposure at the MRHD based on AUC comparison).

How Supplied/Storage and Handling

Steglujan (ertugliflozin and sitagliptin) tablets are available in the strengths listed below:

Steglujan 5 mg/100 mg: ertugliflozin 5 mg and sitagliptin 100 mg tablets are beige, almond-shaped, debossed with "554" on one side and plain on the other side. They are supplied as follows:

NDC 0006-5367-03 unit-of-use bottles of 30

NDC 0006-5367-06 unit-of-use bottles of 90

NDC 0006-5367-07 bulk bottles of 500

Steglujan 15 mg/100 mg: ertugliflozin 15 mg and sitagliptin 100 mg tablets are brown, almond-shaped, debossed with "555" on one side and plain on the other side. They are supplied as follows:

NDC 0006-5368-03 unit-of-use bottles of 30

NDC 0006-5368-06 unit-of-use bottles of 90

NDC 0006-5368-07 bulk bottles of 500

Storage of Bottles

Store at 20°C -25°C (68°F -77°F), excursions permitted between 15°C -30°C (between 59°F -86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions

Instruct patients to read the Medication Guide before starting Steglujan (ertugliflozin and sitagliptin) and to reread it each time the prescription is renewed.

Inform patients of the potential risks and benefits of Steglujan and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.

Instruct patients to take Steglujan only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of Steglujan at the same time.

Pancreatitis

Inform patients that acute pancreatitis has been reported during use of sitagliptin, a component of Steglujan. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue Steglujan and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1)].

Heart Failure

Inform patients of the signs and symptoms of heart failure. Instruct patients to contact their health care provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.7)].

Hypersensitivity Reactions

Inform patients that allergic reactions have been reported during postmarketing use of sitagliptin, a component of Steglujan. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, instruct patients that they must stop taking Steglujan and seek medical advice promptly [see Warnings and Precautions (5.10)].

Severe and Disabling Arthralgia

Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.12)].

Bullous Pemphigoid

Inform patients that bullous pemphigoid may occur with the DPP_4 class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.13)].

Hypoglycemia with Concomitant Use of Insulin and Insulin Secretagogue

Inform patients that the incidence of hypoglycemia may increase when Steglujan is added to insulin and/or an insulin secretagogue and that a lower dose of insulin or insulin secretagogue may be required to reduce the risk of hypoglycemia [see Warnings and Precautions (5.8)].

Fetal Toxicity

Advise pregnant patients of the potential risk to a fetus with treatment with Steglujan. Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [see Use in Specific Populations (8.1)].

Lactation

Advise patients that use of Steglujan is not recommended while breastfeeding [see Use in Specific Populations (8.2)].

Hypotension

Inform patients that symptomatic hypotension may occur with Steglujan and advise them to contact their doctor if they experience such symptoms [see Warnings and Precautions (5.2)]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Ketoacidosis

Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of medicines containing SGLT2 inhibitors, including ertugliflozin. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue Steglujan and seek medical advice immediately [see Warnings and Precautions (5.3)].

Acute Kidney Injury

Inform patients that acute kidney injury has been reported during use of Steglujan. Advise patients to seek medical advice immediately if they have reduced oral intake (due to acute illness or fasting) or increased fluid losses (due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue Steglujan use in those settings [see Warnings and Precautions (5.4)].

Monitoring of Renal Function

Inform patients about the importance of regular testing of renal function when receiving treatment with Steglujan [see Warnings and Precautions (5.4)].

Serious Urinary Tract Infections

Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur [see Warnings and Precautions (5.5)].

Amputation

Inform patients of the potential for an increased risk of amputations. Counsel patients about the importance of routine preventative foot care. Instruct patients to monitor for new pain or tenderness, sores or ulcers, or infections involving the leg or foot and to seek medical advice immediately if such signs or symptoms develop [see Warnings and Precautions (5.6)].

Genital Mycotic Infections in Females (e.g., Vulvovaginitis)

Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.9)].

Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis)

Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.9)].

Laboratory Tests

Due to the mechanism of action of ertugliflozin, inform patients that their urine will test positive for glucose while taking Steglujan.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk8835a-t-1712r000

This Medication Guide has been approved by the U.S. Food and Drug Administration. 12/2017  
Medication Guide
Steglujan™ (STEG-loo-jan)
(ertugliflozin and sitagliptin)
tablets, for oral use
Read this Medication Guide carefully before you start taking Steglujan 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.
What is the most important information I should know about Steglujan?
Steglujan may cause serious side effects, including:
  • Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking Steglujan, tell your doctor if you have ever had:
  • pancreatitis
  • a history of alcoholism
  • kidney problems
  • stones in your gallbladder (gallstones)
  • high blood triglyceride levels
Stop taking Steglujan and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
  • Dehydration. Steglujan 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.
  • Vaginal yeast infection. Women who take Steglujan 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 Steglujan 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 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.
  • Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking Steglujan, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
  • increasing shortness of breath or trouble breathing, especially when you lie down
  • swelling or fluid retention, especially in the feet, ankles or legs
  • an unusually fast increase in weight
  • unusual tiredness

These may be symptoms of heart failure.

What is Steglujan?
  • Steglujan contains 2 prescription diabetes medicines called ertugliflozin (STEGLATRO™) and sitagliptin (JANUVIA®). Steglujan can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • Steglujan is not for people with type 1 diabetes.
  • Steglujan is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take Steglujan.
  • It is not known if Steglujan is safe and effective in children under 18 years of age.
Do not take Steglujan if you:
  • have severe kidney problems or are on dialysis.
  • are allergic to ertugliflozin, sitagliptin, or any of the ingredients in Steglujan. See the end of this Medication Guide for a list of ingredients in Steglujan. Symptoms of a serious allergic reaction to Steglujan 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 you take Steglujan, 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 a history of urinary tract infections or problems with urination.
  • 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. Steglujan may harm your unborn baby. If you become pregnant while taking Steglujan, 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.
    Pregnancy Registry: If you take Steglujan at any time during your pregnancy, talk with your doctor about how you can join the Steglujan pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
  • are breastfeeding or plan to breastfeed. It is not known if Steglujan passes into your breast milk. You should not breastfeed if you take Steglujan.
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 Steglujan?
  • Take Steglujan exactly as your doctor tells you to take it.
  • Take Steglujan by mouth 1 time in the morning each day, with or without food.
  • 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 Steglujan at the same time.
  • Your doctor may tell you to take Steglujan along with other diabetes medicines. Low blood sugar can happen more often when Steglujan is taken with certain other diabetes medicines. See "What are the possible side effects of Steglujan?".
  • Stay on your prescribed diet and exercise program while taking Steglujan.
  • 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 Steglujan.
  • 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 Steglujan, you may have sugar in your urine, which will show up on a urine test.
  • If you take too much Steglujan, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of Steglujan?
Steglujan may cause serious side effects, including:
See "What is the most important information I should know about Steglujan?"
  • 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 Steglujan. 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 Steglujan 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 with Steglujan, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
  • kidney problems (sometimes requiring dialysis). Sudden kidney injury has happened to people treated with Steglujan. 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 Steglujan. 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. Steglujan 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 your Steglujan 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 Steglujan 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 Steglujan. Signs and symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • hunger
  • irritability
  • dizziness
  • confusion
  • sweating
  • feeling jittery or shaky
  • weakness
  • fast heartbeat
  • increased fats in your blood (bad cholesterol or LDL).
  • serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking Steglujan and call your doctor right away. See "Do not take Steglujan if you:". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
  • joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in Steglujan, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
  • skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in Steglujan, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking Steglujan.
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 Steglujan?")
  • changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
The most common side effects of sitagliptin include:
  • upper respiratory infection
  • stuffy or runny nose and sore throat
  • headache
  • stomach upset and diarrhea
Steglujan may have other side effects including swelling of the hands or legs. Swelling of the hands and legs can happen when sitagliptin, one of the medicines in Steglujan, is used with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine.
These are not all the possible side effects of Steglujan.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store Steglujan?
  • Store Steglujan at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Steglujan dry.
  • Store blister packs of Steglujan in the original package.
Keep Steglujan and all medicines out of the reach of children.
General information about the safe and effective use of Steglujan.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Steglujan for a condition for which it was not prescribed. Do not give Steglujan 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 Steglujan that is written for health professionals.
For more information about Steglujan, go to www.Steglujan.com or call 1-800-622-4477.
What are the ingredients in Steglujan?
Active ingredients: ertugliflozin and sitagliptin.
Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, sodium stearyl fumarate, and magnesium stearate.
The tablet film coating contains the following inactive ingredients: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide/black iron oxide, and carnauba wax.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information, go to: www.merck.com/product/patent/home.html. Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
usmg-mk8835a-t-1712r000

PRINCIPAL DISPLAY PANEL - 5 mg/100 mg Tablet Bottle Label

NDC 0006-5367-03

Steglujan™
(ertugliflozin and
sitagliptin) tablets

5 mg / 100 mg

Dispense the accompanying Medication Guide
to each patient.

Each tablet contains 6.48 mg ertugliflozin L-pyroglutamic
acid (equivalent to 5 mg ertugliflozin) and 128.5 mg
of sitagliptin phosphate (equivalent to 100 mg sitagliptin).

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL - 15 mg/100 mg Tablet Bottle Label

NDC 0006-5368-03

Steglujan™
(ertugliflozin and
sitagliptin) tablets

15 mg / 100 mg

Dispense the accompanying Medication Guide
to each patient.

Each tablet contains 19.43 mg ertugliflozin L-pyroglutamic
acid (equivalent to 15 mg ertugliflozin) and 128.5 mg
of sitagliptin phosphate (equivalent to 100 mg sitagliptin).

Rx only

30 Tablets

Steglujan 
ertugliflozin and sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-5367
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERTUGLIFLOZIN PIDOLATE (ERTUGLIFLOZIN) ERTUGLIFLOZIN 5 mg
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
CROSCARMELLOSE SODIUM  
SODIUM STEARYL FUMARATE  
MAGNESIUM STEARATE  
HYPROMELLOSE, UNSPECIFIED  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERROSOFERRIC OXIDE  
CARNAUBA WAX  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (BEIGE) Score no score
Shape OVAL (ALMOND-SHAPED) Size 12mm
Flavor Imprint Code 554
Contains     
Packaging
# Item Code Package Description
1 NDC:0006-5367-03 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0006-5367-06 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:0006-5367-07 500 TABLET, FILM COATED in 1 BOTTLE
4 NDC:0006-5367-09 2 BOTTLE in 1 CARTON
4 NDC:0006-5367-08 7 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209805 12/19/2017
Steglujan 
ertugliflozin and sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-5368
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERTUGLIFLOZIN PIDOLATE (ERTUGLIFLOZIN) ERTUGLIFLOZIN 15 mg
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
CROSCARMELLOSE SODIUM  
SODIUM STEARYL FUMARATE  
MAGNESIUM STEARATE  
HYPROMELLOSE, UNSPECIFIED  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERROSOFERRIC OXIDE  
CARNAUBA WAX  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN Score no score
Shape OVAL (ALMOND-SHAPED) Size 12mm
Flavor Imprint Code 555
Contains     
Packaging
# Item Code Package Description
1 NDC:0006-5368-03 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0006-5368-06 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:0006-5368-07 500 TABLET, FILM COATED in 1 BOTTLE
4 NDC:0006-5368-09 2 BOTTLE in 1 CARTON
4 NDC:0006-5368-08 7 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209805 12/19/2017
Labeler - Merck Sharp & Dohme Corp. (001317601)
Revised: 12/2017   Merck Sharp & Dohme Corp.

Important Information

You should not use Steglujan if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis. Steglujan is not for treating type 1 diabetes.

This medicine can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Ertugliflozin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

Stop taking Steglujan and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

How should I take Steglujan?

Steglujan is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Steglujan with or without 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. Ertugliflozin 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.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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 Steglujan.

This medicine is only part of a 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.

Store at room temperature away from moisture and heat. Keep unused tablets in the foil blister pack in its original container.

Steglujan dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 1 tablet (ertugliflozin 5 mg/sitagliptin 100 mg) orally once a day
-For patients tolerating therapy and requiring additional glycemic control, may increase to 1 tablet (ertugliflozin 15 mg/sitagliptin 100 mg) orally once a day
Maximum dose: ertugliflozin 15 mg/sitagliptin 100 mg per day

For patients already receiving ertugliflozin: Switch to combination product with same ertugliflozin dose

Comments:
-Volume depletion should be corrected prior to initiating therapy.
-This drug is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug has not been studied in patients with a history of pancreatitis; it is not known whether this may increase the risk of developing pancreatitis during therapy.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

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