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Steglujan

Last reviewed on RxList: 2/6/2020
Steglujan Side Effects Center

What Is Steglujan?

Steglujan (ertugliflozin and sitagliptin) is a combination of a sodium glucose co-transporter 2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as 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.

What Are Side Effects of Steglujan?

Common side effects of Steglujan include:

Dosage for Steglujan

The recommended starting dose of Steglujan is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food.

What Drugs, Substances, or Supplements Interact with Steglujan?

Steglujan may interact with insulin and/or an insulin secretagogue, and digoxin. Tell your doctor all medications and supplements you use.

Steglujan During Pregnancy and Breastfeeding

Steglujan is not recommended for use during pregnancy; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sitagliptin during pregnancy. It is unknown if Steglujan passes into breast milk. Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding while using Steglujan is not recommended.

Additional Information

Our Steglujan (ertugliflozin and sitagliptin) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

______________ is another term for type 2 diabetes. See Answer
Steglujan Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical attention right away if you have signs of a rare but serious 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:

  • severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;
  • new pain, tenderness, sores, ulcers, or infections in your legs or feet;
  • severe or ongoing pain in your joints;
  • little or no urination;
  • 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);
  • signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
  • symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain; or
  • symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without nausea and vomiting.

Some side effects may be more likely to occur in older adults.

Common side effects may include:

  • urinating more than usual;
  • upset stomach, diarrhea;
  • headache; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Read the entire detailed patient monograph for Steglujan (Ertugliflozin and Sitagliptin Tablets)

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
Steglujan Professional Information

SIDE EFFECTS

The following important adverse reactions are described elsewhere in the labeling:

  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Ketoacidosis [see WARNINGS AND PRECAUTIONS]
  • Acute Kidney Injury and Impairment in Renal Function [see WARNINGS AND PRECAUTIONS]
  • Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]
  • Lower Limb Amputation [see WARNINGS AND PRECAUTIONS]
  • Heart Failure [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see WARNINGS AND PRECAUTIONS]
  • Necrotizing Fasciitis of the Perineum (Fournier's gangrene) [see WARNINGS AND PRECAUTIONS]
  • Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Increases in Low-Density Lipoprotein (LDL-C) [see WARNINGS AND PRECAUTIONS]
  • Severe and Disabling Arthralgia [see WARNINGS AND PRECAUTIONS]
  • Bullous Pemphigoid [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Ertugliflozin And Sitagliptin

The safety of concomitantly administered ertugliflozin and sitagliptin has been evaluated in 990 patients with type 2 diabetes mellitus treated for 26 weeks in three studies; a factorial study of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg once daily compared to the individual components, a placebo-controlled study of ertugliflozin 5 mg or 15 mg as add-on therapy to sitagliptin 100 mg and metformin once daily, and a placebo-controlled study of initial therapy with ertugliflozin 5 mg or 15 mg once daily in combination with sitagliptin 100 mg once daily [see Clinical Studies]. The incidence and type of adverse reactions in these three studies were similar to the adverse reactions seen with ertugliflozin and described below in Table 1.

Ertugliflozin

Pool Of Placebo-Controlled Trials

The data in Table 1 are derived from a pool of three 26-week, placebo-controlled trials. Ertugliflozin was used as monotherapy in one trial and as add-on therapy in two trials [see Clinical Studies]. These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks. Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily. The mean age of the population was 57 years and 2% were older than 75 years of age. Fifty-three percent (53%) of the population was male and 73% were Caucasian, 15% were Asian, and 7% were Black or African American. At baseline the population had diabetes for an average of 7.5 years, had a mean HbA1c of 8.1%, and 19.4% had established microvascular complications of diabetes. Baseline renal function (mean eGFR 88.9 mL/min/1.73 m²) was normal or mildly impaired in 97% of patients and moderately impaired in 3% of patients.

Table 1 shows common adverse reactions associated with the use of ertugliflozin. These adverse reactions were not present at baseline, occurred more commonly on ertugliflozin than on placebo, and occurred in at least 2% of patients treated with either ertugliflozin 5 mg or ertugliflozin 15 mg.

Table 1: Adverse Reactions Reported in ≥2% of Patients with Type 2 Diabetes MellitusTreated with Ertugliflozin* and Greater than Placebo in Pooled Placebo-Controlled Clinical Studiesof Ertugliflozin Monotherapy or Combination Therapy

Number (%) of Patients
Placebo
N = 515
Ertugliflozin 5 mg
N = 519
Ertugliflozin 15 mg
N = 510
Female genital mycotic infections†3.0%9.1%12.2%
Male genital mycotic infections‡0.4%3.7%4.2%
Urinary tract infections§3.9%4.0%4.1%
Headache2.3%3.5%2.9%
Vaginal pruritus¶0.4%2.8%2.4%
Increased urination#1.0%2.7%2.4%
Nasopharyngitis2.3%2.5%2.0%
Back pain2.3%1.7%2.5%
Weight decreased1.0%1.2%2.4%
ThirstÞ0.6%2.7%1.4%
* The three placebo controlled studies included one monotherapy trial and two add-on combination trials with metformin or with metformin and sitagliptin.
†Includes: genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245).
‡ Includes: balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Percentages calculated with the number of male patients in each group as denominator: placebo (N=280), ertugliflozin 5 mg (N=267), ertugliflozin 15 mg (N=265).
§Includes: cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection.
¶ Includes: vulvovaginal pruritus and pruritus genital. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245).
# Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
Þ Includes: thirst, dry mouth, polydipsia, and dry throat.

Volume Depletion

Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion, particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m²). In patients with moderate renal impairment, adverse reactions related to volume depletion (e.g., dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) were reported in 0%, 4.4%, and 1.9% of patients treated with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. Ertugliflozin may also increase the risk of hypotension in other patients at risk for volume contraction [see Use In Specific Populations].

Ketoacidosis

Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients [see WARNINGS AND PRECAUTIONS].

Impairment In Renal Function

Treatment with ertugliflozin was associated with increases in serum creatinine and decreases in eGFR (see Table 2). Patients with moderate renal impairment at baseline had larger mean changes. In a study in patients with moderate renal impairment, these abnormal laboratory findings were observed to reverse after treatment discontinuation [see Use In Specific Populations].

Table 2: Changes from Baseline in Serum Creatinine and eGFR in the Pool of Three 26-Week Placebo-Controlled Studies and a 26-Week Moderate Renal Impairment Study in Patients withType 2 Diabetes Mellitus

Pool of 26-Week Placebo-Controlled Studies
Placebo
N=515
Ertugliflozin 5 mg
N=519
Ertugliflozin 15 mg
N=510
Baseline MeanCreatinine (mg/dL)0.830.820.82
eGFR (mL/min/1.73 m²)89.588.289.0
Week 6 ChangeCreatinine (mg/dL)0.000.030.03
eGFR (mL/min/1.73 m²)-0.3-2.7-3.1
Week 26 ChangeCreatinine (mg/dL)-0.010.000.01
eGFR (mL/min/1.73 m²)0.70.5-0.6
Moderate Renal Impairment Study
Placebo
N=154
Ertugliflozin 5 mg
N=158
Ertugliflozin 15 mg
N=155
BaselineCreatinine (mg/dL)1.391.381.37
eGFR (mL/min/1.73 m²)46.046.846.9
Week 6 ChangeCreatinine (mg/dL)-0.020.110.12
eGFR (mL/min/1.73 m²)0.6-3.2-4.1
Week 26 ChangeCreatinine (mg/dL)0.020.080.10
eGFR (mL/min/1.73 m²)0.0-2.7-2.6

Renal-related adverse reactions (e.g., acute kidney injury, renal impairment, acute prerenal failure) may occur in patients treated with ertugliflozin, particularly in patients with moderate renal impairment where the incidence of renal-related adverse reactions was 0.6%, 2.5%, and 1.3% in patients treated with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.

Lower Limb Amputation

Across seven Phase 3 clinical trials in which ertugliflozin was studied as monotherapy and in combination with other antihyperglycemic agents, non-traumatic lower limb amputations occurred in 1 of 1,450 (0.1%) in the non-ertugliflozin group, 3 of 1,716 (0.2%) in the ertugliflozin 5 mg group, and 8 of 1,693 (0.5%) in the ertugliflozin 15 mg group.

Hypoglycemia

The incidence of hypoglycemia by study is shown in Table 3.

Table 3: Incidence of Overall* and Severe† Hypoglycemia in Placebo-Controlled Clinical Studies inPatients with Type 2 Diabetes Mellitus

Factorial Study with Sitagliptin as Add-on Combination Therapy with Metformin (26 weeks)Ertugliflozin 5 mg + Sitagliptin
(N = 243)
Ertugliflozin 15 mg + Sitagliptin
(N = 244)
Overall [N (%)]13 (5.3)22 (9.0)
Severe [N (%)]0 (0.0)1 (0.4)
Add-on Combination Therapy with Metformin and Sitagliptin (26 weeks)Placebo
(N = 153)
Ertugliflozin 5 mg
(INI = 156)
Ertugliflozin 15 mg
(INI = 153)
Overall [N (%)]5 (3.3)7 (4.5)3 (2.0)
Severe [N (%)]1 (0.7)1 (0.6)0 (0.0)
Initial Combination Therapy with Sitagliptin (26 weeks)Placebo
(N = 97)
Ertugliflozin 5 mg + Sitagliptin
(N = 98)
Ertugliflozin 15 mg + Sitagliptin
(N = 96)
Overall [N (%)]1 (1.0)6(6.1)3(3.1)
Severe [N (%)]0 (0.0)0 (0.0)2(2.1)
* Overall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL.
†Severe hypoglycemic events: required assistance, lost consciousness, or experienced a seizure regardless of blood glucose.

Genital Mycotic Infections

In the pool of three placebo-controlled clinical trials, the incidence of female genital mycotic infections (e.g., genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis) occurred in 3%, 9.1%, and 12.2% of females treated with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively (see Table 1). In females, discontinuation due to genital mycotic infections occurred in 0% and 0.6% of patients treated with placebo and ertugliflozin, respectively.

In the same pool, male genital mycotic infections (e.g., balanitis candida, balanoposthitis, genital infection, genital infection fungal) occurred in 0.4%, 3.7%, and 4.2% of males treated with placebo, ertugliflozin 5 mg, ertugliflozin 15 mg, respectively (see Table 1). Male genital mycotic infections occurred more commonly in uncircumcised males. In males, discontinuations due to genital mycotic infections occurred in 0% and 0.2% of patients treated with placebo and ertugliflozin, respectively. Phimosis was reported in 8 of 1,729 (0.5%) male ertugliflozin-treated patients, of which four required circumcision.

Sitagliptin

The following additional adverse reactions have been reported in clinical studies with sitagliptin: upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, nausea, diarrhea. In addition, in a study of sitagliptin as add-on combination therapy with metformin and rosiglitazone, peripheral edema was noted with a higher incidence than placebo.

In a pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia was 1.2% in patients treated with sitagliptin 100 mg and 0.9% in patients treated with placebo. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. In the add-on to glimepiride (+/-metformin) study, the overall incidence of hypoglycemia was 12.2% in patients treated with sitagliptin 100 mg and 1.8% in patients treated with placebo. In the add-on to insulin (+/-metformin) study, the overall incidence of hypoglycemia was 15.5% in patients treated with sitagliptin 100 mg and 7.8% in patients treated with placebo. In all studies, adverse reactions of hypoglycemia were based on all reports of symptomatic hypoglycemia. A concurrent blood glucose measurement was not required although most (74%) reports of hypoglycemia were accompanied by a blood glucose measurement ≤70 mg/dL.

In a pooled analysis of 19 double-blind clinical trials that included data from 10,246 patients randomized to receive sitagliptin 100 mg/day (N=5,429) or corresponding (active or placebo) control (N=4,817), the incidence of non-adjudicated acute pancreatitis events was 0.1 per 100 patient-years in each group (4 patients with an event in 4,708 patient-years for sitagliptin and 4 patients with an event in 3,942 patient-years for control).

Laboratory Tests

Ertugliflozin

Increases In Low-Density Lipoprotein Cholesterol (LDL-C)

In the pool of three placebo-controlled trials, dose-related increases in LDL-C were observed in patients treated with ertugliflozin. Mean percent changes from baseline to Week 26 in LDL-C relative to placebo were 2.6% and 5.4% with ertugliflozin 5 mg and ertugliflozin 15 mg, respectively. The range of mean baseline LDL-C was 96.6 to 97.7 mg/dL across treatment groups [see WARNINGS AND PRECAUTIONS].

Increases In Hemoglobin

In the pool of three placebo-controlled trials, mean changes (percent changes) from baseline to Week 26 in hemoglobin were -0.21 g/dL (-1.4%) with placebo, 0.46 g/dL (3.5%) with ertugliflozin 5 mg, and 0.48 g/dL (3.5%) with ertugliflozin 15 mg. The range of mean baseline hemoglobin was 13.90 to 14.00 g/dL across treatment groups. At the end of treatment, 0.0%, 0.2%, and 0.4% of patients treated with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, had a hemoglobin increase greater than 2 g/dL and above the upper limit of normal.

Increases In Serum Phosphate

In the pool of three placebo-controlled trials, mean changes (percent changes) from baseline in serum phosphate were 0.04 mg/dL (1.9%) with placebo, 0.21 mg/dL (6.8%) with ertugliflozin 5 mg, and 0.26 mg/dL (8.5%) with ertugliflozin 15 mg. The range of mean baseline serum phosphate was 3.53 to 3.54 mg/dL across treatment groups. In a clinical trial of patients with moderate renal impairment, mean changes (percent changes) from baseline at Week 26 in serum phosphate were -0.01 mg/dL (0.8%) with placebo, 0.29 mg/dL (9.7%) with ertugliflozin 5 mg, and 0.24 mg/dL (7.8%) with ertugliflozin 15 mg.

Sitagliptin

Across clinical studies, the incidence of laboratory adverse reactions was similar in patients treated with sitagliptin 100 mg compared to patients treated with placebo. A small increase in white blood cell count (WBC) was observed due to an increase in neutrophils. This increase in WBC (of approximately 200 cells/microL vs. placebo, in four pooled placebo-controlled clinical studies, with a mean baseline WBC count of approximately 6,600 cells/microL) is not considered to be clinically relevant. In a 12-week study of 91 patients with chronic renal insufficiency, 37 patients with moderate renal insufficiency were randomized to sitagliptin 50 mg daily, while 14 patients with the same magnitude of renal impairment were randomized to placebo. Mean (SE) increases in serum creatinine were observed in patients treated with sitagliptin [0.12 mg/dL (0.04)] and in patients treated with placebo [0.07 mg/dL (0.07)]. The clinical significance of this added increase in serum creatinine relative to placebo is not known.

Postmarketing Experience

Sitagliptin

Additional adverse reactions have been identified during postapproval use of sitagliptin, a component of STEGLUJAN, as monotherapy and/or in combination with other antihyperglycemic agents. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome [see WARNINGS AND PRECAUTIONS]; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis [see INDICATIONS AND USAGE and WARNINGS AND PRECAUTIONS]; worsening renal function, including acute renal failure (sometimes requiring dialysis) [see WARNINGS AND PRECAUTIONS]; severe and disabling arthralgia [see WARNINGS AND PRECAUTIONS]; bullous pemphigoid [see WARNINGS AND PRECAUTIONS]; constipation; vomiting; headache; myalgia; pain in extremity; back pain; pruritus; mouth ulceration; stomatitis; rhabdomyolysis.

Ertugliflozin

Additional adverse reactions have been identified during postapproval use. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Cases of necrotizing fasciitis of the perineum (Fournier's gangrene) have been seen with SGLT2 inhibitors [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Steglujan (Ertugliflozin and Sitagliptin Tablets)

Related Resources for Steglujan

© Steglujan Patient Information is supplied by Cerner Multum, Inc. and Steglujan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

______________ is another term for type 2 diabetes. See Answer

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