Qtern Side Effects Center

Last updated on RxList: 3/22/2022
Qtern Side Effects Center

What Is Qtern?

Qtern (dapagliflozin and saxagliptin) tablets are a sodium-glucose cotransporter 2 (SGLT-2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.

What Are Side Effects of Qtern?

Common side effects of Qtern include:

Dosage for Qtern

The recommended dose of Qtern is a 10 mg dapagliflozin/5 mg saxagliptin tablet taken orally once daily in the morning with or without food.

What Drugs, Substances, or Supplements Interact with Qtern?

Qtern may interact with ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin. Tell your doctor all medications and supplements you use.

Qtern During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Qtern; it is not recommended for use during the second and third trimesters of pregnancy because it may cause birth defects. It is unknown if Qtern passes into breast milk. Because of the potential for adverse effects in a nursing baby, breastfeeding is not recommended while using Qtern.

Additional Information

Our Qtern (dapagliflozin and saxagliptin) Tablets 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.

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
Qtern Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a 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.

Stop taking this medicine and call your doctor at once if you have:

  • severe or ongoing pain in your joints;
  • serious skin reaction--itching, blisters, breakdown of the outer layer of skin;
  • ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out); or
  • signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, pain in your pelvis or back.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

Common side effects may include:

  • urination problems;
  • abnormal blood levels of cholesterol or triglycerides; or
  • runny nose, stuffy nose, sinus pain.

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 Qtern (Dapagliflozin and Saxagliptin Tablets, for Oral Use)

QUESTION

______________ is another term for type 2 diabetes. See Answer
Qtern Professional Information

SIDE EFFECTS

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

  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Heart Failure [see WARNINGS AND PRECAUTIONS]
  • Ketoacidosis [see WARNINGS AND PRECAUTIONS]
  • Volume Depletion [see WARNINGS AND PRECAUTIONS]
  • Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [see WARNINGS AND PRECAUTIONS]
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Genital Mycotic Infections [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.

The safety of combined use of 10 mg dapagliflozin and 5 mg saxagliptin has been evaluated in adult subjects with type 2 diabetes mellitus in a pooled safety analysis of three phase 3 active/placebo-controlled clinical trials with a median exposure of 51 weeks. The pooled safety analysis included a total of 1169 adults: 492 patients in the combination of saxagliptin and dapagliflozin plus metformin group, 341 patients in the dapagliflozin plus metformin group, 336 patients in the saxagliptin plus metformin group. The mean age of these subjects was 54 years, 0.8% were 75 years or older and 53.7% were female. The population was 80.9% White, 8.3% Black or African American, 3.7% Asian, and 6.6% Other race. At baseline the population had diabetes for an average of 7.5 years and a mean HbA1c of 8.4%. The mean eGFR at baseline was 94.4 mL/min/1.73 m2.

The common adverse reactions were based on the pooled analyses of these studies as shown in Table 1.

Table 1: Adverse Reactions Reported in ≥2% of Subjects Treated with 10 mg Dapagliflozin and 5 mg Saxagliptin plus Metformin (≥1500 mg)

Adverse Reaction
Preferred Term*
Frequency %
Upper respiratory tract infection* 13.6
Urinary tract infection* 5.7
Dyslipidemia* 5.1
Headache 4.3
Diarrhea 3.7
Back pain 3.3
Genital infection* 3.0
Arthralgia 2.4
* Adverse reactions that are medically related were grouped to a single preferred term.

Additionally, adverse reactions reported in <5% and ≥2% from the dapagliflozin development program and ≥1% more frequently compared to placebo included increased urination and discomfort with urination.

Hypoglycemia

In the pooled analysis, the incidences of hypoglycemia (defined as a blood glucose <54 mg/dL regardless of the presence or absence of symptoms) and severe hypoglycemia (event requiring assistance due to neuroglycopenia, characterized by altered mental and/or physical status) was 1% and 0.2%, respectively.

Genital Mycotic Infections

Genital mycotic infections were reported in 15 subjects (3%) treated with QTERN. Reported adverse reactions by frequency included vulvovaginal mycotic infection, balanoposthitis, genital fungal infection, vaginal infection, and vulvovaginitis. The majority of subjects (84.2%) who experienced genital infection adverse reactions were females.

Urinary Tract Infections

Urinary tract infections were reported in 28 subjects (5.7%) treated with QTERN. Reported adverse reactions by frequency included urinary tract infection, Escherichia urinary tract infection, prostatitis, and pyelonephritis. The majority of subjects (80.6%) who experienced urinary tract infection adverse reactions were females.

Volume Depletion

Dapagliflozin causes an osmotic diuresis, which may lead to a reduction in intravascular volume. Events related to volume depletion (hypotension, dehydration, and hypovolemia) were reported in 2 subjects (0.4%) treated with QTERN plus metformin.

Impairment Of Renal Function

Adverse reactions related to decreased renal function were reported in 10 subjects (2.0%) treated with QTERN plus metformin. The reported adverse reactions included decreased glomerular filtration rate, renal impairment, increased blood creatinine, acute renal failure, and decreased urine output. None of the adverse reactions were reported as serious and all but one were mild to moderate in intensity. Three subjects discontinued due to decreased eGFR. Subjects with AEs of renal impairment had lower mean eGFR values at baseline of 64.4 mL/min/1.73 m2 compared to 94.4 mL/min/1.73 m2 in overall population treated with QTERN.

Ketoacidosis

Dapagliflozin

In the cardiovascular outcome study with dapagliflozin in patients with type 2 diabetes mellitus, events of diabetic ketoacidosis were reported in 27 out of 8574 patients in the dapagliflozin-treated group and in 12 out of 8569 patients in the placebo group. The events were evenly distributed over the study period.

Laboratory Findings

Increases in Serum Creatinine and Decreases in eGFR

Dapagliflozin

Initiation of SGLT2 inhibitors, including dapagliflozin causes a small increase in serum creatinine and decrease in eGFR. These changes in serum creatinine and eGFR generally occur within two weeks of starting therapy and then stabilize regardless of baseline kidney function. Changes that do not fit this pattern should prompt further evaluation to exclude the possibility of acute kidney injury. In two studies that included patients with type 2 diabetes mellitus with moderate renal impairment, the acute effect on eGFR reversed after treatment discontinuation, suggesting acute hemodynamic changes may play a role in the renal function changes observed with dapagliflozin.

Decrease in Lymphocyte Counts

Saxagliptin

A dose-related mean decrease in absolute lymphocyte count has been observed with saxagliptin. In a pool of 5 placebo-controlled studies, a mean decrease in absolute lymphocyte count of approximately 100 cells/microL relative to placebo was observed. The proportion of patients who were reported to have a lymphocyte count ≤750 cells/microL was 0.5%, 1.5%, and 0.4% in the 2.5 mg, 5 mg saxagliptin and placebo groups, respectively.

The clinical significance of this decrease in lymphocyte count relative to placebo is not known. The effect of saxagliptin on lymphocyte counts in patients with lymphocyte abnormalities (e.g., human immunodeficiency virus) is unknown.

Increase in Hematocrit

Dapagliflozin

In a pool of 13 placebo-controlled studies with dapagliflozin, increases from baseline in mean hematocrit values were observed in dapagliflozin-treated patients starting at Week 1 and continuing up to Week 16, when the maximum mean difference from baseline was observed. At Week 24, the mean changes from baseline in hematocrit were −0.33% in the placebo group and 2.30% in the 10 mg dapagliflozin group. By Week 24, hematocrit values >55% were reported in 0.4% of placebo-treated patients and 1.3% of 10 mg dapagliflozin-treated patients.

Increase in Low-Density Lipoprotein Cholesterol

Patients treated with QTERN demonstrated a mean percent increase from baseline LDL-cholesterol (ranging from 2.1 to 6.9%).

Elevations in Creatine Kinase

An imbalance in the number of subjects who experienced serum creatine kinase (CK) elevations >10x the upper limit of normal (a marker of muscle injury/necrosis) was observed in 5 subjects (1%) treated with QTERN. The elevations were transient. Rhabdomyolysis was reported for one of those subjects for which no obvious cause was identified.

Decrease in Serum Bicarbonate

In a study of concomitant therapy of 10 mg dapagliflozin with exenatide extended-release (on a background of metformin), four patients (1.7%) on concomitant therapy had a serum bicarbonate value of less than or equal to 13 mEq/L compared to one each (0.4%) in the dapagliflozin and exenatide-extended release treatment groups.

Postmarketing Experience

Additional adverse reactions have been identified during post-approval use of dapagliflozin and saxagliptin. Because the following 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.

Dapagliflozin
  • Ketoacidosis
  • Acute Kidney Injury
  • Urosepsis and pyelonephritis
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
  • Rash
Saxagliptin
  • Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
  • Pancreatitis
  • Severe and disabling arthralgia
  • Bullous pemphigoid
  • Rhabdomyolysis

DRUG INTERACTIONS

Table 2: Clinically Relevant Interactions Affecting Drugs Coadministered with QTERN

Strong Inhibitors of CYP3A4/5 Enzymes
Clinical Impact Ketoconazole significantly increased saxagliptin exposure. Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Intervention Do not coadminister QTERN with strong cytochrome P450 3A4/5 inhibitors [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Positive Urine Glucose Test
Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.

Read the entire FDA prescribing information for Qtern (Dapagliflozin and Saxagliptin Tablets, for Oral Use)

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

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