Saxagliptin and dapagliflozin (Oral)

Saxagliptin and dapagliflozin combination is used along with a proper diet and exercise to treat type 2 diabetes. Saxagliptin helps control blood sugar levels by prompting the pancreas to release more insulin. It also tells the liver to stop producing sugar when there is too much sugar in the blood. Dapagliflozin works in the kidneys to stop glucose (blood sugar) from being absorbed. This helps lower blood sugar levels. This medicine does not help patients with insulin-dependent or type 1 diabetes. Patients with type 1 diabetes must use insulin injections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood and urine tests may be needed to look for unwanted effects.

Pancreatitis (swelling and inflammation of the pancreas) may happen while you use this medicine. Contact your doctor immediately if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Contact your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Drinking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Contact your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

This medicine may increase the risk of urinary tract infections, including pyelonephritis or urosepsis. Contact your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients with a history of genital yeast infections or in men who are not circumcised. Women may experience vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Contact your doctor right away if you have any of these symptoms.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can harm the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Contact your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken with certain other medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People experience different symptoms of low blood sugar. It is important for you to learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty thinking, drowsiness, excessive hunger, a fast heartbeat, persistent headaches, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may happen if you do not take enough of your medicine, skip a dose, overeat, do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important for you to learn which symptoms you have so you can treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while using this medicine.

This medicine may cause severe joint pain. Call your doctor right away if you experience severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Make sure any doctor or dentist who treats you knows you are using this medicine. You may need to stop using this medicine for at least 3 days before having surgery or other procedures that require fasting. This medicine may also affect the results of some medical tests (for example, urine glucose tests may not be accurate).

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on how saxagliptin and dapagliflozin combination affects children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems for older adults that would limit the usefulness of saxagliptin and dapagliflozin combination. However, older patients are more likely to have kidney issues, which may require caution and a dose adjustment for patients taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may want to change the dose, or other precautions may be necessary. When taking this medicine, it is important for your healthcare professional to know if you are taking any of the medicines listed below. The interactions listed have been chosen for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Enoxacin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Lanreotide
• Levofloxacin
• Lithium
• Lomefloxacin
• Mavacamten
• Metolazone
• Moxifloxacin
• Netupitant
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Pasireotide
• Phenobarbital
• Polythiazide
• Pramlintide
• Primidone
• Simeprevir
• Somatrogon-ghla
• Sparfloxacin
• Thioctic Acid
• Triamterene
• Trovafloxacin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Acebutolol
• Acetohexamide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpropamide
• Esmolol
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Alcohol abuse, history of or
• Gallbladder problems (e.g., gallstones) or
• Hypertriglyceridemia (high triglycerides and fats in the blood) or
• Pancreas problems—Use with caution. May increase risk for pancreatitis (swelling of the pancreas).

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with saxagliptin or other dipeptidyl peptidase-4 (DPP-4) inhibitors, history of—Use with caution. May increase the risk of this condition occurring again.

• Dehydration or
• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Genital yeast (fungus) infections (e.g., balanitis, balanoposthitis, vulvovaginitis), history of or
• Heart failure, history of or
• Hypotension (low blood pressure) or
• Kidney disease or
• Urinary tract infection (e.g., pyelonephritis, urosepsis), history of—Use with caution. May worsen these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause issues with blood sugar control.

• Hypovolemia (low blood volume) or
• Pancreatic insulin deficiency, history of—May increase risk for more serious side effects.

• Kidney disease, moderate to severe (e.g., end-stage kidney disease) or
• Patients receiving dialysis or
• Type I diabetes—Should not be used in patients with these conditions.

• Liver disease, severe—Use has not been studied in patients with this condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Less common

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• decreased frequency or amount of urine
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• increased thirst
• loss of appetite
• loss of consciousness
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the face, fingers, or lower legs
• trouble breathing
• unusual tiredness or weakness
• vomiting
• weight gain

Incidence not known

• Agitation
• bloating
• chest pain or tightness
• constipation
• cough
• cracks in the skin
• dark urine
• decreased awareness or responsiveness
• decreased urine output
• difficulty with swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• hostility
• increased urination
• indigestion
• irregular heartbeat
• irritability
• large, hard skin blisters
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• loss of heat from the body
• muscle twitching
• pain, tenderness, redness, or swelling of the area between the anus and genitals
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red, swollen skin
• redness, itching, swelling, or pain around the penis
• scaly skin
• severe joint pain
• severe sleepiness
• shakiness
• sweating
• unexplained weight loss
• unusual drowsiness, dullness, or feeling of sluggishness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain
• ear congestion
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat

Less common

• Back pain
• diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Qtern

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Pharmacologic Class: Dipeptidyl Peptidase IV Inhibitor

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not change your dose unless directed by your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you are on a low-salt or sodium diet.

Swallow the tablet whole. Do not cut, crush, or chew it. You may take this medicine with or without food.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For type 2 diabetes: Adults—At first, 1 tablet once a day, taken in the morning. Each tablet contains 5 milligrams (mg) saxagliptin and 5 mg dapagliflozin or 5 mg saxagliptin and 10 mg dapagliflozin. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.