Dapagliflozin, saxagliptin, and metformin (Oral)

Dapagliflozin, saxagliptin, and metformin combination is used with a proper diet and exercise to lower high blood sugar levels caused by type 2 diabetes. Dapagliflozin works in the kidneys to prevent the absorption of glucose (blood sugar). This helps lower blood sugar levels. Saxagliptin helps control blood sugar levels by causing the pancreas to release more insulin. It also tells the liver to stop producing sugar when there is too much sugar in the blood. Metformin reduces the absorption of sugar from the stomach, decreases the release of stored sugar from the liver, and helps your body use sugar better. This medicine does not help patients who have 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 monitor your progress during regular visits, especially in the first few weeks of taking this medicine. Blood and urine tests might be needed to check for any unwanted effects.

In certain situations, too much metformin can lead to a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and develop quickly. It usually happens when other serious health issues are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include: stomach discomfort, loss of appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you experience more than one of these symptoms together, seek immediate emergency medical help.

Limit alcohol intake while using this medicine. Heavy drinking can increase your risk of lactic acidosis.

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

If you experience rapid weight gain, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrists, ankles, or feet, contact your doctor immediately. These may be signs of a heart problem.

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

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

Notify your doctor if you notice bloody urine, a decrease in urine output or frequency, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, fingers, or lower legs. These could be signs of a serious kidney issue.

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

This medicine may lead to 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 uncircumcised men. Women may have vaginal discharge, itching, or odor. Men may experience redness, itching, swelling, or pain around the penis, or a strong odor from a discharge. 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 damage 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 immediately if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling in the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when taken with certain other medications. Low blood sugar must be treated before it leads to passing out (unconsciousness). Symptoms of low blood sugar can vary. It is important to recognize your typical symptoms so you can treat them quickly. Discuss with your doctor the best way to manage low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough medicine or skip a dose, overeat or 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. Be aware of your symptoms to treat them quickly. Talk to your doctor about the best way to manage high blood sugar.

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

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

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

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the likelihood of pregnancy if you are sexually active. Additionally, you should not use this medicine during the last 6 months of pregnancy. If you are a woman of childbearing age, discuss birth control options with your doctor.

There may be times when you need emergency help for a problem related to your diabetes. Be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or necklace at all times. Also, carry an ID card in your wallet or purse that states you have diabetes and lists all your medicines.

Ensure that any doctor or dentist treating you knows that you are using this medicine. Your doctor may recommend stopping this medicine at least 3 days before major surgery or certain diagnostic tests, especially those that use contrast dye. This medicine may also affect the results of specific medical tests (for example, urine glucose tests may not be accurate).

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

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Let your doctor know if you have ever had an 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 over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how dapagliflozin, saxagliptin, and metformin combination affects children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of dapagliflozin, saxagliptin, and metformin combination. However, older patients are more likely to have kidney issues, which may need caution and a dose adjustment for those taking this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if there could be an interaction. In those cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed are significant and not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change your other medications.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

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 change the dose or frequency of one or both medicines.

• Abametapir
• Abiraterone Acetate
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Lanreotide
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lithium
• Lomefloxacin
• Mavacamten
• Methazolamide
• Metolazone
• Moxifloxacin
• Nateglinide
• Netupitant
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Ombitasvir
• Paritaprevir
• Pasireotide
• Phenobarbital
• Pioglitazone
• Polythiazide
• Pramlintide
• Primidone
• Ranolazine
• Repaglinide
• Semaglutide
• Simeprevir
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Acebutolol
• Acetohexamide
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpropamide
• Colesevelam
• Esmolol
• Fenugreek
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glucomannan
• Glyburide
• Guar Gum
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tolazamide
• Tolbutamide
• Tranylcypromine
• Verapamil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The interactions listed are significant and not all-inclusive.

Other Medical Problems

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

• History of alcohol abuse
• Hypovolemia (low blood volume)
• History of pancreatic insulin deficiency—May increase the risk of serious side effects.
• Dehydration
• Dyslipidemia (high fats or cholesterol in the blood)
• History of genital yeast infections (e.g., balanitis, balanoposthitis, vulvovaginitis)
• History of heart failure
• Hypotension (low blood pressure)
• Ketoacidosis (high ketones and acid in the blood)
• Kidney disease
• Problems with the pancreas (e.g., pancreatitis)
• History of urinary tract infections (e.g., pyelonephritis, urosepsis)
• Vitamin B12 deficiency—Use with caution. May worsen these conditions.

• Diabetic ketoacidosis (high ketones and acid in the blood)
• Moderate to severe kidney disease (e.g., end-stage kidney disease)
• Patients on dialysis
• Type I diabetes—Should not be used in these patients.

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

• Liver disease—Use is not recommended in patients with this condition.

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

Check with your doctor immediately 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

• Agitation
• Anxiety
• Back pain
• Blurred vision
• Chills
• Cold sweats
• Confusion
• Cool, pale skin
• Decreased awareness or responsiveness
• Decreased urine output
• Depression
• Difficulty in moving
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast heartbeat
• Fever
• Groin pain
• Headache
• Hostility
• Increased hunger
• Increased urination
• Irritability
• Itching of the vagina or outside the genitals
• Joint pain
• Loss of consciousness
• Muscle aches, pains, stiffness, or twitching
• Nausea
• Nervousness
• Nightmares
• Pain during sexual intercourse
• Rapid weight gain
• Seizures
• Severe sleepiness
• Shakiness
• Slurred speech
• Stomach pain
• Sweating
• Swelling of the face, ankles, or hands
• Swollen, tender prostate
• Thick, white curd-like vaginal discharge without odor or with mild odor
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Rare

• Dry mouth
• Rapid breathing
• Sunken eyes
• Thirst
• Wrinkled skin

Incidence not known

• Bloating
• Chills
• Constipation
• Cough
• Dark urine
• Diarrhea
• Difficulty swallowing
• Flushed, dry skin
• Fruit-like breath odor
• General feeling of discomfort or illness
• Hives, itching, skin rash
• Indigestion
• Large, hard skin blisters
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• 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
• Right upper quadrant tenderness
• Runny nose
• Severe joint pain
• Shivering
• Sore throat
• Tightness in the chest
• Trouble sleeping
• Troubled breathing
• Unexplained weight loss
• Vomiting
• Weight loss
• 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. Also, your healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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
• Sneezing
• Stuffy nose

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.

Pharmacologic Class: Dapagliflozin

Chemical Class: Metformin

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 stop or 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, break, or chew it. Take this medicine in the morning with food.

Part of the extended-release tablet may pass into your stool (bowel movement). This is normal and nothing to worry about.

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 (extended-release tablets):For type 2 diabetes: Adults—At first, 1 tablet once a day, taken in the morning. Each tablet contains 5 milligrams (mg) dapagliflozin, 5 mg saxagliptin, and 1000 mg or 2000 mg metformin. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mg dapagliflozin, 5 mg saxagliptin, and 2000 mg metformin per day. 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.

If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule.

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.