Dapagliflozin and Saxagliptin: Uses, Side Effects and Dosage

What is the most important information I should know about dapagliflozin and saxagliptin tablets?

Serious side effects can happen to people taking dapagliflozin and saxagliptin tablets, including:

• Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Dapagliflozin and saxagliptin tablets can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.

  Stop taking dapagliflozin and saxagliptin tablets and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

• nausea o tiredness
• vomiting
• stomach area (abdominal) pain
• trouble breathing
• ketones in your urine or blood

• Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the medicines in dapagliflozin and saxagliptin tablets, can cause inflammation of the pancreas, which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking dapagliflozin and saxagliptin tablets, tell your healthcare provider if you have ever had:

  • inflammation of your pancreas (pancreatitis)
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

  It is not known if having these medical problems will make you more likely to get pancreatitis with dapagliflozin and saxagliptin tablets. Stop taking dapagliflozin and saxagliptin tablets and contact your healthcare provider 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.

• Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking dapagliflozin and saxagliptin tablets, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.

  Contact your healthcare provider 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.
• Dehydration. Dapagliflozin and saxagliptin tablets 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). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking dapagliflozin, a component of dapagliflozin and saxagliptin tablets. You may be at a higher risk of dehydration if you:

• take medicines to lower your blood pressure, including water pills (diuretics)
• are on a low salt diet
• have kidney problems
• are 65 years of age or older

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.

What is dapagliflozin and saxagliptin tablets?

Dapagliflozin and saxagliptin tablets are a prescription medicine that contains dapagliflozin and saxagliptin. Dapagliflozin and saxagliptin tablets are used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

• Dapagliflozin and saxagliptin tablets are not for use to improve blood sugar (glucose) control in people with type 1 diabetes.

• It is not known if dapagliflozin and saxagliptin tabletsare safe and effective in children younger than 18 years of age.

Who should not take dapagliflozin and saxagliptin tablets?

Do not take dapagliflozin and saxagliptin tablets if you:

• are allergic to dapagliflozin, saxagliptin, or any of the ingredients in dapagliflozin and saxagliptin tablets. See the end of this Medication Guide for a list of ingredients in dapagliflozin and saxagliptin tablets. Symptoms of a serious allergic reaction to dapagliflozin and saxagliptin tablets may include:

  • swelling of the face, lips, throat and other areas of your skin
  • difficulty with swallowing or breathing
  • rash, itching, flaking, or peeling
  • raised red areas on your skin (hives)

  If you have any of these symptoms, stop taking dapagliflozin and saxagliptin tablets and contact your healthcare provider or go to the nearest hospital emergency room right away.

• have moderate to severe kidney problems or are on dialysis.

Before taking dapagliflozin and saxagliptin tablets, tell your healthcare provider about all of your medical conditions, including if you:

• have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine).
• have a decrease in your insulin dose.
• have a serious infection.
• have a history of infection of the vagina or penis.
• have kidney problems.
• have liver problems.
• have a history of urinary tract infections or problems with urination.
• are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet.
• are going to have surgery. Your healthcare provider may stop your dapagliflozin and saxagliptin tablets before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking dapagliflozin and saxagliptin tablets and when to start it again.
• are eating less or there is a change in your diet.
• are dehydrated.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have heart problems, including heart failure.
• have had a history of swelling of the face, lips, tongue and throat (angioedema) when you have taken a dipeptidyl peptidase 4 (DPP-4) inhibitor like saxagliptin one of the medicines in dapagliflozin and saxagliptin tablets. If you are not sure that you have taken this medicine before, ask your healthcare provider.

• are pregnant or plan to become pregnant. Dapagliflozin and saxagliptin tablets may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar.

• are breastfeeding or plan to breastfeed. It is not known if dapagliflozin and saxagliptin tablets passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking dapagliflozin and saxagliptin tablets. Breastfeeding is not recommended while taking dapagliflozin and saxagliptin tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Dapagliflozin and saxagliptin tablets may affect the way other medicines work, and other medicines may affect how dapagliflozin and saxagliptin tablets works. Contact your healthcare provider if you will be starting or stopping certain other types of medicines such as antibiotics or medicines that treat fungus or HIV/AIDS, because your dose of dapagliflozin and saxagliptin tablets might need to be changed. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine

How should I take dapagliflozin and saxagliptin tablets?

• Take dapagliflozin and saxagliptin tablets exactly as your healthcare provider tells you to take it.

• Take dapagliflozin and saxagliptin tablets by mouth 1 time each day in the morning with or without food.

• Your healthcare provider will tell you how much dapagliflozin and saxagliptin tablets to take and when to take it. Your healthcare provider may change your dose if needed.
• Swallow dapagliflozin and saxagliptin tablets whole. Do not crush, cut or chew dapagliflozin and saxagliptin tablets.
• 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 dapagliflozin and saxagliptin tablets at the same time unless your healthcare provider tells you to do so. Talk to your healthcare provider if you have questions about a missed dose.
• If you take too much dapagliflozin and saxagliptin tablets, call your healthcare provider, or go to the nearest hospital emergency room right away.
• During periods of stress on the body, such as fever, trauma, infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
• Your healthcare provider may tell you to take dapagliflozin and saxagliptin tablets along with other diabetes medicines. Low blood sugar can happen more often when dapagliflozin and saxagliptin tablets is taken with certain other diabetes medicines. See “What are the possible side effects of dapagliflozin and saxagliptin tablets?”.
• dapagliflozin and saxagliptin tablets will cause your urine to test positive for glucose.
• Your healthcare provider may do certain blood tests before you start dapagliflozin and saxagliptin tablets and during treatment as needed. Your healthcare provider may change your dose of dapagliflozin and saxagliptin tablets based on the results of your blood tests.

What are the possible side effects of dapagliflozin and saxagliptin tablets?

Dapagliflozin and saxagliptin tablets may cause serious side effects, including:

• See “What is the most important information I should know about dapagliflozin and saxagliptin tablets?”
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider 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 also may have a fever, back pain, nausea or vomiting.

• Low blood sugar (hypoglycemia). If you take dapagliflozin and saxagliptin tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, this can increase your risk of getting low blood sugar. Tell your healthcare provider if you take other diabetes medicines. Signs and symptoms of low blood sugar may include: o headache

  • drowsiness
  • weakness
  • confusion
  • dizziness
  • sweating
  • hunger
  • shaking or feeling jittery
  • fast heartbeat
  • irritability

  A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in dapagliflozin and saxagliptin tablets. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death.Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:

• • pain or tenderness
  • swelling
  • redness of skin(erythema)

  Serious allergic reaction. If you have any symptoms of a serious allergic reactions, stop taking dapagliflozin and saxagliptin tablets and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take dapagliflozin and saxagliptin tablets?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

• Vaginal yeast infection. Women who take dapagliflozin and saxagliptin tablets may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:

  • ovaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • ovaginal itching

• Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may developthat makes it difficult to pull back the skin around the tip of the 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 the penis

  Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.

• Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, one of the medicines in dapagliflozin and saxagliptin tablets may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.
• Skin reaction. Some people who take DPP-4 inhibitors like saxagliptin, one of the medicines in dapagliflozin and saxagliptin tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking dapagliflozin and saxagliptin tablets. The most common side effects of dapagliflozin and saxagliptin tablets include:
• upper respiratory tract infection
• urinary tract infection
• abnormal amounts of fats in the blood (dyslipidemia)

These are not all of the possible side effects of dapagliflozin and saxagliptin tablets.

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 dapagliflozin and saxagliptin tablets?

Store dapagliflozin and saxagliptin tablets at room temperature between 68^○F to 77^○F (20^○C to 25^○C).

Keep dapagliflozin and saxagliptin tablets and all medicines out of the reach of children.

General information about the safe and effective use of dapagliflozin and saxagliptin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

Dapagliflozin and saxagliptin tablets for a condition for which it was not prescribed. Do not give dapagliflozin and saxagliptin tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about dapagliflozin and saxagliptin tablets that is written for health professionals.

What are the ingredients in dapagliflozin and saxagliptin tablets?

Active ingredients: dapagliflozin and saxagliptin

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium,hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, stearic acid, iron oxide yellow, iron oxide red, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.

For more information about dapagliflozin and saxagliptin tablets, go to www.novadozpharma.com or call 1-855-668-2369.

Manufactured by:

MSN Laboratories Private Limited

Telangana - 509 228,

INDIA

Distributed by:

Novadoz Pharmaceuticals LLC

Piscataway, NJ 08854-3714

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 04/2026