Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Onglyza

Descriptions


Saxagliptin is used with proper diet and exercise to treat high blood sugar (glucose) levels in patients with type 2 diabetes. Saxagliptin helps to control blood sugar levels by making the pancreas gland release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

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

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of 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 performed on the relationship of age to the effects of saxagliptin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saxagliptin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving saxagliptin.

Breastfeeding

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

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Abiraterone Acetate
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorothiazide
  • Chlorthalidone
  • Ciprofloxacin
  • Delafloxacin
  • Enoxacin
  • Fedratinib
  • Fexinidazole
  • Fosnetupitant
  • Furosemide
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroxychloroquine
  • Indapamide
  • Lanreotide Acetate
  • Levofloxacin
  • Lomefloxacin
  • Mavacamten
  • Metolazone
  • Moxifloxacin
  • Netupitant
  • Norfloxacin
  • Octreotide Acetate
  • Ofloxacin
  • Omaveloxolone
  • Pasireotide Diaspartate
  • Phenobarbital
  • Polythiazide
  • Primidone
  • Simeprevir
  • Somatrogon-ghla
  • Sparfloxacin
  • Thioctic Acid
  • Triamterene
  • Trovafloxacin

Using this medicine with any of the following medicines may cause an increased 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 change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorpropamide
  • Esmolol
  • Glecaprevir
  • 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
  • Pibrentasvir
  • Pindolol
  • Practolol
  • Propranolol
  • Sotalol
  • Timolol
  • Tolazamide
  • Tolbutamide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Alcohol, excessive use or
  • Gallstones, history of or
  • Hypertriglyceridemia (high triglycerides or fats in the blood) or
  • Pancreatitis, history of—Use with caution. May cause side effects to become worse.
  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.
  • Heart failure, history of or
  • Kidney disease—May increase risk for heart failure.
  • Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

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

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Swallow the tablet whole. Do not break, cut, or chew it. Take this medicine with or without food.

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—2.5 or 5 milligrams (mg) once a 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.

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

If you are rapidly gaining weight, having trouble breathing, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, and serious skin reactions. These conditions may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, skin flaking or peeling, trouble with breathing, or chest tightness while you are using this medicine.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, 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. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

This medicine may cause severe joint pain. Call your doctor right away if you have severe joint pain with this medicine.

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

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

  1. Anxiety
  2. bladder pain
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. bloody or cloudy urine
  5. blurred vision
  6. body aches or pain
  7. chills
  8. cold sweats
  9. confusion
  10. cool, pale skin
  11. cough
  12. depression
  13. difficult, burning, or painful urination
  14. difficulty with breathing
  15. dizziness
  16. ear congestion
  17. fast heartbeat
  18. fever
  19. frequent urge to urinate
  20. headache
  21. increased hunger
  22. loss of voice
  23. lower back or side pain
  24. nasal congestion
  25. nausea
  26. nightmares
  27. rapid weight gain
  28. runny nose
  29. seizures
  30. shakiness
  31. slurred speech
  32. sneezing
  33. sore throat
  34. tingling of the hands or feet
  35. unusual tiredness or weakness
  36. unusual weight gain or loss

Incidence not known

  1. Chest pain
  2. constipation
  3. darkened urine
  4. decreased urine output
  5. difficulty with swallowing
  6. dilated neck veins
  7. extreme fatigue
  8. flaking or peeling of the skin
  9. hives or skin rash
  10. indigestion
  11. irregular breathing
  12. irregular heartbeat
  13. large, hard skin blisters
  14. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  15. loss of appetite
  16. pains in the stomach, side, or abdomen, possibly radiating to the back
  17. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  18. severe joint pain
  19. swelling of face, fingers, feet, or lower leg
  20. tightness in the chest
  21. troubled breathing
  22. vomiting
  23. weight gain
  24. 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 health care professional may be able to tell you about 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:

Less common

  1. Diarrhea
  2. pain or tenderness around the eyes and cheekbones
  3. redness of the skin
  4. weakness
  5. welts

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.