saxagliptin (Oral route)

sax-a-GLIP-tin

Commonly used brand name(s)

In the U.S.

  • Onglyza

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Dipeptidyl Peptidase IV Inhibitor

Uses For saxagliptin

Saxagliptin is used to treat high blood sugar levels in patients with type 2 diabetes mellitus. In type 2 diabetes, the body does not store excess sugar in the normal way, so the sugar remains in the blood. If a person has high blood sugar levels for a long time, they may develop serious health problems.

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Having a proper diet is the first step in managing type 2 diabetes, but medicines may be needed to help the body store excess sugar. 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.

Saxagliptin does not help patients who have insulin-dependent or type 1 diabetes. Patients with type 1 diabetes do not produce insulin from the pancreas gland. The blood sugar is controlled with insulin injections.

saxagliptin is available only with your doctor's prescription.

Before Using saxagliptin

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 saxagliptin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to saxagliptin 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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 saxagliptin, 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 saxagliptin 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.

  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Eslicarbazepine Acetate
  • Lomitapide
  • Mitotane
  • Nilotinib
  • Piperaquine
  • Primidone
  • Simeprevir
  • Tocophersolan

Interactions with Food/Tobacco/Alcohol

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 saxagliptin. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol, excessive use or
  • Gallstones or
  • Hypertriglyceridemia (high triglycerides or fats in the blood)—May increase risk of pancreatitis.
  • Angioedema (swelling of the face, lips, tongue, or throat) to similar medicines (e.g., linagliptin, sitagliptin), history of—Use with caution. It is not known if patients with this condition are at increased risk of getting angioedema with saxagliptin.
  • Diabetic ketoacidosis (acid or ketones in the blood) or
  • Type I diabetes—Should not be used in patients with these conditions.
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.
  • Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Pancreatitis (inflammation and swelling of the pancreas)—Use with caution. May make this condition worse.

Proper Use of saxagliptin

Follow carefully 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.

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

You may take saxagliptin with or without food.

Swallow the tablet whole. Do not break, cut, or split it.

Dosing

The dose of saxagliptin 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 saxagliptin. 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 saxagliptin, 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 While Using saxagliptin

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

It is very important to follow carefully any instructions from your health care team about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
  • Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

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

saxagliptin may cause serious types of allergic reactions, including anaphylaxis, angioedema, and serious skin reactions. These conditions may be life-threatening and require immediate medical attention. Stop using saxagliptin and 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 saxagliptin.

Saxagliptin may cause hypoglycemia (low blood sugar). However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take saxagliptin with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your family should also know how to use it.

Symptoms of hyperglycemia (high blood sugar) include: blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

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

saxagliptin is only part of a complete program for controlling diabetes. It is important that you always eat a healthy diet, watch your weight, and get regular exercise.

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.

saxagliptin 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
  • Anxiety
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • increased hunger
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nervousness
  • nightmares
  • rapid weight gain
  • runny nose
  • seizures
  • shakiness
  • slurred speech
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Constipation
  • darkened urine
  • difficulty with swallowing
  • flaking or peeling of the skin
  • hives
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • 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
  • shortness of breath
  • skin rash
  • tightness in the chest
  • vomiting
  • wheezing
  • 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
  • Diarrhea
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • weakness
  • 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.

See also: Side effects (in more detail)

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