Saxagliptin

What is Saxagliptin?

• Saxagliptin (ONGLYZA) is a dipeptidyl peptidase-4 (DPP4) inhibitor used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other oral hypoglycemic agents.

Saxagliptin

SaxagliptinBB

What are the uses of this medicine?

• Saxagliptin (ONGLYZA) is a prescription medicine used with diet and exercise to control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
• ONGLYZA lowers blood sugar by helping the body increase the level of insulin after meals.
• ONGLYZA is unlikely by itself to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work well when your blood sugar is low. However, hypoglycemia may still occur with ONGLYZA. Your risk for getting hypoglycemia is higher if you take ONGLYZA with some other diabetes medicines, such as a sulfonylurea or insulin.

Limitation of use:

• ONGLYZA is not for people with type 1 diabetes.
• ONGLYZA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

How does this medicine work?

• Saxagliptin (sax' a glip' tin) is an inhibitor of dipeptidyl peptidase-4, which is the major enzyme responsible for the degradation of glucagon-like peptide-1 (GLP-1), an important gastrointestinal hormone (incretin) that increases glucose dependent insulin secretion by the pancreas.
• By prolonging the effect of GLP-1, saxagliptin increases insulin levels and lowers blood glucose, thereby improving glycemic control in patients with type 2 diabetes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any ingredients in ONGLYZA.

What drug interactions can this medicine cause?

• Significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, Ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
• The dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor.

Is this medicine FDA approved?

• Saxagliptin was approved for use in the United States in 2009 and was the second DPP-4 inhibitor introduced into clinical practice.

How should this medicine be used?

• Assess renal function before starting ONGLYZA and periodically thereafter.

Recommended dosage:

• Recommended dosage is 2.5 mg or 5 mg once daily taken regardless of meals.
• Patients eGFR <45 mL/min/1.73 m2 (with moderate or severe renal impairment, or end-stage renal disease): Recommended dosage is 2.5 mg once daily regardless of meals.

Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 Inhibitors:

• The dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

Administration:

• ONGLYZA can be taken with or without food.
• Do not split or cut ONGLYZA tablets.
• During periods of stress on the body, such as fever, trauma, infection, or surgery.
• Contact your healthcare provider right away as your medication needs may change.
• Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment with ONGLYZA. You may need a lower dose of ONGLYZA if your kidneys are not working well.
• Follow your healthcare provider’s instructions for treating blood sugar that is too low (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.
• If you miss a dose of ONGLYZA, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses 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 ONGLYZA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg and 2.5 mg.

This medicine is available in fallowing brand namesː

• ONGLYZA

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infection
• urinary tract infection
• headache
• hypoglycemia
• Swelling or fluid retention

ONGLYZA can cause serious side effects, including:

• pancreatitis
• hypersensitivity
• Joint pain
• Skin reaction

What special precautions should I follow?

• There have been postmarketing reports of acute pancreatitis in patients taking ONGLYZA. If pancreatitis is suspected, promptly discontinue ONGLYZA.
• Risk of hospitalization for heart failure was higher in the ONGLYZA. Consider the risks and benefits of ONGLYZA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
• When ONGLYZA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia. In add-on to sulfonylurea, add-on to insulin, and add-on to metformin plus sulfonylurea trials, confirmed hypoglycemia was more common in patients treated with ONGLYZA compared to placebo.
• When used with an insulin secretagogue (e.g., sulfonylurea) or insulin, a lower dose of insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia.
• There have been postmarketing reports of serious hypersensitivity reactions in patients treated with ONGLYZA. More common in patients treated with ONGLYZA than in patients treated with placebo; and postmarketing reports of serious hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions. Promptly discontinue ONGLYZA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
• There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
• There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue ONGLYZA.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No dose-related clinical adverse reactions and no clinically meaningful effect on QTc interval or heart rate.

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status.
• Saxagliptin and its active metabolite are removed by hemodialysis (23% of dose over 4 hours).

Can this medicine be used in pregnancy?

• Limited data with ONGLYZA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages.
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of ONGLYZA in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: saxagliptin
• Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.

Who manufactures and distributes this medicine?

'Distributed by:' AstraZeneca Pharmaceuticals LP Wilmington, DE

What should I know about storage and disposal of this medication?

• Store ONGLYZA between 68°F to 77°F (20°C to 25°C).

Antidiabetics

•  Alpha-Glucosidase Inhibitors
  • Acarbose
  • Miglitol
• Incretin-Based Drugs
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
    • Alogliptin
    • Linagliptin
    • Saxagliptin
    • Sitagliptin
  • Glucagon-Like Peptide-1 (GLP-1) Analogues
    • Albiglutide
    • Dulaglutide
    • Exenatide
    • Liraglutide
    • Lixisenatide
•  Insulin
• Metformin
• Metiglinide Analogues
  • Nateglinide
  • Repaglinide
• Pramlintide
• Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitors
  • Canagliflozin
  • Dapagliflozin
  • Empagliflozin
• Sulfonylureas
  • First Generation Sulfonylureas
    • Acetohexamide
    • Chlorpropamide
    • Tolazamide
    • Tolbutamide
  • Second Generation Sulfonylureas
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Glyburide (Glibenclamide)
• Thiazolidinediones
  • Pioglitazone
  • Rosiglitazone
  • Troglitazone

• Dailymed label info on Saxagliptin
• FDA Saxagliptin

Saxagliptin Resources
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