Onglyza®Kombiglyze®XR (as a combination product containing Metformin, Saxagliptin)
AUDIENCE: Patient, Endocrinology, Family Practice, Internal Medicine
ISSUE: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. See the Drug Safety Communication at: Web Sitefor a complete list of all FDA-approved DPP-4 inhibitors.
BACKGROUND: DPP-4 inhibitors are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. These medicines are available as single-ingredient products and in combination with other diabetes medicines such as metformin.
RECOMMENDATION: Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.
For more information visit the FDA website at: Web Siteand Web Site.
Saxagliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals when blood sugar is high. Saxagliptin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
Saxagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take saxagliptin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take saxagliptin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Saxagliptin controls type 2 diabetes but does not cure it. Continue to take saxagliptin even if you feel well. Do not stop taking saxagliptin without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking saxagliptin, tell your doctor and pharmacist if you are allergic to saxagliptin, any other medications, or any of the ingredients in saxagliptin tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); certain medications for HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); insulin or oral medications for diabetes such as acetohexamide, chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glynase, in Glucovance), nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin), rosiglitazone (Avandia, in Avandamet, in Avandaryl), tolazamide, and tolbutamide; nefazodone; and telithromycin (Ketek). You doctor may need to change the doses of your medications or monitor you carefully for side effects.tell your doctor if you have ever had diabetic ketoacidosis and if you have or have ever had HIV or kidney disease.tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking saxagliptin, call your doctor.if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking saxagliptin.talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar and the amount of saxagliptin you may need.
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help saxagliptin work more effectively.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one unless your doctor tells you that you should.
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
Saxagliptin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: stuffed or runny nosesore throatheadachepainful, burning urinationstomach painnauseavomitingdiarrheabloating
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately: rashhivesswelling of the face, lips, tongue or throatdifficulty breathing or swallowinghoarseness
Saxagliptin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory tests to check your body's response to saxagliptin. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to saxagliptin. Your doctor may also tell you how to check your response to saxagliptin by measuring your blood or urine sugar levels at home. Follow these directions carefully.
You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 15, 2015.