Approved Use for ONGLYZA (saxagliptin)

What is ONGLYZA (saxagliptin)?

ONGLYZA (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

ONGLYZA (saxagliptin) should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking ONGLYZA (saxagliptin).

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What is ONGLYZA (saxagliptin)?

ONGLYZA (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

ONGLYZA (saxagliptin) should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking ONGLYZA (saxagliptin).

Important Safety Information

Do not take ONGLYZA (saxagliptin) if you are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA (saxagliptin) and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA (saxagliptin) and contact your doctor right away.

Serious side effects can happen to people taking ONGLYZA (saxagliptin), including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking ONGLYZA (saxagliptin), tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking ONGLYZA (saxagliptin) and contact your doctor 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.

When ONGLYZA (saxagliptin) is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in vision. Follow your doctor’s instructions for treating low blood sugar.

When ONGLYZA (saxagliptin) is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor.

The most common side effects with ONGLYZA (saxagliptin) include upper respiratory tract infection, urinary tract infection, and headache.

Your doctor should test your blood to measure how well your kidneys are working before and during treatment with ONGLYZA (saxagliptin). You may need a lower dose if your kidneys are not working well.

Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA (saxagliptin).

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

This product information is intended for US customers only.

©2013 AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company.

Onglyza® is a trademark of Bristol-Myers Squibb Company.

422US13BR01335-01-01 06/13

IMPORTANT SAFETY INFORMATION for ONGLYZA (saxagliptin) 

Important Safety Information

Do not take ONGLYZA (saxagliptin) if you are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA (saxagliptin) and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA (saxagliptin) and contact your doctor right away.

Serious side effects can happen to people taking ONGLYZA (saxagliptin), including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking ONGLYZA (saxagliptin), tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking ONGLYZA (saxagliptin) and contact your doctor 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.

When ONGLYZA (saxagliptin) is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in vision. Follow your doctor’s instructions for treating low blood sugar.

When ONGLYZA (saxagliptin) is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor.

The most common side effects with ONGLYZA (saxagliptin) include upper respiratory tract infection, urinary tract infection, and headache.

Your doctor should test your blood to measure how well your kidneys are working before and during treatment with ONGLYZA (saxagliptin). You may need a lower dose if your kidneys are not working well.

Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA (saxagliptin).

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for Medication Guide, and click here for US Full Prescribing Information for ONGLYZA (saxagliptin).

WHAT IS
ONGLYZA (saxagliptin)?

Approved Use

ONGLYZA (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

ONGLYZA (saxagliptin) should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking ONGLYZA (saxagliptin).

Value Card Program for Onglyza® (saxagliptin) Program Details and Eligibility Requirements for Patients

  • You may be eligible for this offer if: (1) You are a resident of Puerto Rico or the United States who is 18 years of age or older and are insured by commercial insurance that does not cover the full cost of your prescription (you have a co-pay obligation); and (2) Your prescriptions are not covered in full or in part by any state or federally funded insurance program, including but not limited to Medicare, Medicaid, Medigap, Veterans Affairs (VA) or Department of Defense (DOD). Patients who move from commercial to state or federally funded prescription insurance will no longer be eligible for this offer.
  • Eligible patients with a co-pay (out-of-pocket expense) for a 30-day supply of Onglyza® (saxagliptin) tablets of more than $10 who present an activated card together with a valid prescription for Onglyza tablets at the time of purchase may be able to receive up to $100 in savings per month. Savings not applicable to monthly out-of-pocket expenses of $10 or less.
  • The first activation of the card will be valid for 24 months. Every 12 months thereafter, patients will be required to renew eligibility in order to continue participating in the offer.
  • Your acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value received as may be required by your insurance provider.
  • Patients, pharmacists, and prescribers cannot seek reimbursement, from health insurance or any third party, for any part of the benefit received by the patient through this offer.
  • Card activation and use must take place by 12/31/2013. In accordance with Massachusetts law, program expiration date in MA is July 1, 2015.
  • Only valid in the United States and Puerto Rico; this offer is void where restricted or prohibited by law.
  • This offer is non-transferable, no substitutions are permissible, and offer cannot be combined with any other rebate/coupon, free trial or similar offer for the specified prescription.
  • Card may not be sold, purchased, traded, or counterfeited. Reproductions of this card are void.
  • Bristol-Myers Squibb and AstraZeneca reserve the right to discontinue or change this offer at any time without notice.
  • This offer is not conditioned on any past, present or future purchase, including refills.
  • No membership fees. Card is not an insurance card.
  • By using this card, you and your pharmacist understand and agree to comply with these Program Details and Eligibility Requirements.

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