ONGLYZA (Page 13 of 14)
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ONGLYZA (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 16.
Table 16: ONGLYZA Tablet Presentations
Storage and Handling
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read FDA-approved patient labeling (Medication Guide).
Medication Guide
Healthcare providers should instruct their patients to read the Medication Guide before starting ONGLYZA therapy and to reread it each time the prescription is renewed. Patients should be instructed to inform their healthcare provider if they develop any unusual symptom or if any existing symptom persists or worsens.
Patients should be informed of the potential risks and benefits of ONGLYZA and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.
Pancreatitis
Patients should be informed that acute pancreatitis has been reported during postmarketing use of ONGLYZA. Before initiating ONGLYZA, patients should be questioned about other risk factors for pancreatitis, such as a history of pancreatitis, alcoholism, gallstones, or hypertriglyceridemia. Patients should also be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue ONGLYZA and contact their healthcare provider if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1) ].
Heart Failure
Patients should be informed of the signs and symptoms of heart failure. Before initiating ONGLYZA, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Patients should be instructed to contact their healthcare provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.2) ].
Hypersensitivity Reactions
Patients should be informed that serious allergic (hypersensitivity) reactions, such as angioedema, anaphylaxis, and exfoliative skin conditions, have been reported during postmarketing use of ONGLYZA. If symptoms of these allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking ONGLYZA and seek medical advice promptly.
Severe and Disabling Arthralgia
Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.5) ].
Bullous Pemphigoid
Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if
blisters or erosions occur [see Warnings and Precautions (5.6) ].
Missed Dose
Patients should be informed that if they miss a dose of ONGLYZA they should take the next dose as prescribed, unless otherwise instructed by their healthcare provider. Patients should be instructed not to take an extra dose the next day.
Administration Instructions
Patients should be informed that ONGLYZA tablets must not be split or cut.
Laboratory Tests
Patients should be informed that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C, with a goal of decreasing these levels toward the normal range. A1C is especially useful for evaluating long-term glycemic control. Patients should be informed of the potential need to adjust their dose based on changes in renal function tests over time.
ONGLYZA is a registered trademark of the AstraZeneca group of companies.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Distributed by:Cardinal Health
Dublin, OH 43017
L7696 Rev. A
| MEDICATION GUIDE ONGLYZA® (on-GLY-zah) (saxagliptin) tablets, for oral use | |||
| What is the most important information I should know about ONGLYZA? Serious side effects can happen to people taking ONGLYZA , including: 1) Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking ONGLYZA: Tell your healthcare provider if you have ever had | |||
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| It is not known if having these medical problems will make you more likely to get pancreatitis with ONGLYZA. Stop taking ONGLYZA and contact your healthcare provider 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. 2) Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking ONGLYZA: Tell your healthcare provider if you
Contact your healthcare provider right away if you have any of the following symptoms: | |||
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| These may be symptoms of heart failure. | |||
| What is ONGLYZA?
It is not known if ONGLYZA is safe and effective in children younger than 18 years old. | |||
| Who should not take ONGLYZA? Do not take ONGLYZA if you:
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| If you have these symptoms, stop taking ONGLYZA and contact your healthcare provider right away. | |||
| Before taking ONGLYZA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. ONGLYZA may affect the way other medicines work, and other medicines may affect how ONGLYZA works. Contact your healthcare provider if you will be starting or stopping certain other types of medications, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of ONGLYZA might need to be changed. | |||
| How should I take ONGLYZA?
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| What are the possible side effects of ONGLYZA? ONGLYZA can cause serious side effects, including:
Common side effects of ONGLYZA include:
Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include: | |||
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| Swelling or fluid retention in your hands, feet, or ankles (peripheral edema) may become worse in people who also take a thiazolidinedione to treat diabetes. If you do not know whether you are already on this type of medication, ask your healthcare provider. These are not all of the possible side effects of ONGLYZA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. | |||
| How should I store ONGLYZA? Store ONGLYZA between 68°F to 77°F (20°C to 25°C). Keep ONGLYZA and all medicines out of the reach of children. | |||
| General information about the use of ONGLYZA Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use ONGLYZA for a condition for which it was not prescribed. Do not give ONGLYZA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider for additional information about ONGLYZA that is written for health professionals. | |||
| What are the ingredients of ONGLYZA? 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. | |||
| What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary. | |||
| ONGLYZA is a registered trademark of the AstraZeneca group of companies. Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. For more information, go to www.ONGLYZA.com or call 1-800-ONGLYZA. | |||
| This Medication Guide has been approved by the U.S. Food and Drug Administration. 2/2017 | |||
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