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What is Bydureon Bcise, and how does it work?
- Bydureon Bcise is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus and should be used along with diet and exercise.
- Bydureon Bcise is not recommended as the first choice of medicine for treating diabetes.
- Bydureon Bcise is not for use in people with type 1 diabetes.
- Bydureon Bcise and Bydureon are long-acting forms of the medicine in Byetta (exenatide). Bydureon Bcise should not be used at the same time as Byetta or Bydureon.
- It is not known if Bydureon Bcise can be used in people who have had pancreatitis.
- It is not known if Bydureon Bcise is safe and effective for use in children.
What are the side effects of Bydureon Bcise?
RISK OF THYROID C-CELL TUMORS
- Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether Bydureon Bcise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.
- Bydureon Bcise is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Bydureon Bcise and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with Bydureon Bcise.
Bydureon Bcise may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Bydureon Bcise and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Bydureon Bcise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
- kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse or kidney failure.
- stomach problems. Other medicines like Bydureon Bcise may cause severe stomach problems. It is not known if Bydureon Bcise causes or worsens stomach problems.
- low blood platelet count (drug-induced thrombocytopenia). Bydureon Bcise may cause the number of platelets in your blood to be reduced. When your platelet count is too low, your body cannot form blood clots. You could have serious bleeding that could lead to death. Stop using Bydureon Bcise and call your healthcare provider right away if you have unusual bleeding or bruising. Your blood platelet count may continue to be low for about 10 weeks after stopping Bydureon Bcise.
- serious allergic reactions. Stop using Bydureon Bcise and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
- injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use Bydureon. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.
- gallbladder problems. Gallbladder problems have happened in some people who take Bydureon or other medicines like Bydureon. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include: pain in the right or middle upper stomach area, nausea and vomiting, fever, or your skin or the white part of your eyes turns yellow.
The most common side effects of Bydureon Bcise may include a bump (nodule) at the injection site and nausea.
Nausea is most common when you first start using Bydureon Bcise but decreases over time in most people as their body gets used to the medicine.
Talk to your healthcare provider about any side effect that bothers you or does not go away.
These are not all the possible side effects of Bydureon Bcise.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Bydureon Bcise?
- The recommended dose of Bydureon Bcise is 2 mg subcutaneously once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
- The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before the new day of administration.
- If a dose is missed, administer the dose as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
- If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume Bydureon Bcise with the next regularly scheduled dose.
- Bydureon Bcise is intended for patient self-administration. Prior to initiation, train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered.
- Remove the autoinjector from the refrigerator 15 minutes prior to mixing the injection, in order to reach room temperature.
- Mix by shaking vigorously for at least 15 seconds. After mixing, Bydureon Bcise should appear as an opaque, white to off-white suspension, evenly mixed with no residual medicine along the side, bottom or top of the inspection window.
- Inspect visually for particulate matter and discoloration prior to administration (Bydureon Bcise contains microspheres which appear as white to off-white particles). Do not use if foreign particulate matter is present or if discoloration is observed. Refer patients to the accompanying Instructions for Use for disposal information.
- Administer Bydureon Bcise immediately after the autoinjector is prepared as a subcutaneous injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region.
- Do not administer Bydureon Bcise intravenously or intramuscularly.
- Refer patients to the accompanying Instructions for Use for complete administration instructions with illustrations].
Initiating Bydureon Bcise Therapy
Prior treatment with an immediate-or extended-release exenatide product is not required when initiating Bydureon Bcise therapy. Discontinue an immediate-or extended-release exenatide product prior to initiation of Bydureon Bcise.
Patients changing from immediate-release exenatide to Bydureon Bcise may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations.
Patients changing from another extended-release exenatide product to Bydureon Bcise may do so at the next regularly scheduled dose.
What drugs interact with Bydureon Bcise?
Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Bydureon Bcise and Other Exenatide-Containing Products
|Orally Administered Drugs (e.g., acetaminophen)|
|Clinical Impact||Exenatide slows gastric emptying. Therefore, Bydureon Bcise has the potential to reduce the rate of absorption of orally administered drugs.|
|Intervention||Use caution when administering oral medications with Bydureon Bcise where a slower rate of oral absorption may be clinically meaningful.|
|Clinical Impact||Bydureon Bcise has not been studied with warfarin. However, in a drug interaction study, Byetta did not have a significant effect on INR There have been postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding.|
|Intervention||In patients taking warfarin, the INR should be monitored more frequently after initiating Bydureon Bcise. Once a stable INR has been documented, the INR can be monitored at the intervals usually recommended for patients on warfarin.|
|Concomitant Use of Insulin Secretagogues or Insulin|
|Clinical Impact||Exenatide promotes insulin release from pancreatic beta-cells in the presence of elevated glucose concentrations. The risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.|
|Intervention||Patients may require a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia in this setting.|
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Is Bydureon Bcise safe to use while pregnant or breastfeeding?
- Limited data with exenatide, the active ingredient in Bydureon Bcise, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
- There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
- There is no information regarding the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production.
- Exenatide, the active ingredient in Bydureon Bcise was present in the milk of lactating mice. However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear.
Bydureon Bcise is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus and should be used along with diet and exercise. Serious side effects of Bydureon Bcise include inflammation of your pancreas (pancreatitis), low blood sugar (hypoglycemia), kidney problems, stomach problems, low blood platelet count (drug-induced thrombocytopenia), serious allergic reactions, and others.
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Normal Blood Sugar Levels (Ranges) In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Diabetes Symptoms in Men
Diabetes mellitus is a disease in which a person's blood sugar (blood glucose) is either too high (hyperglycemia) or too low (hypoglycemia) due to problems with insulin regulation in the body. There are two main types of diabetes mellitus, type 1 and type 2. Type 1 diabetes usually occurs during childhood, while type 2 diabetes usually occurs during adulthood, however, rates of both types of diabetes in children, adolescents, and teens is increasing. More men than women have diabetes in the US, and the disease can affect men differently than women.Warning symptoms of diabetes that men have and women do not include low testosterone (low-t), sexual problems, impotence (erectile dysfunction), decreased interest in sex, and retrograde ejaculation. Type 1 and type 2 diabetes symptoms and signs that are the same in men and women include skin infections, numbness or tingling in the feet or hands, nausea, excessive thirst or hunger, fatigue, irritability, blurred vision, weight gain, weight loss, urinary tract infections (URIs), and kidney problems. Treatment for type 1 diabetes is insulin, and treatment for type 2 diabetes are lifestyle changes like eating a healthy diet, getting exercise daily, and if necessary, diabetes medications.
Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss if interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Prediabetes is a situation where a person's blood sugar levels are higher than they should be, but aren't high enough to be diagnosed with type 2 diabetes. There are no signs or symptoms of prediabetes. Some of the risk factors for prediabetes are high blood pressure, high cholesterol, heart disease, smoking, family history, poor diet, and lack of activity. Diet changes along with other healthy lifestyle changes are important in treating prediabetes.
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Type 1 vs. Type 2 Diabetes: Differences
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Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
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Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
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Type 1 diabetes mellitus (juvenile) is an auto-immune disease with no known cause at this time, although there are a few risk factors. Symptoms of type 1 diabetes include frequent urination, unintentional weight loss, dry and itchy skin, vision problems, wounds that heal slowly, and excessive thirst. Type 1 diabetes is diagnosed with blood tests. A healthy lifestyle and controlling blood glucose levels can improve life expectancy.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
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Pregnancy and Gestational Diabetes
Gestational diabetes is a form of diabetes that can occur during pregnancy. Pregnant women with gestational diabetes have not had the condition prior to becoming pregnant. Usually, gestational diabetes has no symptoms or signs and of gestational diabetes. Gestational diabetes can cause insulin resistance, hypoglycemia, hypoglycemia, and diabetic ketoacidosis. Treatment of gestational diabetes is managing the condition by checking your blood sugar as recommended, diet changes, getting enough exercise, and monitoring your baby's growth.
Diabetes and Safe Medications for Colds and the Flu: OTC Medication Guide
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
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Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
Sex, Urinary, and Bladder Problems of Diabetes
Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
Diabetes insipidus is a condition in which the patient has frequent urination. Symptoms of diabetes insipidus include irritable, listless, fever, vomiting, or diarrhea due to the loss of large volumes of urine. There are three types of diabetes insipidus, central, nephrogenic, dipsogenic, and gestational. Treatment depends upon the type of diabetes insipidus.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
What Are the Early Signs of Diabetes?
The early signs of diabetes depend on if one has type 1 or type 2 diabetes. Type 1 diabetes usually occurs in children, whereas type 2 diabetes is prevalent in adults.
Diabetes and Kidney Disease
In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Can Type 2 Diabetes be Cured?
Type 2 diabetes is a long-term medical condition in which the body is not able to regulate blood sugar (glucose) level because of the inability of the body to properly use insulin. An individual can get type 2 diabetes because of a number of factors that reduce insulin action or quantity in the body. The goals of diabetes management are to eliminate symptoms and prevent the development of complications. Many drugs, both oral and injectable, are available for diabetes management.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
Is Diabetes Insipidus Life-Threatening?
Diabetes insipidus (DI) is an uncommon disease that manifests as a frequent urge for urination and extreme thirst. It has nothing to do with blood sugar levels. Although in both diabetes mellitus and insipidus, patients experience a large volume of urine production, the cause is completely different.
What Are the 3 Most Common Symptoms of Undiagnosed Diabetes?
Diabetes mellitus has become a worldwide epidemic, thanks to changing lifestyles and increasing obesity. Type 2 diabetes affects approximately 13% of the population of the United States. Worldwide prevalence of diabetes is estimated to be around 463 million people. Type 2 diabetes accounts for over 90% of patients with diabetes.
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Type 2 Diabetes is a chronic disease characterized by increased blood sugar (glucose) level. Type 2 Diabetes is caused by either insufficient insulin secretion or resistance to that hormone’s action. Insulin is produced by the pancreas and helps process the glucose in the blood. Thus, with inadequate insulin, the bodies can’t burn all the blood sugar for energy in an efficient way. This means the glucose level in the blood rises, causing a variety of symptoms and when severe may even lead to death.
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