you are talking about Byetta
For many people, trying to maintain the right blood sugar levels day after day can be frustrating. BYETTA may help you get improved control of your type 2 diabetes by helping your body produce the right amount of insulin at the right time.
In clinical trials, improvements in blood sugar levels were seen as soon as the first day in patients taking BYETTA. This led to improvements in A1C (a 3-month average of your blood sugar levels). If you check your blood sugar at home, you should see your levels get better, especially after you eat.
You do not need to do extra blood sugar monitoring while on BYETTA. However, since BYETTA is taken before a meal, checking your blood sugar levels 2 hours after you eat will let you know how your BYETTA is working. Following your healthcare professional's recommendations for lab tests and home blood sugar monitoring is important to seeing how well your diabetes is controlled.
Will BYETTA affect my weight?
Patients taking BYETTA may feel less hungry and eat less — in clinical trials, most people lost weight.
If you're trying to lose weight, a combination of physical activity and wise food choices can help you reach your target weight and maintain it. Physical activity is especially good for people with diabetes because it can lower your blood sugar, blood pressure, and cholesterol. In addition, regular activity helps insulin work better, improves your blood circulation, and keeps your joints flexible. Before starting any exercise program, you should check with your healthcare professional.
FAQs: Safety
What were the most common adverse events with BYETTA in clinical trials?
Are there any drug interactions associated with BYETTA?
What was the incidence of withdrawal due to adverse events in clinical trials?
Are there contraindications to the use of BYETTA?
What is known about the nausea reported in BYETTA clinical trials?
Does BYETTA have any effects on fertility?
Can BYETTA be used in nursing mothers?
Can BYETTA be used in pediatric patients?
Can BYETTA be used in geriatric patients?
Can BYETTA be used in patients with renal insufficiency or end-stage renal disease?
What were the most common adverse events with BYETTA in clinical trials?
The most common treatment-emergent adverse event associated with BYETTA (vs placebo) in three 30-week placebo-controlled clinical trials (excluding hypoglycemia) was nausea (44% vs 18%). Other common events were: vomiting (13% vs 4%), diarrhea (13% vs 6%), feeling jittery (9% vs 4%), dizziness (9% vs 6%), headache (9% vs 6%), and dyspepsia (6% vs 3%).
Patients receiving BYETTA in combination with a sulfonylurea had an increased risk of hypoglycemia (14% at 5 mcg and 36% at 10 mcg vs 3% placebo). Patients receiving BYETTA in combination with metformin plus a sulfonylurea had an increased risk of hypoglycemia (19% at 5 mcg and 28% at 10 mcg vs 13% placebo). To reduce the risk of hypoglycemia, clinicians may consider reducing the sulfonylurea dose.
For complete safety profile, see the full Prescribing Information.
Are there any drug interactions associated with BYETTA?
The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs, so it should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption. Medications that are dependent on threshold concentrations for efficacy, such as oral contraceptives and antibiotics, should be taken at least 1 hour before BYETTA injection. If such drugs are to be administered with food, they should be taken with a meal or snack when BYETTA is not administered.
What was the incidence of withdrawal due to adverse events in clinical trials?
The incidence of withdrawal was 7% for BYETTA-treated patients vs. 3 % for placebo-treated patients.
Are there contraindications to the use of BYETTA?
BYETTA is contraindicated in patients with known hypersensitivity to this product or any of its components.
What is known about the nausea reported in BYETTA clinical trials?
Initiation of BYETTA at 5 mcg BID for at least a month followed by dose escalation to 10 mcg BID has been found to minimize the occurrence of nausea. In clinical trials, nausea was mostly mild to moderate and it occurred most commonly upon initiation of therapy. Of BYETTA-treated patients, 3% withdrew due to nausea over the course of the entire study.
Does BYETTA have any effects on fertility?
In toxicology studies, BYETTA produced no impairment of fertility. The effects on human fertility are unknown.
Can BYETTA be used in nursing mothers?
It is not known whether BYETTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BYETTA is administered to a nursing woman.
Can BYETTA be used in pediatric patients?
No. The FDA has approved the use of BYETTA in patients 17 years of age or older. BYETTA has not been studied in pediatric patients.
Can BYETTA be used in geriatric patients?
Yes. BYETTA was studied in 282 patients 65 years of age or older and in 16 patients 75 years or older. No differences in safety or effectiveness were observed between these patients and younger patients
Can BYETTA be used in patients with renal insufficiency or end-stage renal disease?
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30mL/min). In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well tolerated due to gastrointestinal side effects.
2006-09-03 11:43:07
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answer #1
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answered by frida_pie 3
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Yes I have, I saw it at my doctor's office last week. I don't remember the name, but I'll go look and get back to you.
Byetta:
Exenatide ((ex-EN-a-tide)) injection is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. Exenatide helps your body cope with high blood sugar in several ways. Exenatide helps the cells in the pancreas that produce insulin when there is too much sugar in your blood. Exenatide helps the cells of your liver to decrease the amount of sugar the liver dumps into your blood. Exenatide slows down the passage of food from your stomach and helps to decrease the amount of sugar added to your blood after eating. Exenatide also reduces the amount of food needed because the sugar in the bloodstream is processed more effectively.
This medicine is available only with your doctor's prescription, in the following dosage forms:
Injection (U.S.)
back to top Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For exenatide, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to exenatide. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Exenatide has not been studied in pregnant women. However, studies in animals have shown that exenatide can cause birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding
It is not known whether exenatide passes into the breast milk. Because exenatide has been shown to cause adverse effects in animals, it is not recommended during breast-feeding.
Children
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of exenatide in children with use in other age groups.
Older adults
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems
The presence of other medical problems may affect the use of exenatide. Make sure you tell your doctor if you have any other medical problems, especially:
Diabetic ketoacidosis or
Type 1 diabetes— These conditions should be treated with insulin.
Gastrointestinal disease, severe or
Kidney disease, end-stage— May make symptoms such as nausea, diarrhea, and vomiting worse
Liver disease— Use with caution
back to top Proper Use of This Medicine
Dosing
The dose of exenatide will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of exenatide. If your dose is different, do not change it unless your doctor tells you to do so.
For subcutaneous dosage form (injection):
For type 2 diabetes:
Adults—At first, your dose will be an injection to the thigh, upper arm, or stomach of 5 mcg two times a day at any time within the 60–minute period before the morning and evening meals. Your doctor may adjust your dose after the first month of therapy to 10 mcg twice a day.
Children—Use and dose must be determined by your doctor.
Missed dose
If you miss a dose of exenatide, wait until the next scheduled dose to resume therapy.
Storage
To store this medicine:
Store in the refrigerator. However, keep the medicine from freezing.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children. The pen should be discarded 30 days after the first time it is used.
back to top Precautions While Using This Medicine
Your doctor will want to check your progress at regular visits , .
It is very important to follow carefully any instructions from your health care team about :
Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
Other medicines—Do not take other medicines during the time you are taking exenatide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency —There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when exenatide is taken with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur . Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.
If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions .
back to top Side Effects of This Medicine
Side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
More common
Acid or sour stomach; belching; diarrhea; dizziness; feeling jittery; headache; heartburn; indigestion; nausea; stomach discomfort upset or pain; vomiting.
Less common
Appetite decreased; heartburn; increased sweating; lack or loss of strength.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
2006-09-03 11:44:01
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answer #8
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answered by tatufreak1996 3
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