BYETTA PACKAGE INSERT PDF

Samujar Monitor patients on antidiabetic therapy for blood glucose control if niacin nicotinic acid is added or deleted to the medication regimen and adjust dosages as clinically warranted Niacin; Simvastatin: Patients taking antidiabetic agents should be closely monitored for changes in glycemic control, specifically hyperglycemia, if protease inhibitor therapy is initiated. The clinical effects of these competing mechanisms are not known. It is not known whether monitoring serum calcitonin or performing thyroid ultrasounds will diminish human risk of thyroid C-cell tumors. Both hyperglycemia and hypoglycemia have been described in patients treated with acetazolamide. Post-marketing reports of acute pancreatitis in patients taking exenatide have been reported, including necrotizing or hemorrhagic pancreatitis. Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.

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Serious bleeding, which may be fatal, from drug induced immune mediated thrombocytopenia has been reported with exenatide use [see Warnings and Precautions 5. Pen-sharing poses a risk for transmission of blood-borne pathogens. After initiation of BYETTA, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting.

Therefore, patients receiving BYETTA and a sulfonylurea may require a lower dose of the sulfonylurea to reduce the risk of hypoglycemia. In patients at increased risk of hypoglycemia consider reducing the dose of insulin [see Adverse Reactions 6.

For additional information on glucose-dependent effects see Mechanism of Action Some of these events occurred in patients receiving one or more pharmacologic agents known to affect renal function or hydration status, such as angiotensin converting enzyme inhibitors, nonsteroidal anti-inflammatory drugs, or diuretics.

Some events occurred in patients who had been experiencing nausea, vomiting, or diarrhea, with or without dehydration. Reversibility of altered renal function has been observed in many cases with supportive treatment and discontinuation of potentially causative agents, including BYETTA.

Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies. If there is worsening glycemic control or failure to achieve targeted glycemic control, alternative antidiabetic therapy should be considered [see Adverse Reactions 6. If a hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice. Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP 1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with BYETTA [see Adverse Reactions 6.

Drug-induced thrombocytopenia is an immune mediated reaction, with exenatide-dependent anti platelet antibodies. In the presence of exenatide, these antibodies cause platelet destruction.

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Patients should be advised to eat within 20 minutes of mecasermin administration. You are encouraged to report negative side effects of prescription drugs to the FDA. Even if the disposable needle is changed, sharing may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Patients at risk include those with compromised renal function, those fasting for prolonged periods, those that are malnourished, and those receiving high or excessive doses of sulfonamides. If a patient develops hypoglycemia during treatment, adjust anti-diabetic drug regimen accordingly.

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BYETTA PACKAGE INSERT PDF

Volabar Exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Careful monitoring of blood glucose is recommended. Let the autoinjector come to room temperature for approximately 15 minutes before administration. The ijsert is not indicated in infants or neonates. The concurrent use of exenatide with prandial insulin has not been studied. This product information is intended for US Healthcare Professionals only. Thin or smaller individuals can use a 45 degree angle to avoid intramuscular injection.

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