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Therapy with AVANDIA should not be initiated in patients with increased baseline liver enzyme levels (ALT> 2.5X upper limit of normal). In patients with normal baseline liver enzymes, following initiation of therapy with AVANDIA, it is recommended that liver enzymes be monitored every 2 months for the first 12 months, and periodically thereafter. Patients with mildly elevated liver enzymes (ALT levels 2.5X upper limit of normal) at baseline or during therapy with AVANDIA should be evaluated to determine the cause of the liver enzyme elevation. Initiation of, or continuation of, therapy with AVANDIA in patients with mild liver enzyme elevations should proceed with caution and include close clinical follow-up, including more frequent liver enzyme monitoring, to determine if the liver enzyme elevations resolve or worsen. If at any time ALT levels increase to >3X the upper limit of normal in patients on therapy with AVANDIA, liver enzyme levels should be rechecked as soon as possible. If ALT levels remain >3X the upper limit of normal, therapy with AVANDIA should be discontinued. There are no data available from clinical trials to evaluate the safety of AVANDIA in patients who experienced liver abnormalities, hepatic dysfunction, or jaundice while on troglitazone. AVANDIA should not be used in patients who experienced jaundice while taking troglitazone. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with AVANDIA should be guided by clinical judgment pending laboratory evaluations. If jaundice is observed, drug therapy should be discontinued. Text Continues Below
Laboratory Tests: Periodic fasting blood glucose and HbA1c measurements should be performed to monitor therapeutic response. Liver enzyme monitoring is recommended prior to initiation of therapy with AVANDIA in all patients and periodically thereafter (see PRECAUTIONS, General, Hepatic Effects and ADVERSE REACTIONS, Laboratory Abnormalities, Serum Transaminase Levels). Information for Patients: Patients should be informed of the following: Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but in maintaining the efficacy of drug therapy. It is important to adhere to dietary instructions and to regularly have blood glucose and glycosylated hemoglobin tested. Patients should be advised that it can take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see full effect. Patients should be informed that blood will be drawn to check their liver function prior to the start of therapy and every 2 months for the first 12 months, and periodically thereafter. Patients with unexplained symptoms of nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should immediately report these symptoms to their physician. Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on AVANDIA should immediately report these symptoms to their physician. AVANDIA can be taken with or without meals. When using AVANDIA in combination with other hypoglycemic agents, the risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members. Therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking AVANDIA (see PRECAUTIONS, Pregnancy, Pregnancy Category C). Thus, adequate contraception in premenopausal women should be recommended. This possible effect has not been specifically investigated in clinical studies so the frequency of this occurrence is not known. Page: << Prev | 1 | 2 | 3 | 4 | 5
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