카베르골린

is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. ( 5.4 )

is contraindicated in patients with: • Uncontrolled hypertension. • Known hypersensitivity to ergot derivatives. • History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis, or history of pericardial fibrosis [see Warnings and Precautions (5.1) ] . • History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions (5.2) ] . • Uncontrolled hypertension. ( 4 ) • Known hypersensitivity to ergot derivatives. ( 4 ) • History of cardiac valvular disorders, or pericardial fibrosis. ( 5.1 ) • History of pleural, pulmonary, or retroperitoneal fibrotic disorders. ( 5.2 )

• Cardiac Valvulopathy and Pericardial Fibrosis : Before initiating CABERGOLINE, perform a cardiovascular evaluation, including echocardiogram, to evaluate for valvular disease. During CABERGOLINE treatment, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated and monitor for chest pain and signs and symptoms of heart failure (if heart failure occurs, exclude valvular fibrosis and pericarditis). Consider additional clinical and diagnostic monitoring at baseline and as necessary during CABERGOLINE treatment. Use CABERGOLINE in patients treated with other drugs associated with valvulopathy only if the potential benefit of CABERGOLINE outweighs the risk. Discontinue CABERGOLINE if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. ( 5.1 ) • Pleural, Pulmonary and Retroperitoneal Fibrosis : During CABERGOLINE treatment monitor for signs and symptoms of progressive fibrosis, (e.g., pleuro-pulmonary disease, renal impairment, ureteral/abdominal vascular obstruction). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis at baseline and as necessary during CABERGOLINE treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue CABERGOLINE. ( 5.2 ) • Orthostatic Hypotension : Check blood pressure at baseline and during treatment with CABERGOLINE and monitor …

8.1 Pregnancy Risk Summary If conception occurs during CABERGOLINE therapy, discontinue CABERGOLINE if the risks to the mother or fetus outweigh the benefits to the mother. There are risks to the mother associated with the use of CABERGOLINE ( see Clinical Considerations ). The estimated background risk of major birth defects and miscarriage in patients with hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, …