Suganon Special Precautions

Heart failure: Caution should be exercised for patients with functional class I heart failure based on the New York Heart Association (NYHA) criteria as experience of administration is limited in such patients. Use of SUGANON is not recommended to patients with functional class II IV based on the NYHA criteria due to the absence of clinical experience in such patients.
Acute pancreatitis: There is no report of acute pancreatitis in patients administered with SUGANON. However, acute pancreatitis has been reported in patients treated with DPP-4 inhibitors. Thus, characteristic symptoms of acute pancreatitis such as consistent and severe abdominal pain should be informed to patients. If pancreatitis is suspected after administration of SUGANON, the administration of SUGANON should be discontinued and SUGANON should not be re-administered. Caution should be exercised in patients with a medical history of pancreatitis.
Effects on ability to drive and use machines: In clinical trials, dizziness has been reported when treated with SUGANON. Therefore, patients should be cautious when driving or operating machines.
Renal impairment: It is confirmed that approximately 46.1% of the administered radioactivity was excreted in urine and approximately 42.8% in feces in healthy adults. This figure includes both the unchanged form and its metabolites. Since there is a concern that increased blood concentration of the unchanged form may persist in patients with moderate to severe renal impairment compared to patients with normal renal function, SUGANON should be cautiously administered while monitoring the patient's condition. As there is no clinical experience of SUGANON in patients with end-stage renal impairment requiring dialysis, administration of SUGANON is not recommended in such patients.
Hepatic impairment: No study was conducted in patients with hepatic impairment. There is no available data regarding the dose adjustment of SUGANON. Therefore, caution should be exercised in such patients.