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.
Renal impairment: It is confirmed that approximately 46.1% of the radioactivity administered by labeling evogliptin was excreted in urine and approximately 42.8% in feces in 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 and end-stage renal impairment patients undergoing hemodialysis compared to patients with normal renal function, SUGANON should be cautiously administered while monitoring the patient's condition. Evogliptin can be administered regardless of time point of dialysis in end-stage renal impairment patients requiring hemodialysis.
Severe hepatic impairment: No study was conducted in patients with hepatic impairment. Therefore, caution should be exercised 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.
General Precautions: Concomitant administration with drugs known to cause hypoglycemia: Insulin secretagogues such as insulin or sulfonylurea may cause hypoglycemia. Thus, lowering the dose of insulin or insulin secretagogues may be required to minimize the risk of hypoglycemia in case of concomitant administration with SUGANON.
Severe and disabling joint pain: Severe and disabling joint pain has been reported in patients administering other DPP-4 inhibitors in post-marketing studies. The time to onset of symptoms following initiation of drug therapy varied from 1 day to years. Patients experienced relief of symptoms upon discontinuation of the medication. Some patients had a recurrence of severe joint pain when restarted on either their original DPP-4 inhibitor medication or another DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue SUGANON if appropriate.
Bullous pemphigoid: Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with other DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters or erosions while receiving SUGANON. If bullous pemphigoid is suspected, SUGANON should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
Effects on ability to drive and use machines: No effect of DPP4 inhibitor on the ability to drive or operate machinery or mental functions has been known. The possibility of showing impaired ability to drive or operate machinery or impaired mental functions is expected to be low considering its pharmacological mechanism.