Zemiglo Special Precautions

Renal Impairment: No adjustment is required (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Cardiac Impairment: There is limited clinical experience in patients with New York Heart Association (NYHA) Class I cardiac status. Therefore, gemigliptin should be used with caution in this population. Zemiglo is not recommended in patients with NYHA Class II-IV cardiac status.
Hepatic Impairment: No dose adjustment is necessary for patients with mild or moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. Therefore, caution should be exercised in this population.
Hypersensitive Reaction: Care should be taken when administering to patients with allergic and hypersensitive reactions to any of the ingredients in Zemiglo (see Adverse Reactions).
Post-marketing reports of severe hypersensitivity reactions in patients treated with Zemiglo have been reported. These reactions include Stevens-Johnson syndrome. If a severe hypersensitivity reaction is suspected, Zemiglo should be discontinued. Other potential causes for the reaction should be assessed, and alternative treatment for diabetes should be initiated.
Acute Pancreatitis: Pancreatitis has been reported in patients taking Zemiglo. Therefore, patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, gemigliptin should be discontinued and should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
Use with Medicinal Products Known to Cause Hypoglycemia: Sulfonylurea or insulin is known to cause hypoglycemia. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia when used in combination with Zemiglo.
Severe and Disabling Arthralgia: There have been postmarketing reports of severe and disabling arthralgia in patients taking other DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.
Excipient warnings: Gemigliptin tablet contains sunset yellow FCF which may cause allergic reactions.
Bullous pemphigoid: There have been post-marketing reports of bullous pemphigoid requiring hospitalization in patients taking other DPP-4 inhibitors. In reported cases, patients generally recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Patients should be instructed to report development of blisters or erosions to their doctors while receiving Zemiglo. If bullous pemphigoid is suspected, Zemiglo should be discontinued and a dermatologist should be consulted for diagnosis and proper treatment.
Effects on ability to drive and use machines: When driving or using machines, caution should be exercised as dizziness has been reported. In addition, patients should be alerted to the risk of hypoglycemia when Zemiglo is used in combination with other antidiabetic medicinal products known to cause hypoglycemia (e.g. sulfonylureas, insulin).