Aglip Tablet

Aglip is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.

Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved.

The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.

Aglip is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions are observed with the CYP-substrates or inhibitors tested or with renally excreted drugs.

History of a serious hypersensitivity reaction to Alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.

Common side effects are nasopharyngitis, headache and upper respiratory tract infection.

Pregnancy Category B. No adequate or well-controlled studies in pregnant women have been conducted with Alogliptin. Alogliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Alogliptintin is excreted in human milk. caution should be exercised when Alogliptin is administered to a nursing woman.

Acute pancreatitis: If pancreatitis is suspected, promptly Aglip should be discontinued.

Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Aglip such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly Aglip should be discontinued.

Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality can not be excluded. If liver injury is detected, promptly interrupt Aglip and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Aglip if liver injury is confirmed and no alternative etiology can be found.

Hypoglycemia: When an insulin secretagogue (e.g. sulfonylurea) or insulin is used in combination with Aglip, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycaemia.

Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Aglip or any other antidiabetic drug.

Pediatric Use: Safety and effectiveness of Aglip in pediatric patients have not been established.

Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Aglip, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Aglip has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Aglip to patients with liver disease.

Patients with Renal Impairment:

• No dose adjustment of Aglip is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
• The dose of Aglip is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
• The dose of Aglip is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
• Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.

The highest doses of Aglip administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively). No serious adverse events were observed at these doses. In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Aglip is minimally dialyzable; over a 3-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if Aglip is dialyzable by peritoneal dialysis.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.