Vipidia, 12.5mg 28 pcs.

Alogliptin is a potent and highly selective DPP-4 inhibitor. Its selectivity against DPP-4 is more than 10,000 times greater than its activity against other related enzymes, including DPP-8 and DPP-9. DFS-4 is the major enzyme involved in the rapid degradation of the hormones of the insectin family: glucagon-like peptide-1 (GFP-1) and glucose-dependent insulinotropic polypeptide (GIP).

The hormones of the incretin family are secreted in the intestine and their concentration increases in response to food intake. GFP-1 and GIP increase insulin synthesis and secretion by pancreatic beta cells. GFP-1 also inhibits glucagon secretion and decreases glucose production by the liver.

Therefore, by increasing the concentration of incretins, alogliptin increases glucose-dependent insulin secretion and decreases glucagon secretion at elevated blood glucose concentrations.

In patients with type 2 diabetes mellitus with hyperglycemia, these changes in insulin and glucagon secretion lead to a decrease in glycosylated hemoglobin HbA_1c and decreased plasma glucose concentrations on both fasting and postprandial glucose.

Indications

Diabetes mellitus type 2 to improve glycemic control when diet therapy and physical activity are ineffective:
in adults as monotherapy, in combination with other oral hypoglycemic agents or with insulin.

Active ingredient

Alogliptin

How to take, the dosage

The drug is taken orally.

Interaction

Effect of other drugs on alogliptin

Special Instructions

Use with other hypoglycemic drugs

In order to reduce the risk of hypoglycemia, reduction of the dose of sulfonylurea derivatives, insulin or the combination of pioglitazone (thiazolidinedione) with metformin is recommended when used concomitantly with Vipidia^®.

Unstudied combinations

The efficacy and safety of Vipidia^® in combination with sodium-dependent glucose cotransporter 2 inhibitors or glucagon-like peptide analogues and in triple combination with metformin and sulfonylurea derivatives have not been studied.

Renal Impairment

Because patients with moderate renal impairment require dose adjustments of Vipidia^®, renal function assessment is recommended before initiation and periodically during treatment.

The experience with alogliptin in patients on hemodialysis is limited. Vipidia^® should not be used in patients with severe renal impairment and in patients with end-stage chronic renal failure requiring hemodialysis. Alogliptin has not been studied in patients undergoing peritoneal dialysis.

Acute pancreatitis

The use of DPP-4 inhibitors is associated with a potential risk of acute pancreatitis. In a pooled analysis of 13 clinical trials of alogliptin at 25 mg/day, 12.5 mg/day, the comparison drug, and placebo, the incidence of acute pancreatitis was 2, 1, 1, or 0 cases per 1,000 patient-years in each group, respectively. In a study of cardiovascular outcomes, the incidence of acute pancreatitis in patients treated with alogliptin or placebo was 3 and 2 cases per 1,000 patient-years, respectively. Patients should be informed about the characteristic symptoms of acute pancreatitis: persistent severe abdominal pain, which may irradiate to the back. If the development of acute pancreatitis is suspected, the drug Vipidia^® is stopped; if acute pancreatitis is confirmed, the drug is not resumed. There are no data on whether there is an increased risk of pancreatitis during Vipidia^® administration in patients with a history of pancreatitis. Therefore, caution should be exercised when using the drug in patients with a history of pancreatitis.

Hepatic impairment

Postmarketing reports of hepatic dysfunction, including hepatic impairment, have been reported with alogliptin. Their association with the use of the drug has not been established. However, patients should be carefully evaluated for possible liver function abnormalities. If hepatic function abnormalities are found and an alternative etiology of their occurrence has not been established, discontinuation of treatment with the drug should be considered.

Influence on driving and operating ability

Vipidia^® has no or negligible effect on driving and operating ability. However, the risk of hypoglycemia should be considered when using the drug in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin or combined therapy with pioglitazone and metformin) and caution should be exercised when driving vehicles and operating machinery.

Contraindications

• high sensitivity to alogliptin or any excipient, or a history of serious hypersensitivity reactions to any DPP-4 inhibitor, including anaphylactic reactions, anaphylactic shock and angioedema;
• sugar type 1 diabetes;
• diabetic ketoacidosis;
• chronic heart failure (functional class III-IV in the New York Heart Association’s functional classification of chronic heart failure);
• severe hepatic impairment (greater than 9 points on the Child-Pugh scale) due to lack of clinical evidence of use;
• severe renal impairment;
• children under 18 years of age – due to lack of clinical data for use.

With caution

Acute pancreatitis in the anamnesis (see Special Precautions).

In patients with moderate renal insufficiency (see Particular Guidelines).

In combination with a sulfonylurea derivative or insulin (see Special Guidelines).

Taking a three-component combination of Vipidia with metformin and thiazolidinedione (see Special Precautions).

Side effects

Nervous system disorders:

Overdose

The maximum dose of alogliptin in clinical trials was 800 mg/day in healthy volunteers and 400 mg/day in patients with type 2 diabetes for 14 days.