Adult: As an adjunct to diet and exercise to improve glycaemic control: As monotherapy or in combination with other antidiabetic agents: 25 mg once daily.
Special Patient Group
Patients taking concurrent insulin, insulin secretagogues (e.g. sulfonylurea), and metformin with thiazolidinedione combination therapy: A lower dose of other concurrent antidiabetic agents may be required.
Renal Impairment
Patients with ESRD or requiring haemodialysis: 6.25 mg once daily to be given without regard to the timing of haemodialysis.
CrCl (mL/min)
Dosage
<30
6.25 mg once daily.
30-<60
12.5 mg once daily.
Hepatic Impairment
Severe (Child-Pugh class C or score >9): Not recommended.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to alogliptin or history of serious hypersensitivity reaction (e.g. anaphylactic reaction, anaphylactic shock, angioedema) to any dipeptidyl peptidase-4 (DPP-4) inhibitor.
Special Precautions
Patient with history of pancreatitis; CHF (NYHA class III and IV), risk factors for heart failure (e.g. history of heart failure or renal impairment); abnormal LFT results. Not a substitute for insulin in patients requiring insulin. Not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis. Concomitant use with insulin, insulin secretagogues, and metformin with thiazolidinedione combination therapy. Hepatic and moderate to severe renal impairment (including ESRD or requiring haemodialysis). Pregnancy and lactation.
Adverse Reactions
Significant: Increased risk of hospitalisation due to heart failure; chronic pancreatitis, pancreatic cancer; severe and disabling arthralgia; development or exacerbation of bullous pemphigoid; hypersensitivity reactions, including anaphylaxis, angioedema, and severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, erythema multiforme); hypoglycaemia (particularly when used concomitantly with insulin, insulin secretagogues, and metformin with thiazolidinedione combination therapy). Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, GERD, constipation. Investigations: Increased hepatic enzymes. Nervous system disorders: Headache. Renal and urinary disorders: Interstitial nephritis. Respiratory, thoracic and mediastinal disorders: URTI, nasopharyngitis. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria. Potentially Fatal: Acute pancreatitis, including haemorrhagic or necrotising cases; hepatic dysfunction, including hepatic failure.
Monitor serum glucose, blood pressure, renal function (before treatment initiation and periodically thereafter), LFTs (at baseline and as clinically indicated), and HbA1c (twice a year for those who have stable glycaemic control and are meeting the treatment goals, quarterly for patients not meeting the treatment goals or with therapy changes). Assess for signs and symptoms of hypoglycaemia, liver toxicity, pancreatitis, heart failure, and bullous pemphigoid.
Drug Interactions
Increased risk of hypoglycaemia with insulin, insulin secretagogues (e.g. sulfonylurea), and metformin with thiazolidinedione combination therapy.
Action
Description: Mechanism of Action: Alogliptin, an antidiabetic agent, is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4), an enzyme that rapidly inactivates incretin hormones. Incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic β-cells. Additionally, GLP-1 lowers glucagon secretion from pancreatic α-cells, resulting in decreased hepatic glucose production. Alogliptin thereby prolongs active incretin levels in the bloodstream and improves glycaemic control in a glucose-dependent manner. Pharmacokinetics: Absorption: Rapidly and extensively absorbed from the gastrointestinal tract. Bioavailability: Approx 100%. Time to peak plasma concentration: Approx 1-2 hours. Distribution: Plasma protein binding: Approx 20-30%. Metabolism: Minimally metabolised by CYP3A4 and CYP2D6 to form active and inactive metabolites. Excretion: Via urine (76%; 60-71% as unchanged drug); faeces (13%). Terminal elimination half-life: Approx 21 hours.
Chemical Structure
Alogliptin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 11450633, Alogliptin. https://pubchem.ncbi.nlm.nih.gov/compound/Alogliptin. Accessed July 29, 2024.
A10BH04 - alogliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
References
Alogliptin. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/06/2024.Anon. Alogliptin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/06/2024.Brayfield A, Cadart C (eds). Alogliptin Benzoate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/06/2024.Joint Formulary Committee. Alogliptin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/06/2024.Nesina Tablet, Film Coated (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2024.Vipidia 25 mg Film-coated Tablets (Takeda Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 07/06/2024.
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