Classes
DEA Class; Rx
Common Brand Names; Nesina
- Antidiabetics, Dipeptyl Peptidase-IV Inhibitors
Description
Oral DPP-4 inhibitor given once daily; reduces breakdown of GLP-1 which increases insulin secretion
Used for type 2 diabetes mellitus in adults; mean A1C reduction 0.4 to 0.6%
Used as monotherapy or in combination with other hypoglycemic agents including insulin, but not GLP-1 agonists
Indications
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Contraindications
Hypersensitivity to alogliptin, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome
Adverse Effects
- Hypoglycemia (1.5-35%); higher when added to insulin
- Nasopharyngitis (4.4%)
- Headache (4.2%)
- Upper respiratory tract infection (4.2%)
- <1%
- Hypersensitivity (0.6%)
- Pancreatitis (0.2%)
- Severe and disabling arthralgia
- Anaphylaxis, angioedema, rash, urticaria
- Severe cutaneous adverse reactions, including Stevens-Johnson syndrome
- Hepatic enzyme elevations
- Fulminant hepatic failure
- Bullous pemphigoid
- Rhabdomyolysis
- Constipation
- Diarrhea
- Nausea
- Ileus
- Tubulointerstitial nephritis
Warnings
Pancreatitis reported; if pancreatitis suspected, discontinue therapy and initiate appropriate management
Caution with sensitivity to another DPP-4 inhibitor; discontinue if serious hypersensitivity reaction suspected (see Contraindications)
Postmarketing cases of bullous pemphigoid requiring hospitalization reported with DPP-4 inhibitor use; patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor; tell patients to report development of blisters or erosions while receiving therapy; if bullous pemphigoid suspected, therapy should be discontinued and referral to a dermatologist considered for diagnosis and appropriate treatment
Fatal and nonfatal hepatic failure reported; type 2 DM is also known to cause fatty liver disease and liver enzyme elevation; monitor carefully and interrupt alogliptin treatment if LFTs elevated, do not restart alogliptin without another explanation for the liver test abnormalities; do not restart therapy if liver injury is confirmed and no alternative etiology can be found
Insulin and insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose of insulin of insulin secretagogue may be needed to minimize hypoglycemia risk
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with alogliptin or any other antidiabetic drug
DPP-4 inhibitors may cause disabling joint arthralgia; resolves within a month upon discontinuing the drug
Pregnancy and Lactation
Pregnancy Category: B
Lactation: Unknown whether distributed in breast milk
Maximum Dosage
25 mg/day PO.
25 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Alogliptin
tablet
- 6.25mg
- 12.5mg
- 25mg