Classes
DEA Class; Rx
Common Brand Names; Oseni
- Antidiabetics, Dipeptyl Peptidase-IV Inhibitors;
- Antidiabetics, Thiazolidinediones
Description
Oral combination of a thiazolidinedione (pioglitazone) and a dipeptidy-peptidase-4 (DPP-4) inhibitor (alogliptin)
Used for the treatment of type 2 diabetes mellitus in adults
Due to the pioglitazone component, monitor patients for edema or signs/symptoms of heart failure
Indications
Indicated for the treatment of type 2 diabetes mellitus in combination with diet and exercise.
Contraindications
Hypersensitivity to alogliptin or pioglitazone, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome
Do not initiate pioglitazone in patients with NYHA Class III or IV heart failure (see Black Box Warnings)
Adverse Effects
pioglitazone
- Worsening CHF (9.9-13.4%)
- Edema when used in combination with sulfonylurea or insulin
- Hypoglycemia (0.8-4.5%)
- Nasopharyngitis (4%)
- Back pain (4.2%)
- Upper respiratory tract infection (4.1%)
Alogliptin
- 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
Pioglitazone can cause dose-related fluid retention that may lead to or exacerbate CHF (see Black Box Warnings)
Edema; thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin
Pancreatitis reported
Caution with sensitivity to another DPP-4 inhibitor; discontinue if serious hypersensitivity reaction suspected (see Contraindications)
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/pioglitazone treatment if LFTs elevated, do not restart alogliptin/pioglitazone without another explanation for the liver test abnormalities
Insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose may be needed to minimize hypoglycemia risk
Increased fracture risk in females
Macular edema reported with thiazolidinediones (eg, pioglitazone)
Discuss potential for unintended pregnancy with premenopausal women as therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women
Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate
Pregnancy and Lactation
Limited data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage
There is no information regarding presence of pioglitazone or alogliptin in human milk, effects on breastfed infant, or effects on milk production
Maximum Dosage
Alogliptin 25 mg/day PO and pioglitazone 45 mg/day PO.
Alogliptin 25 mg/day PO and pioglitazone 45 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Alogliptin/pioglitazone
tablet
- 12.5mg/15mg
- 12.5mg/30mg
- 12.5mg/45mg
- 25mg/15mg
- 25mg/30mg
- 25mg/45mg
