Generic Name and Formulations:
Alogliptin, pioglitazone; 12.5mg/15mg, 12.5mg/30mg, 12.5mg/45mg, 25mg/15mg, 25mg/30mg, 25mg/45mg; tabs.
Takeda Pharmaceutical Company
Indications for OSENI:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and pioglitazone is appropriate.
Limitations Of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Swallow whole; do not split tabs. Take once daily with or without food. Inadequately controlled on diet/exercise, or on metformin or alogliptin monotherapy: initially 25mg/15mg or 25mg/30mg daily. Previously on pioglitazone alone: initially 25mg/15mg, 25mg/30mg, or 25mg/45mg daily. Previously on alogliptin and pioglitazone: switch on a mg/mg basis. NYHA Class I or II HF: initially 25mg/15mg. All: max 25mg/45mg daily. Renal impairment: moderate (CrCl ≥30–<60mL/min): 12.5mg/15mg, 12.5mg/30mg, or 12.5mg/45mg daily; severe or ESRD: not recommended. Concomitant gemfibrozil or other strong CYP2C8 inhibitors: max 25mg/15mg daily.
NYHA Class III or IV heart failure.
Congestive heart failure.
Symptomatic HF: not recommended. CHF: consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms (after initiation and dose increases); evaluate and consider discontinuing if develops. Edema. Discontinue if pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid is suspected or occurs. History of angioedema to other DPP-4 inhibitors. Renal impairment; monitor prior to starting therapy and periodically thereafter. Hepatic impairment; obtain LFTs before starting therapy; interrupt and evaluate if liver enzymes elevated; do not restart if liver injury is confirmed and no other etiology can be found. Active bladder cancer: not recommended. Prior history of bladder cancer: consider glycemic control benefits vs. risk of cancer recurrence. Risk of fractures (esp. females). Do regular eye exams. Resumption of premenopausal ovulation in anovulatory women may occur (may result in unintended pregnancy). Pregnancy: use adequate contraception. Nursing mothers.
Dipeptidyl peptidase-4 (DPP-4) inhibitor + thiazolidinedione.
Concomitant insulin may cause fluid retention. Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin) or topiramate (monitor for adequate glycemic control). May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.
Nasopharyngitis, back pain, upper respiratory tract infection; fluid retention, edema, macular edema, pancreatitis, heart failure, hypersensitivity reactions, hepatic events, severe and disabling arthralgia, bullous pemphigoid.
Tabs—30, 90, 500