Generic Name and Formulations:
Alogliptin, pioglitazone; 12.5mg/15mg, 12.5mg/30mg, 12.5mg/45mg, 25mg/15mg, 25mg/30mg, 25mg/45mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.
Indications for OSENI:
As 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.

Adult Dose for OSENI:
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. Switching from alogliptin with pioglitazone: start at dose based on current therapy. 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 pioglitazone 15mg daily.

Children's Dose for OSENI:
Not recommended.

Pharmacological Class:
Dipeptidyl peptidase-4 (DPP-4) inhibitor + thiazolidinedione.

Contraindications:
NYHA Class III or IV heart failure.

Warnings/Precautions:
Symptomatic HF: not recommended. Risk of CHF; monitor after initiation and dose increases; consider discontinuation or reduce pioglitazone dose if occurs. Monitor for pancreatitis or serious hypersensitivity reaction; discontinue if suspected. History of angioedema with other DPP-4 inhibitors. Renal impairment; monitor prior to starting therapy and periodically thereafter. Hepatic impairment; obtain LFTs before starting therapy; interrupt and eva luate if liver enzymes elevated; do not restart if liver injury is confirmed and no other etiology can be found. Active bladder cancer: do not use. Do regular eye exams. Resumption of premenopausal ovulation in anovulatory women may occur (may result in unintended pregnancy). Pregnancy (Cat. C); use adequate contraception. Nursing mothers: not recommended.

Interactions:
Concomitant insulin may cause fluid retention. Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Concomitant sulfonylurea or insulin: may need lower dose of sulfonylurea or insulin to reduce risk of hypoglycemia.

Adverse Reactions:
Nasopharyngitis, back pain, upper respiratory tract infection; edema, fractures (esp. females), macular edema.

How Supplied:
Tabs—30, 90, 500