Drug Product Name:

OSENI Rx

OSENI

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

Active Ingredient(s):
Alogliptin, pioglitazone; 12.5mg/15mg, 12.5mg/30mg, 12.5mg/45mg, 25mg/15mg, 25mg/30mg, 25mg/45mg; tabs.

Company
Takeda Pharmaceuticals North America, Inc.

Indication(s):

As adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both alogliptin and pioglitazone is appropriate.
Limitations of use: not for treatment of type 1 diabetes or diabetic ketoacidosis.

Pharmacology:

Alogliptin acts by slowing the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner. Pioglitazone activates peroxisome proliferator-activated receptor-gamma, thereby improving insulin sensitivity in muscle and adipose tissue while inhibiting hepatic gluconeogenesis.

Clinical Trials:

The coadministration of alogliptin and pioglitazone has been studied in patients with T2DM inadequately controlled on either diet and exercise alone or on metformin alone. A total of 655 patients inadequately controlled on diet and exercise alone were evaluated in a 26-week, double-blind, active-controlled study. Patients were randomized to alogliptin 25mg alone, pioglitazone 30mg alone, alogliptin 12.5mg + pioglitazone 30mg, or alogliptin 25mg + pioglitazone 30mg once daily.

Coadministration of alogliptin 25mg + pioglitazone 30mg resulted in statistically significant improvements from baseline in A1C (−1.7%) and fasting blood glucose (FPG; −50mg/dL) compared to either alogliptin 25mg (−1% and −26mg/dL, respectively) or pioglitazone 30mg (−1.2% and −37mg/dL, respectively; P<0.01 compared to individual component regimens) alone at Week 26.

For information on all other studies conducted: see full labeling.

Legal Classification:

Rx

Adults:

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:

Not recommended.

Contraindication(s):

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 evaluate 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 (Category C); use adequate contraception. Nursing mothers: not recommended.

Interaction(s)

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 Reaction(s)

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

How Supplied:

Tabs—30, 90, 500

LAST UPDATED:

8/16/2013

Sign Up for Free e-newsletters