Indicated for:

Monotherapy and Combination Therapy:

OSENI is indicated as an 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.

OSENI is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

After initiation of OSENI or with dose increase, monitor patients carefully for adverse reactions related to fluid retention as has been seen with pioglitazone (e.g., weight gain, edema and signs and symptoms of congestive heart failure).

Do not initiate in patients with NYHA Class III or IV heart failure.

OSENI is not recommended for patients with severe renal impairment or ESRD.

Reports of acute pancreatitis.

Pioglitazone may be associated with an increase in the risk of urinary bladder tumors. There are insufficient data to determine whether pioglitazone is a tumor promoter for urinary bladder tumors. Consequently, OSENI should not be used in patients with active bladder cancer and the benefits of glycemic control versus unknown risks for cancer recurrence with OSENI should be considered in patients with a prior history of bladder cancer.

There have been postmarketing reports of fatal and nonfatal hepatic failure.

Reports of fractures in female patients. The majority of fractures observed in female patients were nonvertebral fractures including lower limb and distal upper limb.

Macular edema has been reported in postmarketing experience in diabetic patients who were taking pioglitazone or another thiazolidinedione.

There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors.

Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin. These reactions include anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome.

Co-administration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately three-fold. Therefore, the maximum recommended dose of OSENI is 25 mg/15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors.

An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with OSENI, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for pioglitazone.

A decrease in the exposure of pioglitazone and its active metabolites were noted with concomitant administration of pioglitazone and topiramate.

Discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women.

Limited data with OSENI in pregnant women are not sufficient to inform a drug associated risk for major birth defects or miscarriage. Animal studies: delayed development and reduced fetal weight.

There is no information regarding the presence of pioglitazone or alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Pioglitazone and alogliptin are present in rat milk.

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• Use in patients under the age of 18. GoToSource

Bone fractures in female patients, upper respiratory infection, urinary tract infection, nasopharyngitis, skin lesions, pruritus (severe itching) and water retention. GoToSource

Increased risk of bladder cancer. GoToSource

Pancreatitis (inflammation of pancreas) and liver injury. GoToSource

Anaphylaxis (potentially life-threatening allergic reaction), angioedema (swelling in deep layers of the skin) and stevens-johnson syndrome (severe skin reaction). GoToSource 

Severe and disabling joint pain. GoToSource

Hypoglycemia (low blood sugar). GoToSource

Macular edema (build-up of fluid in the retina). GoToSource

Bullous pemphigoid (blistering skin condition). GoToSource

Rhabdomyolysis (destruction of skeletal muscle). GoToSource

Increased risk of heart failure. GoToSource

Lawsuits filed for bullous pemphigoid, pancreatic cancer, heart failure, rhabdomyolysis, pancreatitis and thyroid cancer.