ARX-PIOGLITAZONE

What it is

ARX-PIOGLITAZONE is pioglitazone hydrochloride, available as tablets containing 15 mg, 30 mg or 45 mg of pioglitazone. Pioglitazone is a thiazolidinedione antidiabetic agent that decreases insulin resistance in the periphery and in the liver, resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.

Approved indications

ARX-PIOGLITAZONE is indicated for the treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise in the following ways: — As monotherapy. — As dual therapy in combination with metformin or sulfonylurea. — As dual therapy in combination with insulin. — As triple therapy in combination with metformin and sulfonylurea.

Dosing overview

The dose should not exceed 45 mg per day since doses higher than 45 mg per day have not been studied in clinical trials. ARX-PIOGLITAZONE should be taken once daily with or without food.

Key safety warnings

Pioglitazone can cause or exacerbate congestive heart failure in some patients. After initiation and after dose increases, patients should be observed carefully for signs and symptoms of heart failure including excessive rapid weight gain, dyspnoea and/or oedema. If these signs and symptoms develop, pioglitazone should be discontinued. Thiazolidinediones can cause fluid retention, and pioglitazone should be used with caution in patients with oedema. Oedema was reported more frequently in patients treated with pioglitazone than in placebo-treated patients in clinical trials. Pioglitazone should not be used in patients with bladder cancer or a history of bladder cancer. The risk of bladder cancer should be considered in the care of all patients treated with pioglitazone. Risk factors for bladder cancer should be assessed before initiating treatment, including age, smoking history, and exposure to occupational or chemotherapy agents such as cyclophosphamide or prior radiation treatment in the pelvic region. An increased incidence in bone fractures in women was seen in a pooled analysis of clinical trials. Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.

Contraindications

ARX-PIOGLITAZONE is contraindicated in patients with known hypersensitivity or allergy to pioglitazone or any of the excipients. Initiation of pioglitazone is contraindicated in patients with New York Heart Association Class II, III or IV heart failure. ARX-PIOGLITAZONE should not be used in type 1 diabetes or for the treatment of diabetic ketoacidosis.

PBS listing

ARX-PIOGLITAZONE is listed on the PBS in three strengths: 15 mg, 30 mg and 45 mg tablets as hydrochloride. Each strength is listed with 2 PBS items with restriction type restricted. The ex-manufacturer prices are A$6.18 for 15 mg, A$9.51 for 30 mg and A$12.37 for 45 mg.

Regulatory history

ARX-PIOGLITAZONE was first registered on the ARTG on 11 November 2010 in three strengths (15 mg, 30 mg and 45 mg tablets).