Three New DPP-4 formuations approved by the FDA….
Alogliptin was approved by the US Food and Drug Administration (FDA) on January 25, 2013, and should be on the market sometime in the summer. Alogliptin isn’t very different from the other DPP-4 inhibitors, so we will be familiar with its use. Alogliptin comes in 3 different formulations:
- Alogliptin alone;
- Alogliptin plus metformin; and
- Alogliptin plus pioglitzaone.
Once upon a time, alogliptin was slated to be the first DPP-4 inhibitor to make it to the market, but the approval process slowed. Changes at the FDA led to the requirement for more data on cardiovascular and other risks, so the drug was approved much later than we originally thought it would be. Alogliptin will be the fourth in line to be available in the US market.
The names of the different formulations are interesting. Patients might come in asking about these drugs, or they might already be taking them. Alogliptin alone is called Nesina, alogliptin plus metformin is called Kazano, and alogliptin plus pioglitazone is called Oseni. All are manufactured by Takeda Pharmaceuticals USA, Inc. (Deerfield, Illinois).
In terms of dosing, alogliptin alone is given once daily as a 25-mg tablet. The dose must be adjusted in patients with renal insufficiency, so if the patient’s glomerular filtration rate (GFR) is 30-60 mL/min/1.73 m2, the dose should be halved (12.5 mg). If the GFR is < 30 mL/min/1.73 m2, the dose should be halved again (6.25 mg). Alogliptin alone will be available in tablets at all 3 of these doses.
For metformin plus alogliptin, only 1 formulation (12.5 mg of alogliptin plus 1000 mg of metformin) will be available.
Finally, the combination of alogliptin with pioglitazone comes in 6 different pill strengths: 25 mg of alogliptin plus 15, 30, or 45 mg of pioglitazone, and 12.5 mg of alogliptin plus 15, 30, or 45 mg of pioglitazone.
The most common side effect observed in studies of alogliptin was an increased rate of nasopharyngitis compared with placebo. The other side effects are similar to those associated with the DPP-4 inhibitors. The side effects of the other drug in the combination formulations must be kept in mind as well. For example, metformin carries a potential increased risk for lactic acidosis and should not be used in patients with renal insufficiency. Pioglitazone increases the risk for congestive heart failure and edema. It should not be used in individuals with bladder cancer, and it also may cause some bone loss, so I don’t use it in patients with significant osteoporosis. I prescribe pioglitazone at a lower dose (15 or 30 mg); I find that this dose tends to reduce the side effects while keeping some of the benefits.
Takeda News Release 2-17-2013