Availability: Kombiglyze XR is available in tablets of 5 mg saxagliptin/500 mg metformin, 5 mg saxagliptin/1,000 mg of metformin, and 2.5 mg of saxagliptin/1,000 mg of metformin, and should be taken once daily with food.
Drug labeling changes
Product: Colesevelam HCL (Welchol for Oral Suspension)
Reason for label change: Welchol is prescribed for blood glucose control in people with Type 2 diabetes and to lower LDL (low-density lipoprotein, or “bad”) cholesterol. The FDA has recently expanded dosing options for Welchol Oral Suspension to allow people taking the drug to dissolve their doses — one 3.75-gram packet once daily or one 1.375-gram packet twice daily — in 4 to 8 ounces of diet soda or fruit juice. The original guidelines stated the drug could only be taken with water.
Product: Humalog (insulin lispro injection [rDNA origin])
Reason for label change: The FDA has issued several labeling changes to the Humalog label: People using Humalog in a pump can now use the insulin in the pump’s reservoir for up to seven days and should change infusion sets and insertion sites every three days. Before the label change, both the insulin in the reservoir and the insertion sites needed to be replaced every two days.
Product: Humulin R (insulin regular) U-500
Reason for label change: Lilly, the manufacturer of Humulin R U-500, changed that drug’s label to prevent confusion with Humulin R U-100. U-500 insulin is five times as concentrated as U-100 insulin, the type used by most people in the United States. U-500 vials are now marked with a band of diagonal brown stripes, while the U-100 vials have no stripes. “U-500” is now also highlighted in red on the label.
Product: Pioglitazone (Actos, ActoPlus Met, ActoPlusMet XR, Duetact)
Reason for label change: The FDA has decided that the labels for the Type 2 diabetes drug pioglitazone (and combination drugs that include pioglitazone) should carry a warning that use of the drug for more than a year may increase a person’s risk of developing bladder cancer. The FDA’s 5-year interim review of a 10-year study on the relationship between the pioglitazone and bladder cancer found that people taking the drug were 1.4 times as likely to develop bladder cancer than people taking a placebo. The new label warns of that risk, and recommends that people who have or have a history of bladder cancer avoid the drug. It also urges people taking pioglitazone to watch for symptoms of bladder problems, such as blood in the urine or painful urination.
Product: Rosiglitazone (Avandia, Avandamet, Avandaryl)
Reason for label change: In late 2010, the FDA announced severe restrictions on the prescribing of the Type 2 diabetes drug rosiglitazone, due to the higher risk of heart attack associated with the drug. These restrictions, which state that doctors can only prescribe rosiglitazone if all other diabetes drugs have failed to achieve blood glucose control, have this year been added to the drug’s label and Medication Guide (the paper handout that comes with a prescription drug when, among other reasons, the FDA determines it carries a health risk or side effect that people taking it need to know about). The Medication Guide also now includes detailed information about the cardiovascular risks involved with taking rosiglitazone.