FDA approves Zituvio for Type 2 diabetes

People with Type 2 diabetes now have another option to help manage blood sugar. The U.S. Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. Manufactured by Zydus Pharmaceuticals, this medication joins other diabetes medications with the same active ingredient that are already on the market, namely Januvia (sitagliptin) and Janumet, a metformin-sitagliptin combination medication.  

This approval is noteworthy because in 2022 the FDA found nitrosamine impurities in certain samples of sitagliptin, raising concerns about potential shortages of these two drugs. Merck is still working to resolve the cause of the contamination. Prior to the approval, Zituvio underwent quality testing to ensure it was not contaminated with these potential carcinogens.

What is Zituvio (sitagliptin)?

Zituvio (sitagliptin) is an oral diabetes medication, taken by mouth once a day in 25 mg, 50 mg, or 100 mg dosages. Sitagliptin is used alone and also in combination with metformin. Metformin, sold under the brand names Fortamet and Glumetza, is still considered the first-line treatment for Type 2 diabetes. However, research shows sitagliptin is an effective second-line therapy when metformin alone fails. Zituvio is most effective as an adjunct to exercise and diet to improve glycemic (blood sugar) control in adults with Type 2 diabetes. Zituvio is not indicated for people with Type 1 diabetes. 

How does Zituvio work?

Zituvio (sitagliptin) is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Also known as gliptins, these medications work by spurring the pancreas to produce more insulin to allow your body to lower your blood sugar levels. Other DPP-4 inhibitors approved for Type 2 diabetes include Onglyza (saxagliptin), Tradjenta (linagliptin), and Nesina (alogliptin). 

What are the possible side effects of Zituvio?

Research suggests that gliptins are generally not associated with a high incidence of adverse events. The most common side effects of sitagliptin include:

• Headache
• Stuffy or runny nose
• Sore throat
• Hypoglycemia (low blood sugar)

Hypoglycemia is more common when taking sitagliptin in addition to a sulfonylurea drug (such as glimepiride, glipizide, or glyburide) or insulin. Less common, more serious side effects are also possible, and require an immediate call to your healthcare provider, or emergency medical attention, such as:

• Stomach pain
• Diarrhea
• Fever
• Nausea and vomiting
• Symptoms of heart failure, such as shortness of breath, swelling of feet or ankles, or rapid weight gain
• Joint pain
• Pancreatitis (severe pain in the upper stomach, with or without vomiting)

If you experience symptoms of an allergic reaction (hives, trouble breathing or swallowing, or swelling of the face, lips, tongue, or throat) or skin reaction (blistering/peeling skin, rash, fever, sore throat, burning eyes), get emergency medical help right away.

RELATED: Januvia side effects | Janumet side effects 

When will Zituvio be available?

Zydus has not announced when Zituvio will be available for purchase.

How much will Zituvio cost?

Zydus has not announced pricing for Zituvio. “Through our industry-leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients,” said Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas in a statement. “We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives.”