ZITUVIO and ZITUVIMET For Type 2 Diabetes

In late 2023, Zydus Lifesciences introduced two oral diabetic medications in the United States: ZITUVIO and ZITUVIMET. ZITUVIO, approved by the FDA in mid-October 2023, is a DPP-4 inhibitor containing sitagliptin as its active ingredient. ZITUVIMET followed shortly after. Combining sitagliptin and metformin in one pill, ZITUVIMET was appproved on November 3, providing patients with a convenient option for dual therapy in managing type 2 diabetes.

ZITUVIMET and ZITUVIO are bioequivalent to Janumet and Januvia, respectively, meaning they contain the same active ingredients and work in the same way. However, it's important to note that ZITUVIMET and ZITUVIO are branded medications, not generic versions. Despite being newer brands, their cash prices are much more affordable compared to their counterparts. These medications are exclusively available through Marley Drug for $80 per month.

Note: ZITUVIMET and ZITUVIO are not suitable for those with type 1 diabetes or individuals with a history of pancreatitis, a condition characterized by inflammation of the pancreas.

How They Work

ZITUVIO

ZITUVIO primarily works by targeting an enzyme called dipeptidyl peptidase-4 (DPP-4). This enzyme breaks down incretin hormones that play a crucial role in regulating blood sugar levels.

In individuals with type 2 diabetes, there's often reduced responsiveness to these hormones, leading to inadequate insulin secretion and elevated blood sugar levels. ZITUVIO works by blocking the action of DPP-4, thereby prolonging the activity of incretin hormones like GLP-1 and GIP. By enhancing the effects of these hormones, ZITUVIO stimulates insulin secretion and inhibits glucagon release, ultimately helping to lower blood sugar levels, particularly after meals when blood sugar tends to spike.

ZITUVIMET

ZITUVIMET combines two medications: Sitagliptin and Metformin, each targeting different aspects of blood sugar regulation.

Sitagliptin, a DPP-4 inhibitor like ZITUVIO, works by inhibiting the action of DPP-4 enzyme, similar to ZITUVIO. This results in increased levels of active incretin hormones, promoting insulin secretion and suppressing glucagon release, thereby lowering blood sugar levels.

In addition to Sitagliptin, ZITUVIMET also contains Metformin, which lowers blood sugar levels through different mechanisms. Metformin reduces glucose production in the liver, improves insulin sensitivity in muscle cells, and may also reduce glucose absorption from the intestines. By combining these two medications, ZITUVIMET offers a comprehensive approach to managing blood sugar levels in individuals with type 2 diabetes, targeting multiple pathways involved in blood sugar regulation.

In summary, while ZITUVIO and ZITUVIMET both aim to lower blood sugar levels in individuals with type 2 diabetes, they do so through slightly different mechanisms. ZITUVIO focuses on enhancing the effects of incretin hormones, while ZITUVIMET combines the actions of Sitagliptin and Metformin to address various aspects of blood sugar regulation, providing a more comprehensive approach to diabetes management.

Administration and Dosing

ZITUVIMET

ZITUVIMET is typically taken orally twice daily with meals. Taking it with food can help reduce the likelihood of experiencing stomach upset.

Strengths:

• Sitaglipin 50 mg + Metformin 500 mg
• Sitaglipin 50 mg + Metformin 1000 mg

For individuals not currently using Metformin, the initial treatment usually consists of taking 50 mg of Sitagliptin and 500 mg of Metformin HCl twice daily. To minimize gastrointestinal side effects commonly associated with Metformin, it's recommended to gradually increase the dose.

If patients are taking Metformin HCl 850 mg twice daily, the suggested starting dose of ZITUVIMET comprises 50 mg of Sitagliptin and 1000 mg of Metformin HCl administered twice daily.

ZITUVIO

• ZITUVIO is taken orally once daily, with or without food.
• Strengths: 25 mg, 50 mg, 100 mg
• Recommended dosage is 100 mg

Side Effects

Common Side Effects

Both ZITUVIMET and ZITUVIO share common side effects of low blood sugar levels which include:

• Headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, feeling jittery, weakness, or having a fast heartbeat.

If you experience low blood sugar, consume or drink a fast-acting sugar source, such as fruit juice, hard candy, raisins, or non-diet soda.

Serious Side Effects

While ZITUVIMET and ZITUVIO share some serious side effects, each medication has its own specific risks:

ZITUVIMET

• Severe joint pain.
• Severe stomach pain, diarrhea, nausea, and/or vomiting.
• Severe eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Severe headache, confusion, slurred speech, arm or leg weakness, difficulty walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Symptoms of heart failure, such as shortness of breath, even while lying down, swelling in your legs or feet, and rapid weight gain.
• Signs of an allergic reaction, such as hives, breathing difficulties, or swelling in your face or throat.

ZITUVIO

• Severe autoimmune reactions, such as itching and blisters.
• Severe or ongoing pain in your joints.
• Fever.
• Little or no urination.
• Symptoms of heart failure, such as shortness of breath, even while lying down, swelling in your legs or feet, and rapid weight gain.
• Signs of an allergic reaction, such as hives, difficulty breathing, or swelling in your face or throat.
• Symptoms of severe skin reactions, such as fever, sore throat, burning sensation in your eyes, skin pain, or a red or purple rash that spreads and leads to blistering and peeling.
• Symptoms of pancreatitis, such as severe upper stomach pain spreading to your back, with or without vomiting.

If you experience any of these serious side effects, immediately call your doctor and stop taking the medication. Additionally, if you experience any common side effects, discuss them with your healthcare provider to determine if a dose adjustment or switching to a different medication is necessary.

Warnings

ZITUVIMET

Medications containing Metformin carry a boxed warning indicating a potential risk of lactic acidosis, a rare but potentially severe condition characterized by the accumulation of acids in the body.

Stop taking ZITUVIMET and call your doctor right away if you are experiencing dizziness or lightheadedness, feel cold in your hands or feet, feel very weak or tired, experience abnormal muscle pain, have difficulty breathing, or experience stomach pains, nausea, or vomiting.

Serious allergic reactions may be caused by symptoms such as rash, raised red patches on the skin, hives, or swelling of your face, lips, tongue, and throat, potentially leading to difficulties breathing or swallowing.

Those who have previously experienced hypersensitivity reactions to ZITUVIMET, sitagliptin, metformin, or any of the inactive components in the tablets should avoid using this medication.

Additionally, this medication is not recommended for individuals with severe kidney disease, metabolic acidosis, or diabetic ketoacidosis.

ZITUVIO

If you experience symptoms of an allergic reaction such as hives, difficulty breathing, or swelling in your face or throat, or if you develop a severe skin reaction with fever, sore throat, burning sensation in your eyes, skin pain, or a red or purple rash that spreads and leads to blistering and peeling, get immediate medical attention.

If you experience symptoms of heart failure, including shortness of breath, even when lying down, swelling in your legs or feet, or rapid weight gain, it is important to contact your doctor immediately for evaluation and guidance.

Additionally, discontinue the use of ZITUVIO and promptly contact your doctor if you notice signs of pancreatitis, including intense pain in your upper stomach that extends to your back, with or without vomiting.

Interactions

ZITUVIMET

Avoid using ZITUVIMET with medications that could reduce metformin clearance, such as ranolazine and cimetidine, or with medications that could affect glycemic control, such as thiazides and other diuretics, phenytoin, or oral contraceptives, alcohol, insulin secretagogues or insulin.

ZITUVIO

ZITUVIO may interact with certain medications, such as insulin, or supplements, and may not work as well when you use other medications at the same time, as many other drugs can also affect your blood sugar control. That’s why it's important to always inform your doctor and pharmacist about any other medications or supplements, including prescribed and over-the-counter, vitamins, and dietary or herbal supplements, that you are currently taking.

Speak With Your Doctor

When discussing ZITUVIMET and ZITUVIO with your doctor, it's important to provide any existing health conditions, allergies, and medications you're currently taking. Be sure to mention any previous experiences with diabetes medications and any concerns or questions you may have about these drugs.

Your doctor can then provide personalized guidance on whether these medications are suitable for you, potential side effects to watch for, and how to manage your diabetes effectively while taking them.