Glucagon (HCl)

Zituvimet is an oral combination treatment containing sitagliptin and metformin that may be used to lower blood glucose (sugar) in adults with type 2 diabetes alongside diet and exercise. Zituvimet works in two different ways. The sitagliptin component is thought to work by increasing insulin release and decreasing glucagon levels by slowing the inactivation of incretin hormones. Incretin hormones are released by the intestine throughout the day and in response to food. These hormones are rapidly inactivated by an enzyme called dipeptidyl peptidase 4 (DPP-4). Sitagliptin inhibits DDP-4 and belongs to the class of medicines known as DPP-4 inhibitors. The metformin component works by increasing the ability of cells to uptake glucose by improving their insulin sensitivity. It also decreases the amount of glucose made by the liver and decreases the absorption of glucose from the intestine. Metformin belongs to the class of medicines known as biguanides. Together, the combination lowers blood glucose levels by several mechanisms: increasing insulin release, decreasing glucagon levels, increasing the ability of cells to uptake glucose, decreasing the production of glucose by the liver, and decreasing the absorption of glucose from the intestine. Zituvimet was FDA-approved on November 6, 2023.

Zituvimet is an oral combination treatment containing sitagliptin and metformin that may be used to lower blood glucose (sugar) in adults with type 2 diabetes alongside diet and exercise. Zituvimet works in two different ways. The sitagliptin component is thought to work by increasing insulin release and decreasing glucagon levels by slowing the inactivation of incretin hormones. Incretin hormones are released by the intestine throughout the day and in response to food. These hormones are rapidly inactivated by an enzyme called dipeptidyl peptidase 4 (DPP-4). Sitagliptin inhibits DDP-4 and belongs to the class of medicines known as DPP-4 inhibitors. The metformin component works by increasing the ability of cells to uptake glucose by improving their insulin sensitivity. It also decreases the amount of glucose made by the liver and decreases the absorption of glucose from the intestine. Metformin belongs to the class of medicines known as biguanides. Together, the combination lowers blood glucose levels by several mechanisms: increasing insulin release, decreasing glucagon levels, increasing the ability of cells to uptake glucose, decreasing the production of glucose by the liver, and decreasing the absorption of glucose from the intestine. Zituvimet was FDA-approved on November 6, 2023.

Before you take Zituvimet, tell your healthcare provider about all of your medical conditions, including if you have: kidney or liver problems heart failure stones in your gallbladder (gallstones) high blood triglyceride levels to get an injection of dye or contrast agents for an X-ray procedure or have had inflammation of your pancreas (pancreatitis) have low levels of vitamin B12 in your blood, or drink alcohol very often or drink a lot of alcohol in short-term “binge” drinking irregular periods or your periods do not come at all and are of childbearing potential are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed.

The most common side effects of Zituvimet are: diarrhea upper respiratory tract infections and headache.

Zituvimet carries a Boxed Warning for lactic acidosis. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking Zituvimet and call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet feel dizzy or lightheaded have a slow or irregular heartbeat feel very weak or tired have unusual (not normal) muscle pain have trouble breathing feel sleepy or drowsy have stomach pains, nausea, or vomiting. The risk of developing lactic acidosis is increased in those who are dehydrated, have a contrast X-ray, have kidney problems, drink alcohol excessively, have surgery, have a heart attack, severe infection, or stroke, or are 65 years of age or older. Inflammation of the pancreas (pancreatitis) is another, potentially fatal, serious side effect that may occur. Certain medical problems make you more likely to get pancreatitis. Stop taking Zituvimet and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Zituvimet may also increase your risk of developing heart failure . Heart failure means that your heart does not pump blood well enough. Before you start taking Zituvimet tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down swelling or fluid retention, especially in the feet, ankles, or legs an unusually fast increase in weight unusual tiredness. People with a history of hypersensitivity reactions to Zituvimet, sitagliptin, metformin, or any of the inactive ingredients in the tablets should not take this medicine. Symptoms of a serious allergic reaction may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If symptoms of an allergic reaction occur, stop taking Zituvimet and seek urgent medical advice. May also increase the risk for acute kidney failure, severe joint pain, and bullous pemphigoid. Long-term use has been associated with vitamin B12 deficiency – your healthcare provider should measure your B12 levels at 2 to 3-year intervals and treat if low. It is not known if Zituvimet is safe and effective in children. Zituvimet is not for people with type 1 diabetes. To report suspected adverse reactions, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or the FDA at 1-800-FDA1088 or www.fda.gov/medwatch.

Zituvimet carries a Boxed Warning for lactic acidosis. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking Zituvimet and call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet feel dizzy or lightheaded have a slow or irregular heartbeat feel very weak or tired have unusual (not normal) muscle pain have trouble breathing feel sleepy or drowsy have stomach pains, nausea, or vomiting. The risk of developing lactic acidosis is increased in those who are dehydrated, have a contrast X-ray, have kidney problems, drink alcohol excessively, have surgery, have a heart attack, severe infection, or stroke, or are 65 years of age or older. Inflammation of the pancreas (pancreatitis) is another, potentially fatal, serious side effect that may occur. Certain medical problems make you more likely to get pancreatitis. Stop taking Zituvimet and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Zituvimet may also increase your risk of developing heart failure . Heart failure means that your heart does not pump blood well enough. Before you start taking Zituvimet tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down swelling or fluid retention, especially in the feet, ankles, or legs an unusually fast increase in weight unusual tiredness. People with a history of hypersensitivity reactions to Zituvimet, sitagliptin, metformin, or any of the inactive ingredients in the tablets should not take this medicine. Symptoms of a serious allergic reaction may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If symptoms of an allergic reaction occur, stop taking Zituvimet and seek urgent medical advice. May also increase the risk for acute kidney failure, severe joint pain, and bullous pemphigoid. Long-term use has been associated with vitamin B12 deficiency – your healthcare provider should measure your B12 levels at 2 to 3-year intervals and treat if low. It is not known if Zituvimet is safe and effective in children. Zituvimet is not for people with type 1 diabetes. To report suspected adverse reactions, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or the FDA at 1-800-FDA1088 or www.fda.gov/medwatch.

0.25 to 2 mg (1.1 (1.125)) As recommended. IV — As a diagnostic aid 1 to 2 mg (1.5 (1.5)) As recommended. IM — As a diagnostic aid Scraped Dose — Take Zituvimet tablets 2 times a day by mouth. Your healthcare provider will tell you exactly how many Zituvimet tablets to take and when you should take them. Take it with meals to help to lower your chance of having an upset stomach. Do not break or cut the Zituvimet tablets before swallowing. If you cannot swallow the tablets whole, tell your healthcare provider. Low blood sugar levels may happen more frequently when you take Zituvimet alongside other diabetes medicines. The amount of diabetes medicine that you need may change when your body is under some type of stress, such as fever, trauma (such as a car accident), infection, or surgery. Tell your healthcare provider right away if you have any of these problems and follow your healthcare provider’s instructions. Your healthcare provider will do blood tests to check how well your kidneys are working before and during your treatment. Zituvimet XR tablets are

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you take: Carbonic anhydrase inhibitors - these may increase the risk of lactic acidosis Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) Other diabetes medications, including insulin. There may be an increased risk of low blood sugar levels when Zituvimet is used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required Alcohol. Do not drink excessively. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Store in a well closed container, at room temperature, Below 15°C. Inj (reconstituted soln) Store in a well closed container. Refrigeration is recommended. Use within 48 hrs if kept at room temperature.