Xultophy Inj

Xultophy (insulin degludec and liraglutide) Injection

Xultophy is a pre-filled, disposable pen containing an injectable prescription medicine that combines two diabetes medications: insulin degludec and liraglutide. While the user specified "ABBOTT," multiple sources indicate Xultophy is manufactured by Novo Nordisk.

• Name: Xultophy (Brand name). The common names for its active ingredients are insulin degludec and liraglutide.
• Composition: Each milliliter of Xultophy solution contains 100 units of insulin degludec and 3.6 mg of liraglutide. The solution is clear, colorless, and isotonic. Other inactive ingredients include glycerol, phenol, zinc, hydrochloric acid, sodium hydroxide, and water for injection.
• Uses: Xultophy is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. It is used as an adjunct to diet and exercise to improve glycemic control, often in addition to other oral medicinal products for diabetes. It is not recommended for type 1 diabetes or diabetic ketoacidosis.
• Dosage and Administration: Xultophy is administered once daily by subcutaneous injection in the thigh, upper arm, or abdomen. It can be taken at any time of the day, preferably at the same time each day, with or without food. The recommended starting dose for patients new to basal insulin or GLP-1 receptor agonists is 10 units (10 units insulin degludec and 0.36 mg liraglutide). The maximum daily dose is 50 units (50 units insulin degludec and 1.8 mg liraglutide). Injection sites should be rotated within the same region to reduce the risk of lipodystrophy.
• Side Effects: Common side effects include nausea, diarrhea, headache, nasopharyngitis (stuffy or runny nose, sore throat), upper respiratory tract infection, and increased blood levels of lipase. Serious side effects can include hypoglycemia (low blood sugar), pancreatitis (inflammation of the pancreas), severe allergic reactions, kidney damage, gallbladder problems, and low potassium levels.
• Precautions: Xultophy carries a boxed warning regarding the risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), observed in animal studies with liraglutide. It is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Caution is advised for patients with a history of pancreatitis, and those taking thiazolidinediones (TZDs) due to an increased risk of heart failure. Patients should be monitored for symptoms of thyroid tumors (e.g., a lump in the neck, trouble swallowing, hoarseness).
• Storage: Unopened Xultophy pens should be stored in a refrigerator (2°C to 8°C or 36°F to 46°F) until the expiration date, protected from light. Do not freeze. After first use, the pen can be stored for 21 days at controlled room temperature (15°C to 30°C or 59°F to 86°F) or in a refrigerator (2°C to 8°C or 36°F to 46°F). Always remove the needle after each injection.

Xultophy (Insulin Degludec and Liraglutide) Injection: Frequently Asked Questions

Xultophy 100/3.6 is an injectable prescription medicine combining two medications, insulin degludec and liraglutide, used to help manage blood sugar levels in adults with type 2 diabetes mellitus. It is typically used as an adjunct to diet and exercise when other treatments have not provided adequate glycemic control.

Here are some frequently asked questions about Xultophy:

What is Xultophy used for?

Xultophy is indicated for adults with type 2 diabetes mellitus whose blood sugar is not adequately controlled. It is used as an adjunct to diet and exercise to improve glycemic control. It is not recommended as a first-line therapy for patients whose type 2 diabetes is inadequately controlled by diet and exercise alone.

How does Xultophy work?

Xultophy combines two active ingredients: insulin degludec and liraglutide, which work together to lower blood sugar. Insulin degludec is a long-acting insulin that helps regulate glucose metabolism by stimulating glucose uptake by muscle and fat cells and inhibiting glucose production from the liver. Liraglutide is a GLP-1 (Glucagon-Like Peptide-1) receptor agonist that increases glucose-dependent insulin secretion, lowers inappropriately high glucagon secretion, and slows gastric emptying.

What is the usual dosage of Xultophy?

Xultophy is administered once daily by subcutaneous injection at the same time each day, with or without food. The dose is measured in "dose steps" using a pre-filled pen. Each dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. The maximum daily dose is 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide).

For patients new to basal insulin or a GLP-1 receptor agonist, the recommended starting dosage is typically 10 dose steps. For those transitioning from basal insulin or a GLP-1 receptor agonist, the recommended starting dose is often 16 dose steps, and the prior therapy should be discontinued. Your doctor will adjust your dose based on your individual needs and blood glucose monitoring results.

What are the possible side effects of Xultophy?

Common side effects of Xultophy can include low blood sugar (hypoglycemia), headache, nausea, diarrhea, vomiting, stuffy or runny nose, sore throat, upper respiratory tract infection, indigestion, and injection site reactions (such as pain, bruising, or redness).

More serious, though less common, side effects can include inflammation of the pancreas (pancreatitis), gallbladder problems (like gallstones), kidney damage, serious allergic reactions, and low potassium levels. Xultophy also carries a boxed warning regarding the potential risk of thyroid C-cell tumors, as observed in animal studies with liraglutide.

Is Xultophy safe during pregnancy or breastfeeding?

There is no clinical experience with Xultophy in pregnant women, and treatment with Xultophy should be discontinued if a patient wishes to become pregnant or if pregnancy occurs. It is not known if Xultophy passes into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Xultophy and any potential adverse effects on the breastfed infant.

Can Xultophy be taken with other medications?

Xultophy can interact with other medications, potentially affecting glucose metabolism. Substances that may reduce the Xultophy requirement include other antidiabetic medicinal products, MAOIs, beta-blockers, ACE inhibitors, salicylates, anabolic steroids, and sulfonamides. Conversely, substances that may increase the Xultophy requirement include oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones, and danazol.

Beta-blockers can also mask the symptoms of hypoglycemia. Due to the liraglutide component, Xultophy may slightly delay the absorption of concomitantly administered oral medications. Close monitoring of blood glucose is recommended when taking Xultophy with other medications. You should always inform your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking.

What precautions should be taken?

Xultophy should not be used if you have type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is also contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Patients should be instructed on the symptoms of hypoglycemia and hyperglycemia and what to do if they occur. Rotate injection sites within the same region (thigh, upper arm, or abdomen) to reduce the risk of lipodystrophy. Never share your Xultophy pen with other people, even if the needle is changed, to avoid the risk of transmitting infections.

What happens if a dose is missed?

If you miss a dose of Xultophy, take it as soon as you remember, then resume your usual once-daily dosing schedule. However, ensure a minimum of 8 hours between injections. Do not take a double dose to make up for a missed dose. If you miss doses for an extended period (e.g., more than three days), contact your doctor for guidance on how to restart your treatment, as a lower dose might be recommended.

How should Xultophy be stored?

Unopened Xultophy pens should be stored in a refrigerator (between 2°C and 8°C or 36°F and 46°F) in the original carton to protect from light, until the expiration date. Do not freeze Xultophy, and discard if it has been frozen.

Once opened or in use, Xultophy pens can be stored for up to 21 days either in the refrigerator (2°C to 8°C) or at room temperature (below 30°C or 86°F). Keep the pen cap on when not in use and store without an injection needle attached. Protect from excessive heat and sunlight.