XULTOPHY ® 100 / 3.6 ( INSULIN DELUDEC / LIRAGLUTIDE ) SOLUTION FOR SUBCUTANEOUS USE — 3 ML PRE-FILLED PEN

Xultophy® 100 units/ ml + 3.6 mg/ ml (Insulin Degludec + Liraglutide) – Important Safety Information

Contraindications

Xultophy® 100/3.6 should not be used in patients with:

• Personal or family history of MTC.
• Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2).
• Episodes of hypoglycemia.
• Known hypersensitivity to insulin degludec, liraglutide, or any formulation component.

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.

Warnings and Precautions

Acute Pancreatitis

Cases of acute pancreatitis, including severe and fatal forms, have been reported with GLP-1 receptor agonists. Discontinue treatment immediately if pancreatitis is suspected.

Hypoglycemia

Hypoglycemia is the most common adverse reaction associated with insulin-containing products and may be severe or life-threatening. Close glucose monitoring is recommended, particularly during treatment initiation, dose adjustments, or changes in lifestyle and concomitant medications.

Hyperglycemia and Insulin Regimen Changes

Changes in insulin therapy, injection technique, or injection site may affect glycemic control and increase the risk of hypo- or hyperglycemia. Adjustments should be made under medical supervision.

Medication Errors

Patients should verify the product label before each injection to avoid accidental mix-ups with other insulin products. The maximum recommended dose is 50 units daily.

Acute Kidney Injury

Dehydration resulting from gastrointestinal adverse effects such as nausea, vomiting, or diarrhea may contribute to acute kidney injury. Renal function should be monitored in at-risk patients.

Gastrointestinal Effects

Nausea, vomiting, diarrhea, and other gastrointestinal reactions may occur and can occasionally be severe. Xultophy® 100/3.6 is not recommended for patients with severe gastroparesis.

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis, angioedema, bronchospasm, hypotension, and shock, may occur. Treatment should be discontinued immediately if a severe hypersensitivity reaction develops.

Gallbladder Disease

GLP-1 receptor agonists have been associated with gallbladder disorders, including cholelithiasis and cholecystitis. Appropriate evaluation is recommended if gallbladder disease is suspected.

Hypokalemia

Insulin therapy may reduce serum potassium levels and potentially lead to serious complications. Potassium monitoring should be considered in high-risk patients.

Fluid Retention and Heart Failure

Patients receiving thiazolidinediones (TZDs) in combination with Xultophy® 100/3.6 should be monitored for signs and symptoms of heart failure.

Pulmonary Aspiration Risk

Delayed gastric emptying associated with liraglutide may increase the risk of pulmonary aspiration during procedures requiring general anesthesia or deep sedation. Patients should inform healthcare providers before planned surgical procedures.

Pen Sharing

Xultophy® 100/3.6 pens must never be shared between patients, even if the needle is changed, due to the risk of transmitting blood-borne pathogens.

Adverse Reactions

The most frequently reported adverse reactions (≥5%) include:

• Nasopharyngitis
• Headache
• Nausea
• Diarrhea
• Increased lipase levels
• Upper respiratory tract infection

Drug Interactions

Certain medications may alter glucose metabolism and require dose adjustments or enhanced blood glucose monitoring.

Liraglutide may delay gastric emptying and potentially affect the absorption of concomitantly administered oral medications. Appropriate clinical monitoring is advised.

Use in Special Populations

Pregnancy

Xultophy® 100/3.6 should be used during pregnancy only when the anticipated benefit outweighs the potential risk to the fetus.

Indications

Xultophy® 100/3.6 is a fixed-ratio combination of insulin degludec and liraglutide indicated, in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

• Not recommended for use with other liraglutide-containing products or GLP-1 receptor agonists.
• Not indicated for the treatment of diabetic ketoacidosis.
• Has not been studied in combination with prandial (mealtime) insulin.

Patient Information

Patients should use Xultophy® 100/3.6 exactly as prescribed and attend regular follow-up appointments for monitoring of blood glucose and treatment response. Any symptoms suggestive of severe hypoglycemia, pancreatitis, allergic reactions, thyroid abnormalities, or gallbladder disease should be reported promptly to a healthcare professional.

Write a review