XULTOPHY 100 I.U./3.6 MG/ML PREFILLED PEN 3 ml

XULTOPHY 100 I.U./3.6 MG/ML PREFILLED PEN 3 ml

Description:

Xultophy 100 iu/3.6 mg/ml prefilled pen 3 ml is a prescription diabetes medicine used for the treatment of adults with type 2 diabetes mellitus. It is a fixed-ratio combination of a long-acting basal insulin analogue (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide). Xultophy is administered as a once-daily subcutaneous injection to help achieve and maintain optimal blood glucose control, reduce HbA1c, and lower the risk of hyperglycemia in patients who require both basal insulin and GLP-1 therapy. It is part of comprehensive diabetes care and should be used under medical supervision as an adjunct to diet and exercise.

Indications:

• Management of type 2 diabetes mellitus in adults who are insufficiently controlled on basal insulin (less than 50 units) or liraglutide alone, or on oral antidiabetic medicines.
• Improves glycemic control by lowering fasting and postprandial blood glucose levels.
• Helps reduce elevated HbA1c (A1C) in patients with type 2 diabetes.
• May support modest weight reduction or weight neutrality compared with basal insulin alone (based on liraglutide component), as directed by the treating physician.
• Used as part of a long-term diabetes management plan together with diet, physical activity, and regular blood glucose monitoring.

Active Ingredients / Key Components:

• Insulin degludec – 100 units/ml (ultra-long-acting basal insulin analogue).
• Liraglutide – 3.6 mg/ml (GLP-1 receptor agonist).
• Each prefilled pen contains 3 ml of solution for injection, corresponding to 300 units of insulin degludec and 10.8 mg of liraglutide in total.
• Other excipients (such as glycerol, phenol, metacresol, zinc acetate, hydrochloric acid/sodium hydroxide for pH adjustment, and water for injections) are typically present, but the full excipient list and exact concentrations , please check the product leaflet or the manufacturer’s official website. Please refer to the official package leaflet for a complete ingredient list.

Dosage & Administration / How to Use:

• Xultophy is for subcutaneous injection only. Do not administer intravenously or intramuscularly.
• Usual starting dose (when switching from basal insulin or GLP-1 alone) is determined individually by the prescribing physician based on current therapy, blood glucose levels, and clinical status. Follow your doctor’s exact instructions.
• Administer once daily, preferably at the same time each day, with or without food.
• Inject into the subcutaneous tissue of the abdomen, thigh, or upper arm. Rotate injection sites within the same region to reduce the risk of lipodystrophy or skin reactions.
• Use the prefilled pen as instructed in the patient leaflet: attach a new sterile needle, perform a safety check (flow check/prime) if recommended, dial the prescribed dose, insert the needle into the skin, and press and hold the injection button for the recommended time before removing the needle.
• Do not share your Xultophy pen or needles with anyone else to avoid cross-infection.
• If a dose is missed, follow your doctor’s guidance or the patient information leaflet. Do not double the dose to make up for a missed dose.
• Regularly monitor blood glucose as advised by your healthcare provider and report any episodes of hypoglycemia or persistent hyperglycemia.
• Any dose adjustments, initiation, or discontinuation must be done only under medical supervision.

Clinical Benefits:

• Provides stable, ultra-long-acting basal insulin coverage (insulin degludec) for up to approximately 42 hours, helping to maintain steady fasting blood glucose levels.
• Combines insulin degludec with liraglutide to target multiple pathophysiological defects in type 2 diabetes, improving both fasting and postprandial glucose control.
• Helps significantly reduce HbA1c (A1C) when used as prescribed, supporting long-term glycemic control and reducing the risk of diabetes-related complications.
• Once-daily dosing simplifies treatment regimens for patients who require both basal insulin and GLP-1 therapy, potentially improving adherence.
• Liraglutide component may support modest weight loss or limit weight gain compared to basal insulin alone, as assessed by the treating physician.
• May reduce the total daily insulin requirement compared with basal insulin intensification alone in some patients, which can help lower the risk of insulin-related side effects.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to insulin degludec, liraglutide, or any of the excipients.
• Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
• Not recommended for use in children and adolescents; safety and efficacy in this age group have not been established.
• Use with caution in patients with a history of pancreatitis; discontinue and seek medical attention if severe abdominal pain occurs.
• Use with caution in patients with severe renal or hepatic impairment; dose adjustments and close monitoring may be required.
• Risk of hypoglycemia, especially if used with other antidiabetic agents, in case of missed meals, excessive exercise, or overdose. Patients must be educated on recognizing and managing hypoglycemia.
• May cause dehydration, especially in combination with gastrointestinal side effects (nausea, vomiting, diarrhea); ensure adequate fluid intake.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Your doctor will decide if therapy should be continued or changed.
• Inform your doctor about all medications you are taking, including other antidiabetic drugs, beta-blockers, corticosteroids, diuretics, ACE inhibitors, and others, as they may affect blood glucose or insulin requirements.
• Do not drive or operate machinery if you experience symptoms of hypoglycemia (such as dizziness, confusion, blurred vision) until you are sure you can do so safely.
• Consult your doctor before use if you have thyroid disease, gastrointestinal disorders, or a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2), as GLP-1 receptor agonists may not be appropriate in these conditions.
• Keep out of reach of children.

Side Effects:

• Common side effects may include nausea, vomiting, diarrhea, decreased appetite, headache, and injection site reactions (redness, swelling, itching).
• Hypoglycemia (low blood sugar) is a frequent side effect, especially when combined with other glucose-lowering medicines. Symptoms include sweating, shakiness, fast heartbeat, hunger, dizziness, confusion, and blurred vision.
• Less common side effects may include lipodystrophy (thickening or thinning of the skin at injection sites), allergic reactions, or mild skin rashes.
• Serious but rare side effects may include pancreatitis (severe, persistent abdominal pain, possibly radiating to the back), severe allergic reactions (swelling of face, tongue, throat, difficulty breathing), or significant changes in kidney function.
• Seek immediate medical attention if you experience signs of severe hypoglycemia, severe abdominal pain, difficulty breathing, swelling of the face or throat, or any other severe or unusual symptoms.

Storage Instructions:

Store in a refrigerator at 2–8°c before first use. Do not freeze. Keep away from the freezer compartment and do not use if the product has been frozen. After first use, the pen may usually be kept at room temperature (below 30°c) or in a refrigerator, according to the manufacturer’s instructions; refer to the package leaflet for exact post-opening storage conditions. Protect from direct sunlight and heat. Keep the cap on the pen when not in use to protect from light. Keep container out of the sight and reach of children.

Specifications:

• Product type: prescription antidiabetic medicine (fixed-ratio combination of basal insulin and GLP-1 receptor agonist).
• Form: solution for injection in a prefilled pen.
• Strength: 100 units insulin degludec/ml + 3.6 mg liraglutide/ml.
• Pen size: 3 ml prefilled pen.
• Route of administration: subcutaneous injection.
• Intended use: adult patients with type 2 diabetes mellitus requiring combination therapy with basal insulin and GLP-1 receptor agonist as part of a comprehensive diabetes management plan.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.