Xultophy 3.6mg 100iu Inj 3ml

Overview

Xultophy 100/3.6 mg/mL Injection 3 mL is a prescription injectable medicine used for blood glucose control in adults with type 2 diabetes mellitus. It combines two antidiabetic agents in one pre-filled pen: insulin degludec, a long-acting basal insulin, and liraglutide, a GLP-1 receptor agonist. The product is intended to be used along with diet, exercise, and, where prescribed, other oral diabetes medicines when glucose control remains insufficient.

This medicine is not an ordinary surgical disposable despite the listed store category. It is a cold-chain, prescription-only diabetes injection and should be supplied, stored, dispensed, and used with appropriate clinical supervision.

Benefits

• Helps improve blood glucose control in eligible adults with type 2 diabetes
• Combines basal insulin action with GLP-1 receptor agonist activity
• May simplify treatment for patients prescribed this fixed-ratio combination
• Can be used with diet, exercise, and prescribed oral diabetes medicines

Key Features

• Contains insulin degludec 100 units/mL and liraglutide 3.6 mg/mL
• 3 mL pre-filled injectable pen
• Once-daily subcutaneous administration
• Dose adjusted in dose steps according to individual glucose control needs
• For adults with type 2 diabetes mellitus

Dosage and How to Use

• How to use: Inject subcutaneously into the abdomen, thigh, or upper arm using the pre-filled pen. Rotate injection sites. Do not inject into a vein or muscle, do not use in an insulin pump, do not mix with other medicines, and do not share the pen.
• Administration: Subcutaneous injection only; abdomen, thigh, or upper arm. Rotate injection sites and attach a new needle before each use.
• Recommended dose: Dose must be individualized by the prescriber. Xultophy is usually given once daily; one dose step contains 1 unit insulin degludec and 0.036 mg liraglutide.
• Adult dose: Individualized once-daily dose based on fasting plasma glucose and clinical response. Starting and titration doses must be determined by the prescriber.
• Pediatric use: Safety and effectiveness in children and adolescents have not been established; not recommended unless specifically advised by a specialist.
• Elderly use: May be used in older adults only with medical supervision; closer glucose monitoring may be needed due to increased risk of hypoglycaemia or comorbid conditions.
• When to take: Once daily at the same time each day, with or without food, as directed by the prescriber.
• With food: May be used with or without food.
• Maximum daily dose: 50 dose steps daily, equivalent to 50 units insulin degludec and 1.8 mg liraglutide. Do not exceed the prescribed dose.
• Missed dose: Do not take two doses together or increase the dose to compensate. Follow the patient leaflet and prescriber’s advice; if multiple doses are missed, contact a healthcare professional before restarting.
• Overdose: Overdose may cause severe hypoglycaemia and gastrointestinal symptoms such as severe nausea or vomiting. Seek urgent medical advice or emergency care immediately.

Specifications

Side Effects

Common side effects

• Hypoglycaemia
• Nausea
• Diarrhoea
• Vomiting
• Constipation
• Indigestion or abdominal discomfort
• Decreased appetite
• Headache
• Dizziness
• Injection-site reaction

Serious side effects (seek medical help)

• Severe hypoglycaemia
• Pancreatitis
• Severe allergic reaction or anaphylaxis
• Gallbladder problems
• Kidney problems related to dehydration
• Possible thyroid tumour symptoms
• Worsening heart failure when used with thiazolidinediones in susceptible patients

Allergic reaction

Stop use and seek urgent medical help if signs of serious allergy occur, including rash, swelling of face or throat, breathing difficulty, dizziness, or collapse.

Safety and Precautions

• Risk of hypoglycaemia, especially with missed meals, excess dose, increased exercise, alcohol, or other glucose-lowering medicines
• Not for type 1 diabetes or diabetic ketoacidosis
• Possible pancreatitis warning; seek help for severe persistent abdominal pain
• Possible thyroid tumour warning with liraglutide-containing medicines
• Do not share pens or needles
• Monitor blood glucose as advised
• Use caution with kidney, liver, pancreatic, thyroid, stomach-emptying, or heart problems
• Review all medicines with a doctor or pharmacist
• Check the pen label before every injection
• Do not use if solution is cloudy, coloured, frozen, or contains particles

When not to use

Hypersensitivity to insulin degludec, liraglutide, or any excipient | Current episode of hypoglycaemia | Personal or family history of medullary thyroid carcinoma or MEN 2 where contraindicated by local labeling or prescriber guidance

Special populations

• Pregnancy: There is limited clinical experience in pregnancy. If pregnancy occurs or is planned, consult the doctor promptly; treatment may need to be changed.
• Breastfeeding: It is not known whether the active substances pass into human breast milk. Use during breastfeeding only if a healthcare professional determines it is appropriate.
• Fertility: Human fertility data are limited; discuss reproductive planning with a healthcare professional before use.
• Liver: Use with caution in liver disease. Dose needs and glucose response may change; medical monitoring is required.
• Kidney: Use with caution in kidney disease. Gastrointestinal side effects may cause dehydration and worsen kidney function; monitoring is advised.
• Heart: Tell your doctor if you have heart failure or other heart disease. Heart failure may worsen when insulin-containing therapy is combined with thiazolidinediones.
• Driving: Hypoglycaemia can impair concentration and reaction time. Avoid driving or operating machinery until you know how the medicine affects you and how to manage low blood sugar.
• Alcohol: Alcohol may increase or decrease the blood-glucose-lowering effect and can raise the risk of hypoglycaemia. Avoid or limit alcohol as advised by your doctor.

Interactions

Drugs:

• Other antidiabetic medicines may increase hypoglycaemia risk
• Sulfonylureas may require dose reduction when used with Xultophy
• MAO inhibitors, beta-blockers, ACE inhibitors, salicylates, anabolic steroids, and sulfonamides may reduce insulin requirement
• Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, and danazol may increase insulin requirement
• Beta-blockers may mask hypoglycaemia symptoms
• Octreotide or lanreotide may increase or decrease insulin requirement
• Warfarin or coumarin derivatives may require closer INR monitoring when treatment starts
• Do not combine with another liraglutide-containing product or another GLP-1 receptor agonist unless specifically directed

Food:

• No specific food restriction is established, but missed meals, major diet changes, or reduced carbohydrate intake can increase hypoglycaemia risk and may require medical review of dosing.

Conditions:

• Type 1 diabetes
• Diabetic ketoacidosis
• Pancreatitis or history of pancreatic disease
• Severe gastroparesis or serious gastrointestinal disease
• Kidney impairment
• Liver impairment
• Heart failure
• Thyroid disease, medullary thyroid carcinoma, or MEN 2 where relevant

Storage and Disposal

• Before first use, refrigerate at 2°C to 8°C and do not freeze. Keep away from the freezing element and protect from light. After opening, store according to the patient leaflet, generally up to 21 days at a maximum of 30°C or refrigerated.
• Cold-chain product. Store unopened at 2°C to 8°C. Do not freeze. After first use, follow in-use storage limits and discard after the stated period.
• Keep out of the sight and reach of children.
• Discard used needles safely in a sharps container. Do not reuse needles. Dispose of expired, frozen, damaged, or unused medicine according to local pharmacy or medical-waste guidance.

Disclaimer

This content is for product information only and is not a substitute for professional medical advice, diagnosis, or treatment. Use Xultophy only with a valid prescription and exactly as directed by a qualified healthcare professional. Always read the patient leaflet and seek urgent help for serious side effects.