Saxenda (Liraglutide) 6mg/ml – 3ml Pre Filled Injection Pen
Saxenda
Prescription MedicinesGLP-1 receptor agonist for weight management
Certifications
- UK Licensed medicinal product (Marketing Authorisation held by Novo Nordisk Limited).
- Subject to medical prescription only.
- Manufactured under EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
- Product information and safety profile in line with EMA and MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
- UK Licensed medicinal product (Marketing Authorisation held by Novo Nordisk Limited).
- Subject to medical prescription only.
- Manufactured under EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
- Product information and safety profile in line with EMA and MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
GLP-1 receptor agonist for weight management
Description
Saxenda (liraglutide) 6mg/ml – 3ml pre-filled injection pen is a once-daily GLP-1 receptor agonist licensed as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m² to <30 kg/m²) with at least one weight-related comorbidity (e.g. dysglycaemia, hypertension, dyslipidaemia or obstructive sleep apnoea). Each pre-filled pen contains 3 ml of solution (18 mg liraglutide) and is designed for subcutaneous self-injection after appropriate training. Saxenda acts by enhancing satiety, reducing appetite, slowing gastric emptying and thereby reducing energy intake. It is normally used as part of a comprehensive weight management programme under medical supervision.
Bnefits
- Clinically proven GLP-1 receptor agonist for chronic weight management in adults with obesity or overweight plus weight-related comorbidities.
- Once-daily subcutaneous injection with a titration schedule up to 3 mg to balance efficacy and tolerability.
- Pre-filled multi-dose pen delivers accurate doses (0.6, 1.2, 1.8, 2.4 or 3.0 mg) with clear dose markings to reduce dosing errors.
- Evidence of clinically meaningful weight loss and improvement in obesity-related risk factors (e.g. glycaemic control, blood pressure, lipid profile) when combined with diet and exercise.
- Can support reduction in long-term obesity-related health risks when used as part of a structured weight-management programme.
- Pen design and once-daily regimen support home self-administration and treatment adherence when supervised by a prescriber.
Indications
- Adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI ≥30 kg/m² (obese).
- Adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
- Use only on prescription and under the supervision of a healthcare professional experienced in managing obesity/weight-related conditions.
Composition
- Active ingredient: Liraglutide 6 mg/ml.
- Each pre-filled pen contains 18 mg liraglutide in 3 ml solution.
- Excipients: Disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
- Sterile, clear, colourless, isotonic solution for injection.
Formulation
- Solution for injection in pre-filled, multi-dose pen.
- Concentration: 6 mg/ml liraglutide.
- Route of administration: subcutaneous injection (abdomen, thigh or upper arm).
Packaging
- Single-patient-use pre-filled multi-dose pen containing 3 ml solution (18 mg liraglutide).
- Pen designed to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg.
- Commercial packs may contain 1, 3 or 5 pens depending on market; pharmacy/wholesaler pack configuration may vary.
- Pens are supplied with patient information leaflet; compatible disposable pen needles are supplied separately.
Usage
- Saxenda must be prescribed by an appropriate prescriber and patients should receive training in pen use and injection technique.
- Administer once daily by subcutaneous injection into the abdomen, thigh or upper arm; rotate injection sites to reduce risk of lipodystrophy.
- Saxenda can be injected at any time of day, with or without food, but it is recommended to inject at approximately the same time each day.
- Typical adult titration schedule (as per SmPC/local guidance): Week 1: 0.6 mg once daily; Week 2: 1.2 mg once daily; Week 3: 1.8 mg once daily; Week 4: 2.4 mg once daily; Week 5 and thereafter: 3.0 mg once daily (maintenance dose).
- If a patient cannot tolerate a higher dose during titration, consider delaying dose escalation by an additional week; if the 3.0 mg dose is not tolerated, discontinuation may be required.
- Assess treatment response after 12 weeks on the 3.0 mg/day maintenance dose; discontinue treatment if the patient has not lost at least 5% of initial body weight, as continued therapy is unlikely to provide meaningful benefit.
- Do not share pens between patients, even with a new needle, to prevent cross-infection.
- Use a new sterile pen needle for each injection and safely dispose of used needles in an approved sharps container.
- If a dose is missed and remembered within 12 hours of the usual time, administer it as soon as possible. If more than 12 hours have passed, skip the missed dose and resume with the next scheduled dose; do not take an extra dose or increase the next dose to make up for the missed one.
- Continue with a reduced-calorie diet, increased physical activity and other lifestyle/behavioural measures throughout treatment as advised by the healthcare professional.
Contraindications
- Hypersensitivity to liraglutide or any of the excipients.
- Personal or family history of medullary thyroid carcinoma (MTC).
- Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Pregnancy (use is contraindicated; discontinue if pregnancy occurs).
- Breast-feeding is not recommended during Saxenda therapy.
- Not indicated for patients with BMI below the licensed thresholds or for treatment of type 2 diabetes in combination with other GLP-1-based therapies.
- Use with caution and under specialist supervision in patients with a history of pancreatitis, severe renal or hepatic impairment, or severe heart failure.
Adverse Effects
- Very common: nausea, vomiting, diarrhoea, constipation; these are usually mild to moderate, dose-related and often diminish with continued treatment.
- Common: hypoglycaemia (especially in patients with type 2 diabetes on concomitant sulfonylureas or insulin), decreased appetite, dyspepsia, abdominal pain, gastro-oesophageal reflux, flatulence, fatigue, injection-site reactions, headache, dizziness.
- Uncommon but important: pancreatitis (acute pancreatitis including severe cases) – discontinue if pancreatitis is suspected (e.g. persistent severe abdominal pain radiating to the back).
- Gallbladder-related events such as cholelithiasis and cholecystitis, likely related to rapid weight loss in some patients.
- Possible increase in heart rate; monitor in patients with pre-existing cardiac conditions as clinically appropriate.
- Rare: serious hypersensitivity reactions including anaphylaxis and angioedema – discontinue immediately and seek urgent medical attention.
- Potential risk of thyroid C-cell tumours observed in rodents; relevance to humans is uncertain but underlies contraindication in MTC/MEN 2.
Storage Conditions
- Unopened pens: store in a refrigerator at 2°C–8°C. Do not freeze. Keep away from the freezer compartment and cooling element.
- In-use pens: may be stored for a limited period (e.g. up to 1 month) at room temperature not exceeding 30°C, or in a refrigerator (2°C–8°C), according to the current SmPC/leaflet; always keep the cap on the pen when not in use to protect from light.
- Do not use Saxenda if it has been frozen or if the solution is not clear and colourless.
- Keep out of the sight and reach of children.
- Dispose of pens and needles in accordance with local requirements for sharps and pharmaceutical waste.
Duration
Long-term treatment. Reassess after 12 weeks on the 3.0 mg maintenance dose; discontinue if \u22655% weight loss from baseline has not been achieved. Ongoing duration should be regularly reviewed based on efficacy, safety and clinical need.
Onset
Appetite suppression and reduced food intake may occur within days to weeks of initiation as the dose is titrated; clinically meaningful weight loss is generally evaluated after several weeks to months, with formal assessment at 12 weeks on the 3.0 mg dose.
