Saxenda 6 mg/ml (liraglutide) 18 mg/3 ml pre Filled pen
Saxenda
Prescription MedicinesGLP-1 receptor agonist for weight management
Certifications
- UK Licensed prescription Only medicinal product (Marketing Authorisation held by Novo Nordisk Limited / Novo Nordisk A/S, depending on jurisdiction).
- Manufactured in compliance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicines.
- Product information and safety profile conform to the current Summary of Product Characteristics (SmPC) and Patient Information Leaflet approved by regulatory authorities (e.g. EMA and MHRA).
- UK Licensed prescription Only medicinal product (Marketing Authorisation held by Novo Nordisk Limited / Novo Nordisk A/S, depending on jurisdiction).
- Manufactured in compliance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicines.
- Product information and safety profile conform to the current Summary of Product Characteristics (SmPC) and Patient Information Leaflet approved by regulatory authorities (e.g. EMA and MHRA).
GLP-1 receptor agonist for weight management
Description
Saxenda 6 mg/ml solution for injection in pre-filled pen is a once-daily GLP-1 receptor agonist used as an adjunct to a reduced-calorie diet and increased physical activity for weight management. Each pre-filled pen contains 3 ml of solution with 6 mg/ml liraglutide (18 mg total) and is designed to deliver adjustable doses (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg) by subcutaneous injection. Saxenda enhances satiety, reduces appetite, slows gastric emptying and lowers energy intake, helping adults with obesity or overweight plus weight-related comorbidities achieve clinically meaningful weight loss under medical supervision.
Bnefits
- Clinically proven GLP-1 receptor agonist for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity.
- Once-daily subcutaneous injection with a stepwise titration schedule to a maintenance dose of 3.0 mg to optimise efficacy and tolerability.
- Pre-filled multi-dose pen provides clear dose markings and adjustable doses (0.6–3.0 mg), supporting accurate self-administration.
- Demonstrated reductions in body weight and improvements in obesity-related risk factors (e.g. glycaemic control, blood pressure, lipids) when combined with diet and exercise.
- Dial-a-dose pen design supports convenient home use and adherence to long-term therapy when patients are appropriately trained.
- Extensive clinical trial data and post-marketing experience supporting a well-characterised efficacy and safety profile.
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 supervision of a healthcare professional experienced in the management of obesity and weight-related conditions.
Composition
- Active ingredient: Liraglutide 6 mg/ml.
- Each pre-filled pen contains 18 mg liraglutide in 3 ml solution.
- Liraglutide is a human GLP-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
- Excipients: Disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), water for injections.
- Pharmaceutical form: clear, colourless or almost colourless isotonic solution, pH approximately 8.15.
Formulation
- Sterile, clear solution for injection in a pre-filled, multi-dose dial-a-dose pen.
- Concentration: 6 mg/ml liraglutide.
- Intended for subcutaneous use only (abdomen, thigh or upper arm).
Packaging
- Single-patient-use pre-filled multi-dose pen containing 3 ml solution (18 mg liraglutide).
- Pen able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
- Commercial pack sizes typically contain 1, 3 or 5 pre-filled pens (needles not included).
- Supplied in a carton with patient information leaflet and pen-specific Instructions for Use.
Usage
- Saxenda must be prescribed and initiated by an appropriate healthcare professional. Patients should be trained in correct pen handling and injection technique before self-administration.
- Administer once daily by subcutaneous injection in the abdomen, thigh or upper arm. Rotate injection sites within the same region to reduce the 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.
- Standard adult titration schedule (unless local guidance differs): 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 an increased dose, consider delaying dose escalation by an additional week; if the 3.0 mg dose is not tolerated, discontinuation may be necessary.
- Assess treatment response after 12 weeks on the 3.0 mg/day maintenance dose. If patients have not lost at least 5% of baseline body weight, discontinue therapy as further benefit is unlikely.
- Use a new sterile pen needle for each injection. Do not share pens between patients, even with a new needle.
- If a dose is missed and remembered within 12 hours of the usual time, take it as soon as possible. If more than 12 hours have passed, skip the missed dose and take the next dose at the usual time. Do not take an extra dose or increase the next dose to make up for a missed one.
- Continue concurrent lifestyle measures (reduced-calorie diet, increased physical activity and behavioural interventions) 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: Saxenda is contraindicated and should be discontinued if pregnancy occurs.
- Breast-feeding: use is not recommended.
- Not indicated for concurrent use with other GLP-1 receptor agonists or weight-loss medicines that act via GLP-1 pathways.
- Use with caution, and only after careful risk–benefit assessment, in patients with a history of pancreatitis, severe renal or hepatic impairment or severe heart failure.
Adverse Effects
- Very common: nausea, vomiting, diarrhoea, constipation; usually mild to moderate and dose-related, often decreasing over time with continued treatment and appropriate titration.
- Common: decreased appetite, dyspepsia, gastritis, abdominal pain, gastro-oesophageal reflux, flatulence, dry mouth, headache, dizziness, fatigue, injection-site reactions, mild hypoglycaemia (particularly in patients with type 2 diabetes on concomitant insulin or sulfonylureas).
- Uncommon but clinically important: acute pancreatitis (including severe cases); discontinue immediately if pancreatitis is suspected (e.g. persistent severe abdominal pain, possibly radiating to the back).
- Gallbladder-related events, including cholelithiasis and cholecystitis, which may be associated with rapid weight loss.
- Increased heart rate has been observed; monitor patients with pre-existing cardiovascular disease as clinically appropriate.
- Rare: serious hypersensitivity reactions including anaphylaxis and angioedema; discontinue and seek urgent medical attention if they occur.
- Potential risk of thyroid C-cell tumours observed in rodent studies; human relevance is uncertain but underlies contraindication in MTC/MEN 2.
Storage Conditions
- Unopened pens: store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezer compartment and cooling element.
- In-use pens: store at room temperature (not above 30°C) or in a refrigerator (2°C–8°C), protected from heat and light, in accordance with the expiry period stated in the package leaflet (commonly up to 1 month after first use).
- Do not use if the solution is not clear and colourless or almost colourless, or if the pen has been frozen.
- Keep out of the sight and reach of children.
- Dispose of used pens and needles safely according to local requirements for sharps and pharmaceutical waste.
Duration
Intended for long-term weight management. Reassess after 12 weeks on the 3.0 mg maintenance dose; discontinue if at least 5% weight loss from baseline has not been achieved. Ongoing duration should be periodically reviewed based on efficacy, tolerability and clinical need.
Onset
Appetite reduction and decreased food intake may be observed within days to weeks as the dose is titrated. Clinically meaningful weight loss is generally evaluated over several weeks to months, with formal assessment at 12 weeks on the 3.0 mg dose.
