Saxenda Pens 6mg/ml 3ml Solution
Saxenda
Prescription MedicinesGLP-1 receptor agonist for weight management
Certifications
- UK Licensed prescription Only medicinal product with marketing authorisation held by Novo Nordisk Limited/A/S in relevant territories.
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable products.
- Regulatory documentation (SmPC and PIL) approved by competent authorities (e.g. MHRA, EMA) describing indications, dosing, safety and risk management.
- UK Licensed prescription Only medicinal product with marketing authorisation held by Novo Nordisk Limited/A/S in relevant territories.
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable products.
- Regulatory documentation (SmPC and PIL) approved by competent authorities (e.g. MHRA, EMA) describing indications, dosing, safety and risk management.
GLP-1 receptor agonist for weight management
Description
Saxenda Pens 6mg/ml 3ml Solution are pre-filled, multi-dose injection pens containing liraglutide, a GLP-1 receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management. Each pen contains 3 ml of solution with a concentration of 6 mg/ml (18 mg liraglutide per pen) and is designed for once-daily subcutaneous self-injection after appropriate training. Saxenda helps reduce appetite, increase satiety and slow gastric emptying, thereby lowering overall energy intake and supporting clinically meaningful weight loss in adults with obesity or overweight and weight-related comorbidities when used under medical supervision.
Bnefits
- Clinically proven GLP-1 receptor agonist for chronic weight management in adults with obesity or overweight plus weight-related comorbidities.
- Each 3 ml pre-filled pen contains 18 mg liraglutide at a concentration of 6 mg/ml, with adjustable doses (0.6–3.0 mg) to allow stepwise titration.
- Once-daily subcutaneous dosing supports convenient home self-administration after training.
- Improves satiety, reduces appetite and slows gastric emptying, leading to reduced energy intake and weight loss when combined with diet and exercise.
- Has demonstrated improvements in obesity-related risk factors (such as glycaemic control, blood pressure and lipid parameters) in clinical studies when used with lifestyle modification.
- Dial-a-dose pen with clear markings may help reduce dosing errors and support adherence to long-term therapy.
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) and at least one weight-related comorbidity (such as dysglycaemia, hypertension, dyslipidaemia or obstructive sleep apnoea).
- To be prescribed and monitored by healthcare professionals experienced in the management of obesity and 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 for injection.
Formulation
- Sterile solution for injection in a pre-filled, multi-dose pen.
- Concentration: 6 mg/ml liraglutide.
- Route of administration: Subcutaneous injection into the abdomen, thigh or upper arm.
Packaging
- Single-patient-use pre-filled multi-dose pen containing 3 ml (18 mg) liraglutide solution.
- Pen designed to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg once daily.
- Commercial packs typically contain multiple pens (e.g. 1, 3 or 5 pens per carton) with a patient information leaflet; pen needles supplied separately according to local practice.
Usage
- Saxenda should be prescribed and initiated by a suitable healthcare professional; patients must receive training in pen handling and subcutaneous injection technique before self-use.
- Inject once daily subcutaneously into the abdomen, thigh or upper arm; rotate injection sites within the same region to minimise the risk of lipodystrophy.
- Saxenda can be taken at any time of day, with or without food, but it is recommended to administer at approximately the same time each day.
- Typical adult titration schedule (subject to local guidance and prescriber judgement): 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 the patient cannot tolerate an increased dose during titration, consider delaying dose escalation by an additional week; if the 3.0 mg dose is not tolerated, discontinuation may be necessary.
- Assess response after 12 weeks on the 3.0 mg 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.
- Use a new sterile pen needle for each injection and discard needles safely in an appropriate sharps container; do not share pens between patients.
- 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 a missed one.
- Continue a reduced-calorie diet, increased physical activity and other recommended lifestyle measures throughout treatment as part of a holistic weight-management programme.
Contraindications
- Hypersensitivity to liraglutide or any of the excipients in the formulation.
- Personal or family history of medullary thyroid carcinoma (MTC).
- 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 during treatment.
- Not indicated for patients with BMI below the licensed thresholds or for use in combination with other GLP-1 receptor agonists.
- 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; usually mild to moderate, dose-related and often transient with continued treatment and appropriate dose titration.
- Common: decreased appetite, dyspepsia, abdominal pain, gastro-oesophageal reflux, flatulence, dry mouth, headache, dizziness, fatigue, injection-site reactions, mild hypoglycaemia (especially in patients with type 2 diabetes on concomitant insulin or sulfonylureas).
- Uncommon but important: acute pancreatitis (including severe cases); discontinue immediately if pancreatitis is suspected (persistent severe abdominal pain, possibly radiating to the back).
- Gallbladder-related events (e.g. cholelithiasis, cholecystitis), which may be associated with substantial weight loss.
- Increased heart rate has been observed; monitoring may be advisable in patients with pre-existing cardiovascular disease.
- 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 rodents; human relevance is uncertain but underlies the 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 (as specified in the current product information, typically up to 1 month) at temperatures up to 30°C or in a refrigerator (2°C–8°C); always keep the pen cap on when not in use to protect from light.
- Do not use Saxenda if it has been frozen or if the solution is cloudy, coloured or contains particles.
- Keep out of the sight and reach of children.
- Dispose of pens and used needles in accordance with local regulations for sharps and pharmaceutical waste.
Duration
Intended for long-term use as part of chronic weight management. Treatment should be reassessed after 12 weeks at the 3.0 mg maintenance dose and periodically thereafter; discontinue if adequate weight loss (\u22655% of baseline body weight) has not been achieved or maintained, or if continued treatment is no longer clinically appropriate.
Onset
Appetite reduction and decreased food intake may appear within days to weeks as the dose is titrated. Clinically meaningful weight loss is generally evaluated over several weeks to months, with formal assessment recommended after 12 weeks on the 3.0 mg maintenance dose.
