Saxenda 6mg/1ml Pre Filled Pen 3ml (Pack of 5)
Saxenda
Prescription MedicinesGLP-1 receptor agonist for weight management
Certifications
- UK Licensed prescription Only medicine (POM) containing liraglutide 6 mg/ml solution for injection in pre Filled pen.
- Marketing authorisation held by Novo Nordisk Limited / Novo Nordisk A/S and regulated by the MHRA and EMA.
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
- Product information and use are governed by the approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
- UK Licensed prescription Only medicine (POM) containing liraglutide 6 mg/ml solution for injection in pre Filled pen.
- Marketing authorisation held by Novo Nordisk Limited / Novo Nordisk A/S and regulated by the MHRA and EMA.
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
- Product information and use are governed by the approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
GLP-1 receptor agonist for weight management
Description
Saxenda 6mg/1ml Pre-Filled Pen 3ml (Pack of 5) is a prescription-only weight loss medicine containing liraglutide, a GLP-1 receptor agonist. Each pre-filled pen holds 3 ml of solution with a concentration of 6 mg/ml (18 mg liraglutide per pen). Saxenda mimics the action of the naturally occurring gut hormone GLP-1, acting on appetite-regulating receptors in the brain to help you feel fuller and less hungry. Used once daily by subcutaneous injection alongside a reduced-calorie diet and increased physical activity, it helps adults with obesity or overweight plus weight-related health problems to lose weight and maintain weight loss under medical supervision. This pack contains 5 pre-filled multi-dose pens.
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 that reduces appetite, increases satiety and helps reduce overall food intake.
- Each 3 ml pen (18 mg liraglutide at 6 mg/ml) allows adjustable dosing (0.6–3.0 mg) for stepwise titration and personalised therapy.
- Demonstrated weight loss and improvements in obesity-related risk factors (such as blood glucose, blood pressure and serum lipids) when used with diet and exercise.
- Pack of 5 pens provides a convenient multi-week supply for ongoing treatment when prescribed.
- Dial-a-dose pen system supports accurate dosing and self-administration at home after appropriate training.
- Licensed and MHRA-approved medicine with a well-characterised safety and efficacy profile from large clinical studies.
Indications
- Adjunct to a reduced-calorie diet and increased physical activity for weight management in adults (≥18 years) with an initial BMI ≥30 kg/m² (obese).
- Adjunct to a reduced-calorie diet and increased physical activity for weight management in adults (≥18 years) with an initial BMI ≥27 kg/m² to <30 kg/m² (overweight) and at least one weight-related health problem such as type 2 diabetes, hypertension, dyslipidaemia or obstructive sleep apnoea.
- Use only under the supervision of a doctor experienced in the management of obesity or weight-related conditions.
Composition
- Active substance: Liraglutide 6 mg/ml.
- Each pre-filled pen contains 18 mg liraglutide in 3 ml solution.
- Liraglutide is a human GLP-1 (glucagon-like peptide-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
- Other ingredients (excipients): Disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and 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, dial-a-dose pen.
- Concentration: 6 mg/ml liraglutide.
- Intended for subcutaneous administration only (abdomen, thigh or upper arm).
Packaging
- Pack of 5 single-patient-use pre-filled multi-dose pens, each containing 3 ml solution (18 mg liraglutide).
- Each pen can deliver multiple doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg once daily.
- Supplied in an outer carton with a Patient Information Leaflet and pen-specific Instructions for Use.
- Compatible disposable pen needles are supplied separately in accordance with local practice.
Usage
- Saxenda must be prescribed and initiated by a healthcare professional. Follow your doctor’s instructions exactly.
- Inject once daily by subcutaneous injection into the abdomen, thigh or upper arm. Rotate injection sites to reduce the risk of lipodystrophy.
- Saxenda can be injected at any time of day, with or without food, but should be taken at approximately the same time each day.
- Typical adult titration schedule (unless your prescriber advises otherwise): 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 onwards: 3.0 mg once daily (maintenance dose).
- If you cannot tolerate an increased dose, your doctor may advise delaying the dose increase by an extra week. If you cannot tolerate the 3.0 mg dose, your doctor may consider stopping treatment.
- You should only continue Saxenda if you have lost at least 5% of your initial body weight after 12 weeks on the 3 mg/day dose; consult your doctor before continuing beyond this point.
- Use a new sterile pen needle for each injection. Do not share your pen with anyone else, even if the needle is changed.
- If you miss a dose and remember within 12 hours of the usual time, inject 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 to follow the reduced-calorie diet and exercise programme recommended by your doctor while using Saxenda.
- Always read the enclosed Patient Information Leaflet carefully before first use and keep it for future reference.
Contraindications
- Hypersensitivity to liraglutide or any of the excipients.
- Personal or family history of medullary thyroid carcinoma (MTC).
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Pregnancy – Saxenda should not be used during pregnancy and must be discontinued if pregnancy occurs.
- Breast-feeding – use is not recommended while breast-feeding.
- Not recommended for use in children and adolescents under 18 years, as safety and efficacy have not been established in this age group.
Adverse Effects
- Very common: nausea, vomiting, diarrhoea, constipation – usually dose-related and often decrease over time with continued treatment and appropriate 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 diabetes using other glucose-lowering medicines).
- Potential for dehydration due to nausea, vomiting or diarrhoea, particularly at treatment initiation; patients should drink plenty of fluids and seek medical advice if unable to maintain hydration.
- Uncommon but serious: acute pancreatitis – characterised by persistent, severe abdominal pain, sometimes radiating to the back; discontinue Saxenda and seek urgent medical attention if suspected.
- Gallbladder-related events (gallstones and inflamed gallbladder), especially in the context of substantial weight loss; report persistent upper abdominal pain, fever or jaundice to a doctor.
- Possible increase in heart rate; patients with palpitations or a racing heartbeat at rest should consult their doctor.
- Rare: serious hypersensitivity reactions including anaphylaxis and angioedema; stop treatment and seek immediate medical help if symptoms such as difficulty breathing, swelling of the face, tongue or throat, or severe rash occur.
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: store at room temperature (not above 30°C) or in a refrigerator (2°C–8°C), according to the leaflet. Keep the pen cap on 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 used pens and needles safely in a sharps container in accordance with local regulations.
Duration
Long-term treatment for chronic weight management. Reassess after 12 weeks on the 3.0 mg maintenance dose; discontinue if at least 5% of initial body weight has not been lost. Ongoing duration should be regularly reviewed based on clinical response, tolerability and overall benefit\u2013risk.
Onset
Appetite reduction and decreased food intake may appear within days to weeks during dose titration. Clinically meaningful weight loss is typically assessed over several weeks to months, with formal evaluation at 12 weeks on the 3.0 mg/day dose.
