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Ozempic 0.5 mg solution for injection in pre Filled pen (1 x 1.5 mL)

Ozempic 0.5 mg solution for injection in pre Filled pen (1 x 1.5 mL)

Ozempic

Medicinal Products
  • Authorised in the European Union and United Kingdom as Ozempic 0.5 mg solution for injection in pre Filled pen with semaglutide as the active ingredient.
  • UK marketing authorisation held by Novo Nordisk Limited, with product information published via the electronic Medicines Compendium (eMC).
  • Centrally authorised by the European Medicines Agency (EMA) under EU/1/17/1251 with approved summary of product characteristics and patient information leaflet.
  • Approved in other major markets (e.g. United States, Australia, etc.) under corresponding regulatory frameworks as a prescription Only GLP 1 receptor agonist.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) standards for human medicinal products at licensed Novo Nordisk facilities.
  • Classified under ATC code A10BJ06 (semaglutide) as a GLP 1 receptor agonist antidiabetic agent.
  • Subject to pharmacovigilance programmes including adverse reaction reporting (e.g. MHRA Yellow Card scheme in the UK) and periodic safety updates.
GLP-1 receptor agonist pre-filled injection pen for type 2 diabetes mellitus

Description

Ozempic 0.5 mg solution for injection in pre-filled pen is a once-weekly prescription medicine containing semaglutide, a long-acting human glucagon-like peptide-1 (GLP-1) receptor agonist. Each 1.5 mL glass cartridge pre-filled pen contains 2 mg semaglutide in a clear, colourless aqueous solution, delivering four individual doses of 0.5 mg (0.37 mL) for subcutaneous injection. It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. Semaglutide enhances glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion, slows gastric emptying and reduces appetite, thereby lowering blood glucose and promoting weight loss. The 0.5 mg dose is typically used as the first maintenance dose following initiation at 0.25 mg once weekly and may be further escalated to 1 mg or 2 mg once weekly in patients requiring additional glycaemic control.

Bnefits

  • Once-weekly subcutaneous injection, which can support adherence compared with therapies requiring daily injections or multiple daily doses.
  • Improves glycaemic control (reduces HbA1c) in adults with type 2 diabetes when used alongside diet and exercise.
  • Reduces the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease.
  • Reduces the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
  • Associated with clinically meaningful weight loss in many patients, due to reduced appetite and energy intake.
  • Low intrinsic risk of hypoglycaemia when used as monotherapy or in combination with agents not associated with hypoglycaemia (e.g. metformin, SGLT2 inhibitors); risk mainly increases when combined with sulfonylureas or insulin.
  • The 0.5 mg strength provides an effective maintenance dose for many patients while balancing efficacy and gastrointestinal tolerability, and serves as a step between the 0.25 mg initiation dose and higher maintenance doses.
  • Pre-filled, multi-dose dial-a-dose pen designed for self-administration after appropriate training, with very thin single-use pen needles.
  • Long-acting GLP-1 analogue with approximately weekly dosing interval, offering relatively stable plasma concentrations and continuous receptor activation.
  • Can be used as monotherapy when metformin is contraindicated or not tolerated, or as add-on therapy to other glucose-lowering agents including basal insulin.

Indications

  • Adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.
  • Monotherapy in adults with type 2 diabetes when metformin is considered inappropriate due to intolerance or contraindications.
  • Combination therapy with other medicinal products for the treatment of type 2 diabetes (such as metformin, sulfonylureas, SGLT2 inhibitors, thiazolidinediones or insulin) when these do not provide adequate glycaemic control.
  • Reduction of the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • Reduction of the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
  • Use only in adults (18 years and older) with type 2 diabetes; not indicated for type 1 diabetes mellitus, diabetic ketoacidosis or primary weight management in the absence of type 2 diabetes.

Composition

  • Active ingredient: Semaglutide, a human GLP-1 analogue produced in Saccharomyces cerevisiae by recombinant DNA technology.
  • Each 1 mL of solution contains 1.34 mg semaglutide.
  • Each pre-filled pen (1.5 mL) contains 2 mg semaglutide and delivers four doses of 0.5 mg (each dose 0.37 mL solution).
  • Excipients: disodium phosphate dihydrate, propylene glycol, phenol and water for injections.
  • Hydrochloric acid and/or sodium hydroxide may be used during manufacture for pH adjustment (target pH approximately 7.4).
  • Solution characteristics: sterile, clear, colourless or almost colourless aqueous solution for subcutaneous injection.

Formulation

  • Pharmaceutical form: solution for injection in pre-filled pen.
  • Presentation: 1.5 mL type I glass cartridge containing 2 mg semaglutide assembled into a disposable, single-patient-use pen.
  • Dose per injection: 0.5 mg semaglutide in 0.37 mL solution; each 1.5 mL pen delivers four 0.5 mg doses.
  • Route of administration: subcutaneous injection into the abdomen, thigh or upper arm.
  • Therapeutic class: glucagon-like peptide-1 (GLP-1) receptor agonist antidiabetic agent.
  • Typical regimen: after 4 weeks at 0.25 mg once weekly, increase to 0.5 mg once weekly; 0.5 mg may be maintained long-term or further escalated to 1 mg (and in some territories 2 mg) once weekly after at least 4 weeks at the previous dose if additional glycaemic control is needed.
  • Mechanism of action: semaglutide selectively binds to and activates GLP-1 receptors, enhancing glucose-dependent insulin secretion, lowering inappropriately elevated glucagon, slowing gastric emptying and reducing appetite, which together lower blood glucose and body weight.
  • Device: dial-a-dose pen compatible with NovoFine Plus or equivalent single-use pen needles; intended for single-patient multiple-use until empty or beyond in-use expiry.

Packaging

  • Cartridge: 1.5 mL type I glass cartridge closed with a chlorobutyl rubber plunger at one end and an aluminium cap with a laminated bromobutyl/polyisoprene rubber sheet at the other end.
  • Pen-injector: disposable pre-filled pen made of medical-grade plastics (polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene) enclosing the glass cartridge.
  • Pack sizes: cartons containing 1 pre-filled pen and 4 disposable NovoFine Plus needles, or 3 pre-filled pens and 12 disposable NovoFine Plus needles (availability may vary by market).
  • Each retail pack includes a patient information leaflet (PIL) and detailed instructions for use describing dose selection, injection technique and pen handling.
  • Outer carton labelling: product name (Ozempic 0.5 mg), strength, pharmaceutical form, number of doses per pen, route of administration, storage conditions, batch number and expiry date.
  • Pens and cartons are colour-coded and clearly labelled to distinguish the 0.5 mg strength from other Ozempic strengths.

Usage

  • Treatment with Ozempic should be initiated and supervised by a healthcare professional experienced in the management of type 2 diabetes.
  • Usual initiation: 0.25 mg once weekly for 4 weeks. The 0.25 mg dose is for treatment initiation and is not intended as a maintenance dose.
  • After 4 weeks at 0.25 mg, increase the dose to 0.5 mg once weekly. The 0.5 mg dose may be maintained as long-term therapy or, if additional glycaemic control is needed and tolerated, escalated after at least 4 weeks to 1 mg once weekly and potentially higher where authorised.
  • Administer once weekly on the same day of the week, at any time of day, with or without meals.
  • Inject subcutaneously into the abdomen, thigh or upper arm. Rotate injection sites within a region to reduce the risk of lipodystrophy and local reactions.
  • Use a new, sterile pen needle for each injection. Do not reuse needles and do not share pens or needles with other individuals.
  • Before each injection, check the pen label to ensure it is Ozempic 0.5 mg and visually inspect the solution; use only if it is clear and colourless and the pen appears intact.
  • Prime a new pen according to the instructions for use before the first injection to ensure correct dose delivery.
  • If a weekly dose is missed, follow the instructions in the local patient leaflet or from the prescriber (e.g. inject as soon as possible within a defined time window and then resume the usual weekly schedule, or skip and continue as planned; rules differ by jurisdiction and labelling).
  • When used together with a sulfonylurea or insulin, consider reducing the dose of the sulfonylurea or insulin to minimise hypoglycaemia risk; this should be done by a healthcare professional.
  • Patients should be advised about common gastrointestinal side effects (nausea, vomiting, diarrhoea) especially during dose escalation and may benefit from smaller meals and avoiding very rich or fatty foods if symptoms occur.
  • Patients should promptly seek medical attention if they experience severe, persistent abdominal pain (with or without vomiting), signs of pancreatitis, gallbladder disease, allergic reactions, severe dehydration or worsening visual symptoms.
  • Pens should be used only by the patient to whom they are prescribed and should be kept out of the reach of children.

Contraindications

  • Hypersensitivity to semaglutide or to any of the excipients (disodium phosphate dihydrate, propylene glycol, phenol, water for injections or pH-adjusting agents).
  • Use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis (ineffective and not indicated).
  • Not recommended for use in patients with severe gastrointestinal disease, including severe gastroparesis, due to limited experience and the drug’s effect on gastric emptying.
  • Use during pregnancy is not recommended; semaglutide should be discontinued prior to a planned pregnancy in accordance with product information, and effective contraception is advised during treatment and for a washout period after discontinuation.
  • Use during breastfeeding is not recommended unless potential benefits clearly outweigh potential risks; decision should be made with a healthcare professional.
  • Caution and generally avoidance in patients with a history of pancreatitis; if pancreatitis is suspected, Ozempic should be discontinued and not restarted if pancreatitis is confirmed.
  • Patients with severe dehydration or at high risk of dehydration should be monitored closely because gastrointestinal adverse reactions may lead to fluid loss and renal impairment.
  • Patients with pre-existing diabetic retinopathy should be monitored, as rapid improvement in glycaemic control has been associated with temporary worsening of retinopathy.
  • Any additional contraindications or specific restrictions described in the current Summary of Product Characteristics (SmPC) or local prescribing information must be observed.

Adverse Effects

  • Very common gastrointestinal adverse reactions: nausea, vomiting, diarrhoea, constipation and abdominal pain, particularly during dose escalation.
  • Decreased appetite and weight loss, which may be beneficial but can be excessive in some patients.
  • Dyspepsia, eructation (belching), flatulence and gastro-oesophageal reflux.
  • Hypoglycaemia, especially when Ozempic is used in combination with insulin or sulfonylureas; symptoms may include sweating, tremor, palpitations, hunger, confusion or loss of consciousness.
  • Injection-site reactions such as erythema, pruritus, swelling or mild pain.
  • Acute pancreatitis (rare), typically presenting as persistent, severe abdominal pain that may radiate to the back, sometimes accompanied by vomiting.
  • Gallbladder-related disorders, including cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation).
  • Possible worsening of diabetic retinopathy in patients with pre-existing disease, especially with rapid improvement in glycaemic control.
  • Renal impairment or acute kidney injury, secondary to dehydration resulting from severe persistent vomiting or diarrhoea.
  • Hypersensitivity reactions including rash, pruritus, urticaria and, rarely, anaphylactic reactions or angioedema.
  • Increased heart rate, fatigue, dizziness and headache reported in some patients.
  • Preclinical findings of thyroid C-cell tumours in rodents exposed to semaglutide; the relevance to humans is uncertain but underlies warnings regarding use in patients with personal or family history of medullary thyroid carcinoma or MEN 2 in some jurisdictions.

Storage Conditions

  • Unopened pens: store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze; discard if the pen has been frozen.
  • Keep unopened pens in the original carton to protect from light.
  • In-use pens: may be stored either in a refrigerator (2°C to 8°C) or at room temperature (according to local SmPC, typically not above 25–30°C) for a specified in-use period (for example, up to 6 weeks); after this period, any remaining solution must be discarded even if the pen is not empty.
  • Always replace the pen cap after each injection to protect the solution from light.
  • Do not store the pen with a needle attached, to prevent leakage, contamination or air entry.
  • Protect from excessive heat and direct sunlight; do not store near heat sources or in hot vehicles.
  • Keep out of the sight and reach of children.
  • Dispose of used pens and needles in accordance with local regulations for sharps and pharmaceutical waste (e.g. in approved sharps containers).

Duration

Ozempic 0.5 mg is intended for long-term, chronic therapy in adults with type 2 diabetes mellitus when clinically appropriate. Duration of treatment is individualised based on glycaemic control, cardiovascular and renal risk, weight management goals, tolerability and patient preference. Therapy may continue for years if the benefit\u2013risk profile remains favourable and should be reviewed periodically by a healthcare professional.

Onset

Improvement in fasting and postprandial glucose can occur within the first weeks of therapy, with substantial HbA1c reductions typically observed after 12\u201316 weeks of once-weekly dosing. Appetite reduction and weight loss may begin within weeks, but the extent and timing of response vary between individuals. Cardiovascular and renal risk-reduction effects are based on long-term use in outcome trials.

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