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Ozempic (semaglutide) injection

Ozempic (semaglutide) injection

Ozempic

Medicinal Products
  • Authorised in the European Union and United Kingdom as a centrally approved medicinal product under the brand name Ozempic (INN semaglutide).
  • Authorised in the United Kingdom by the MHRA (e.g. PLGB licences for Ozempic solution for injection in pre Filled pen).
  • Approved in the United States by the Food and Drug Administration (FDA) under NDA 209637 as Ozempic (semaglutide) injection for subcutaneous use.
  • Complies with Good Manufacturing Practice (GMP) requirements for human medicinal products at licensed Novo Nordisk manufacturing facilities.
  • Classified pharmacologically as a GLP 1 receptor agonist according to major regulatory and pharmacopoeial references.
  • Subject to additional risk Minimisation and pharmacovigilance measures in some territories, including warnings regarding thyroid C Cell tumours, pancreatitis and diabetic retinopathy.
GLP-1 receptor agonist for type 2 diabetes mellitus

Description

Ozempic (semaglutide) injection is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise for adults with type 2 diabetes mellitus. It is indicated to improve glycaemic control, 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. Ozempic is supplied as a clear, colourless solution for subcutaneous injection in pre-filled, multi-dose disposable pens delivering various fixed weekly doses (0.25 mg, 0.5 mg, 1 mg and 2 mg). The active substance semaglutide is a long-acting human GLP-1 analogue that increases glucose-dependent insulin secretion, decreases glucagon secretion, slows gastric emptying and reduces appetite, thereby lowering blood glucose and body weight. The medicine is administered once weekly in the abdomen, thigh or upper arm, with dose escalation over several weeks to minimise gastrointestinal side effects. Ozempic is a prescription-only medicine.

Bnefits

  • Once-weekly subcutaneous injection, which may support adherence compared with once- or twice-daily injectable therapies.
  • Improves glycaemic control (lowering HbA1c) in adults with type 2 diabetes when used as an adjunct to 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 with type 2 diabetes, owing to reduced appetite and energy intake.
  • Low intrinsic risk of hypoglycaemia when used alone or in combination with agents that do not cause hypoglycaemia (e.g. metformin, SGLT2 inhibitors); hypoglycaemia risk mainly increases when used with insulin or sulfonylureas.
  • Provides continuous GLP-1 receptor activation with relatively stable semaglutide plasma concentrations due to long half-life and albumin binding.
  • Can be used as monotherapy when metformin is contraindicated or not tolerated, or as add-on therapy to other glucose-lowering agents including insulin.
  • Pre-filled pen presentation with very thin disposable needles is designed for patient self-administration after training.
  • Demonstrated cardiovascular and renal outcome benefits in large randomised clinical trials in people with type 2 diabetes.

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, thiazolidinediones, SGLT2 inhibitors or insulin) when these do not adequately control blood glucose.
  • 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; it is not indicated for type 1 diabetes, diabetic ketoacidosis or for primary weight management (obesity) without type 2 diabetes.

Composition

  • Active ingredient: Semaglutide, a human GLP-1 receptor agonist (GLP-1 analogue).
  • Each 1 mL solution contains 1.34 mg semaglutide (concentration may vary slightly by strength and presentation).
  • Inactive ingredients (excipients): disodium phosphate dihydrate, propylene glycol, phenol, water for injections.
  • Hydrochloric acid and/or sodium hydroxide may be added during manufacture for pH adjustment (target pH approximately 7.4).
  • Solution characteristics: sterile, aqueous, clear, colourless or almost colourless solution for injection.

Formulation

  • Pharmaceutical form: Solution for injection in pre-filled, disposable, multi-dose pens.
  • Available strengths (pen content): pens containing 2 mg/1.5 mL, 4 mg/3 mL or 8 mg/3 mL semaglutide, delivering various dose regimens.
  • Typical dosing scheme: start at 0.25 mg once weekly for 4 weeks, increase to 0.5 mg once weekly; may be escalated after at least 4 weeks at 0.5 mg to 1 mg once weekly, and after at least 4 weeks at 1 mg to 2 mg once weekly as needed and tolerated (maximum recommended dose 2 mg once weekly).
  • Route of administration: subcutaneous injection in the abdomen, thigh or upper arm.
  • Pen devices: colour-coded pens that deliver 0.25 mg and 0.5 mg (red label), 1 mg (blue label) or 2 mg (yellow label) maintenance doses; each pen is intended for single-patient use only.
  • Therapeutic class: glucagon-like peptide-1 (GLP-1) receptor agonist, antidiabetic agent.
  • Mechanism of action: enhances glucose-dependent insulin secretion, reduces inappropriate glucagon secretion, slows gastric emptying and reduces appetite and energy intake.

Packaging

  • Pre-filled, disposable, multi-dose glass cartridge enclosed in a single-patient-use pen-injector.
  • Cartridge volume: 1.5 mL or 3 mL solution for injection depending on strength.
  • Outer carton typically contains 1 or 3 pens and a corresponding number of disposable pen needles (where included by market).
  • Pen needles: very thin (e.g. 32G, 4 mm) single-use needles are provided in many packs; patients may also be supplied needles separately depending on local practice.
  • Carton and pen labelling include strength, number of doses, lot number, expiry date, storage conditions, and prescribing/usage instructions.
  • Packaging is designed for cold-chain distribution and protection from light during storage.

Usage

  • Ozempic is a prescription-only medicine and should be initiated and supervised by a healthcare professional experienced in managing type 2 diabetes.
  • Recommended starting dose in adults is 0.25 mg once weekly for 4 weeks; this dose is for treatment initiation and is not a maintenance dose.
  • After 4 weeks, increase to 0.5 mg once weekly. If additional glycaemic control is required after at least 4 weeks at 0.5 mg, the dose may be increased to 1 mg once weekly; after at least 4 weeks at 1 mg, it may be further increased to 2 mg once weekly if needed and tolerated, without exceeding 2 mg weekly.
  • Administer Ozempic once weekly on the same day each week, at any time of day, with or without meals.
  • Inject subcutaneously into the abdomen, thigh or upper arm. Rotate injection sites within the same region to reduce the risk of lipodystrophy or local irritation.
  • Use a new, sterile disposable needle for each injection and never share pens or needles with other people to avoid cross-infection.
  • Check the pen label to ensure the correct medicinal product and strength before each injection and visually confirm that the solution is clear and colourless.
  • Follow the pen’s Instructions for Use for priming (flow check) when starting a new pen, dose selection and injection technique.
  • If a weekly dose is missed, follow the local prescribing information (for example, in many labels, the missed dose can be taken within a certain number of days, otherwise the missed dose is skipped and regular weekly schedule resumed). Patients must follow the specific instructions provided in their patient leaflet or by their prescriber.
  • When used with a sulfonylurea or insulin, a reduction in the dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycaemia; this adjustment should be overseen by a healthcare professional.
  • Patients should be counselled on potential gastrointestinal side effects during dose escalation and advised on measures such as smaller meals and avoiding high-fat, heavy foods if nausea occurs.
  • Patients should promptly report symptoms of pancreatitis (such as persistent, severe abdominal pain), gallbladder disease, severe gastrointestinal reactions, dehydration, worsening diabetic retinopathy, or signs of allergic reactions.

Contraindications

  • Hypersensitivity to semaglutide or to any of the excipients (disodium phosphate dihydrate, propylene glycol, phenol, water for injections, or pH-adjusting agents).
  • Personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2), in line with boxed warning and product labelling.
  • Not recommended for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • Severe gastrointestinal disease, including severe gastroparesis, is a precaution; use in such patients is generally not recommended due to delayed gastric emptying.
  • Use during pregnancy is not recommended; treatment should be discontinued prior to a planned pregnancy in accordance with product labelling. Breastfeeding use should be discussed with a healthcare professional.
  • Caution in patients with a history of pancreatitis; if pancreatitis is suspected, Ozempic should be discontinued and not restarted if confirmed.
  • Any other specific contraindications, warnings and precautions detailed in the local Summary of Product Characteristics (SmPC) or Prescribing Information must be observed.

Adverse Effects

  • Very common gastrointestinal reactions: nausea, vomiting, diarrhoea, constipation and abdominal pain, particularly during dose escalation.
  • Decreased appetite and weight loss, which may be desirable in many patients but can be excessive in some individuals.
  • Dyspepsia, eructation, flatulence and gastro-oesophageal reflux symptoms.
  • Injection-site reactions such as erythema, pruritus or mild discomfort.
  • Hypoglycaemia, especially when Ozempic is used in combination with insulin or sulfonylureas.
  • Possible acute pancreatitis, indicated by persistent, severe abdominal pain (sometimes radiating to the back); if suspected, Ozempic should be discontinued and appropriate medical evaluation undertaken.
  • Gallbladder-related events including cholelithiasis and cholecystitis.
  • Potential worsening of diabetic retinopathy complications in patients with pre-existing diabetic retinopathy, particularly with rapid improvement in glycaemic control.
  • Renal impairment or acute kidney injury secondary to dehydration from severe gastrointestinal adverse reactions.
  • Hypersensitivity reactions including rash, urticaria and, rarely, anaphylactic reactions or angioedema.
  • Fatigue, dizziness or slight increases in heart rate reported in some patients.
  • Long-term rodent studies show semaglutide-induced thyroid C-cell tumours; human relevance is unknown, but a boxed warning advises against use in patients with personal/family history of MTC or MEN 2.

Storage Conditions

  • Unopened pens: store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light by keeping the pen in the original carton until use.
  • If a pen has been frozen, it should not be used and must be discarded.
  • In-use pens: may be stored either in a refrigerator (2°C to 8°C) or at room temperature (typically not above 25°C to 30°C, depending on local labelling) for a limited period (for example 6–8 weeks) as specified in the SmPC/Prescribing Information. After this in-use period, the pen must be discarded even if it still contains product.
  • Always replace the pen cap after each injection to protect from light.
  • Do not store the pen with a needle attached to avoid contamination or leakage.
  • Keep out of the reach and sight of children.
  • Transport and store according to cold-chain requirements where applicable, avoiding excessive heat, direct sunlight and prolonged exposure outside the recommended temperature range.

Duration

Ozempic is intended for long-term, chronic treatment of adults with type 2 diabetes mellitus when clinically appropriate. Duration of therapy is individualised based on glycaemic response, tolerability, cardiovascular and renal risk profile, and treatment goals, and should be periodically reassessed by a healthcare professional. Treatment may continue for years if benefits outweigh risks and no contraindications develop.

Onset

Improvement in fasting and postprandial blood glucose may be observed within the first weeks of therapy, with progressive reductions in HbA1c typically seen over 12 to 16 weeks of once-weekly dosing. Cardiovascular and renal risk reduction benefits accrue over longer-term treatment based on outcome studies.

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