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Ozempic 1 mg solution for injection in pre Filled pen

Ozempic 1 mg solution for injection in pre Filled pen

Ozempic

Medicinal Products
  • Authorised in the United Kingdom as Ozempic 1 mg solution for injection in pre Filled pen with semaglutide as the active ingredient, under a UK marketing authorisation held by Novo Nordisk Limited.
  • Centrally authorised in the European Union as Ozempic (semaglutide) under the European Medicines Agency (EMA) with a European Public Assessment Report and product information (SmPC and PIL).
  • Approved by major regulatory authorities including the US Food and Drug Administration (FDA) under New Drug Application 209637 as Ozempic (semaglutide) injection for subcutaneous use.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for human medicinal products in licensed Novo Nordisk facilities.
  • Classified within the Anatomical Therapeutic Chemical (ATC) system as A10BJ06 – semaglutide.
  • Subject to national and EU pharmacovigilance requirements, including MHRA Yellow Card reporting for suspected adverse drug reactions in the UK.
  • Labelled and supplied as a prescription Only medicine (POM) in the UK, with distribution through licensed pharmacies such as The Crystal Pharmacy.
GLP-1 receptor agonist pre-filled injection pen for type 2 diabetes mellitus

Description

Ozempic 1 mg solution for injection in pre-filled pen is a prescription-only medicine containing semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. It is authorised in the UK 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. Each pre-filled pen contains a clear, colourless solution for subcutaneous injection that delivers fixed weekly doses of semaglutide, with the 1 mg strength used as a maintenance dose after dose titration. Semaglutide enhances glucose-dependent insulin secretion, reduces inappropriate glucagon secretion, slows gastric emptying and decreases appetite, thereby lowering blood glucose and promoting weight loss. In aesthetic and weight-management practice, Ozempic pens are sometimes prescribed off-label for weight reduction in adults with obesity or overweight and weight-related comorbidities, under the supervision of UK-registered prescribers. The Crystal Pharmacy supplies Ozempic 1 mg pens on the basis of a valid prescription in which the prescriber confirms the patient’s body mass index (BMI) and, where BMI is 27–29.9 kg/m², documents relevant weight-related comorbid conditions.

Bnefits

  • Once-weekly subcutaneous injection that simplifies treatment compared with once- or twice-daily injectable therapies.
  • Improves glycaemic control (reduces HbA1c) in adults with type 2 diabetes when used alongside diet and exercise.
  • Demonstrated reduction in 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.
  • Associated with clinically relevant weight loss in many patients with type 2 diabetes due to reduced appetite and caloric intake.
  • Low intrinsic risk of hypoglycaemia when used without insulin or sulfonylureas, because its insulinotropic effect is glucose-dependent.
  • Available in a pre-filled, dial-a-dose pen designed for patient self-administration after appropriate training.
  • Stable, long-acting GLP-1 analogue with a long half-life, enabling once-weekly dosing and relatively stable plasma levels.
  • Can be used as monotherapy when metformin is not tolerated or contraindicated, or in combination with other glucose-lowering agents including insulin.
  • The 1 mg strength provides a commonly used maintenance dose after initial titration from 0.25 mg and 0.5 mg, allowing escalation of efficacy while balancing tolerability.
  • In weight-management pathways (off-label use), weekly semaglutide injections may support sustained weight reduction in adults with obesity or overweight plus comorbidities, when combined with diet and lifestyle interventions under medical supervision.

Indications

  • Licensed indication (UK/EU): treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.
  • Use as monotherapy in adults with type 2 diabetes when metformin is considered inappropriate due to intolerance or contraindications.
  • Use in combination 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.
  • Use only in adults (18 years and older) with type 2 diabetes; not indicated for type 1 diabetes or diabetic ketoacidosis.
  • Off-label use in some UK weight-management clinics for chronic weight management in adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbid condition (such as hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes), subject to individual prescriber assessment and informed consent.

Composition

  • Active ingredient: Semaglutide, a human GLP-1 analogue produced in Saccharomyces cerevisiae by recombinant DNA technology.
  • Strength: Ozempic 1 mg solution for injection – each 1 mL of solution contains 1.34 mg semaglutide.
  • Pen content (1 mg dose pen): Each pre-filled pen contains 3 mL solution with either 4 mg or 8 mg semaglutide, providing multiple 1 mg doses (e.g. 4 × 1 mg or 8 × 1 mg injections) depending on presentation.
  • Each dose: 1 mg semaglutide delivered in 0.37–0.74 mL solution depending on pen configuration, as specified in the SmPC.
  • Excipients: disodium phosphate dihydrate, propylene glycol, phenol and water for injections.
  • pH adjustment: hydrochloric acid and/or sodium hydroxide may be used during manufacture to adjust pH to approximately 7.4.
  • Solution characteristics: sterile, aqueous, clear and colourless or almost colourless solution for subcutaneous injection.

Formulation

  • Pharmaceutical form: solution for injection in pre-filled, disposable, single-patient-use pen.
  • Route of administration: subcutaneous (SC) injection into the abdomen, thigh or upper arm.
  • Therapeutic class: glucagon-like peptide-1 (GLP-1) receptor agonist, antidiabetic agent.
  • Typical dosing regimen (diabetes): initiate with 0.25 mg once weekly for 4 weeks, then increase to 0.5 mg once weekly; if additional glycaemic control is required, the dose may be escalated after at least 4 weeks at 0.5 mg to 1 mg once weekly. In some territories a 2 mg weekly dose is also authorised after dose escalation.
  • The 1 mg strength is used as a maintenance dose after initial titration and may be the maximum dose for many patients depending on clinical need and tolerability.
  • Pens are dial-a-dose devices designed to deliver only the labelled dose size (for example, a 1 mg pen delivers four or eight 1 mg doses depending on pen version).
  • Mechanism of action: semaglutide selectively binds to and activates GLP-1 receptors, stimulating glucose-dependent insulin secretion, suppressing glucagon in hyperglycaemia, slowing gastric emptying and reducing appetite, resulting in improved glycaemic control and reduced body weight.

Packaging

  • Pre-filled glass cartridge (3 mL) assembled into a disposable pen-injector with dose selector and push button.
  • Outer carton presentations commonly include 1 or 3 pens, each pen provided with a corresponding number of disposable NovoFine Plus needles in many markets.
  • Carton labelling specifies strength (Ozempic 1 mg), active substance (semaglutide), dosage form, number of doses per pen, route of administration, storage conditions, batch number and expiry date.
  • Individual pens are colour-coded and labelled to distinguish them from other Ozempic strengths (for example, distinct label colours for 0.5 mg, 1 mg and 2 mg pens).
  • Each pack is supplied with a patient information leaflet (PIL) and instructions for use detailing injection technique, dose escalation schedule and safety information.
  • Wholesale packs may contain multiple retail cartons and are designed to maintain cold-chain storage during distribution.

Usage

  • Ozempic 1 mg pens are prescription-only; treatment must be initiated and supervised by a physician or suitably qualified prescriber experienced in the management of type 2 diabetes and/or obesity medicine.
  • For type 2 diabetes, begin treatment with 0.25 mg once weekly for 4 weeks, then increase to 0.5 mg once weekly. After at least 4 weeks at 0.5 mg, the dose may be increased to 1 mg once weekly if additional glycaemic control is needed and the patient tolerates treatment.
  • Administer once weekly on the same day each week, at any time of day, with or without food.
  • Inject subcutaneously into the abdomen, thigh or upper arm. Rotate injection sites within the same region to minimise the risk of lipodystrophy and local irritation.
  • Use a new, sterile pen needle for each injection. Do not reuse needles and never share pens or needles with other individuals.
  • Before each use, check the pen label to confirm it is Ozempic 1 mg and visually inspect the solution; use only if the solution is clear and colourless and the pen appears undamaged.
  • Prime a new pen (flow check) according to the instructions for use before the first injection to ensure proper dose delivery.
  • If a dose is missed, follow the instructions provided in the local patient leaflet (for example, inject as soon as remembered within a defined time window, then resume the regular weekly schedule; otherwise skip the missed dose and continue as planned). Specific rules vary by territory and must be followed as per the SmPC/PIL.
  • When Ozempic is used together with a sulfonylurea or insulin, a reduction in the dose of the sulfonylurea or insulin may be needed to reduce the risk of hypoglycaemia; this adjustment should be made only under medical supervision.
  • Patients should be counselled that gastrointestinal side effects (nausea, vomiting, diarrhoea) are common during dose escalation and are often transient; eating smaller, lighter meals and avoiding very fatty or heavy foods may help.
  • In weight-management pathways used by The Crystal Pharmacy’s prescribers, the prescriber must independently verify the patient’s BMI. For BMI ≥ 30 kg/m², or BMI ≥ 27 kg/m² with at least one weight-related comorbid condition (such as hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes), the prescriber documents the BMI and, where applicable, the comorbidities in the directions section of the prescription.
  • Patients should be advised to seek urgent medical attention if they experience severe, persistent abdominal pain (with or without vomiting), visual changes, signs of allergic reaction, symptoms of gallbladder disease or signs of dehydration.
  • Read and retain the patient information leaflet supplied with the pack and follow all locally approved instructions; consult a healthcare professional with any questions about dosing or side effects.

Contraindications

  • Hypersensitivity to semaglutide or to any of the excipients in the formulation (disodium phosphate dihydrate, propylene glycol, phenol, water for injections, or pH-adjusting agents).
  • Not indicated for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • Patients with a personal or family history of medullary thyroid carcinoma (MTC) or with multiple endocrine neoplasia syndrome type 2 (MEN 2), in line with class warnings for semaglutide and other GLP-1 receptor agonists (particularly in jurisdictions where a boxed thyroid C-cell tumour warning is in force).
  • Use in pregnancy is not recommended; semaglutide should be discontinued prior to a planned pregnancy in accordance with product labelling, and effective contraception is advised during treatment and for a washout period after stopping.
  • Use during breastfeeding is not recommended unless the potential benefit justifies the potential risk; decisions should be made case by case with a healthcare professional.
  • Caution, and often avoidance, in patients with a history of pancreatitis; if pancreatitis is suspected, semaglutide should be discontinued and not restarted if pancreatitis is confirmed.
  • Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis, due to limited experience and the drug’s effect on gastric emptying.
  • Patients with severe dehydration or at high risk of dehydration should be monitored carefully due to the possibility of gastrointestinal adverse effects leading to volume depletion.
  • Any additional contraindications or special warnings listed in the current UK Summary of Product Characteristics (SmPC) must be followed.

Adverse Effects

  • Very common gastrointestinal reactions, especially during titration: nausea, vomiting, diarrhoea, constipation and abdominal pain.
  • Decreased appetite and weight loss, which may be therapeutically desirable but can lead to excessive weight loss or nutritional deficiencies in some cases.
  • Dyspepsia, eructation (belching), flatulence and gastro-oesophageal reflux symptoms.
  • Hypoglycaemia, particularly when used in combination with insulin or sulfonylureas; symptoms include sweating, tremor, palpitations, hunger, confusion and, rarely, loss of consciousness.
  • Injection-site reactions such as redness, itching, swelling or discomfort at the injection site.
  • Possible acute pancreatitis, characterised by persistent, severe abdominal pain (with or without vomiting); treatment should be stopped if pancreatitis is suspected.
  • Gallbladder-related disorders such as cholelithiasis (gallstones) and cholecystitis (inflammation of the gallbladder).
  • Worsening of diabetic retinopathy complications in some patients with pre-existing diabetic retinopathy, particularly when glycaemic control improves rapidly.
  • Renal impairment or acute kidney injury secondary to dehydration from severe vomiting, diarrhoea or reduced fluid intake.
  • Hypersensitivity reactions including rash, pruritus, urticaria and, rarely, anaphylactic reactions or angioedema.
  • Increased heart rate, fatigue, dizziness and headache reported in some patients.
  • Laboratory and long-term rodent studies show increased incidence of thyroid C-cell tumours with GLP-1 receptor agonists; the clinical relevance to humans remains uncertain but is reflected in class warnings and prescribing precautions.

Storage Conditions

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

Duration

Ozempic 1 mg is intended for long-term, chronic therapy in adults with type 2 diabetes mellitus when clinically appropriate. Treatment duration is individualised based on glycaemic targets, cardiovascular and renal risk, weight-loss goals, tolerability and patient preference. Prescribers periodically reassess the need for continued therapy and may continue treatment for years if the benefit\u2013risk balance remains favourable. For off-label weight-management use, treatment duration and continuation criteria should follow the prescriber\u2019s protocol, clinical guidelines and patient response, typically with regular review of weight, metabolic parameters and tolerability.

Onset

Reductions in fasting and postprandial glucose can be observed within the first weeks of therapy; significant HbA1c reductions are usually apparent within 12\u201316 weeks of once-weekly dosing. Appetite suppression and early weight change may be noticed within the first few weeks, although the degree and timing of response vary between individuals. Cardiovascular and renal protective effects are based on long-term use in outcome trials.

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