Ozempic 1 mg solution for injection in pre Filled pen

Ozempic

Medicinal Products

GLP-1 receptor agonist pre-filled injection pen for type 2 diabetes mellitus

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) with an EMA European Public Assessment Report and approved product information.
Approved by the US Food and Drug Administration (FDA) as Ozempic (semaglutide) injection for subcutaneous use under NDA 209637.
Manufactured in accordance with Good Manufacturing Practice (GMP) for human medicinal products at licensed Novo Nordisk facilities.
Classified under ATC code A10BJ06 (semaglutide) as a GLP 1 receptor agonist antidiabetic medicine.
Subject to national pharmacovigilance systems such as the MHRA Yellow Card Scheme in the UK for reporting suspected adverse reactions.
Supplied only as a prescription Only medicine (POM) in the UK, requiring a valid prescription and compliant storage, transport and dispensing practices, including cold Chain management for refrigerated items.

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) with an EMA European Public Assessment Report and approved product information.
Approved by the US Food and Drug Administration (FDA) as Ozempic (semaglutide) injection for subcutaneous use under NDA 209637.
Manufactured in accordance with Good Manufacturing Practice (GMP) for human medicinal products at licensed Novo Nordisk facilities.
Classified under ATC code A10BJ06 (semaglutide) as a GLP 1 receptor agonist antidiabetic medicine.
Subject to national pharmacovigilance systems such as the MHRA Yellow Card Scheme in the UK for reporting suspected adverse reactions.
Supplied only as a prescription Only medicine (POM) in the UK, requiring a valid prescription and compliant storage, transport and dispensing practices, including cold Chain management for refrigerated items.

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 once-weekly prescription medicine containing semaglutide, a long-acting human glucagon-like peptide-1 (GLP-1) receptor agonist. Each pre-filled, disposable pen contains a clear, colourless aqueous solution for subcutaneous injection and is designed to deliver four individual 1 mg doses of semaglutide. Ozempic is licensed in the UK and EU 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 works by enhancing glucose-dependent insulin secretion, reducing inappropriate glucagon secretion, slowing gastric emptying and decreasing appetite, leading to improved blood glucose control and weight loss. MirrorPharma supplies Ozempic 1 mg pre-filled pens as a fridge item that must be kept refrigerated and dispenses them only against a valid prescription from a suitably qualified healthcare professional, requiring the original prescription to be received within 72 hours of ordering and restricting purchases to qualified health professionals.

Bnefits

Once-weekly subcutaneous injection, which may improve adherence compared with therapies requiring daily injections or multiple daily doses.
Improves glycaemic control (reduces 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 mellitus 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 due to reduced appetite and caloric intake.
Low intrinsic risk of hypoglycaemia when used alone or with agents not associated with hypoglycaemia (e.g. metformin, SGLT2 inhibitors); hypoglycaemia risk mainly increases when combined with sulfonylureas or insulin.
Pre-filled, dial-a-dose pen designed for patient self-administration after training, with clear dose counter and use with very thin single-use pen needles.
Long-acting GLP-1 analogue with a pharmacokinetic profile that supports once-weekly dosing and relatively stable plasma levels.
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.
The 1 mg dose provides a commonly used maintenance dose for many adults with type 2 diabetes following titration from lower doses (0.25 mg and 0.5 mg).

Indications

Treatment of 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 patients with type 1 diabetes mellitus, for diabetic ketoacidosis or as a primary weight-loss medicine in the absence of type 2 diabetes.

Composition

Active ingredient: Semaglutide, a human GLP-1 analogue produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Concentration: 1 mL of solution contains 1.34 mg semaglutide.
Pre-filled pen content (1 mg dose pen): 3 mL solution containing 4 mg or 8 mg semaglutide depending on pen design, delivering four 1 mg doses (either 1 mg in 0.74 mL or 1 mg in 0.37 mL per injection as per approved product information).
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 (approx. 7.4).
Solution characteristics: sterile, clear, colourless or almost colourless aqueous solution for subcutaneous injection.

Formulation

Pharmaceutical form: solution for injection in pre-filled, disposable, single-patient-use pen.
Strength: 1 mg semaglutide per dose; each pen contains sufficient solution for four 1 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 dosing regimen: initiate at 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, dose may be increased to 1 mg once weekly if additional glycaemic control is needed and treatment is tolerated. In some patients, dose can be further increased to 2 mg once weekly as per current labelling.
Device: dial-a-dose pre-filled pen compatible with NovoFine Plus or other recommended single-use pen needles; designed to deliver only the labelled 1 mg dose per injection.
Mechanism of action: semaglutide selectively activates GLP-1 receptors, increasing glucose-dependent insulin secretion, reducing inappropriate glucagon secretion, slowing gastric emptying and reducing appetite, resulting in lower blood glucose and reduced body weight.

Packaging

Pre-filled type I glass cartridge (3 mL) closed with a chlorobutyl rubber plunger and an aluminium cap with laminated rubber disc, assembled into a disposable pen-injector.
Retail cartons typically contain 1 or 3 pre-filled pens and a corresponding number of single-use pen needles (e.g. 4 or 12 needles) depending on market and pack size.
Each pack includes a patient information leaflet and detailed instructions for use describing dose selection, pen priming, injection technique and storage.
Outer carton labelling states product name (Ozempic 1 mg), active substance (semaglutide), strength, pharmaceutical form, number of doses per pen, route of administration, storage conditions, batch number and expiry date.
Pens and cartons are colour-coded to distinguish the 1 mg maintenance-dose pen from other Ozempic strengths.
MirrorPharma supplies Ozempic as a refrigerated (fridge) item using appropriate insulated packaging and cold-chain logistics to maintain temperature during delivery.

Usage

Therapy with Ozempic must be initiated and supervised by a physician or suitably qualified prescriber experienced in managing type 2 diabetes.
Starting regimen: 0.25 mg once weekly for 4 weeks; this initiation dose is not intended as 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 and treatment is well tolerated, increase to 1 mg once weekly (using the 1 mg pen).
Administer once weekly on the same day of the 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 reduce the risk of lipodystrophy and local irritation.
Use a new, sterile, single-use needle for each injection. Do not share pens or needles with other people.
Before each injection, check the pen label to confirm that it is Ozempic 1 mg and visually inspect the solution; use only if it is clear and colourless and the pen appears undamaged.
Prime each new pen (flow check) according to the Instructions for Use before the first injection to ensure correct dose delivery.
If a dose is missed, follow the guidance in the local patient leaflet or from the prescriber (e.g. administer as soon as possible within a defined time window and then resume the usual weekly schedule, or skip the missed dose if too close to the next scheduled dose).
When Ozempic is used in combination with a sulfonylurea or insulin, consider reducing the dose of the sulfonylurea or insulin to reduce the risk of hypoglycaemia, under medical supervision.
Patients should be counselled that nausea, vomiting or diarrhoea are common during dose escalation and usually transient; eating smaller meals and avoiding high-fat, heavy foods may help.
Patients should seek urgent medical attention if they experience persistent, severe abdominal pain (with or without vomiting), symptoms suggestive of pancreatitis or gallbladder disease, severe dehydration, allergic reactions or sudden visual changes.
MirrorPharma supplies Ozempic only on receipt of a valid prescription; qualified health professionals purchasing for patients must ensure correct indication, BMI criteria where relevant and documentation of any weight-related comorbidities according to current guidance and product labelling.

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 (Ozempic is not a substitute for insulin).
Use in pregnancy is not recommended; semaglutide should be discontinued prior to a planned pregnancy in line with the product information, 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 to the infant; decisions should be made case by case.
Caution and generally avoidance in patients with a history of pancreatitis; if pancreatitis is suspected, treatment should be stopped and not restarted if pancreatitis is confirmed.
Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis, due to limited experience and the medicine’s effect on gastric emptying.
Patients with severe dehydration or at high risk of dehydration should be monitored closely, particularly if significant gastrointestinal adverse reactions occur.
Patients with pre-existing diabetic retinopathy should be monitored because rapid improvements in glycaemic control have been associated with temporary worsening of retinopathy.
Any additional contraindications, warnings and precautions described in the current Summary of Product Characteristics (SmPC) or prescribing information for Ozempic must be observed.

Adverse Effects

Very common gastrointestinal reactions: nausea, vomiting, diarrhoea, constipation and abdominal pain, especially during dose escalation.
Decreased appetite and weight loss, which may be therapeutically beneficial but can occasionally be excessive.
Dyspepsia, eructation (belching), flatulence and gastro-oesophageal reflux symptoms.
Hypoglycaemia, particularly when used with insulin or sulfonylureas; symptoms include sweating, trembling, palpitations, hunger, confusion and, in severe cases, loss of consciousness.
Injection-site reactions (e.g. erythema, pruritus, swelling or mild pain).
Acute pancreatitis (rare); characterised by persistent, severe abdominal pain which may radiate to the back and may be accompanied by vomiting.
Gallbladder-related disorders including cholelithiasis and cholecystitis.
Possible worsening of diabetic retinopathy in patients with pre-existing retinopathy, particularly when glycaemic control improves rapidly.
Renal impairment or acute kidney injury secondary to dehydration from severe gastrointestinal adverse reactions.
Hypersensitivity reactions such as rash, pruritus, urticaria and, rarely, anaphylactic reactions or angioedema.
Increased heart rate, fatigue, dizziness and headache reported in some patients.
Preclinical rodent studies have shown an increased incidence of thyroid C-cell tumours with semaglutide; the relevance to humans is uncertain but underlies precautions regarding use in patients with personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 in certain jurisdictions.

Storage Conditions

Unopened pens: store in a refrigerator at 2°C to 8°C. 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 either in a refrigerator (2°C to 8°C) or at room temperature (within the range specified in local product information, typically not above 25–30°C) for a defined in-use period (e.g. up to 6–8 weeks); after this period the pen must be discarded even if it still contains solution.
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 and air entry.
Protect from excessive heat and direct sunlight and avoid storing in hot environments such as parked vehicles.
Keep out of the sight and reach of children.
MirrorPharma labels Ozempic 1 mg as a fridge item and ships under refrigerated conditions; Friday orders are dispatched on the next working day (Monday, excluding bank holidays) to maintain cold-chain integrity and product availability.
Used pens and needles should be disposed of in an appropriate sharps container according to local regulations for medical waste.

Duration

Ozempic 1 mg is intended for long-term, chronic treatment of adults with type 2 diabetes mellitus when clinically appropriate. The duration of therapy is individualised based on glycaemic targets, cardiovascular and renal risk profiles, weight-loss goals, tolerability and patient preference. Treatment may continue for years if the benefit\u2013risk balance remains favourable and is reviewed periodically by a healthcare professional.

Onset

Reductions in fasting and postprandial glucose may be observed within the first weeks of treatment, with clinically relevant reductions in HbA1c typically evident after 12\u201316 weeks of once-weekly dosing. Appetite suppression and weight changes may appear within weeks, although timing and magnitude of response vary between individuals. Cardiovascular and renal benefits are based on longer-term use in outcome trials.