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Mounjaro Injections (tirzepatide)

Mounjaro Injections (tirzepatide)

Mounjaro

Prescription Medicine
  • Authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as Mounjaro (tirzepatide) for type 2 diabetes and for weight management and weight loss in eligible adults.
  • Centrally authorised by the European Medicines Agency (EMA) with an active European public assessment report (EPAR) and ongoing post Authorisation updates.
  • Manufactured under Good Manufacturing Practice (GMP) in line with EU, UK and international regulatory requirements for sterile parenteral medicines.
  • Subject to formal risk management plans, periodic safety update reports and pharmacovigilance obligations in the UK, EU and other markets.
  • Supplied in the UK via MHRA Licensed pharmaceutical wholesalers and pharmacies; online and distance Selling pharmacies must also hold appropriate GPhC registration and comply with UK medicines legislation.
Antidiabetic & Weight Management Injection (GIP/GLP-1 receptor agonist)

Description

Mounjaro injections contain tirzepatide, a once-weekly, subcutaneous dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. In the UK, Mounjaro is a prescription-only medicine licensed for the treatment of adults with type 2 diabetes and for weight loss and weight management in adults with obesity or overweight with weight-related conditions. By regulating appetite, food intake and blood sugar, it helps patients feel fuller for longer, reduces hunger and improves glycaemic control when used alongside a reduced-calorie diet and increased physical activity.

Bnefits

  • Once-weekly injection schedule, which may improve convenience and adherence compared with some daily injectables.
  • Dual GIP and GLP-1 receptor agonist mechanism that improves blood glucose control and reduces appetite.
  • Clinically proven reductions in HbA1c and significant body-weight loss in adults with type 2 diabetes and in adults with obesity or overweight.
  • Helps people feel fuller between meals, lowers appetite and reduces cravings, supporting sustained calorie reduction.
  • Approved in the UK for weight management and weight loss as well as for type 2 diabetes when used with diet and exercise.
  • Available in a range of strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg) to allow gradual dose escalation based on tolerability and response.
  • Delivered via pre-filled pens (KwikPen presentations) designed for patient self-injection after appropriate training.
  • Genuine UK-licensed product supplied via regulated pharmacy services when prescribed by an appropriate healthcare professional.

Indications

  • Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
  • • as monotherapy when metformin is inappropriate due to intolerance or contraindications;
  • • in combination with other medicinal products for the treatment of diabetes, according to the Summary of Product Characteristics.
  • Weight loss and weight management (including weight maintenance) in adults with obesity or overweight and weight-related health problems, as authorised by the MHRA and set out in UK product information.
  • Use as part of a comprehensive weight management programme that includes a reduced-calorie diet, increased physical activity and behavioural support.
  • Use only in adults; paediatric safety and efficacy have not yet been established in routine care.

Composition

  • Active substance: tirzepatide in various strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) per fixed dose depending on pen presentation.
  • Each UK KwikPen presentation contains a defined total amount of tirzepatide in 2.4 mL solution and delivers four once-weekly doses (e.g. 30 mg per pen for 7.5 mg/0.6 mL; strengths differ by pen).
  • Excipients in EU/UK KwikPen presentations include: benzyl alcohol, phenol, sodium chloride, sodium phosphate dibasic heptahydrate, glycerol and water for injections; sodium hydroxide and hydrochloric acid are used for pH adjustment (exact list and quantities vary by strength and presentation; see SmPC).
  • Solution characteristics: clear, colourless to slightly yellow aqueous solution for injection.
  • The product is preservative-containing in multi-dose KwikPen presentations; U.S. single-dose pens are preservative-free (not all presentations are available in every market).
  • Tirzepatide itself is a synthetic peptide-based, long-acting dual GIP and GLP-1 receptor agonist.

Formulation

  • Pharmaceutical form: solution for injection in pre-filled, disposable pen devices.
  • Available UK presentation: multi-dose Mounjaro KwikPen, containing sufficient solution for four once-weekly doses at a fixed strength.
  • Route of administration: subcutaneous injection into the abdomen, thigh or upper arm.
  • Mechanism of action: tirzepatide activates GIP and GLP-1 receptors, enhancing glucose-dependent insulin secretion, reducing inappropriate glucagon secretion, slowing gastric emptying and increasing satiety.
  • Classified pharmacologically as an incretin-based therapy; related to GLP-1 receptor agonists but with additional GIP receptor agonism.
  • Non-insulin injectable; not intended for the treatment of type 1 diabetes or diabetic ketoacidosis.

Packaging

  • Each carton normally contains one multi-dose KwikPen pre-filled with tirzepatide solution at a specific strength (e.g. 2.5 mg/0.6 mL, 5 mg/0.5 mL, 7.5 mg/0.6 mL, etc.).
  • Each KwikPen provides four fixed weekly doses; after four doses the pen must be discarded even if some solution appears to remain.
  • The pen body is colour-coded and clearly labelled with the Mounjaro brand, strength and dosing information.
  • Primary container: glass cartridge within a disposable plastic pen housing, sealed with a rubber stopper and crimped aluminium cap inside the pen.
  • Outer carton and label include product name, active substance, strength, batch number, expiry date, storage conditions and manufacturer details.
  • Needles are not typically supplied in the same carton in the UK; compatible single-use pen needles are dispensed separately according to pharmacy and prescriber practice.

Usage

  • Mounjaro injections must only be used on prescription and under the supervision of a suitably qualified healthcare professional.
  • In adults, treatment is usually started at 2.5 mg once weekly and the dose is gradually increased over time (e.g. to 5 mg, then higher strengths) based on tolerability and local prescribing guidance; dose schedules are set by the prescriber.
  • Inject once weekly, on the same day each week, at any time of day, with or without food, into the abdomen, thigh or upper arm, rotating injection sites each week.
  • Use the pen exactly as described in the Instructions for Use: attach a new sterile needle for each injection, perform any priming steps if required, dial the prescribed dose and inject as demonstrated by a healthcare professional.
  • The pen is for single-patient use only and must never be shared, even if the needle is changed, due to the risk of cross-infection.
  • If a dose is missed, the patient should follow the instructions in the Patient Information Leaflet or seek advice from their prescriber or pharmacist rather than taking extra doses without guidance.
  • Continue to follow a reduced-calorie diet and increased physical activity plan alongside use of Mounjaro; other antidiabetic medicines such as insulin or sulfonylureas may require dose adjustment to minimise hypoglycaemia risk.
  • Do not use the pen if the solution is cloudy, coloured, contains particles, has been frozen, is past its expiry date or if the pen is damaged.
  • Dispose of used needles in a sharps container and discard used or expired pens according to local regulations or pharmacy guidance.
  • Patients should read the full Patient Information Leaflet and follow all warnings and instructions provided with each pack.

Contraindications

  • Hypersensitivity to tirzepatide or to any of the excipients in the formulation (including benzyl alcohol where present).
  • Use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; Mounjaro is not a substitute for insulin.
  • Severe gastrointestinal disease, including severe gastroparesis, due to the drug’s effect on gastric emptying.
  • Use during pregnancy is not recommended; treatment should be stopped before a planned pregnancy and avoided during pregnancy unless the potential benefit clearly outweighs the risk, in line with product information and specialist advice.
  • Breastfeeding is not recommended while using tirzepatide because it is unknown whether the medicine passes into human breast milk.
  • Caution or restriction in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2), according to local product information and national guidance.
  • Not indicated for individuals under 18 years of age; safety and efficacy in children and adolescents have not been established.
  • Any additional contraindications or restrictions listed in the current MHRA-approved Summary of Product Characteristics and national prescribing guidance.

Adverse Effects

  • Very common gastrointestinal side effects such as nausea, vomiting, diarrhoea, decreased appetite and constipation, particularly during dose escalation.
  • Abdominal pain, dyspepsia, abdominal distension, flatulence, belching and gastro-oesophageal reflux.
  • Injection-site reactions including redness, itching, pain or swelling.
  • Hypoglycaemia, especially when Mounjaro is used in combination with insulin or sulfonylureas; dose adjustments of these concomitant medicines may be needed.
  • Headache, dizziness, fatigue and general weakness (asthenia) have been reported.
  • Gallbladder-related events such as gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis), particularly in the context of rapid or significant weight loss.
  • Acute pancreatitis has been reported; severe, persistent abdominal pain (with or without vomiting) can be a sign and requires urgent medical evaluation.
  • Possible worsening of diabetic retinopathy in some patients with pre-existing disease due to rapid improvement in glycaemic control; eye monitoring may be advised.
  • Worsening of renal function or acute kidney injury, often associated with dehydration from severe gastrointestinal side effects; maintaining adequate fluid intake is important.
  • Hypersensitivity reactions including rash, urticaria and, rarely, serious allergic reactions such as anaphylaxis or angioedema.

Storage Conditions

  • Store unopened Mounjaro pens in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F).
  • Do not freeze; discard the pen if it has been frozen.
  • Keep pens in the original carton to protect from light.
  • During use or if kept out of the refrigerator, pens may be stored at room temperature up to the maximum temperature and in-use period specified in the Patient Information Leaflet (e.g. up to 30 °C for a limited number of days); after this period the pen must be discarded, even if it still contains medicine.
  • Do not expose pens to direct sunlight or excessive heat.
  • Do not use after the expiry date printed on the label and carton.
  • Keep out of the sight and reach of children.
  • Dispose of used pens and needles safely in an approved sharps container following local requirements.

Duration

Treatment duration is individualised and determined by the prescribing clinician based on clinical response, treatment goals for weight and glycaemic control, tolerability and guideline recommendations. Mounjaro is generally used as long-term therapy for chronic conditions such as type 2 diabetes and obesity, with regular review of benefits and risks. Each KwikPen provides approximately four weeks of therapy at a fixed weekly dose.

Onset

Initial appetite suppression and improvements in fasting and postprandial glucose may be observed within the first weeks of therapy. Larger effects on HbA1c and body weight are typically assessed over several months of once-weekly dosing. Individual onset and magnitude of response vary between patients.

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