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Mounjaro 2.5 mg pre Filled pen

Mounjaro 2.5 mg pre Filled pen

Mounjaro

Prescription Medicine
  • Authorised by the European Medicines Agency (EMA) as Mounjaro (tirzepatide) for type 2 diabetes and, in many EU/EEA countries, for weight management, with a centralised marketing authorisation.
  • Authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for type 2 diabetes and for weight management/weight loss in specified adult populations.
  • Approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus in adults; tirzepatide Based products are also authorised for chronic weight management in the U.S. under related brand names.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products and quality systems compliant with international standards (e.g. ICH, EU GMP, U.S. cGMP).
  • Subject to national and international pharmacovigilance systems, including periodic safety update reporting and risk management plans.
Antidiabetic & Weight Management Injection (GIP/GLP-1 receptor agonist)

Description

Mounjaro 2.5 mg pre-filled pen is a once-weekly, single-dose subcutaneous injection containing tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It is used, together with diet and exercise, to improve blood sugar control in adults with type 2 diabetes and is also authorised in many regions for chronic weight management in adults with overweight or obesity and weight-related health problems. Each 2.5 mg pen is typically used as the starting dose before gradual dose escalation, as directed by a healthcare professional.

Bnefits

  • Once-weekly single-dose injection that simplifies treatment compared with some daily injectable therapies.
  • Improves glycaemic control in adults with type 2 diabetes when used alongside diet and exercise, with significant reductions in HbA1c seen in clinical trials.
  • Supports clinically meaningful weight loss in adults with obesity or overweight with weight-related comorbidities when combined with lifestyle measures.
  • Dual GIP and GLP-1 receptor agonist mechanism enhances insulin secretion in a glucose-dependent manner, reduces glucagon secretion and slows gastric emptying.
  • Helps reduce appetite and caloric intake, aiding long-term weight management when used as part of a structured programme.
  • Available as an easy-to-use, pre-filled, single-dose pen designed for patient self-administration after appropriate training.
  • Clear, colourless to slightly yellow solution with defined quality specifications and extensive regulatory review (FDA, EMA, MHRA and others).

Indications

  • Treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, either as monotherapy when metformin is inappropriate or in combination with other medicinal products for the treatment of diabetes (indications vary by region and local label).
  • Chronic weight management in adults with obesity (for example, BMI ≥ 30 kg/m²) or overweight (for example, BMI ≥ 27 kg/m²) with at least one weight-related comorbidity such as prediabetes, hypertension, dyslipidaemia or cardiovascular disease, in combination with a reduced-calorie diet and increased physical activity (where authorised, e.g. UK and EU).
  • May be used in line with national guidelines (e.g. NICE TA924 and equivalent international guidance) for type 2 diabetes and weight management alongside comprehensive lifestyle intervention.

Composition

  • Active ingredient: tirzepatide 2.5 mg per 0.5 mL solution in each single-dose pre-filled pen.
  • Excipients (U.S. single-dose pen formulation): sodium chloride, sodium phosphate dibasic heptahydrate, water for injections; hydrochloric acid and/or sodium hydroxide may be used to adjust pH.
  • European multi-dose KwikPen presentations additionally contain benzyl alcohol, glycerol, phenol, sodium phosphate dibasic heptahydrate, sodium chloride, sodium hydroxide and hydrochloric acid, depending on strength and market presentation.
  • Solution characteristics: clear, colourless to slightly yellow, pH approximately 6.5–7.5.
  • Does not contain insulin; not derived from animal insulin sources.

Formulation

  • Pharmaceutical form: solution for injection in a pre-filled, single-dose or multi-dose pen (depending on market).
  • Strength: 2.5 mg tirzepatide in 0.5 mL (single-dose pen) or 2.5 mg per 0.6 mL dose from a multi-dose KwikPen delivering four 2.5 mg doses (EU/UK KwikPen presentation).
  • Route of administration: subcutaneous injection.
  • Mechanism of action: dual agonist at GIP and GLP-1 receptors, enhancing glucose-dependent insulin secretion, reducing inappropriate glucagon secretion, slowing gastric emptying and promoting satiety.
  • Non-insulin, incretin-based therapy classified pharmacologically with GLP-1 receptor agonists and related incretin mimetics.
  • Preservative status: U.S. single-dose pens are preservative-free; EU multi-dose KwikPens include benzyl alcohol and phenol as preservatives.

Packaging

  • Each carton typically contains 1 pre-filled single-dose pen (0.5 mL, 2.5 mg) or, in some markets, packs of multiple pens (e.g. 4 pens) at the same strength.
  • Pen device is colour-coded and labelled for the 2.5 mg strength (commonly grey theme on carton and pen label).
  • Each pen is supplied with a protective cap and internal glass cartridge within a plastic housing.
  • Needles are usually supplied separately according to local pharmacy or healthcare system practice; in some markets compatible pen needles may be co-packaged.
  • Carton and pen labelling include product name, strength, batch number, and expiry date, as well as storage and handling instructions.
  • Non-sterile outer packaging; sterile product within the sealed primary container (glass cartridge) until first use.

Usage

  • Mounjaro should only be used under the supervision of a qualified healthcare professional who determines indication, dose and titration schedule based on the approved product information and the patient’s clinical situation.
  • The 2.5 mg pen is typically used as the starting dose, given once weekly by subcutaneous injection, with later dose increases according to the official prescribing information and medical advice.
  • Inject subcutaneously into the abdomen, thigh or upper arm, using a different injection site each week and avoiding areas that are tender, bruised, scarred, or hardened.
  • Each single-dose pen is intended for one injection only and should be disposed of after use, even if some solution appears to remain; multi-dose KwikPens must be used exactly as described in their Instructions for Use and never manipulated to withdraw extra doses.
  • The pen is for single-patient use only; it must never be shared with another person, even if a new needle is used, due to the risk of infection transmission.
  • Patients should be trained on pen use by a healthcare professional and must read the full Instructions for Use provided with the product before the first injection.
  • If a dose is missed, follow the instructions in the patient leaflet or prescribing information for when to take the next dose; patients should contact their prescriber or pharmacist for advice rather than changing the schedule on their own.
  • Do not use the medicine if the solution is discoloured, cloudy, or contains particles, or if the pen has been frozen or appears damaged.
  • Continue to follow the recommended diet, exercise programme and other medications as advised by the healthcare team while using Mounjaro.

Contraindications

  • Known hypersensitivity to tirzepatide or to any of the excipients in the formulation.
  • Use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (Mounjaro is not a substitute for insulin and is not indicated for these conditions).
  • Severe gastrointestinal disease, including severe gastroparesis, is generally a reason to avoid tirzepatide due to its mechanism of slowing gastric emptying.
  • In some regulatory regions and product labels, caution or specific warnings exist regarding personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2); see local label for exact wording and restrictions.
  • Use during pregnancy is not recommended; women of childbearing potential should discuss contraception and planning of pregnancy with their healthcare professional before starting Mounjaro.
  • Breastfeeding: use is not recommended due to limited data; decisions should be made with the prescribing clinician.
  • Any other situations listed as contraindications or "do not use" conditions in the local Summary of Product Characteristics (SmPC), Prescribing Information or Patient Information Leaflet.

Adverse Effects

  • Very common gastrointestinal effects such as nausea, vomiting, diarrhoea, decreased appetite and constipation, especially during dose escalation; these are usually mild to moderate and tend to decrease over time.
  • Abdominal pain, dyspepsia (indigestion), belching and gastro-oesophageal reflux may occur.
  • Injection-site reactions including redness, itching or discomfort.
  • Hypoglycaemia, particularly when Mounjaro is used in combination with insulin or insulin secretagogues such as sulfonylureas; dose adjustments of concomitant therapies may be required.
  • Headache, dizziness and fatigue have been reported.
  • Possible pancreatitis: severe, persistent abdominal pain (sometimes radiating to the back) can be a sign of pancreatitis; patients should seek urgent medical attention if this occurs.
  • Gallbladder-related events, such as cholelithiasis (gallstones) or cholecystitis, have been reported with incretin-based therapies including tirzepatide.
  • Worsening of diabetic retinopathy in some patients with pre-existing disease when glycaemic control improves rapidly; regular eye monitoring may be advised in at-risk individuals.
  • Acute kidney injury and worsening of chronic kidney disease have been reported, often in association with severe gastrointestinal fluid loss; maintaining hydration is important.
  • Hypersensitivity reactions, including rash and, rarely, serious allergic reactions (e.g. anaphylaxis or angioedema).

Storage Conditions

  • Store unopened pens 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 pens in the original carton to protect from light.
  • According to the manufacturer, pens may be kept at room temperature (up to 30 °C / 86 °F) for a limited time period (commonly up to 21 days), after which they must be discarded if not used; once kept at room temperature, pens should not be returned to the refrigerator (follow local label for exact conditions).
  • Do not use the medicine 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 in an appropriate sharps container in accordance with local regulations and pharmacy or clinic guidance.

Duration

Duration of treatment is individualised and determined by the prescribing clinician based on glycaemic control, weight management goals, tolerability, guideline recommendations and regulatory indications; in clinical practice, treatment is often long term for chronic conditions such as type 2 diabetes and obesity, provided the benefits continue to outweigh risks.

Onset

Improvements in fasting and postprandial blood glucose can be observed within weeks of initiating therapy, with full effects on HbA1c and body weight typically assessed after several months of once-weekly dosing; individuals may experience reduced appetite and some weight change earlier, but response varies.

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