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Mounjaro 7.5 mg/0.6 mL KwikPen

Mounjaro 7.5 mg/0.6 mL KwikPen

Mounjaro

Prescription Medicine
  • Authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for weight management/weight loss and for improving glycaemic control in adults with type 2 diabetes, at strengths including 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg tirzepatide per dose.
  • Centrally authorised by the European Medicines Agency (EMA) as Mounjaro (tirzepatide) with multi Dose KwikPen and vial presentations across a range of strengths.
  • Manufactured under EU and international Good Manufacturing Practice (GMP) and Eli Lilly’s global quality systems.
  • Subject to ongoing pharmacovigilance, including risk management plans, periodic safety update reports and post Authorisation safety studies.
  • Distributed in the UK through MHRA Authorised wholesalers and pharmacy services, including DD Group’s temperature Controlled supply chain for prescription medicines.
Antidiabetic & Weight Management Injection (GIP/GLP-1 receptor agonist)

Description

Mounjaro 7.5 mg/0.6 mL KwikPen is a once-weekly, multi-dose pre-filled pen containing tirzepatide, a dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. It is licensed and approved in the UK for weight management and weight loss in eligible adults, and also for improving blood glucose control in adults with type 2 diabetes, when used together with diet and exercise. The 7.5 mg/0.6 mL strength pen delivers four weekly doses and is used as an intermediate dose in the treatment escalation schedule prescribed by a healthcare professional.

Bnefits

  • Once-weekly subcutaneous injection, which can be more convenient than some daily injectable regimens.
  • Dual GIP and GLP-1 receptor agonist mechanism improves glycaemic control and reduces appetite, helping patients feel fuller between meals and lowering overall calorie intake.
  • Clinically proven to reduce HbA1c and improve blood sugar control in adults with type 2 diabetes when used with diet and exercise.
  • Licensed and approved for weight management and weight loss in the UK for adults who meet BMI and co-morbidity criteria, when used with a reduced-calorie diet and increased physical activity.
  • Supports significant, sustained weight loss in many patients, which may reduce obesity-related risks such as type 2 diabetes, hypertension and dyslipidaemia.
  • Delivered in an easy-to-use multi-dose KwikPen that contains four 7.5 mg doses (each 0.6 mL), with one dose taken each week.
  • Clear, colourless to slightly yellow sterile solution with tightly controlled manufacturing standards and extensive regulatory review (MHRA, EMA and other authorities).
  • Can be used alone or in combination with other glucose-lowering medicines (excluding type 1 diabetes or diabetic ketoacidosis) according to the approved label and clinical judgement.

Indications

  • Weight management and weight loss in adults with obesity or overweight and weight-related health problems, in accordance with UK marketing authorisation and relevant national guidance, when used alongside a reduced-calorie diet and increased physical activity.
  • 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, according to the Summary of Product Characteristics.
  • Use in adults who require a once-weekly injectable incretin-based therapy to improve glycaemic control and support weight reduction when other options are inadequate or not tolerated.

Composition

  • Active substance: tirzepatide 7.5 mg per 0.6 mL dose.
  • Each multi-dose pre-filled KwikPen contains 30 mg of tirzepatide in 2.4 mL solution (12.5 mg/mL) and delivers four doses of 7.5 mg (0.6 mL) each.
  • Excipients (EU/UK multi-dose KwikPen): benzyl alcohol (5.4 mg per 0.6 mL dose) as a preservative, sodium chloride, sodium phosphate dibasic heptahydrate and water for injections; sodium hydroxide and hydrochloric acid are used for pH adjustment (full list in the official SmPC).
  • Solution characteristics: clear, colourless to slightly yellow, with pH in the range specified in the product information (approximately 6.5–7.5).
  • Does not contain insulin; tirzepatide is a synthetic peptide-based dual GIP/GLP-1 receptor agonist.

Formulation

  • Pharmaceutical form: solution for injection in a multi-dose pre-filled pen (KwikPen).
  • Strength: 7.5 mg tirzepatide per 0.6 mL dose.
  • Each KwikPen is a disposable, single-patient-use device containing four fixed doses (four weeks of therapy when one dose is administered weekly).
  • 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, thereby improving glycaemic control and reducing body weight.
  • Contains benzyl alcohol and is preserved, multi-dose in the EU/UK KwikPen presentation; patients must follow the in-use storage and discard times exactly as stated in the leaflet.
  • Classified pharmacologically within incretin-based therapies, related to GLP-1 receptor agonists but with additional GIP receptor activity.

Packaging

  • Each carton typically contains one multi-dose Mounjaro 7.5 mg/0.6 mL KwikPen pre-filled pen (2.4 mL total).
  • The pen is colour-coded and clearly labelled for the 7.5 mg strength, with dose window and operating mechanism integrated in the KwikPen design.
  • Each pen provides four 0.6 mL doses, one administered each week; leftover medicine after the fourth dose is normal and the pen must be discarded even if some solution remains.
  • Outer carton and pen label include product name, strength, batch number, expiry date, storage instructions and manufacturer information.
  • Pen needles are usually supplied separately according to local pharmacy practice; only compatible single-use pen needles should be used.
  • Non-sterile outer packaging; sterile medicine within the sealed glass cartridge in the pen until first use.

Usage

  • Mounjaro must be prescribed and supervised by a suitably qualified healthcare professional who decides the indication (type 2 diabetes and/or weight management), starting dose and escalation schedule according to the approved product information and clinical guidelines.
  • The 7.5 mg/0.6 mL KwikPen is generally used after initial titration from lower doses (such as 2.5 mg and 5 mg) as part of a stepwise dose-escalation schedule; patients should never change dose without medical advice.
  • Inject 0.6 mL (7.5 mg) once weekly, on the same day each week, as a subcutaneous injection into the abdomen, thigh or upper arm, rotating injection sites each week.
  • The KwikPen is a multi-dose, single-patient-use device; never share a pen with anyone else, even if a new needle is used, due to the risk of infection transmission.
  • Use a new, sterile pen needle for each injection; attach the needle, prime if instructed in the Instructions for Use, set the prescribed dose and inject as demonstrated by the healthcare professional.
  • If a dose is missed, follow the advice in the patient leaflet or from the prescriber (e.g. take as soon as possible within a defined window or skip and resume the regular schedule); do not take two doses within 3 days of each other unless specifically advised.
  • Continue following a reduced-calorie diet, increased physical activity and any other prescribed diabetes or weight-management medication while using Mounjaro; some concomitant therapies, particularly insulin or sulfonylureas, may need dose adjustment to reduce the risk of hypoglycaemia.
  • 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 appears damaged.
  • Dispose of used needles and pens in an approved sharps container; follow local regulations and pharmacy or clinic guidance for disposal.
  • Read and follow the full Instructions for Use provided with the pen before the first injection, and ask a healthcare professional to demonstrate correct technique.

Contraindications

  • Hypersensitivity to tirzepatide or to any of the excipients (including benzyl alcohol) in the formulation.
  • 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, is a reason to avoid tirzepatide due to its effect on gastric emptying.
  • Use during pregnancy is not recommended; tirzepatide should generally be discontinued before a planned pregnancy and avoided during pregnancy unless clearly needed under specialist guidance.
  • Breastfeeding is not recommended while using tirzepatide due to limited data on excretion in human milk; a risk–benefit discussion with the clinician is required.
  • Caution or avoidance is advised in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2), in line with product information and local regulatory advice.
  • Not indicated for paediatric patients; safety and efficacy in individuals under 18 years have not been established in current UK/EMA labelling.
  • Any additional contraindications, warnings or restrictions listed in the current Summary of Product Characteristics or national guidance should be observed.

Adverse Effects

  • Very common gastrointestinal effects such as nausea, vomiting, diarrhoea, decreased appetite and constipation, particularly during dose escalation; these are often mild to moderate and tend to lessen over time.
  • Abdominal pain, dyspepsia, abdominal distension, flatulence, belching and gastro-oesophageal reflux.
  • Injection-site reactions including pain, erythema, pruritus or induration at the injection site.
  • Hypoglycaemia, especially when tirzepatide is used in combination with insulin or sulfonylureas; dose adjustments of concomitant glucose-lowering drugs may be necessary.
  • Headache, dizziness, fatigue, asthenia, malaise or lethargy.
  • Gallbladder-related events including cholelithiasis and cholecystitis, particularly in the context of substantial weight loss.
  • Pancreatitis has been reported; severe, persistent abdominal pain (with or without vomiting) may indicate pancreatitis and requires urgent medical evaluation.
  • Acute kidney injury or worsening of chronic kidney disease, often associated with dehydration from severe gastrointestinal side effects; maintaining adequate hydration is important.
  • Hair loss and changes in heart rate have been observed in some patients in clinical trials.
  • Hypersensitivity reactions including rash, urticaria, and rarely serious allergic reactions such as anaphylaxis or angioedema.

Storage Conditions

  • Store unopened Mounjaro KwikPens 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 be discarded and not used.
  • Keep the pen in the original carton to protect from light.
  • When in use or if kept out of the refrigerator, the pen may be stored at room temperature (up to the maximum temperature and duration specified in the leaflet, typically up to 30 °C for a limited period such as 21–30 days); after this in-use period the pen must be discarded even if it still contains medicine.
  • Do not expose the pen to direct heat or sunlight.
  • 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 safely in an appropriate sharps container in line with local regulations.

Duration

Treatment duration is individualised and may be long term for chronic conditions such as type 2 diabetes and obesity, provided the patient continues to benefit and tolerates therapy. A single 7.5 mg/0.6 mL KwikPen contains four weekly doses (approximately four weeks\u2019 supply) when used as directed.

Onset

Initial improvements in fasting and postprandial glucose, appetite and satiety can be observed within weeks of starting therapy. Clinically significant reductions in HbA1c and body weight are generally assessed over several months of once-weekly dosing; individual response and speed of onset vary.

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