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Mounjaro KwikPen Range

Mounjaro KwikPen Range

Mounjaro

Prescription Medicine
  • Authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as Mounjaro KwikPen 7.5 mg solution for injection in pre Filled pen for adults with type 2 diabetes and, where specified, for weight management.
  • Centrally authorised by the European Medicines Agency (EMA) as part of the Mounjaro (tirzepatide) range, with published European Public Assessment Report (EPAR) and product information.
  • Manufactured in accordance with EU/UK and international Good Manufacturing Practice (GMP) standards for sterile parenteral medicinal products.
  • Subject to ongoing pharmacovigilance, including risk management plans, periodic safety update reports and post Authorisation safety studies in the EU/UK and other markets.
  • Distributed via licensed pharmaceutical wholesalers and pharmacies that comply with GDP (Good Distribution Practice) and national medicines legislation.
Antidiabetic & Weight Management Injection (GIP/GLP-1 receptor agonist)

Description

Mounjaro KwikPen 7.5 mg/0.6 mL 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 used in adults with type 2 diabetes, in combination with diet and exercise, to improve blood glucose control, and is also authorised in the UK/EU and other regions for weight management in adults with obesity or overweight and weight-related health problems. The 7.5 mg dose is an intermediate step in the titration schedule between lower and higher strengths, providing enhanced glycaemic and weight-loss effects under medical supervision.

Bnefits

  • Once-weekly dosing, which can improve convenience and adherence compared with some daily injectable therapies.
  • Dual GIP and GLP-1 receptor agonist mechanism that improves glycaemic control and reduces appetite, supporting weight loss.
  • Clinically proven reductions in HbA1c and significant body weight loss in adults with type 2 diabetes and in adults with obesity or overweight.
  • Helps patients feel fuller for longer, lowers appetite and reduces overall caloric intake, aiding sustained weight reduction when combined with lifestyle changes.
  • Used as a step-up dose after initial titration from lower strengths (such as 2.5 mg and 5 mg), allowing gradual dose escalation tailored to tolerability and response.
  • Multi-dose KwikPen provides four fixed weekly doses of 7.5 mg (0.6 mL) in a single disposable device.
  • Clear, colourless to slightly yellow solution with well-characterised composition and extensive regulatory review by 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 product information and clinical judgement.

Indications

  • Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
  • • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;
  • • in combination with other medicinal products for the treatment of diabetes, in accordance with the Summary of Product Characteristics.
  • Weight management and weight loss (including weight maintenance) in adults with obesity or overweight and weight-related comorbidities, where authorised (e.g. UK/EU), when used alongside a reduced-calorie diet and increased physical activity.
  • Use in adults requiring an intermediate (7.5 mg) once-weekly tirzepatide dose as part of a structured titration regimen to optimise efficacy and tolerability.

Composition

  • Active substance: tirzepatide 7.5 mg per 0.6 mL dose.
  • Each multiple-dose pre-filled KwikPen contains 30 mg tirzepatide in 2.4 mL solution (12.5 mg/mL), delivering four 7.5 mg doses.
  • Excipients (EU/UK KwikPen presentations): benzyl alcohol (5.4 mg per 0.6 mL dose), sodium phosphate dibasic heptahydrate, glycerol, phenol, sodium chloride, sodium hydroxide, concentrated hydrochloric acid and water for injections.
  • Solution characteristics: clear, colourless to slightly yellow aqueous solution for injection.
  • Preservative-containing multi-dose presentation (benzyl alcohol and phenol) designed for single-patient, multi-use over a limited in-use period.

Formulation

  • Pharmaceutical form: solution for injection in a multi-dose, pre-filled disposable pen (KwikPen).
  • Strength: 7.5 mg tirzepatide per 0.6 mL dose; each KwikPen delivers four fixed doses.
  • Route of administration: subcutaneous injection (abdomen, thigh or upper arm).
  • Mechanism of action: dual agonist at GIP and GLP-1 receptors, enhancing glucose-dependent insulin secretion, reducing inappropriate glucagon secretion, slowing gastric emptying and increasing satiety.
  • Non-insulin incretin-based injectable therapy; not intended for type 1 diabetes or diabetic ketoacidosis.
  • Multi-dose, single-patient-use design with dose window and dial mechanism; pen is discarded after four doses, even if residual liquid remains.
  • pH adjusted to approximately 6.5–7.5 using sodium hydroxide and/or hydrochloric acid, as specified in regulatory product information.

Packaging

  • Each carton typically contains one Mounjaro KwikPen 7.5 mg/0.6 mL multi-dose pre-filled pen (2.4 mL total).
  • Each KwikPen delivers four 0.6 mL doses containing 7.5 mg tirzepatide per dose (four-week supply at the prescribed weekly dose).
  • Pen body is colour-coded and clearly labelled for the 7.5 mg strength, with integrated dose selector and injection button.
  • Primary container: glass cartridge with rubber stopper and crimped seal housed inside the disposable pen.
  • Outer carton and pen label display product name, strength, active ingredient, batch number, expiry date, storage instructions and manufacturer details.
  • Pen needles are not usually supplied in the carton in many markets; compatible single-use pen needles are provided separately by pharmacies according to local practice.

Usage

  • Mounjaro KwikPen 7.5 mg/0.6 mL must only be used under the guidance of a suitably qualified healthcare professional and on prescription.
  • Therapy is typically initiated at 2.5 mg once weekly and titrated upwards (e.g. to 5 mg then 7.5 mg and beyond) according to tolerability, glycaemic control, weight-loss response and local prescribing guidelines; patients should not change dose without medical advice.
  • Administer one 0.6 mL dose (7.5 mg) 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, rotating injection sites each week and avoiding areas that are tender, bruised, scarred or hardened.
  • Use a new, sterile pen needle for each injection; attach the needle, perform any priming steps as per Instructions for Use, dial the prescribed dose and inject as demonstrated by the healthcare professional.
  • The KwikPen is a multi-dose, single-patient-use device; it must never be shared with another person, even if the needle is changed, due to risk of cross-infection.
  • If a dose is missed, follow the instructions in the Patient Information Leaflet or SmPC (e.g. administer as soon as possible within a defined window or skip and resume the usual schedule) and seek healthcare advice rather than taking extra doses without guidance.
  • Do not use the pen if the solution appears cloudy, coloured, contains particles, has been frozen, is damaged, or is past its expiry date.
  • Continue a reduced-calorie diet and increased physical activity as advised; concomitant glucose-lowering medicines (particularly insulin or sulfonylureas) may require dose adjustment to reduce hypoglycaemia risk.
  • Dispose of used needles immediately after injection into an approved sharps container and discard the pen after four doses or at the end of its in-use period, following local disposal regulations.

Contraindications

  • Hypersensitivity to tirzepatide or to any of the excipients in the formulation (including benzyl alcohol).
  • Use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; tirzepatide 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 generally be discontinued prior to a planned pregnancy and avoided during pregnancy unless the potential benefit clearly outweighs the risk under specialist advice.
  • Use during breastfeeding is not recommended because it is unknown whether tirzepatide passes into human milk; risk–benefit assessment is required.
  • 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 the authorised 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, warnings or restrictions specified in the current MHRA/EMA-approved Summary of Product Characteristics (SmPC).

Adverse Effects

  • Very common gastrointestinal reactions, including nausea, vomiting, diarrhoea, decreased appetite and constipation, especially 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 such as pain, erythema, itching or swelling at the injection site.
  • Hypoglycaemia, particularly when used in combination with insulin or sulfonylureas; dose reduction of concomitant therapies may be required.
  • Headache, dizziness, fatigue and asthenia (general weakness).
  • Gallbladder-related events including cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation), especially in the context of rapid or substantial weight loss.
  • Acute pancreatitis has been reported; severe, persistent abdominal pain (with or without vomiting) may be a sign of pancreatitis and requires urgent medical attention.
  • Possible worsening of diabetic retinopathy in patients with pre-existing disease when glycaemic control improves rapidly; regular eye monitoring may be advisable.
  • Acute kidney injury or worsening of chronic kidney disease, often related to dehydration secondary to severe gastrointestinal side effects; adequate fluid intake is important.
  • Hypersensitivity reactions including rash, urticaria and, rarely, severe 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; discard the pen if it has been frozen.
  • Keep the pen in the original carton to protect it 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 for the in-use duration specified in the Patient Information Leaflet (commonly up to 30 °C for a limited number of days, such as 21–30 days); after this period, the pen must be discarded even if it still contains medicine.
  • Do not expose the pen 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 in an appropriate sharps container according to local regulations and pharmacy or clinic guidance.

Duration

Long-term therapy for chronic conditions such as type 2 diabetes and obesity, with duration determined individually by the prescribing clinician based on treatment goals, benefits, safety and current guidelines. Each Mounjaro KwikPen 7.5 mg/0.6 mL provides four weekly doses (approximately four weeks of treatment) when used as directed.

Onset

Initial improvements in fasting and postprandial glucose and reductions in appetite may be observed within the first weeks of therapy. Full effects on HbA1c and body weight are typically evaluated over several months of once-weekly dosing, with onset and magnitude of response varying between individuals.

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