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Mounjaro Injectable Pen 7.5 mg/0.5 mL

Mounjaro Injectable Pen 7.5 mg/0.5 mL

Mounjaro

Prescription Medicine
  • Product Level authorisation for Mounjaro (tirzepatide) injection by national authorities such as the FDA, EMA and MHRA for type 2 diabetes (and weight management where applicable).
  • Manufactured in accordance with current Good Manufacturing Practice (cGMP) for sterile injectable medicinal products.
  • Quality and safety oversight via risk management plans, periodic safety update reports and pharmacovigilance systems in the EU/UK, US and other regions.
  • Distributed through GDP Compliant (Good Distribution Practice) pharmaceutical supply chains.
  • Conforms to applicable pharmacopeial standards and regulatory specifications for identity, purity, potency, sterility, endotoxins and particulate matter.
Antidiabetic Injection (GIP/GLP-1 receptor agonist)

Description

Mounjaro Injectable Pen 7.5 mg/0.5 mL is a once-weekly, pre-filled single-dose pen containing tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It is used, alongside diet and exercise, to improve glycaemic control in adults with type 2 diabetes mellitus. Each single-use pen delivers one 7.5 mg dose of tirzepatide in 0.5 mL solution for subcutaneous injection and is part of a titration schedule that allows stepwise dose escalation under medical supervision.

Bnefits

  • Once-weekly single-dose pen simplifies treatment compared with some daily injectable regimens.
  • Dual GIP and GLP-1 receptor agonist mechanism improves glycaemic control by enhancing glucose-dependent insulin secretion and reducing inappropriate glucagon release.
  • Clinically proven to significantly lower HbA1c and fasting blood glucose in adults with type 2 diabetes when combined with diet and exercise.
  • Some patients experience meaningful body weight reduction as an additional metabolic benefit.
  • Pre-filled, ready-to-use single-dose pen designed for patient self-administration after appropriate training.
  • Sterile, preservative-free solution with tightly controlled composition and pH (6.5–7.5).
  • Fixed 7.5 mg dose fits into a structured titration sequence (after lower doses such as 2.5 mg and 5 mg) to balance efficacy and tolerability.
  • Backed by extensive phase 3 clinical trial data and regulatory review by authorities such as the FDA, EMA and MHRA (product-level approval; specific presentations may vary by region).

Indications

  • Once-weekly adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
  • May be used as monotherapy when metformin is inappropriate due to intolerance or contraindication (subject to local product information).
  • May be used in combination with other medicinal products for the treatment of type 2 diabetes (e.g. metformin, SGLT2 inhibitors, insulin) according to the approved prescribing information and clinical judgement.
  • In some regions, tirzepatide-based products and/or the Mounjaro brand are additionally authorised for chronic weight management; the 7.5 mg strength forms part of these regimens where locally approved and prescribed.

Composition

  • Active ingredient: tirzepatide 7.5 mg per 0.5 mL solution in each pre-filled single-dose pen.
  • Excipients (single-dose pen formulation): sodium chloride 4.1 mg, sodium phosphate dibasic heptahydrate 0.7 mg, water for injection.
  • Hydrochloric acid solution and/or sodium hydroxide solution may be used to adjust pH.
  • Solution characteristics: clear, colourless to slightly yellow, pH 6.5–7.5.
  • Sterile, preservative-free aqueous solution for subcutaneous injection.

Formulation

  • Pharmaceutical form: solution for injection in a pre-filled single-dose disposable pen.
  • Strength: 7.5 mg tirzepatide in 0.5 mL (15 mg/mL) per pen.
  • Route of administration: subcutaneous injection.
  • Mechanism of action: dual agonist at GIP and GLP-1 receptors, enhancing glucose-dependent insulin secretion, reducing glucagon secretion, slowing gastric emptying and promoting satiety.
  • Non-insulin injectable incretin-based therapy belonging to the GLP-1 receptor agonist drug class in many formularies.
  • Preservative-free formulation intended for single use; any residual solution after injection must be discarded.

Packaging

  • Each carton typically contains 4 single-dose pre-filled pens of Mounjaro 7.5 mg/0.5 mL (exact pack size may vary by market).
  • Each pen is colour-coded and clearly labelled with the strength (7.5 mg/0.5 mL), brand name and active ingredient.
  • Primary container: glass cartridge sealed with a rubber plunger and crimped cap, integrated within a disposable pen device.
  • Outer carton displays product name, dosage strength, dosage form, route of administration, batch number, expiry date and storage instructions.
  • Accompanied by a Medication Guide / Patient Information Leaflet and detailed Instructions for Use.
  • Pen needles are often dispensed separately; compatible single-use pen needles must be used according to local practice.

Usage

  • Use only under the supervision of a suitably qualified healthcare professional and with a valid prescription.
  • Typical initiation involves starting at a lower once-weekly dose (e.g. 2.5 mg) and escalating through intermediate strengths (such as 5 mg) before progressing to 7.5 mg once weekly, in line with the approved dosing schedule and individual tolerability.
  • Administer one full 7.5 mg/0.5 mL dose 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; rotate injection sites each week and avoid injecting into areas that are tender, bruised, scarred, or hardened.
  • Each pre-filled pen is for single use only and delivers one dose; discard the pen after injection, even if some solution appears to remain.
  • Use a new, sterile needle for each injection. Attach the needle, remove needle caps as directed, press the pen against the skin and activate the injection button per the Instructions for Use.
  • The pen is for single-patient use only. Never share a pen with anyone else, even if the needle is changed, due to risk of infection transmission.
  • If a dose is missed, follow the guidance in the Patient Information Leaflet or from your healthcare provider (e.g. administer as soon as possible within a defined time window or skip and resume the usual schedule); do not inject two doses within a short interval without medical advice.
  • Continue prescribed diet, exercise and concomitant antidiabetic medicines; concurrent therapies such as insulin or sulfonylureas may require dose adjustment to minimise 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 is visibly damaged.

Contraindications

  • Known hypersensitivity to tirzepatide or to any of the excipients 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, 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 supervision.
  • Use during breastfeeding is not recommended because it is unknown whether tirzepatide is excreted in human milk; a risk–benefit discussion with a clinician 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 regional product information and guidance.
  • Not indicated for patients under 18 years of age; safety and efficacy in paediatric populations have not been established.
  • Any additional contraindications, warnings or precautions listed in the current local prescribing information (e.g. FDA label, SmPC) must be observed.

Adverse Effects

  • Very common gastrointestinal 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 pain, erythema, itching or swelling at the injection site.
  • Hypoglycaemia, especially when used in combination with insulin or sulfonylureas; dose adjustment of concomitant glucose-lowering medicines may be necessary.
  • Headache, dizziness, fatigue and asthenia (general weakness).
  • Gallbladder-related events such as cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation), particularly in the context of substantial weight loss.
  • Acute pancreatitis has been reported; severe, persistent abdominal pain with or without vomiting may be a sign and requires urgent medical evaluation.
  • Possible worsening of diabetic retinopathy in patients with pre-existing disease due to rapid improvement in glycaemic control; regular ophthalmologic monitoring may be advised.
  • Acute kidney injury or worsening of chronic kidney disease, often associated with dehydration resulting from severe gastrointestinal side effects; maintaining adequate hydration 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 the pen in the original carton to protect it from light.
  • If permitted by local labelling, unopened pens may be kept at room temperature up to the specified maximum temperature and duration; after this period the pen must be discarded, and pens kept at room temperature should not be returned to the refrigerator (follow local prescribing information).
  • 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 appropriate sharps container in accordance with local regulations.

Duration

Intended as long-term therapy for chronic type 2 diabetes, with duration determined individually by the prescribing clinician based on glycaemic control, tolerability, weight evolution, comorbidities and guideline recommendations. Packs of 4 pens typically provide 4 weeks of treatment at a once-weekly 7.5 mg dose.

Onset

Improvements in fasting and postprandial glucose may be observed within the first weeks of treatment, while full effects on HbA1c and body weight are generally evaluated after several months of once-weekly dosing. Onset and magnitude of response vary between individuals.

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