Tirzepatide 5 mg solution for injection (weekly)

Mounjaro

Prescription medicine (antidiabetic / weight‑management drug)

GLP\u20111 / GIP receptor agonist; subcutaneous injection

Marketing authorisation in UK under trade‑name Mounjaro for tirzepatide (SmPC PL 15482) for type 2 diabetes and weight management. :contentReference[oaicite:25]{index=25}

Marketing authorisation in UK under trade‑name Mounjaro for tirzepatide (SmPC PL 15482) for type 2 diabetes and weight management. :contentReference[oaicite:25]{index=25}

GLP\u20111 / GIP receptor agonist; subcutaneous injection

Description

Tirzepatide is a dual glucose‑dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered via subcutaneous injection once weekly. It improves glycaemic control in adults with type 2 diabetes mellitus, and — at appropriate doses together with reduced‑calorie diet and physical activity — is indicated for weight management in people with overweight or obesity. :contentReference[oaicite:0]{index=0}

Bnefits

Lowers elevated blood glucose and improves glycaemic control in type 2 diabetes. :contentReference[oaicite:1]{index=1}
Aids weight loss and maintenance when combined with diet and exercise, for adults with obesity or overweight with comorbidities. :contentReference[oaicite:2]{index=2}
Dual action via both GIP and GLP-1 receptors — potentially more effective than GLP-1‑only agents in improving insulin secretion, reducing glucagon, and lowering appetite. :contentReference[oaicite:3]{index=3}
Once-weekly dosing and subcutaneous injection facilitates convenience and adherence. :contentReference[oaicite:4]{index=4}

Indications

Type 2 diabetes mellitus with insufficient glycaemic control, as monotherapy when metformin is inappropriate, or in combination with other antidiabetic agents. :contentReference[oaicite:5]{index=5}
Weight management (weight loss and maintenance) as adjunct to a reduced-calorie diet and increased physical activity in adults with BMI ≥ 30 kg/m² (obesity), or BMI ≥ 27 to < 30 kg/m² with at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, type 2 diabetes). :contentReference[oaicite:6]{index=6}

Composition

Active substance: tirzepatide (peptide molecule, molecular weight ~4813.53 g/mol). :contentReference[oaicite:7]{index=7}
Excipients (in solution for injection): sodium phosphate dibasic heptahydrate, sodium chloride, glycerol, phenol, benzyl alcohol (E1519), water for injections; pH adjusted with sodium hydroxide / hydrochloric acid as needed. :contentReference[oaicite:8]{index=8}

Formulation

Sterile, clear, colourless to slightly yellow aqueous solution for subcutaneous injection, supplied in a pre-filled pen (KwikPen) or single‑dose vial, depending on market. :contentReference[oaicite:9]{index=9}

Packaging

Pre-filled multi-dose pen (KwikPen) containing 4 doses of 0.6 mL solution (depending on strength; note that 5 mg dose is achieved via appropriate pen settings). :contentReference[oaicite:10]{index=10}

Usage

Administer subcutaneously once weekly into abdomen, thigh or upper arm. :contentReference[oaicite:11]{index=11}
Starting dose: 2.5 mg once weekly for first 4 weeks, then increase to 5 mg once weekly. Further dose escalation (if needed) may be done in increments of 2.5 mg after at least 4 weeks on current dose. Maintenance doses: 5, 10 or 15 mg weekly. Maximum dose: 15 mg/week. :contentReference[oaicite:12]{index=12}
Injection timing: any time of day, with or without meals. Rotate injection sites with each dose. If also injecting insulin, use a different injection site for tirzepatide. :contentReference[oaicite:13]{index=13}
If a dose is missed: administer as soon as possible within 4 days after the missed dose; if >4 days have passed, skip the missed dose and resume next dose on regular schedule. :contentReference[oaicite:14]{index=14}

Contraindications

Hypersensitivity to tirzepatide or any excipient. :contentReference[oaicite:17]{index=17}
History of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). :contentReference[oaicite:18]{index=18}
Use in children (< 18 years old) — safety and efficacy not established. :contentReference[oaicite:19]{index=19}

Adverse Effects

Common: gastrointestinal — nausea, vomiting, diarrhoea, constipation, decreased appetite, dyspepsia, abdominal discomfort. :contentReference[oaicite:20]{index=20}
Injection-site reactions. :contentReference[oaicite:21]{index=21}
Less common / serious: acute pancreatitis (reported post‑marketing), risk of dehydration and renal impairment if gastrointestinal side effects lead to fluid loss, hypoglycaemia when used with insulin or insulin secretagogues, potential for thyroid C-cell tumours (observed in animal studies — relevance to humans unknown) according to non-clinical data. :contentReference[oaicite:22]{index=22}

Storage Conditions

Shelf life before use: up to 24 months (unopened). :contentReference[oaicite:23]{index=23}
Store as per manufacturer packaging instructions; do not mix with other medicinal products due to lack of compatibility data. :contentReference[oaicite:24]{index=24}

Duration

Long-term \u2014 as directed by physician. For weight management, efficacy should be reassessed if <\u202f5% initial body weight loss after 6 months on highest tolerated dose. :contentReference[oaicite:15]{index=15}

Onset

Not publicly listed as a specific time to full efficacy; pharmacokinetic data show steady\u2011state exposure achieved after approximately 4 weeks of once\u2011weekly dosing. :contentReference[oaicite:16]{index=16}