MOUNJARO® 5mg KwikPen®, 1 Stk.

What is MOUNJARO® 5mg KwikPen®

MOUNJARO® 5mg KwikPen® is a multi-dose, pre-filled injection device intended to deliver 5 mg tirzepatide in 0.6 mL once weekly by subcutaneous administration. It is used for the treatment of adults with type 2 diabetes mellitus and for weight management in patients meeting BMI criteria. Each device contains 2.4 mL of solution (total 20 mg tirzepatide) and supplies four fixed doses. The solution is clear, colourless to slightly yellow, designed for subcutaneous injection into the abdomen, thigh, or upper arm.

• Per dose: 5 mg tirzepatide (0.6 mL)

• Total pen content: 20 mg/2.4 mL (8.33 mg/mL)

• Number of doses: 4

• Injection sites: Abdomen, thigh, upper arm

• Device type: Disposable multi-dose pen

What is the Administration Protocol for MOUNJARO® 5mg KwikPen®

This strength is administered once weekly, with or without meals, at the same time each week. A titration process is followed to enhance tolerability and clinical effect.

• Initiation: 2.5 mg weekly for 4 weeks, then increase to 5 mg

• Titration: May escalate in 2.5 mg increments every ≥4 weeks up to 15 mg

• Maintenance options: 5 mg, 10 mg, or 15 mg weekly

• Missed dose protocol:

  • If ≤4 days late: administer as soon as possible

  • If >4 days late: skip and resume at next scheduled dose

• Technique:

  • Attach a sterile needle before each use

  • Dial pen to 1 (=0.6 mL dose)

  • Inject subcutaneously, hold for 5 seconds until window shows 0

• Site rotation: Rotate between abdomen, thigh, and upper arm

What are the Indications for MOUNJARO® 5mg KwikPen®

MOUNJARO® is indicated for metabolic disorders in adults, particularly glycaemic regulation and weight reduction. Contraindications and clinical cautions must be observed.

• Indications:

  • Adults with type 2 diabetes mellitus, alone or with other antidiabetic agents

  • Adults with BMI ≥30 kg/m² (obesity)

  • Adults with BMI ≥27 to <30 kg/m² plus comorbidities (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes)

• Contraindications:

  • Hypersensitivity to tirzepatide or excipients

• Precautions:

  • History of pancreatitis

  • Severe gastrointestinal disease (e.g., gastroparesis)

• Adverse effects:

  • Common: Nausea, diarrhoea, vomiting, abdominal pain, constipation

  • Hypoglycaemia risk with insulin or sulphonylurea

  • Mild injection-site reactions

  • Gallbladder events occasionally reported

  • Rare: acute pancreatitis, hypersensitivity reactions

What is the composition of MOUNJARO® 5mg KwikPen®

Each injection contains tirzepatide as the active ingredient with excipients ensuring formulation stability and sterility.

• Active substance: Tirzepatide 5 mg/0.6 mL

• Total pen content: 20 mg/2.4 mL

• Concentration: 8.33 mg/mL

• Excipients: Disodium hydrogen phosphate heptahydrate, benzyl alcohol (~5.4 mg per dose), glycerol, phenol, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections

• Sodium content: <1 mmol sodium per dose (sodium-free)

• Appearance: Clear, colourless to slightly yellow solution

What Comes in the MOUNJARO® 5mg KwikPen® Package

The packaging is designed to ensure proper dosing but does not include pen needles.

• Device presentation: Pre-filled KwikPen® with 2.4 mL solution (4 doses)

• Pack sizes: Available in single or three-pen cartons

• Needles: Not provided; must be acquired separately

• Documentation: Patient Information Leaflet and Instructions for Use

Does MOUNJARO® 5mg KwikPen® cause side effects?

Yes, adverse reactions are possible, with gastrointestinal events most commonly observed. Incidence is highest during initiation and titration phases.

• Very common: Nausea, diarrhoea, vomiting, abdominal pain, constipation

• Hypoglycaemia: More likely with sulphonylurea or insulin; severe hypoglycaemia rare (~0.2%)

• Injection-site reactions: Up to 3–8% of patients

• Gallbladder events: Up to 2% incidence in trials

• Uncommon but serious: Acute pancreatitis

• Rare: Severe allergic reactions, including anaphylaxis and angioedema

• Laboratory findings: Elevations in amylase and lipase

How should MOUNJARO® 5mg KwikPen® be stored?

Proper storage conditions are required to preserve product efficacy.

• Unopened pens: Refrigerate at 2–8 °C

• Do not freeze; discard if frozen

• After first use: Store at ≤30 °C for up to 30 days

• Discard after 30 days, even if solution remains

• Needles: Remove after each use, dispose of in sharps container

• Keep out of sight and reach of children