MOUNJARO® 12.5mg KwikPen®, 1 Stk.

This section highlights the design, composition, and usability aspects that make Mounjaro 5mg KwikPen a convenient treatment for both patients and healthcare professionals.

• Active ingredient: Tirzepatide 5 mg per 0.6 mL dose (8.33 mg/mL).

• Multi-dose system: Each pen contains 2.4 mL of solution, providing 4 doses of 5 mg each.

• Therapeutic categories: Type 2 diabetes mellitus and weight management for BMI ≥ 30 kg/m² or ≥ 27 kg/m² with comorbidities (e.g., hypertension, dyslipidaemia, OSA).

• Pharmaceutical form: Clear, colorless to slightly yellow solution for subcutaneous injection.

• Dosing frequency: Once weekly, administered at any time of day, with or without meals.

• Device type: KwikPen® – a prefilled, disposable, single-patient-use injection device.

• Storage: Unopened pens refrigerated at 2 °C – 8 °C; once opened, may be stored up to 30 °C for 30 days.

• Safety additives: Contains 5.4 mg of benzyl alcohol per dose and is essentially sodium-free (< 1 mmol).

• Injection flexibility: Can be injected into abdomen, thigh, or upper arm, with site rotation recommended weekly.

Mounjaro 5mg KwikPen is indicated for adults with type 2 diabetes mellitus to improve glycaemic control, and for weight reduction and long-term weight maintenance as an adjunct to diet and physical activity.

Therapeutic Indications:

• Monotherapy: When metformin is unsuitable due to intolerance or contraindications.

• Combination therapy: In conjunction with metformin, SGLT2 inhibitors, sulphonylureas, or insulin.

• Weight management: For adults with BMI ≥ 30 kg/m², or BMI ≥ 27 kg/m² plus at least one weight-related condition.

Contraindications:

• Hypersensitivity to tirzepatide or excipients.

• Pregnancy and lactation: Not recommended; discontinue at least 1 month prior to planned pregnancy.

• Severe gastrointestinal diseases (e.g., gastroparesis) or history of pancreatitis require caution.

Common Side Effects:
Adverse effects are typically mild-to-moderate and occur mainly during dose escalation.

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

• Common: Decreased appetite, fatigue, dyspepsia, injection-site redness or itching.

• Uncommon/Rare: Hypoglycaemia (especially with insulin), acute pancreatitis, gallbladder disease, hair loss, allergic reactions (e.g., urticaria, angioedema).

• In clinical studies, 37%–43% of patients experienced mild GI events, which declined over time

This section outlines the composition, formulation, and packaging of the 5 mg KwikPen.

Each 0.6 mL dose contains 5 mg of tirzepatide in an aqueous glycerol-phosphate buffer, with the following inactive ingredients:

• Glycerol, disodium phosphate, sodium phosphate monohydrate, benzyl alcohol, and water for injection.

• The solution is sterile, colorless, and particle-free.

• Concentration: 8.33 mg/mL; total 2.4 mL per pen.

• Packaging: Pre-filled disposable KwikPen with a dose window and tactile click system for accuracy.

• Needles not included: Use KwikPen-compatible needles supplied separately.

• Labelling: Color-coded (blue for 5 mg dose) for easy differentiation.

• Shelf life: 30 days after first use.

The pen ensures consistent delivery of four equal doses and incorporates a mechanical dose lock once the four injections are completed, preventing reuse.

The Mounjaro 5mg KwikPen is intended for once-weekly subcutaneous administration. Patients should receive proper training before self-injection to ensure safety and efficacy.

Instructions for Use:

1. Check the pen label to confirm the correct strength and expiry date.

2. Attach a new sterile needle before each injection; never reuse needles.

3. Prime the pen by turning the dose knob until two clicks are heard and pressing to release a small drop of liquid.

4. Select injection site: Abdomen, thigh, or upper arm. Rotate sites weekly.

5. Dial the dose until “1” appears in the window (equivalent to 0.6 mL).

6. Inject subcutaneously, pressing and holding the dose knob for 5 seconds until “0” appears in the window.

7. Dispose of needle immediately in a sharps container.

8. Recap the pen and store properly until next use.

Missed Dose:

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

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

• Maintain at least 3 days between injections.

Patients should continue prescribed dietary and exercise routines, and never share their device.