Mounjaro 12.5 mg KwikPen — Tirzepatide 2.4 ml Prefilled Pen Cold chain · Storage +2…+8 °C

Mounjaro 12.5 mg KwikPen is supplied as a clear, colorless to slightly yellow solution for subcutaneous injection in a pre-filled multi-dose KwikPen injector:

• Packaging Configuration: 1 pre-filled multi-dose KwikPen containing 2.4 ml of solution (delivering 4 doses).
• Active Ingredient: Tirzepatide — 12.5 mg per single dose. Total active drug content per pen is 50 mg.
• Inactive Excipients: Sodium phosphate dibasic heptahydrate, sodium chloride, benzyl alcohol (preservative), water for injections, sodium hydroxide and/or hydrochloric acid (for pH adjustment).

Pharmacodynamics: Tirzepatide is a 39-amino-acid synthetic peptide engineered with a C20 fatty diacid moiety that enables non-covalent binding to human albumin, extending its half-life to approximately 5 days. Tirzepatide binds to and activates both GIP and GLP-1 receptors. Simultaneous activation stimulates glucose-dependent insulin secretion, suppresses glucagon release, lowers fasting and postprandial glucose levels, slows gastric emptying, and acts on hypothalamic feeding centers to increase satiety and reduce caloric intake.

Pharmacokinetics: Following subcutaneous administration, maximum plasma concentration (Cmax) is attained within 8 to 72 hours. Absolute bioavailability is approximately 80%. Steady-state plasma concentrations are achieved following 4 weeks of once-weekly administration. Tirzepatide is metabolized via proteolytic cleavage of the peptide backbone and beta-oxidation of the fatty acid side chain. The terminal elimination half-life (T1/2) is approximately 5 days (120 hours), supporting once-weekly dosing. Elimination occurs via urine and feces as metabolic fragments.

Mounjaro 12.5 mg KwikPen is indicated for adult patients in the following therapeutic areas:

• 🔹 Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, either as monotherapy (when metformin is inappropriate) or in combination with other antihyperglycemic agents (metformin, sulfonylureas, SGLT-2 inhibitors, insulin).
• 🔹 Chronic Weight Management: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m² (obesity) or ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).

Mounjaro 12.5 mg KwikPen is formulated strictly for subcutaneous injection:

• 💊 Dose Escalation Schedule: Therapy must be initiated at 2.5 mg once weekly for 4 weeks. After 4 weeks, increase the dose in 2.5 mg increments every 4 weeks (2.5 mg ➔ 5 mg ➔ 7.5 mg ➔ 10 mg ➔ 12.5 mg ➔ 15 mg). Escalation to the 12.5 mg dose should only occur after completing at least 4 weeks of treatment on the 10 mg dose.
• ⏱️ Administration Schedule: Administer 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 with each weekly dose.
• 💉 KwikPen Operation: The multi-dose KwikPen is pre-configured to deliver a fixed 12.5 mg Tirzepatide dose per injection. Attach a new sterile pen needle before each administration.
• 🚫 Missed Dose Management: If a dose is missed, administer it as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have elapsed, skip the missed dose and resume the regular weekly schedule on the next planned day.

Mounjaro 12.5 mg KwikPen is strictly contraindicated in patients presenting with:

• ❌ Hypersensitivity to Tirzepatide or to any of the inactive excipients in the formulation.
• ❌ Personal or family history of Medullary Thyroid Carcinoma (MTC).
• ❌ Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• ❌ Type 1 diabetes mellitus or treatment of diabetic ketoacidosis.
• ❌ Severe gastrointestinal disease, including severe gastroparesis.
• ❌ Pregnancy and breastfeeding.
• ❌ Pediatric patients under 18 years of age (safety and efficacy not established).

Consider the following interactions when administering Mounjaro 12.5 mg KwikPen:

• ⚠️ Insulin and Insulin Secretagogues (Sulfonylureas): Co-administration increases the risk of hypoglycemia. A dose reduction of insulin or sulfonylurea may be required.
• ⚠️ Oral Medications: Mounjaro causes a delay in gastric emptying, which may impact the rate and extent of absorption of concomitantly administered oral medications (e.g., oral contraceptives, antibiotics, narrow therapeutic index drugs). Patients taking oral contraceptives should switch to a non-oral method or add a barrier method for 4 weeks after initiation and for 4 weeks after each dose escalation.

Mounjaro 12.5 mg KwikPen is **contraindicated during pregnancy**. Animal reproduction studies have shown potential embryofetal toxicity. Women of childbearing potential should use effective contraception during treatment. Discontinue Mounjaro at least 2 months prior to a planned pregnancy. It is unknown whether Tirzepatide is excreted in human milk; breastfeeding should be discontinued during treatment.

Mounjaro 12.5 mg KwikPen at the 12.5 mg dose may cause adverse reactions, most commonly involving the gastrointestinal tract, which typically subside over time:

• 🤢 Gastrointestinal (Very Common): Nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, eructation, flatulence, gastroesophageal reflux disease.
• 💆 General Disorders: Fatigue, asthenia, dizziness, injection site reactions (erythema, pruritus, hematoma).
• 📉 Metabolic & Laboratory: Hypoglycemia (when used with insulin or sulfonylureas), decreased appetite, elevated serum lipase/amylase.
• ⚠️ Rare but Serious Events: Acute pancreatitis, gallbladder disease (cholelithiasis, cholecystitis), acute kidney injury (secondary to dehydration from GI adverse reactions), severe hypersensitivity reactions (anaphylaxis, angioedema).

Overdose Symptoms: Massive overdosage of Tirzepatide may lead to severe gastrointestinal distress (severe nausea, persistent vomiting, diarrhea) and significant hypoglycemia, particularly if co-administered with other antidiabetic agents.

Overdose Management: Provide supportive medical treatment according to clinical symptoms. Monitor blood glucose levels closely and maintain adequate fluid and electrolyte balance. No specific antidote exists.

Storage instructions for Mounjaro 12.5 mg KwikPen:

• ❄️ Unopened Pens: Store refrigerated between 2 °C to 8 °C. Do not freeze! Discard if the device has been frozen.
• 🌡️ In-Use / Room Temperature Storage: An in-use or unopened pen may be stored at room temperature up to 30 °C for a maximum period of 30 days. Discard the pen after 30 days, even if medication remains inside.
• 💧 Light Protection: Store in the original outer carton to protect from direct light. Keep the cap on the pen when not in use.
• 👶 Safety Precautions: Keep out of reach and sight of children. Store the pen without a needle attached.

To ensure the authenticity of your Mounjaro 12.5 mg KwikPen device, check for the following anti-counterfeiting security features:

• 🛡️ Packaging Design: The original carton features crisp graphics with a distinct blue corner accent block, prominent Mounjaro® and KwikPen® trademarks, and official Lilly branding. The front panel explicitly indicates "12.5 mg" and "Once weekly".
• 🔍 Batch and Expiry Markings: The side panel of the carton and the pen label display deeply stamped or thermal-printed Lot Number (LOT) and Expiration Date (EXP), which must be identical.
• 📦 KwikPen Build Quality: The authentic device consists of a sturdy grey body with a purple cap and blue dose accents matching the official 12.5 mg color code. The dose window clearly displays fixed unit indicators. The liquid solution inside the glass cartridge must be completely clear, colorless to light yellow, and free of visible particles.