Tizaro Zepbound

[Product Name] Tirzepatide Injection

[Specifications] 2.5 mg/vial/box; 5 mg/vial/box; 7.5 mg/vial/box

[Manufacturer] Ziska Pharmaceuticals Limited

[Indications]

1. Blood glucose-lowering effect: Tirzepatide helps lower blood glucose levels by enhancing insulin secretion and inhibiting glucagon secretion.

Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitation of use: Not indicated for patients with type 1 diabetes mellitus.

2. Weight loss effect: Reduces appetite and food intake, aiding in weight management.

[Dosage and Administration]

Route of administration: Tirzepatide should be administered via subcutaneous injection.

Dosage instructions:

The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is intended for treatment initiation and is not intended for glycemic control.

After 4 weeks, increase the dosage to 5 mg once weekly. If additional glycemic control is required, increase the dosage in 2.5 mg increments after a minimum of 4 weeks at the current dosage. The maximum dosage is 15 mg injected subcutaneously once weekly.

If a dose is missed, patients should be instructed to administer the dose as soon as possible within 4 days (96 hours) of the missed dose. If more than 4 days have elapsed, skip the missed dose and administer the next dose on the regularly scheduled day. In either case, patients may resume their regular once-weekly dosing schedule.

The day of weekly administration may be changed if necessary, provided that the time between two doses is at least 3 days (72 hours).

Preparation and administration:

The needle cap of the pre-filled syringe contains dry natural rubber (a latex derivative), which may cause allergic reactions.

Do not freeze. Do not use Tirzepatide that has been frozen. Protect the pre-filled syringe from light.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration. Do not use any pre-filled syringe showing particulate matter or discoloration.

Handle with care. Do not use the pre-filled syringe if it has been dropped on a hard surface.

Do not dilute tirzepatide or mix it with other medication solutions.

Administration Instructions

Administer once weekly at any time of day, with or without food.

Inject subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites with each dose. If used alongside insulin, inject separately; never mix them. Tirzepatide and insulin may be injected into the same body region, but the injection sites should not be adjacent.

Pre-injection preparation:

1. Allow the medication to warm up: After removing it from the refrigerator, wait approximately 30 minutes for the medication to reach room temperature before injecting. Injecting cold medication can increase irritation.

2. Choose the correct site and rotate: Recommended injection sites are the abdomen (avoiding a 5 cm radius around the navel), the front of the thighs, and the upper arms. Change the specific injection point each time and maintain sufficient distance (at least 2.5 cm) from the previous site to allow the skin to recover.

3. Thorough disinfection: Disinfect the injection site with an alcohol swab and wait for the alcohol to evaporate completely before injecting.

Post-injection care:

Do not rub: After the injection, simply withdraw the needle gently and apply light pressure with a dry cotton ball for a moment. Do not massage or rub the injection site, as this can cause the medication to spread, aggravating irritation and the formation of lumps.

Local cold compress: If a lump forms and causes discomfort, apply a cold compress (an ice pack wrapped in a clean towel) for 5–10 minutes, a few hours after the injection. This helps reduce inflammation and swelling.

Later warm compress (use with caution): For induration (hard lumps) that has persisted for a day or two, a warm compress (using a warm towel) can be applied to promote local blood circulation and accelerate medication absorption and the resolution of the lump. However, do not apply heat if the lump remains red, swollen, hot, or painful, as this could worsen inflammation. Tirzepatide Maintenance Treatment Regimen

Treatment Phase | Weeks | Weekly Dosage | Notes

Initial Dose | Weeks 1–4 | 2.5 mg | 1. Skip this phase if previously treated with semaglutide. <br> 2. If no prior use of similar products but physical condition is good, this dose may be used for just one week.

Dose Escalation | Weeks 5–8 | 5 mg | 1. If the current dose provides a sense of fullness and results in a monthly weight loss of 2–5 catties (4–10 jin), maintaining this dose is recommended. <br> 2. If no weight loss occurs during this week, increase to the next dose level. <br> 3. If the dose is not tolerated or severe adverse reactions occur, discontinue use or consult a physician about reverting to the previous dose. <br> 4. Clinical data shows that 5 mg of tirzepatide is comparable to 1 mg of semaglutide in terms of weight loss efficacy. <br> 5. If weight loss is achieved at 5 mg, it is recommended to use 5 mg as the maintenance dose.

Weeks 9–12 | 7.5 mg |

Weeks 13–16 | 10 mg |

Weeks 17–20 | 12.5 mg |

Maintenance Dose | Week 20 onwards | 12.5 mg or 15 mg |

【Interactions】

Drug Interactions: Consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to lower the risk of hypoglycemia. Tirzepatide delays gastric emptying; therefore, it may affect the absorption of concomitantly administered oral medications. Patients should be monitored when taking oral medications that rely on threshold concentrations or drugs with a narrow therapeutic index (e.g., warfarin). Patients using oral hormonal contraceptives are advised to switch to a non-oral contraceptive method or add a barrier method during the first 4 weeks of treatment and for 4 weeks after each dose escalation.

Non-oral hormonal contraceptives should not be affected.

【Contraindications】

Tirzepatide is contraindicated in patients with a known hypersensitivity to tirzepatide or any other component of this product. It is also contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). [Side Effects]

The most common side effects are nausea, diarrhea, loss of appetite, vomiting, constipation, indigestion, and abdominal pain.

[Common Issues]

Tirzepatide is a solution; when injected into the subcutaneous fat layer, it causes some local tissue irritation.

The body recognizes this as a "minor event" and dispatches immune cells (such as macrophages) to address it. This process is accompanied by a mild inflammatory response, resulting in redness, swelling, induration (lumps), itching, or mild pain.

This is usually benign, indicating that the drug is being absorbed slowly, and it will resolve on its own within a few days.

[Pregnancy and Breastfeeding]

Poorly controlled diabetes during pregnancy poses risks to both the mother and the fetus. Tirzepatide should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Consideration should be given to the developmental and health benefits of breastfeeding, the mother's clinical need for tirzepatide, and any potential adverse effects of tirzepatide or the underlying maternal condition on the breastfed infant.

[Precautions and Warnings]

Inform patients of the potential risk of MTC (medullary thyroid carcinoma) associated with tirzepatide use and educate them on the symptoms of thyroid tumors. Monitor patients closely for signs and symptoms of pancreatitis after initiating treatment. If pancreatitis is suspected, discontinue tirzepatide and initiate appropriate treatment. Reducing the dosage of sulfonylureas (or other concomitant insulin secretagogues) or insulin can lower the risk of hypoglycemia. Discontinue tirzepatide if hypersensitivity reactions occur; treat immediately according to standard care and monitor until signs and symptoms resolve. For patients with renal impairment reporting severe gastrointestinal adverse reactions, monitor renal function when initiating or increasing the dosage. Patients with a history of diabetic retinopathy should be monitored for the progression of the condition. If gallstones are suspected,

diagnostic gallbladder studies and appropriate clinical follow-up are required.

[Use in Special Populations]

Use in children and adolescents: The safety and efficacy of tirzepatide have not been established in patients under 18 years of age. [Effects of Overdose]

Appropriate supportive treatment should be administered based on the patient's clinical signs and symptoms. Given that the half-life of tirzepatide is approximately 5 days, a period of observation and treatment for these symptoms may be required.

[Storage Conditions]

Keep out of the reach of children. Store in a refrigerator at 2°C to 8°C. Do not freeze and protect from light. Do not use if the product has been frozen.