(10% off when purchasing multiple boxes) Japanese Mounjaro Weight-Loss Injection, Manjianle Tirzepatide, Long-Acting GIP/GLP-1 Receptor Agonist for Lowering Cholesterol and Weight Loss

8. Important Basic Precautions

1. 8.1 This product is not an insulin substitute. Confirm insulin dependence prior to administration. There have been reports of acute hyperglycemia and diabetic ketoacidosis following a switch from insulin to a GLP-1 receptor agonist.
2. 8.2 Monitor blood glucose and urine glucose levels regularly to assess effectiveness; if the treatment is not effective after 3 to 4 months, consider switching to a more appropriate treatment.
3. 8.3 Long-acting formulations may continue to have an effect after discontinuation; therefore, attention must be paid to fluctuations in blood glucose levels, as well as the prevention and management of side effects.
4. 8.4 Patients must be fully informed of the symptoms of hypoglycemia and how to manage them.
5. 8.5 This medication may cause hypoglycemia; exercise caution when working at heights, driving, or performing similar activities.
6. Common precautions for other similar medications: acute pancreatitis, gastrointestinal disorders/dehydration/ acute kidney injury, thyroid symptoms, biliary tract disorders, decreased blood pressure, self-injection training and disposal, diabetic retinopathy; must not be used in combination with other chirzepatide formulations (such as Zepbound) or other GLP-1 receptor agonists; efficacy and safety when used in combination with DPP-4 inhibitors have not been established.

9. Severe gastrointestinal disorders, history of pancreatitis, predisposition to hypoglycemia, severe diabetic retinopathy, history of abdominal surgery/ history of intestinal obstruction, risk of aspiration under general anesthesia or deep sedation, women who may be pregnant must use contraception during treatment and for 1 month after the final dose; do not administer to pregnant women; use during breastfeeding requires careful consideration; not tested in children; use with caution in the elderly.

10.2 Precautions for Concomitant Use　Diabetes medications (increased risk of hypoglycemia, especially sulfonylureas, rapid-acting insulin secretagogues, and insulin; consider reducing the dose); Oral contraceptives (effectiveness may be reduced during the initial phase of initiation or dose escalation; delayed gastric emptying); narrow-therapeutic-index oral medications such as warfarin (delayed Tmax; monitoring required).

11.1 Serious Adverse Effects　Hypoglycemia (frequency unknown); acute pancreatitis (less than 0.11 TP3T); cholecystitis (frequency unknown), cholangitis (less than 0.11 TP3T), cholestatic jaundice (frequency unknown); Allergic reactions, angioedema (frequency unknown); ileus (frequency unknown). Common: nausea, diarrhea, loss of appetite, etc.

20. To prevent freezing, store at 2–8°C away from light; do not use if frozen. Store in the original packaging at room temperature not exceeding 30°C and use within 21 days.

Plasma concentrations in Japanese patients with type 2 diabetes (Week 32):

Cumulative incidence of major cardiovascular events (compared with dulaglutide):

In the cardiovascular outcomes trial, the change in HbA1c at Week 144 was: this drug, −1.80 ± 1.37 (5,530 patients); dulaglutide, −0.93 ± 1.36 (5,390 patients). The incidence of severe hypoglycemia was approximately 0.71 TP3T in both groups. Major adverse effects in the study drug group: nausea 23.31 TP3T, diarrhea 19.61 TP3T, and loss of appetite 16.01 TP3T.

1. 2.1 Patients with a history of allergy to any of the ingredients in this product
2. 2.2 Diabetic ketoacidosis, diabetic coma or precoma, patients with type 1 diabetes [Must be treated promptly with insulin; this product should not be administered.]
3. 2.3 Emergency situations such as severe infections or surgery [Blood glucose should be managed with insulin preparations; this product is not suitable for use in these situations.]

This product must not be administered to pregnant women or women who may be pregnant. This product is a controlled substance and a prescription drug; it must be used only as prescribed by a physician. For details, refer to the original Japanese package insert.