Japanese Version "Mounjaro Mounjaro Weight Loss Pen Tirzepatide Diet Pen Tirzepatide" Instructions-Price-Indications-Side Effects and Precautions

1. As an adjunct to diet and exercise, it is used to improve blood glucose control in adults with type 2 diabetes.
2. Restrictions on Use: No studies have been conducted in patients with a history of pancreatitis; not indicated for patients with type 1 diabetes.

1. The recommended starting dose is 2.5 mg administered once weekly by subcutaneous injection. The 2.5 mg dose is used to initiate treatment and is not intended for blood glucose control.
2. After 4 weeks, increase the dose to 5 mg, administered once weekly by subcutaneous injection.
3. If additional blood glucose control is needed, increase the dose in 2.5 mg increments after at least 4 weeks on the current dose.
4. The maximum dose is 15 mg, administered once weekly by subcutaneous injection.
5. If you miss a dose, take it as soon as possible within 4 days (96 hours) of missing it. If more than 4 days have passed, skip the missed dose, take the next dose on the regularly scheduled date, and then resume your regular once-weekly dosing schedule.
6. If necessary, the weekly dosing schedule may be adjusted, provided that there is an interval of at least 3 days (72 hours) between doses.

Preparing for the injection

1. Remove the insulin pen from the refrigerator.
2. Do not remove the gray base cap before preparing for the injection.
3. Check the label on the pen to make sure the medication and dosage are correct and that it has not expired.
4. Check that the pen is not damaged.
5. Inspection of the medication: Not frozen, not cloudy, colorless to slightly yellow, and free of particles.
6. Wash your hands.

Step 1: Choose an injection site
Your doctor can help you choose the most appropriate injection site. You can inject into your abdomen or thigh, or have someone else inject you in the back of your upper arm. Rotate your injection sites weekly. You can inject into the same area, but be sure to choose a different spot within that area each time.

Step 2: Pull down the gray base
Make sure the pen is locked. Do not unlock the pen until you have applied the clear base to your skin and are ready to inject. Pull the gray cap off and throw it in the trash. Do not put the gray cap back on, as this may damage the needle. Do not touch the needle.

Step 3: Attach the transparent base to your skin, then unlock it.
Place the transparent base flat against the skin at the injection site, and turn the locking ring to unlock it.

Step 4: Press and hold for 10 seconds
Press and hold the purple injection button for 10 seconds. Listen for the sounds: the first beep indicates the start of the injection, and the second beep indicates the end of the injection. When the gray plunger becomes visible, the injection is complete. After the injection, place the used pen in a sharps container.

1. What should I do if I see bubbles in the pen? It's normal to have bubbles.
2. What should I do if my pen isn't at room temperature? There's no need to warm the pen up to room temperature.
3. What happens if I unlock the pen first, then press the purple injection button, and then remove the gray cap? Do not remove the gray cap. Discard the pen and replace it with a new one.
4. What should I do if there is a drop of liquid on the needle tip when I remove the gray cap? It is normal for there to be a drop of liquid on the needle tip. Do not touch the needle.
5. Do I need to hold down the injection button until the injection is complete? It's not necessary, but it can help you keep the pen steady.
6. During the injection, I heard more than two clicks—two loud clicks and one soft click. Is the injection finished? Some people may hear a soft click before the second loud click. That’s normal; do not remove the pen from your skin until you hear the second loud click.
7. I'm not sure if my pen is working properly. Check to see if you received the injection. If the gray plunger is visible, it means the dose was delivered correctly.
8. What should I do if there's a drop of fluid or blood on my skin after the injection? This is normal. Press a cotton ball or gauze against the injection site. Do not rub the injection site.

1. Take Mounjaro once a week, at any time of day, with or without food.
2. Administer Mounjaro by subcutaneous injection in the abdomen, thigh, or upper arm.
3. Rotate injection sites with each injection.
4. Visually inspect Mounjaro before injection; it should be clear, colorless to slightly yellow. Do not use if you notice any particulate matter or discoloration.
5. When using Mounjaro with insulin, administer them as separate injections; do not mix them. It is acceptable to inject into the same area of the body, but do not inject too close to the same spot.

In the event of an overdose, contact a poison control center for the most up-to-date management recommendations. Initiate appropriate supportive care based on the patient’s clinical symptoms and signs. Given that the half-life of tirzepatide is approximately 5 days, observation and treatment of these symptoms may be required for some time.

Insulin-releasing hormone or insulin
When you start taking Mounjaro, consider reducing the dose of any concomitant insulin secretagogues (such as sulfonylureas) or insulin to lower the risk of hypoglycemia.

Mounjaro delays gastric emptying and may therefore affect the absorption of oral medications taken at the same time. Caution is advised when oral medications are taken concomitantly with Mounjaro. Particular caution is warranted for patients whose oral medications are monitored based on therapeutic threshold concentrations, as well as for patients receiving concomitant medications with a narrow therapeutic index (e.g., warfarin). Patients using oral hormonal contraceptives are advised to switch to a non-oral method of contraception or to add a barrier method 4 weeks after initiation and 4 weeks after each dose increase. Non-oral hormonal contraceptives are not expected to be affected.

Pregnancy
There are insufficient data from pregnant women to assess the risk of drug-related major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Poorly controlled gestational diabetes poses risks to both the mother and the fetus. Based on animal reproductive studies, exposure during pregnancy may pose a risk to the fetus. The drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. Based on AUC, reduced fetal growth and fetal abnormalities were observed in pregnant rats administered the drug during organogenesis at maternal clinical exposure levels; reduced fetal growth was also observed at clinically relevant exposure levels during organogenesis. These adverse effects on animal embryos/fetuses are consistent with the pharmacological effects on maternal body weight and food intake.

Breastfeeding Period
There are no data on the presence of tirzepatide in animal or human breast milk, its effects on breastfed infants, or its effects on lactation. The benefits of breastfeeding for the infant’s development and health should be weighed against the mother’s clinical need for Mounjaro and any potential adverse effects of Mounjaro or the mother’s underlying medical condition on the breastfed infant.

Women and men of reproductive age
Due to delayed gastric emptying, the use of Mounjaro may reduce the effectiveness of oral hormonal contraceptives. This delay is greatest after the first dose and decreases over time. Patients using oral hormonal contraceptives are advised to switch to a non-oral method of contraception or to add a barrier method 4 weeks after initiation and 4 weeks after each dose escalation.

Pediatric Medications
The safety and efficacy in pediatric patients (under 18 years of age) have not yet been established.

Medications for the Elderly
In seven clinical trials, 1,539 (30.1%) of the treated patients were 65 years of age or older, and 212 (4.1%) had a baseline age of 75 years or older. No overall differences in safety or efficacy were detected between these patients and younger patients; however, the possibility of greater sensitivity in some older adults cannot be ruled out.

Impaired kidney function
Dose adjustment is not recommended for patients with impaired renal function. No changes in the pharmacokinetics (PK) of tirzepatide were observed in subjects with impaired renal function (including end-stage renal disease [ESRD]). Monitor renal function when initiating or increasing the dose in patients with impaired renal function who report severe gastrointestinal adverse reactions.

Liver dysfunction
Dose adjustment is not recommended for patients with hepatic impairment. In a clinical pharmacology study involving subjects with varying degrees of hepatic impairment, no changes in the pharmacokinetics (PK) of tirzepatide were observed.

Mounjaro (Tirzepatide) for subcutaneous injection contains tirzepatide, a once-weekly GIP receptor and GLP-1 receptor agonist. It is a 39-amino acid modified peptide based on the GIP sequence. At positions 2 and 13, tirzepatide contains two non-coding amino acids (aminobutyric acid, Aib), a C-terminal amide, and a Lys residue at position 20, which is linked via a linker to 1,20-docosadienoic acid. The molecular weight is 4813.53 Da, and the chemical formula is C₂₂₅H₃₄₈N₄₈O₆₈。

Mounjaro is a clear, colorless to slightly yellow, sterile, preservative-free solution for subcutaneous injection. Each single-dose pen contains 0.5 milliliters of a tirzepatide solution containing 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.

Active Ingredients: Tirzepatide
Inactive Ingredients: Sodium chloride, disodium hydrogen phosphate heptahydrate, and water for injection. Hydrochloric acid and/or sodium hydroxide solutions may be added to adjust the pH.

Tirzepatide is a GIP and GLP-1 receptor agonist; it is a 39-amino acid modified peptide containing a C20 fatty acid moiety that binds to albumin and prolongs its half-life. Tirzepatide selectively binds to and activates the GIP and GLP-1 receptors, which are the natural targets of GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion and reduces glucagon levels, both of which occur in a glucose-dependent manner.

1. Before using this medication, tell your doctor about all of your medical conditions, including whether you: have or have had problems with your pancreas or kidneys; have serious stomach problems, such as slow gastric emptying (gastroparesis) or difficulty digesting food; have a history of diabetic retinopathy; or are pregnant or planning to become pregnant. It is not known whether this medication could harm an unborn baby; if you become pregnant while taking this medication, tell your doctor. Oral contraceptives may be less effective while taking this medication. If you are taking oral contraceptives, your doctor may recommend an alternative method of birth control for the first 4 weeks after starting this medication and for 4 weeks after each dose increase. You are breastfeeding or planning to breastfeed. It is not known whether this medication passes into breast milk; consult your doctor about the best way to feed your baby.
2. Tell your doctor about all the medications you are taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements. Mounjaro may affect how certain medications work, and certain medications may also affect how Mounjaro works.
3. Before using this medication, tell your doctor if you are taking any other medications for diabetes, including insulin or sulfonylureas, as these medications may increase your risk of hypoglycemia.
4. Do not use Mounjaro to treat conditions not for which it is prescribed. Do not give Mounjaro to anyone else, even if they have the same symptoms as you. Doing so could harm them.