MOUNJARO 5 mg/dose KwikPen: Injection Solution in a Pre-Filled Pen

Product Description

MOUNJARO 5 mg/dose KwikPen: Injection Solution in a Pre-Filled Pen

Indication:

Mounjaro 5 mg, with its active ingredient tirzepatide, is a prescription medication primarily used for the treatment of type 2 diabetes mellitus in adults. It helps to lower blood sugar levels, but only when the sugar levels are elevated, thus minimizing the risk of hypoglycemia. In addition to diabetes management, Mounjaro is also prescribed for weight reduction in overweight or obese adults (those with a BMI of at least 27 kg/m²). By affecting the appetite regulation mechanism in the brain, the medication helps users eat less and subsequently reduce body weight.

Mounjaro is highly effective in:

1. Type 2 Diabetes:
   • It is prescribed as a standalone therapy for patients who cannot tolerate metformin (a common diabetes medication).
   • It can also be used in combination with other diabetes treatments when existing therapies do not provide sufficient control over blood sugar levels. These treatments may include medications taken orally or injected insulin.
2. Obesity and Weight Management:
   Mounjaro is recommended for weight reduction and weight management for adults who:
   • Have a BMI of 30 kg/m² or higher (obesity).
   • Have a BMI of 27 kg/m² to less than 30 kg/m² (overweight) along with weight-related health problems. Such problems may include prediabetes, high blood pressure, high cholesterol, sleep apnea, or a history of cardiovascular issues like a heart attack or stroke.

It’s crucial to continue following your doctor’s advice on diet and exercise while using Mounjaro to achieve the best outcomes.

Dosage:

Always take Mounjaro 5 mg exactly as prescribed by your healthcare provider. If you have any questions about the dosage or administration, consult your doctor or pharmacist.

Starting Dose:

• The initial dose of Mounjaro is 2.5 mg taken once a week for four weeks.
• After this period, your doctor will increase your dose to 5 mg once a week, which is the standard dose for most patients.

Incremental Dose Adjustments:

• If necessary, your healthcare provider may gradually increase the dose by 2.5 mg at a time, up to a maximum of 15 mg once weekly.
• Any dose increase is done after maintaining the current dose for at least four weeks to ensure safe and effective titration.

Do not change your dosage unless your doctor specifically instructs you to do so.

Choosing the Time for Administration:

Mounjaro can be injected at any time of the day, with or without food. Try to inject the medication on the same day each week to maintain a consistent schedule. Marking your calendar can be a helpful reminder.

If you need to change your weekly injection day, you can do so as long as at least three days have passed since your last injection. Once you change the day, continue following the new weekly schedule.

Monitoring Blood Sugar Levels:

For patients who are using Mounjaro in combination with sulfonylureas or insulin, it is important to regularly check your blood sugar levels as advised by your doctor. This ensures that your blood sugar remains within a safe range and allows for timely adjustments to your treatment plan.

Missed Dose Instructions:

• If you forget to take your dose and it has been four days or less, inject the dose as soon as you remember. Resume your regular schedule with the next dose on your usual day.
• If more than four days have passed, skip the missed dose and take your next scheduled dose as normal.
• Never take a double dose to make up for a missed one, as this could lead to low blood sugar (hypoglycemia) or other adverse effects. Make sure there are at least three days between any two doses.

If You Use More Than You Should:

Taking more than the prescribed dose of Mounjaro can result in hypoglycemia, nausea, or vomiting. If this happens, contact your healthcare provider immediately for guidance.

Stopping Treatment:

Do not stop taking Mounjaro without first consulting your doctor. Abruptly discontinuing the medication could cause your blood sugar to rise, especially if you have type 2 diabetes.

Administration Method:

Mounjaro is administered via a subcutaneous injection, meaning it is injected under the skin. The preferred injection sites are:

• Abdomen (at least 5 cm away from the belly button).
• Thigh.
• Upper arm (you may need assistance if injecting in this area).

It is acceptable to use the same area for injections each week, but you should rotate the exact injection site within that area to avoid irritation. If you are also injecting insulin, make sure to use a different injection site for each medication.

Before using the KwikPen for the first time, carefully read the leaflet that comes with the pen for detailed instructions.

Side Effects:

As with all medications, Mounjaro may cause side effects, although not everyone experiences them.

Serious Side Effects:

• Uncommon:
  • Acute pancreatitis (inflammation of the pancreas), which can result in severe, persistent pain in the abdomen and back. Seek immediate medical attention if you experience these symptoms.
• Rare:
  • Severe allergic reactions such as anaphylaxis or angioedema. Symptoms may include difficulty breathing, rapid heartbeat, and swelling of the lips, tongue, or throat. Immediate medical intervention is necessary.

Common Side Effects:

• Very common:
  • Nausea and diarrhea are frequently reported, especially when starting treatment. These symptoms typically decrease as your body adjusts.
  • Hypoglycemia (low blood sugar) is very common when Mounjaro is combined with sulfonylureas or insulin for type 2 diabetes treatment. Symptoms may include dizziness, headache, weakness, sweating, irritability, and confusion. You may need to adjust your insulin or sulfonylurea dose to prevent hypoglycemia.
• Common:
  • Reduced appetite.
  • Abdominal pain, vomiting, indigestion, and constipation.
  • Fatigue, dizziness, and reactions at the injection site (e.g., redness or itching).

Uncommon Side Effects:

• Gallstones and inflammation of the gallbladder.
• Increased calcitonin levels, a hormone associated with thyroid function.

If you notice any side effects, even those not listed here, inform your doctor, pharmacist, or nurse immediately.

Drug Interactions:

It’s important to inform your healthcare provider of all medications you are currently taking, including prescription, over-the-counter, and herbal supplements. Certain medications may interact with Mounjaro, potentially affecting its efficacy or increasing the risk of side effects.

Contraindications:

Mounjaro should not be used if you are allergic to tirzepatide or any other components of this medication.

Pregnancy and Breastfeeding:

• Pregnancy: If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using Mounjaro. The effects of tirzepatide on unborn babies are not well understood, and it is generally advised to avoid the medication during pregnancy.
• Breastfeeding: It is not known whether tirzepatide passes into breast milk. A healthcare provider should be consulted to determine whether to discontinue breastfeeding or delay the use of Mounjaro.

Patient Information:

Before starting Mounjaro, discuss your full medical history with your doctor, especially if you have:

• Gastroparesis or severe digestive issues.
• A history of pancreatitis.
• Diabetic retinopathy or other eye problems.

Avoid driving or operating heavy machinery if you experience symptoms of hypoglycemia such as dizziness or weakness.