Mounjaro

About Tirzepatide

• Mounjaro (Tirzepatide) is indicated for adults with type 2 diabetes mellitus. It is administered through subcutaneous injection, and acts as a GIP-analogue, activating both GIP and GLP-1 receptors. 
• It serves as a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, recommended as an adjunct to diet and exercise to enhance glycemic control.
• These hormones play crucial roles in blood sugar control, especially after meals, by stimulating insulin secretion from intestinal cells.
• However, it’s important to note certain limitations of use, such as the lack of studies in patients with a history of pancreatitis and the contraindication for use in individuals with type 1 diabetes mellitus. 
• These considerations emphasize the importance of careful evaluation and adherence to prescribing guidelines when considering tirzepatide therapy.
• Tirzepatide, a GIP and GLP-1 receptor agonist, is a modified peptide with a C20 fatty diacid moiety, prolonging its half-life through albumin binding. 
• By selectively activating GIP and GLP-1 receptors, it enhances insulin secretion in response to glucose and reduces glucagon levels, effectively improving blood sugar control.
• Before starting the treatment, inform your healthcare professional about all the pre-existing medical conditions. 

Strength: 

Mounjaro is available as 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in a single-dose pen. 

Recommended Dosage:

Before administering the injection, retrieve the Pen from the refrigerator and ensure the gray base cap remains on until ready for use. Verify the Pen label to confirm the correct medicine, dosage, and expiration date. Examine the Pen for any damage and check that the medication is not frozen, is cloudy, has a colorless to slightly yellow appearance, and is free from particles. Wash your hands thoroughly. Select the injection site, with guidance from your healthcare provider, either in the stomach (abdomen) or thigh for self-administration or the back of the upper arm for injection by another person. 

Rotate the injection site weekly, even if using the same body area. After confirming the Pen is locked, remove the gray base cap straight off, ensuring not to touch the needle, and discard it properly. Place the clear base flat against the skin at the chosen injection site, unlock it by turning the lock ring, and press and hold the purple injection button for up to 10 seconds. Listen for the first click, indicating the start of the injection, and the second click, signaling completion. The gray plunger should be visible to confirm the injection’s conclusion. Dispose of the used Pen in a sharps container following the procedure.

• The recommended initial dose for Mounjaro is 2.5 mg administered subcutaneously once weekly, primarily for treatment initiation rather than glycemic control. 
• Following a 4-week period, the dosage should be increased to 5 mg subcutaneously once weekly. 
• If additional glycemic control is required, the dose may be escalated in 2.5 mg increments after at least 4 weeks on the current dose. The maximum prescribed dosage for Mounjaro is 15 mg subcutaneously once weekly.
• In case of a missed dose, patients should be advised to administer Mounjaro as soon as possible within 4 days (96 hours) after the missed dose. 
• If more than 4 days have elapsed, patients should skip the missed dose and administer the next dose according to the regular weekly schedule. In either situation, patients can resume their usual once-weekly dosing schedule.
• If needed, the day of weekly administration can be adjusted, ensuring a minimum interval of 3 days (72 hours) between the two doses.
• Do not mix insulin and Mounjaro together in the same injection

Important:

When starting Mounjaro, it’s advisable to reduce the dosage of concurrently administered insulin secretagogues (e.g., sulfonylureas) or insulin to minimize the risk of hypoglycemia. Prior to beginning Mounjaro injections, discuss your medical history and current medications, including smoking and alcohol use, with your healthcare provider. Ensure you provide a comprehensive list of medications for a safe introduction of new drugs. Always consult your doctor before initiating the medicine and inform them promptly if you encounter any side effects while taking it.

Warnings & Precautions

• Mounjaro is contraindicated in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or those diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 
• Additionally, individuals with known serious hypersensitivity to tirzepatide or any excipients in Mounjaro should avoid its use.
• Cases of pancreatitis have been reported during clinical trials, and discontinuation is advised if pancreatitis is suspected. 
• Concurrent use of Mounjaro with insulin secretagogues or insulin may increase the risk of hypoglycemia, including severe cases, necessitating adjustments to the dose of insulin secretagogue or insulin. 
• Immediate discontinuation of Mounjaro is recommended if hypersensitivity reactions are suspected. 
• Renal function should be monitored in patients with renal impairment reporting severe adverse gastrointestinal reactions. 
• Use may be linked to gastrointestinal adverse reactions, sometimes severe, and is not recommended for patients with severe gastrointestinal disease. 
• Caution is advised, especially in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema, with regular monitoring for progression. 
• Clinical trials have reported occurrences of acute gallbladder disease, and if cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated. Mounjaro poses a risk of thyroid C-cell tumors based on rodent studies, with uncertainty about its impact on humans. 
• Patients should be counseled on the potential risk, informed about symptoms of thyroid tumors, and monitored for such symptoms, but routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.
• Before starting the treatment, discuss pre-existing medical conditions with healthcare providers before initiating Mounjaro and promptly report any adverse reactions.

Common Mounjaro Side Effects:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Abdominal pain
• Belching
• Bloating
• Acid reflux
• Decreased appetite
• Pain
• Redness
• Swelling, or itching at the injection site
• Fatigue
• Headache

Use in Specific Population

• Limited data on Mounjaro use during pregnancy make it challenging to evaluate the risk of major birth defects, miscarriage, or adverse outcomes for both the mother and fetus. Poorly controlled diabetes during pregnancy poses additional risks. 
• Animal studies indicate potential fetal risks with tirzepatide exposure. Therefore, the decision to use Mounjaro in pregnancy should be carefully considered, weighing potential benefits against potential fetal risks.
• The presence of Mounjaro in human milk and its impact on the breastfed infant, along with its effects on milk production, remain unknown. 
• The decision to breastfeed should carefully consider developmental and health benefits, the mother’s clinical need for Mounjaro, and the potential adverse effects on the infant.
• Additionally, the use of Mounjaro may affect the efficacy of oral hormonal contraceptives due to delayed gastric emptying, with the delay being most significant after the initial dose and decreasing over time. 
• Patients using oral hormonal contraceptives should be advised to switch to a non-oral method or incorporate a barrier method for 4 weeks after initiation and 4 weeks after each dose escalation with Mounjaro.
• It’s important to note that the safety and effectiveness of Mounjaro have not been established in pediatric patients (those younger than 18 years of age). Furthermore, no dosage adjustment for Mounjaro is recommended for patients with renal and hepatic impairment.

Storage and Handling

• Keep Mounjaro refrigerated at temperatures between 36°F to 46°F (2°C to 8°C). If necessary, the single-dose pen can be kept at temperatures not exceeding 86°F (30ºC) for up to 21 days. 
• Avoid freezing Mounjaro, and refrain from using it if it has been frozen. 
• Store Mounjaro in its original carton to shield it from light.
• Keep the medicine away from pets and children.