Z Medi Clinics and Z Medi Spa
Disclaimer: At Z Med Clinics we are NOT prescribing the Brandname Mounjaro but we are prescribing the generic compounded (Tirzepatide) injection which is an injectable prescription medicine used for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥25) who also have weight-related medical problems to help them lose weight and keep the weight off.
Important Safety Information
Warning: Risk of Thyroid C-Cell Tumors
Tirzepatide, in both male and female rats, has been found to induce dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. The potential risk of tirzepatide causing thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans remains uncertain, as the human relevance of tirzepatide-induced thyroid C-cell tumors in rodents has not been determined.
Tirzepatide Contraindications
Tirzepatide is contraindicated in the following cases:
- Patients with a personal or family history of MTC.
- Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Patients should be counseled about the potential risk of MTC associated with the use of Tirzepatide and informed about symptoms of thyroid tumors, such as the presence of a neck mass, dysphagia, dyspnea, or persistent hoarseness. Routine monitoring of serum calcitonin levels or the use of thyroid ultrasound for early detection of MTC in patients on Tirzepatide is of uncertain value. Such monitoring may increase the risk of unnecessary procedures due to the low specificity of serum calcitonin testing and the high background incidence of thyroid disease. Significantly elevated serum calcitonin values (>50 ng/L) may indicate MTC, and patients with elevated levels should be further evaluated. Furthermore, patients with thyroid nodules detected through physical examination or neck imaging should undergo further assessment.
Pancreatitis
Pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has also been reported in Tirzepatide clinical trials. Notably, Tirzepatide has not been studied in patients with a history of pancreatitis, and it is unclear whether such patients are at an elevated risk of pancreatitis while taking Tirzepatide. Patients should be closely monitored for signs and symptoms of pancreatitis, such as persistent severe abdominal pain, sometimes radiating to the back and possibly accompanied by vomiting. If pancreatitis is suspect ed, Tirzepatide should be discontinued, and appropriate management initiated.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Concomitant use of Tirzepatide with insulin secretagogues (e.g., sulfonylureas) or insulin may heighten the risk of hypoglycemia, including severe hypoglycemia. To reduce the risk of hypoglycemia, consider lowering the dose of sulfonylureas (or other concurrently administered insulin secretagogues) or insulin. Patients using these concomitant medications should be informed about the risk of hypoglycemia and educated about its signs and symptoms.
Hypersensitivity Reactions
Patients treated with Tirzepatide have reported serious hypersensitivity reactions, such as anaphylaxis and angioedema. In the event of hypersensitivity reactions, immediate discontinuation of Tirzepatide is necessary, and standard care should be administered while monitoring the patient until signs and symptoms resolve. Tirzepatide should not be used in patients with a documented history of serious hypersensitivity reactions. Additionally, caution should be exercised in patients with a history of angioedema or anaphylaxis associated with a GLP-1 receptor agonist because it is unclear if these patients are predisposed to similar reactions with Tirzepatide.
Acute Kidney Injury
Tirzepatide has been linked to gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, which can lead to dehydration. Severe dehydration has the potential to induce acute kidney injury. In patients treated with GLP-1 receptor agonists, post marketing reports have noted instances of acute kidney injury and the exacerbation of chronic renal failure, occasionally necessitating hemodialysis. Most of these cases have occurred in patients without known underlying renal disease. For patients with renal impairment who report severe adverse gastrointestinal reactions, renal function should be monitored upon initiating or escalating Tirzepatide doses.
Severe Gastrointestinal Disease
Use of Tirzepatide has been associated with gastrointestinal adverse reactions, including severe cases. Tirzepatide has not been evaluated in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended for use in these patients.
Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy
Rapid improvement in glucose control has been linked to a temporary deterioration of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy necessitating acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be closely monitored for potential progression.
Acute Gallbladder Disease
Clinical trials have reported acute gallbladder disease in Tirzepatide-treated patients. Should cholelithiasis be suspected, gallbladder diagnostic studies and appropriate clinical follow-up are advised.
Common Adverse Reactions
The most frequently reported adverse reactions (≥5%) among Tirzepatide -treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Drug Interactions
Upon initiation of Tirzepatide, consider reducing the dose of concurrently administered insulin secretagogues (e.g., sulfonylureas) or insulin to decrease the risk of hypoglycemia. Tirzepatide's impact on gastric emptying may affect the absorption of concurrently administered oral medications; therefore, caution should be exercised.
Pregnancy
Limited data are available on Tirzepatide use in pregnant women to determine the drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from tirzepatide exposure. Use Tirzepatide only if the potential benefit justifies the potential fetal risk.
Lactation
There is no information available regarding the presence of tirzepatide in human milk, its effects on the breastfed infant, or its effects on milk production. The decision to use Tirzepatide in lactating mothers should consider the benefits of breastfeeding alongside the mother's clinical need for Tirzepatide and potential adverse effects on the breastfed infant.
Females of Reproductive Potential
Females using oral hormonal contraceptives should switch to a non-oral contraceptive method or add a barrier method of contraception for four weeks after initiating Tirzepatide and for four weeks following each dose escalation.
Pediatric Use
Tirzepatide's safety and effectiveness in patients under 18 years of age have not been established, and its use is not recommended in this age group.
Consent to treatment by a physician extender: You may be evaluated and treated by a physician assistant (P.A.) or a nurse practitioner (N.P.) whose recommended care and treatment is subject to supervision and review by a licensed physician.
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