The medical landscape is experiencing a transformative shift in weight management with the emergence of semaglutide and tirzepatide. These medications are causing a revolution in how healthcare professionals approach obesity treatment, offering new hope to millions struggling with weight-related health issues. The rise of compounded versions of these medications has further expanded access to weight loss treatments. This article delves into compounded tirzepatide, exploring its mechanisms of action, efficacy, potential risks, and how it compares to brand-name options.
The Obesity Crisis and the Need for New Solutions
The global obesity crisis has reached alarming proportions, with 1 in 8 people worldwide living with obesity in 2022. This epidemic has more than doubled among adults and quadrupled among adolescents since 1990. The prevalence of overweight and obesity in adults has climbed to 43% and 16%, respectively. Conventional weight loss programs, including nutrition counseling, physical activity, and behavior therapy, have shown limited effectiveness in addressing obesity. Meta-analyzes reveal small but statistically significant effect sizes for these treatments. Additionally, unrealistic expectations and high dropout rates often hinder the success of traditional approaches.
In response to the limitations of traditional treatments, semaglutide and tirzepatide have emerged as game-changing medications for weight loss. These drugs, initially developed for type 2 diabetes management, have shown remarkable efficacy in promoting weight loss. Compounded semaglutide and tirzepatide often come at lower prices and are more readily available compared to their brand-name counterparts.
What is Tirzepatide?
Tirzepatide represents a groundbreaking advancement in weight management as the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes treatment. This innovative medication activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which play crucial roles in regulating insulin secretion and food intake. Tirzepatide is quickly becoming a game-changer for those looking to manage weight and diabetes. As more people turn to compounded tirzepatide for personalized treatments, understanding its pricing, effects, and where to obtain it becomes essential.
How Tirzepatide Works
Tirzepatide activates receptors of hormones secreted from the intestine, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), to reduce appetite and food intake. Both Semaglutide and Tirzepatide are designed to reduce food intake and improve insulin sensitivity by interacting with the GLP-1 receptor.
Read also: Comprehensive guide: Tirzepatide and Semaglutide for weight management
Clinical Trial Results
Clinical trials have demonstrated tirzepatide’s remarkable effectiveness in promoting weight loss. In a 72-week study, participants taking tirzepatide experienced substantial and sustained reductions in body weight. The mean percentage change in weight at week 72 ranged from -15.0% to -20.9%, depending on the dosage, compared to -3.1% with placebo. Impressively, 50% to 57% of participants in the higher dose groups achieved a reduction in body weight of 20% or more.
Beyond its impressive weight loss effects, tirzepatide shows promise in addressing various metabolic health concerns. Studies have reported significant improvements in cardiometabolic risk factors, including blood pressure, lipid levels, and glycemic control. Notably, over 95% of participants with prediabetes at baseline reverted to normoglycemia after treatment with tirzepatide. Furthermore, tirzepatide has shown superiority over existing GLP-1 receptor agonists like semaglutide in reducing HbA1c and body weight in patients with type 2 diabetes. As research continues, tirzepatide’s potential to cause a revolution in obesity treatment and related metabolic disorders becomes increasingly apparent.
*All doses of tirzepatide have shown the average patient losing 10% of their weight. Based off CDC data on average adult weight, men could expect an average loss of 19.98lbs over full course of treatment while women could expect 17.08lbs over the full course of treatment.
Compounded Tirzepatide: A Closer Look
Compounded tirzepatide is a customized formulation of the medication tirzepatide, commonly marketed under the brand name Mounjaro for type 2 diabetes management. While Mounjaro is effective for regulating blood sugar, tirzepatide has gained popularity for its off-label use in weight loss programs. Compounded Tirzepatide is considered a game-changer in the treatment of weight loss and type 2 diabetes, combining both GLP-1 and GIP receptor agonists - the hormones that influence blood sugar and hunger levels.
What is a Compounded Medication?
The FDA defines “traditional” pharmacy compounding as “combining, mixing, or altering ingredients to create a customized medication for an individual patient based on a licensed practitioner’s prescription.” Compounded drugs use FDA-approved ingredients, but the customized medication itself is not FDA-approved. This means the FDA does not specifically review the safety, effectiveness, or quality of compounded medications before they are given to patients.
Read also: Weight Loss Patterns with Tirzepatide 2.5 mg
Customizing medications can offer several benefits, such as:
- Providing alternative dosage forms (e.g., liquids for patients who have trouble swallowing)
- Re-flavoring medications to improve taste
- Removing allergens found in commercially manufactured products
- Creating specific doses that are not commercially available
Community pharmacies vary in their ability to perform basic compounding based on their space and materials. In most cases, medications that require compounding are sent to pharmacies that specialize in this service.
Advantages of Compounded Tirzepatide
Using compounded tirzepatide offers several advantages. Patients can obtain a customized dosage that is adjusted to their specific needs. The starting dose of tirzepatide for weight loss often begins at 2.5 mg, with gradual increases depending on how your body reacts to the medication. Another major benefit is the cost of compounded tirzepatide. Brand-name medications like Mounjaro can be expensive, especially without insurance.
Is Compounded Tirzepatide the Same as Mounjaro?
In terms of the active ingredient, yes.
Availability and Cost
Compounded tirzepatide often comes at lower prices and is more readily available compared to their brand-name counterparts. The compounded tirzepatide price varies depending on the dosage, formulation, and pharmacy you choose. For those searching for the best compounded tirzepatide deals.
Read also: Comprehensive Analysis: Tirzepatide and Semaglutide
Starting at: $550/month based on four (4) weekly injections of up to 7.5 mg.
Where to Obtain Compounded Tirzepatide
Many patients ask, where to get compounded tirzepatide or how to buy compounded tirzepatide online. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Safety and Risks of Compounded Tirzepatide
While compounded medications can offer benefits, it's crucial to be aware of the potential risks.
Lack of FDA Approval
Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed. As with all compounded drugs, drugs compounded by outsourcing facilities have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process. Because they are subject to a lower regulatory standard, compounded drugs should only be distributed to health care facilities or dispensed to patients to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.
Adulteration and Misbranding
Compounded GLP-1RAs have been the subject of numerous lawsuits. Manufacturers like Eli Lilly (tirzepatide) have sued compounding pharmacies for producing adulterated (contaminated or tainted) or misbranded products and for dispensing medications without proper prescriptions.
In the ongoing lawsuits the most commonly cited adulteration is compounding manufacturers dispensing contaminated medications or producing medications in unsanitary conditions. The most common instances of misbranding has been when compounded medications contain less active ingredient than advertised.
Risks of Incorrect Dosing
Reports of adverse events, including hospitalizations, have been linked to dosing errors with compounded GLP-1ra products. Across the country poison control centers saw a nearly 1,500 percent increase in calls in 2023 related to accidentally overdosing on injected weight-loss drugs. The FDA dispersed an alert highlighting that these errors often stem from confusion with units of measurement (e.g., milliliters, milligrams, and units) and the variation in concentrations offered by different compounders. Unlike FDA-approved GLP-1ra, which are available in standard concentrations and prefilled pens, compounded versions may come in multiple-dose vials or prefilled syringes with varying strengths. This lack of standardization increases the risk of miscalculation or unintentionally drawing up an inappropriate dose. For example, patients unfamiliar with using syringes have accidentally administered 5-20 times the intended dose, and providers have miscalculated conversions from milligrams to units, leading to severe side effects and in some instances hospitalization.
The FDA estimates that 10 deaths and 100 hospitalizations may be linked to the use of compounded GLP-1RAs.
FDA's Stance on Compounded GLP-1 Drugs
The FDA has issued safety alerts when they become aware of specific compounding pharmacies operating illegally or notice safety issues, such as increased medication overdoses. However, their responses are often reactive, meaning action is usually taken only after a patient experiences a negative outcome. This delay is partly due to how the law defines the FDA’s authority over outsourcing compounding pharmacies.
The FDA states “as with all compounded drugs, drugs compounded by outsourcing facilities have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process. Because they are subject to a lower regulatory standard, compounded drugs should only be distributed to health care facilities or dispensed to patients to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.”
Salt Forms of Semaglutide
The agency is aware that some semaglutide products sold by compounders may be the salt forms. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.
Recommendations for Consumers
The agency encourages patients to be vigilant and know the source of their medicine. Carefully check labels of compounded GLP-1 drugs for warning signs such as spelling errors or incorrect addresses and ensure your medicine is provided by a licensed pharmacy and prescribed by a licensed health care provider. If you receive a product with a licensed pharmacy name on the label that you think might be fraudulent, contact the pharmacy to ask if it is their product.
Dosing Concerns
FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug. Additionally, the agency has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what is in the FDA-approved drug label. This could mean using more product in a single dose, taking doses more frequently or increasing the amount more quickly (titration schedule). Some of the adverse events are serious and some patients reported seeking medical attention for their symptoms, including nausea, vomiting, diarrhea, abdominal pain and constipation. Health care providers should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients. The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide.
Potential Side Effects of Tirzepatide
Tirzepatide is generally well-tolerated, but it’s important to be aware of potential side effects of tirzepatide. As with any medication, tirzepatide may cause side effects. Common reactions include abdominal pain, burping, constipation, diarrhea, dyspepsia, fatigue, gastroesophageal reflux disease, hypoglycemia, hair loss, hypersensitivity reactions, injection site reactions, nausea, and vomiting. Some individuals may experience more severe side effects, such as allergic reactions or pancreatitis. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.
More serious side effects of Compounded Tirzepatide treatments are rare but can occur.
Important Considerations
- Thyroid Tumors: This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
- Pancreatitis: Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
- Gallbladder Problems: Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
- Diabetic Retinopathy: This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.
- Stomach and Bowel Problems: This medicine may cause severe stomach and bowel problems. Check with your doctor right away if you have stomach problems that are severe or will not go away.
- Hypoglycemia: This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use tirzepatide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Allergic Reactions: This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
- Dehydration and Kidney Injury: This medicine may cause dehydration which can lead to acute kidney injury. Check with your doctor right away if you have a bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
- Mental Health: This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.
Drug Interactions and Other Precautions
- Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
- Alcohol: Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Pregnancy:
- Mounjaro®: Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant.
- Zepbound®: Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away. If you are using birth control pills, your doctor may recommend another type of birth control for 4 weeks after you start using this medicine and after each increase in your dose.
How Tirzepatide is Administered
Tirzepatide is administered once weekly by subcutaneous (under the skin) injection. A Hayat Pharmacy pharmacist will administer the initial 4 doses (once per week for the first month) via a walk-in appointment. After the first month, doses can be administered by our pharmacist or training and support can be provided for self-injection at home.
Storage and Mixing
Storing and mixing tirzepatide correctly is essential for maintaining its efficacy. Patients often ask, how long can tirzepatide compound be out of the fridge? It’s important to store tirzepatide in the refrigerator, where it can last up to 28 days.
Tirzepatide and Lifestyle
Tirzepatide is a groundbreaking medication that has been for weight loss and diabetes management. It works by targeting both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) to help regulate blood sugar levels and promote weight loss.
The Importance of a Holistic Approach
It’s crucial to remember that these medications are just one part of a comprehensive approach to health and wellness.
Special Considerations
For adults with type 2 diabetes or those using birth control pills, it’s essential to talk to your doctor about how tirzepatide may interact with your medications. People with multiple endocrine neoplasia syndrome type 2 or a history of thyroid C-cell tumors should avoid tirzepatide due to potential risks. If you’re planning to become pregnant, it’s important to discuss this with your healthcare provider. Finally, consult your doctor if you have concerns related to endocrine neoplasia syndrome or any other pre-existing conditions before starting tirzepatide.
Personal Account
A male health outcomes investigator, in age bracket 55 - 65, with BMI = 27 kg/m2, but without type 2 diabetes, took compounded tirzepatide 7.5 mg/week therapy as an experiment to see if he could achieve a 10% reduction in body weight over approximately four weeks and restore BMI = 25 kg/m2. Secondary endpoints included maintenance of weight-lifting strength, maintenance of speed and endurance in lap swimming, and maintenance of a nutrient-dense vegan diet.
With four weeks of compounded tirzepatide therapy, the investigator achieved a 5% reduction in body weight and a BMI of 25.8. Despite continuing to participate in daily exercise, having a healthy vegan diet, and supplementing with many vitamins, minerals, electrolytes, and nutrient-dense foods, the investigator regained 5% body weight within two weeks after the conclusion of the study.
The investigator experienced side effects similar to those reported for GLP-1 RA class of injectable drugs, including tirzepatide. However, the treatment revealed an undulating pattern in which the compounded tirzepatide injection produced the desired effects, but intermittently the patient experienced neither a sense of satiety nor a sense of delayed digestion post injections, therefore, ate a normal meal and/or snacks. Adverse events included generalized bloating and flatulence, carbohydrate-specific temporary weight gain and bloating, intestinal rapid emptying comparable to excessive laxative use, and profound thirst with water consumption approximately double his normal level.
Weight-lifting strength was maintained across a wide variety of equipment stations; lap swimming speed was maintained, and endurance was increased on compounded tirzepatide therapy. Apparent negative and positive neuroplasticity in the study period enabled the investigator to overcome a craving for one high caloric sugary snack, and to overcome an endurance barrier in the laps swam per set and per workout.
The compounded tirzepatide tested in this 4-week study produced less weight loss than was intended and side effects that would be intolerable in a work environment with nearby colleagues.
Arguably, the dual GIP RA and GLP-1 RA drugs take patients on a proverbial roller coaster ride of weight loss and regain and intense yo-yo dieting.
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