Friday, November 15, 2024

Coming Off Testosterone Therapy: Managing Symptoms and Restoring Hormone Balance

Quitting TRT: What to Expect and How to Manage the Transition

Stopping TRT: Challenges, Solutions, and the Road to Recovery

Testosterone replacement therapy (TRT) is a common treatment for men with low testosterone levels, helping to improve energy, mood, muscle mass, and overall well-being. Treatment for men has become popular as the understanding of hormone balance by qualified healthcare providers has led to a better understanding of the health benefits from a proper protocol. We have treated countless patients for testosterone therapy and the vast majority of our patients stay on testosterone therapy long term, however, there may come a time when you decide to stop TRT—whether it’s due to financial considerations, side effects, medical advice, or personal choice. Understanding what to expect when discontinuing TRT and how to manage the transition can be crucial for a smooth process of coming off TRT and mitigate and side effects from cessation of treatment. Here’s a guide on coming off testosterone therapy, including the symptoms you may experience, the steps to take, and tips for maintaining health and hormone balance. It should be noted that stopping any medically supervised treatment should be don’t in collaboration with your prescribing physician, and anyone stopping testosterone therapy that they are undergoing without physician guidance or prescription (which we strongly do not recommend) SHOULD seek out the expertise of a licensed physician.



Why Come Off TRT?

Whereas the majority of our patients stay on hormone therapy for a long period of time, sometime patients may decide to stop therapy. There are various reasons why someone might decide to stop TRT. These can include:

Unwanted Side Effects: Some men experience side effects on TRT like water retention, acne, increased blood pressure, or mood swings. While these are often manageable, they can sometimes prompt discontinuation. Usually these side effects can be managed with slight adjustments to the patients protocol however the mere presence of any side effects can be enough to dissuade a patient from continuation of treatment.

Health Concerns: Certain health risks are associated with long-term TRT use, particularly in individuals with pre-existing conditions. Patients that may have preexisting heart conditions or prostate cancer may not be good candidates for therapy.

Desire to Boost Natural Testosterone: Some men prefer to pursue lifestyle changes, supplements, or other therapies to boost natural testosterone production rather than rely on TRT. Things like diet, sleep, exercise and stress management may help increase testosterone and for some patients this may be a suitable course of action.

Fertility Considerations: TRT can suppress natural testosterone production and potentially reduce sperm count, impacting fertility. Often we have patients Discontinuing TRT is sometimes necessary for men looking to restore fertility, however there are medications that can help maintain fertility when on TRT like enclomiphene, FSH, LH and hCG.



Effects of Coming Off TRT

For those that do decide to stop hormone therapy there are a few issues that they may deal with, especially for the first few weeks after quitting treatment. Testosterone replacement therapy introduces exogenous synthetic or bioidentical testosterone into the body, often causing the body’s natural testosterone production to slow down or halt once the hypothalamus detects increased levels in the bloodstream. When you stop TRT, the endocrine system realizes that it needs to start making more of the hormone and thus your body needs time to recalibrate. The hypothalamus will begin releasing more GnRH which in turn causes the pituitary to secrete more LH and FSH which then triggers the testes to produce testosterone. Unfortunately, this process make take some time to “reboot the system” which can lead to several effects:

  1. Drop in Energy Levels: A decrease in energy is common as the body adjusts. Many men report feeling sluggish, fatigued and there may be a decline in physical endurance and motivation to do things like hit the gym or exercise. This often can resolve itself however many men have stated they go back to feeling like they did PRIOR to starting TRT. Considering they started TRT because of how they felt, this often leads to feelings of frustration and many men will decide to restart treatment as a result.
  2. Mood Changes: Testosterone influences mood regulation, so you may feel irritable, anxious, or even depressed while coming off TRT. It turns out that optimized hormones leads to men feeling better physically and this will influence their mood. When the benefits of TRT no longer exist, they may feel more irritable as a result.
  3. Reduction in Muscle Mass and Strength: Testosterone supports muscle protein synthesis, so you may notice a decrease in muscle mass and strength without TRT. Men feel weaker, lose definition and motivation to workout. They may gain fat as well as lose muscle starting a cycle that accelerates testosterone depletion.
  4. Lowered Libido: Testosterone plays a key role in sex drive, so you may experience reduced libido and sexual function initially.  Many men start TRT for specifically its role in increasing testosterone and improving erectile function.
  5. Changes in Sleep: Some men find it challenging to sleep well when coming off TRT, often reporting insomnia or disrupted sleep patterns. There is a definite link between testosterone levels and sleep. Sleep is when men produce testosterone so when you cant sleep well, they cycle get exacerbated and levels decline even more. Better sleep equals better testosterone. Lower testosterone leads to poor sleep. It’s like being stuck between a rock and a hard place.
  6. Possible Weight Gain: Without TRT, metabolism can slow down, leading to potential weight gain if dietary habits are not adjusted accordingly. Patients with low testosterone usually have higher estrogen and gain fat around their midsection. When you factor in a decrease in energy, and muscle synthesis, this can quickly spiral out of control.


Planning for the Transition Off TRT

Stopping TRT requires a planned and gradual approach, ideally under the supervision of a healthcare provider. Usually, they will come up with a “tapering off” protocol to ease the transition and mitigate side effects. Other physicians may decide to have a patient go off “cold turkey” to restart the natural production as quickly as possible. Each patient will have a different and unique approach. Here are some steps to consider when coming off of testosterone therapy, whether its injections, creams or pellets:

1. Consult with Your Healthcare Provider

Your doctor can provide guidance on the safest way to taper off TRT. Abruptly stopping testosterone can lead to a sudden drop in levels, causing more severe symptoms. A gradual reduction in dosage can help your body adjust more smoothly.

2. Consider a PCT (Post-Cycle Therapy)

Post-cycle therapy (PCT) involves medications or supplements that encourage the body to restart natural testosterone production. Common options include:

  • Enlomiphene:  Enclomiphene is a selective estrogen receptor modulator (SERM) that stimulates the body’s production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), promoting natural testosterone production in men. Sometimes doctors will prescribe Clomid, however enclomiphene has been shown to demonstrate fewer side effects and is a better option for most patients, though every patient is unique so it’s best to consult with an experienced physician or endocrinologist/urologist to determine which medication is best for you, enclomiphene of clomid when stopping TRT.
  • Human Chorionic Gonadotropin (hCG): hCG mimics Luteinizing hormone (LH), a hormone released by the pituitary in response to the hypothalamus releasing GnRh. It works by stimulating the testes to produce testosterone and prevent testicular shrinkage for men who take exogenous testosterone injections. Its probably the best solution for this however recently it’s become more difficult to obtain and has increased in costs due to FDA regulatory changes in 2020, which limited compounding pharmacies and their ability to manufacture the medicine. As a result the demand and costs have increased while the supply has dwindled.
  • Tamoxifen (Nolvadex): Like Clomid, tamoxifen is a SERM that can help restore hormone balance. Tamoxifen is a selective estrogen receptor modulator often referred to as a SERM. It’s commonly used to treat and prevent breast cancer by blocking estrogen’s effects on certain cells however in men it’s sometimes utilized in post-cycle therapy (PCT) for individuals who have used anabolic steroids in an effort to help restore natural hormone balance.

Your doctor may recommend one or a combination of these therapies based on your specific needs, but note that PCT may not be necessary for everyone as everyone will have different needs, results and goals.




3. Adopt Healthy Lifestyle Habits to Support Testosterone

This is kind of a no brainer and something that we should all do regardless of our HRT status, but especially after TRT, focusing on lifestyle choices can help to make a significant difference in your hormone levels and overall well-being. Key areas for people to focus on include:

  • Exercise: Resistance training, such as plyometrics and weightlifting, has been shown to not only support testosterone levels, but actually increase them. Patients who engage in regular exercise, incorporating both strength training and cardiovascular exercise will see improved overall health as well as more optimized hormone levels as a result of their efforts.
  • Diet: A diet that is rich in items such as lean proteins, healthy fats, and essential nutrients (like zinc and vitamin D) can help support testosterone production. Avoiding processed foods, excess sugar, and alcohol can also benefit hormone balance. Here’s a link to learn more about foods that can help increase testosterone levels. If eating healthy is an issue, then consider taking a multivitamin to ensure proper micronutrient supplementation into your diet.
  • Sleep: Quality sleep is crucial for testosterone production. Men make testosterone overnight when they are sleeping. Aim for 7–9 hours per night to promote recovery and reduce stress. Even adding one extra hour of rest per night will potentially have a tremendous impact on testosterone production.
  • Stress Management: This one is easier said than done. We all have stress whether it’s work or family related. Chronic stress elevates cortisol, a hormone that can suppress testosterone production in men. Practicing mindfulness, yoga, or meditation can be beneficial to reducing stress. Just finding time out to engage in activities that one enjoys is important for maintaining a healthy and happy lifestyle.



Managing Symptoms After Coming Off TRT

While adjusting off TRT, you may start to experience a range of symptoms that can be challenging and often overwhelming at first. Here are a few proven strategies for managing them while adjusting your body’s new hormone levels.

1. Fatigue and Low Energy

This is one of the biggest complaints we hear from patients after they stop TRT. Many times, [patients will call to ask why they feel so run down and we politely explain to them, that this is just how many patients feel with Low T. To combat low energy, focus on a balanced diet, regular exercise, and sufficient sleep. Avoid over-relying on caffeine, as it can lead to crashes later in the day. Instead, try natural energy boosters like green tea or B vitamins. After a period of time, these may help boost T levels and help increase natural testosterone production as well.

2. Mood Swings and Irritability

Mood swings can be difficult to handle but are often temporary. Men typically feel good with optimized hormone levels so when you come off of TRT, you may feel sluggish, down and the dumps and grumpy. This is hard for the man as well as his loved ones, friends,  and coworkers. Practicing stress management techniques like deep breathing or progressive muscle relaxation can help. Talking with a counselor or therapist can also be helpful if you experience significant mood changes or depressive symptoms.

3. Loss of Muscle Mass and Strength

A decrease in muscle mass is common after stopping TRT. However, resistance training can help you retain muscle and even stimulate some natural testosterone production but expect to lose size and strength as well as definition. Consistency with a structured workout routine is key in staying healthy but the reality is, without optimized testosterone levels, a patient is going to see a decrease is muscle mass.

4. Reduced Libido and Sexual Function

Libido quite often declines when coming off TRT, but it may improve as your body adapts.  Typically our patients notice a large increase in their sex drive when they start TRT and unfortunately a swift decline once they stop. Open communication with your partner and realistic expectations are essential when this occurs. Additionally, a healthy diet, regular exercise, and stress reduction can positively impact libido over time and may be needed to combat the lower suboptimal testosterone levels.

5. Weight Gain

Without TRT, metabolism may slow, leading to weight gain, especially in the abdominal area for men. Focusing on nutrient-dense foods, portion control, and regular physical activity can help you manage your weight especially after stopping TRT. A combination of resistance training and cardiovascular exercise is effective for maintaining a healthy body composition/BMI and will help maximize the body’s natural testosterone production. Avoiding processed foods, sugars and fast food is important during the transitional period to prevent rapid weight gain post HRT cessation.

Natural Supplements to Support Testosterone Levels

There are several natural supplements which may help to support testosterone levels during this transition, although the increase in T production may be slight, especially in comparison to prescription testosterone. There are many over the counter testosterone boosters on the market, however studies have shown that most of these are ineffective and in many cases actually can LOWER your testosterone levels. Some popular options of testosterone boosters include:

  • Zinc: Zinc is an essential mineral known for its ability to help raise/optimize testosterone production. You can get zinc through various food sources, such as red meat, poultry, shellfish (like oysters), beans, nuts, whole grains, and dairy products. Zinc is also available in supplement form, either as standalone zinc tablets or in multivitamins and mineral supplements which can be purchase at most local pharmacies, supermarkets and sports nutritional stores like GNC.
  • Vitamin D: Low vitamin D is associated with low testosterone. Vitamin D can be obtained by people through sunlight exposure, as the skin produces it when exposed to UVB rays but this may not be suitable or even possible for everyone. You can also get vitamin D from foods like fatty fish (salmon, mackerel), fortified dairy products, egg yolks, and by taking vitamin D supplements when needed, especially in areas with limited sunlight.
  • Ashwagandha: Ashwagandha is an adaptogenic herb traditionally used in Ayurvedic medicine to help the body manage stress, promote relaxation, and improve overall well-being. Known for its potential to support cognitive function, energy levels, and hormone balance, ashwagandha may also have benefits for reducing anxiety, enhancing physical endurance, and supporting immune health all of which may have a positive impact of testosterone levels.
  • Fenugreek: Fenugreek is commonly used in traditional medicine and cooking, known for its potential health benefits, including supporting hormone balance, digestion, and blood sugar regulation. Often taken as a supplement, fenugreek may also help enhance libido and testosterone levels in men, as well as support milk production in breastfeeding women. Fenugreek has shown some promise in supporting testosterone and libido, though more research is needed to fully understand its benefits towards this process.



Stopping TRT: Patience and Monitoring

For patients coming off TRT, it is a journey that requires patience and a strong commitment to lifestyle adjustments in order to prevent the potential side effects that are most likely to occur after ending treatment. Hormonal balance can take time to restore naturally, so allow yourself several months in order for your body to adjust fully back to natural pre-trt production, especially for older men who have been on long term testosterone therapy. It’s normal to experience fluctuations in energy, mood, and libido as your natural testosterone production resumes and be aware that they will usually only bounce back to pre-trt levels and often don’t even get to be that high. Everyone is different.

It's vital to schedule regular check-ups with your healthcare provider who can ensure your transition is progressing smoothly under their guidance. Blood tests can provide insight into your hormone levels and how quickly they’re rebounding and will help your doctor determine if additional support, like PCT or natural supplements, may be necessary to help restart your endocrine production.

While coming off TRT may present challenges for most men, focusing on a holistic approach to health—through diet, exercise, sleep, and stress management—can ease the process and is something that we should all be doing anyway. Over time, you may find a new balance that allows you to enjoy improved well-being without needing long-term testosterone supplementation, however it’s in everyone’s best interest to seek the care of an experienced healthcare provider to allow us to make the most informed decisions possible about our health.



Thursday, November 7, 2024

Is Long-Term Testosterone Therapy Safe? What Every Man Should Know

The Truth About Long-Term Testosterone Therapy: Benefits, Risks, and What to Expect



Is TRT Safe for Long-Term Use?

Testosterone Replacement Therapy (TRT) is an increasingly popular medical treatment among men experiencing symptoms associated with low testosterone, including reduced muscle mass, low libido, poor sleep quality, unwanted weight gain and mood changes. While TRT has shown promising results in addressing these symptoms, many wonder about the safety of TRT over the long term. At NovaGenix Health and Wellness, we prioritize educating our patients about both the benefits and potential risks of any treatment. As it turns out there is a significant body of research which highlights the health benefits and safety of TRT. Here, we’ll explore the considerations around long-term TRT safety, based on the latest research and clinical insights from unbiased clinical researchers through evidence based trials and peer reviewed literature.

Understanding How TRT Works

TRT aims to restore testosterone levels to a healthy range.  Testosterone, a hormone produced in the testicles, plays a key role in male health, impacting muscle mass, bone density, energy, and sexual function. Low testosterone (or "low T") can result from age-related decline, certain medical conditions, or lifestyle factors. TRT provides a way to supplement testosterone levels through various methods, such as injections, gels, patches, or pellets, each with its own benefits depending on a patient's lifestyle and health needs. After a consultation with a licensed and experienced physician, the protocol and dose of testosterone may be determined based on the patient’s blood work and signs/symptoms. The dose and frequency will vary from patient to the next and after a few weeks, follow up blood work will be conducted to determine the efficacy of treatment and if any adjustments need to be made.



Immediate Benefits of TRT

For many, TRT provides substantial health and quality of life benefits shortly after starting treatment. Patients often report improved energy levels, a clearer focus, increased libido, and better mood regulation within weeks to months. Some men also notice improved muscle tone, decreased body fat, and a general sense of well-being. For those struggling with the symptoms of low T, TRT can be transformative. Every patient is different and the time frame and results will be unique, which is why its best to work with healthcare professionals that are experienced in hormone therapy to maximize the potential benefits of treatment.

Links to Scholarly Articles and Clinical Research Trials

1.Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study

2.On the effects of testosterone on brain behavioral functions

3.Testosterone and Its Effects on Human Male Adolescent Mood and Behavior: A Systematic Review

4.Effects of testosterone and growth hormone on muscle function

5.Testosterone and weight loss: the evidence

 


Common Concerns with Long-Term TRT

The question of long-term safety with TRT is understandable, as it involves a continuous adjustment to one’s hormonal balance. Historically there has been much confusion and misinformation regarding the safety of testosterone therapy however, it’s been studied and shown to be not only safe when done under the guidance of a medical professional but can also improve overall health and quality of life in patients with optimized hormone levels. An This is clearly outilend ina  n article title “Efficacy and Safety of Testosterone Treatment in Men: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians.” It states that In older men with low testosterone levels without well-established medical conditions known to cause hypogonadism, testosterone therapy may provide improvements in sexual functioning and quality of life. In another article titled “Testosterone Replacement Therapy: Long-Term Safety and Efficacy” it was concluded that “Among men with androgen deficiency, those who were dispensed T prescriptions were associated with a lower risk of CV outcomes “

 


Here are the most common concerns associated with prolonged TRT use and what the latest research tells us:

Cardiovascular Health: Testosterone has been linked to heart health in complex ways. Some early studies raised concerns about an increased risk of cardiovascular events like heart attacks and strokes in men on TRT. However, it was concluded that many of the male subjects in the studies that came to this conclusion were older men with preexisting heart conditions. More recent studies suggest that men with testosterone levels in the normal range have a lower risk of cardiovascular issues compared to those with low levels. A study in the Journal of the American Heart Association even found that men on TRT had fewer heart issues when testosterone levels were optimized, particularly when monitored by a healthcare provider.

Prostate Health: Testosterone has long been thought to influence prostate health, and there were concerns that TRT could increase the risk of prostate cancer or benign prostatic hyperplasia (BPH). While high testosterone levels may stimulate prostate cell growth, no strong evidence links TRT to an increased prostate cancer risk. In fact, a 2016 study in European Urology found no significant difference in prostate cancer rates between men on TRT and those who were not. Regular screenings and PSA testing are essential, as they allow healthcare providers to monitor prostate health carefully. Its even been concluded that TRT can help patients that have had prostate cancer post treatment. In a statement made from the American Urological Association, it states…“Several studies have suggested that TTh may decrease the risk of developing aggressive prostate cancer or developing a biochemical recurrence after radical prostatectomy.” [Testosterone Therapy for Patients with a History of Prostate Cancer By: Mohit Khera, MD, MBA, MPH | Posted on: 01 Apr 2022]


Fertility Considerations: Long-term TRT can impact fertility by reducing sperm production. This happens because external testosterone creams/gels and injections can signal the hypothalamus to trigger the body to stop producing its own testosterone, thereby affecting the production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), both crucial for sperm production. Men who wish to preserve fertility may explore alternative options or adjunct therapies, such as human chorionic gonadotropin (hCG), to maintain sperm production while on TRT. Discussing fertility goals with a healthcare provider before starting TRT is important for any man considering long-term use.

Red Blood Cell Count (Polycythemia): TRT can stimulate the production of red blood cells, potentially leading to a condition called polycythemia, where the blood becomes thicker. Elevated red blood cell counts can increase the risk of blood clots, stroke, and other cardiovascular issues. Regular blood tests allow healthcare providers to monitor red blood cell counts and hematocrit levels for patients on TRT and adjust dosages or recommend phlebotomy (blood donation) if levels get too high or other strategies aimed at lowering red blood cell counts.

Mood and Mental Health: Testosterone is closely tied to mental well-being whether levels are either too high or too low. Many men report improved mood and reduced anxiety when on TRT, and some studies even show a correlation between low testosterone and mood disorders. While the short-term mood benefits are generally positive, it’s crucial to monitor any long-term mood changes when taking hormones. In some cases, too high or unstable testosterone levels may contribute to irritability or mood swings and T levels that are too low may contribute to depression. An article published by the National Library of Medicine stated “…testosterone administration yielded positive results in the treatment of depression. It should be stated that not all cases may benefit from the administration of testosterone, but the fact that the link exists speaks volumes about the relationship between mental health and hormone balance in men.




Importance of Medical Monitoring

One of the keys to the safe, long-term use of TRT is consistent medical oversight from a licensed and experienced physician like Dr. Timothy W. Mackey from NovaGenix. At NovaGenix Health and Wellness, we recommend regular check-ins with our healthcare providers to monitor testosterone levels and overall health indicators such as the signs and symptoms of Low T. Routine blood tests allow for monitoring of things like red blood cell count, PSA levels, and hormone levels, ensuring that any adjustments to the therapy can be made proactively. Adjusting the TRT dose as needed helps minimize risks and promotes sustainable, long-term benefits and improves overall medical outcomes from therapy.

Lifestyle and Health Considerations

Maintaining a healthy lifestyle can enhance the effectiveness and safety of TRT for patients looking to get the most from therapy. Proper diet, regular exercise, adequate sleep, and managing stress levels all support hormonal health and amplify the benefits of TRT tremendously. Weight management is essential for good health, as excess body fat can lead to an increase in estrogen levels, which can counteract the effects of testosterone, so having a plan in place and support from a medical team can make a tremendous difference.



A Balanced Perspective on Long-Term TRT Safety

While no medical treatment is without risks, current research and clinical practices indicate that TRT can be safe and beneficial when managed correctly. The long-term safety of TRT hinges on a personalized approach from a doctor who is both knowledgeable and experienced in hormone therapy, taking into account individual health factors, lifestyle, and specific treatment goals. By closely monitoring health markers by having regular lab work and making necessary adjustments over time, the benefits of TRT often outweigh potential risks for many men.

For men struggling with the effects of low testosterone and suboptimal androgen deficiency, TRT offers a promising path to regain vitality, confidence, and quality of life. Long-term use of TRT can be safe when properly managed by a knowledgeable healthcare provider who keeps a close watchful eye on critical health indicators. At NovaGenix, we’re committed to providing high-quality, personalized TRT plans that prioritize both effectiveness and patient safety with all-inclusive HRT programs for both men and women. If you’re considering TRT and want to learn more about what long-term therapy could mean for you, schedule a consultation with us. We offer convenient online telemedicine appointments for patients. Our team is here to guide you toward the best choices for your health and well-being.

Thursday, October 17, 2024

Your Guide to Purchasing Semaglutide (Wegovy) Locally and Online Through NovaGenix Health and Wellness

Where to Buy Wegovy Online and Locally: Your Best Options for Finding Semaglutide




Where to find Semaglutide: Your Trusted Source for GLP-1 Weight Loss Medication with NovaGenix

Semaglutide is a groundbreaking GLP-1 agonist medication for weight management, and recently has taken the health world by storm, offering a new FDA approved weight loss solution for people struggling to lose weight through traditional methods. Whether you’re dealing with obesity related health concerns or are just simply trying to maintain a healthy weight to look good and increase self-esteem and confidence, Prescription weight loss medications like Wegovy offers a safe and effective option. They’ve become incredibly popular with celebrities like Oprah Winfrey telling an interviewer about using the GLP-1 medications to help achieve her incredible weight loss results. But how can you purchase Wegovy in a way that’s reliable, convenient, safe, and medically sound? That’s where clinics like NovaGenix, a trusted health and wellness clinic that offers online telemedicine consultations, come in. If you’re wondering where to buy Wegovy online and locally, NovaGenix offers the perfect blend of medical expertise, convenience, and personalized care.

Why Choose Wegovy for Weight Loss?

Semaglutide injections, work by mimicking a hormone in the body that targets areas of the brain that regulate appetite. These medications are called GLP-1 agonists. Popular brands are Wegovy, Ozempic, Zepbound and Mounjaro. When taken, they have been shown to help reduce hunger and food intake, supporting sustainable weight loss when used alongside a healthy diet and exercise. The medication has been proven in clinical trials and medical studies to help people lose significant weight, making it a game-changer for those who struggle with obesity or weight-related health issues like type 2 diabetes or high blood pressure. In adults with overweight or obesity, and type 2 diabetes, semaglutide 2·4 mg once  weekly helped patients achieve a superior and clinically meaningful lowering of their bodyweight compared with a group that had taken a placebo. (https://pubmed.ncbi.nlm.nih.gov/33667417/) In one trial published in the New England Journal of Medicine, adults with obesity or who were overweight (without diabetes) achieved a significant 14.9% mean weight loss with semaglutide plus lifestyle interventions, compared to 12.4% greater weight loss than the placebo group. Semaglutide led to substantial improvements in cardiometabolic risk factors, including waist circumference, blood pressure, and inflammation, and about 70% of participants achieved at least 10% weight loss. (https://www.nejm.org/doi/full/10.1056/NEJMoa2032183)

However, due to its rapid rise in popularity, finding a reliable and safe place to buy Semaglutide has become a concern for many. This is where telemedicine clinics like NovaGenix stand out, offering a seamless experience for obtaining Wegovy under the guidance of medical professionals like Dr. Timothy W. Mackey. How much weight a patient can lose in a month can depend on several factors but having a support system in place can only help improve the results.



The Benefits of Buying Semaglutide/Wegovy Through Telemedicine

With the rise of telemedicine, healthcare has become more accessible and convenient than ever before. Clinics like NovaGenix allow you to access high-quality medical care from the comfort of your own home. Whether you're unable to visit a local clinic due to time constraints, mobility issues, or simply because you're seeking a more private option, telemedicine offers a solution.

Here are some of the key benefits of buying semaglutide through telemedicine with NovaGenix:

1. Convenient and Discreet

One of the main advantages of using a telemedicine clinic like NovaGenix is the convenience factor. You no longer need to drive to a physical location, wait in a crowded waiting room, or take time off work for appointments. Through NovaGenix, you can consult with licensed healthcare professionals online, at a time that suits you, from the privacy of your own home or office.

This is particularly beneficial for individuals who may feel self-conscious or uncomfortable discussing their weight management journey in person. Many people hate sitting in the doctor’s office waiting to be called into an exam room where they sit for an equally long time just to talk with a nurse for 2 minutes. Telemedicine allows for a discreet, patient-focused experience and lets the patient ask as many questions as possible to the provider and they need without the feeling of being rushed because there’s another patient in the room next door waiting to speak to the provider.

2. Expert Guidance from Licensed Professionals

Semaglutide is a prescription medication, and it’s crucial to receive proper medical guidance from an experienced and licensed healthcare provider when starting any new treatment. NovaGenix specializes in weight management, hormone therapy, and other wellness solutions, meaning you'll receive expert advice from a licensed healthcare provider who has successfully help to treat patients just like you. They’ll help you determine if GLP-1 medications like semaglutide (Wegovy or Ozempic) is right for you, taking into account your medical history, current health conditions, and weight loss goals. Each patient is unique and has individual needs when it comes to their healthcare.

The clinic provides personalized consultations where the team will assess your needs, discuss potential side effects, and make sure you're fully informed about the medication. You won’t feel like “just another patient” but rather as someone receiving a tailored health solution. Telemedicine options also allow for the patient to have more access to the physician which is important when seeking advice regarding your healthcare journey.

3. Easy Prescription Process

Once Dr. Mackey at NovaGenix determines that a GLP-1 agonist like semaglutide is the right choice for you, they’ll handle the prescription process. They ensure that your prescription is sent to a reputable pharmacy, making sure the process is smooth and efficient. NovaGenix works with licensed and accredited US based pharmacies to provide options for how you receive your FDA approved medication which can be shipped directly to you.

Whether you prefer to pick up your prescription locally or have it delivered to your door, NovaGenix ensures you get your medication promptly and securely. Their streamlined process takes the hassle out of filling prescriptions, so you can focus on your health and wellness journey.

4. Ongoing Support and Monitoring

Weight management is not a quick fix that you accomplish over the weekend. It’s a long-term commitment, and it’s important to have ongoing medical support when using medications like Semaglutide or Tirzepatide (Wegovy or Mounjaro). NovaGenix offers continued monitoring to ensure the medication is working effectively and safely for you. They provide follow-up consultations with patients to help assess efficacy and maintain accountability, answer any questions or concerns you may have, and adjust your treatment plan if necessary to determine how long you need to take Wegovy for.

This level of ongoing care sets NovaGenix apart from other telemedicine providers or generic online platforms. Some of the larger companies have too many patients to develop an induvial relationship with each person. Rather they push out Rx’s and treat everyone like they’re on an assembly line. Dr Mackey will emphasize the importance of comprehensive health management, ensuring that you receive not only the medication but also the support to succeed in your weight loss journey whenever you need it.



Local vs. Online: What’s the Best Option?

When considering where to buy Wegovy or generic semaglutide, the choice often comes down to local pharmacies or online providers and cost.

Local Pharmacies

Buying Wegovy from a local pharmacy like CVS may offer a sense of familiarity, but there are several drawbacks. First, availability can be limited due to high demand. Some pharmacies may be out of stock or have long waiting times to fill prescriptions. Additionally, the process may involve more time spent waiting for in-person appointments with your doctor and traveling to the pharmacy.

However, if you prefer picking up medication locally and have easy access to your pharmacy, this can be a viable option, especially if you already have a relationship with your pharmacist. Just be warned that the cost of brand named GLP-1 medications like Wegovy can be prohibitively high, with some patients paying $1,349.02 a month for JUST the medication (not including physician costs, supplies and other associated costs) Semaglutide through a clinic like NovaGenix can cost a fraction of the price.



Online Solutions to Start GLP-1 Medications like Semaglutide

Online clinics offer a more convenient option, especially for those with busy schedules or limited access to local healthcare services. By choosing a clinic like NovaGenix, you can bypass the delays and challenges associated with local pharmacies who are often back ordered due to high demand and medications being on short supply. You can complete the consultation, prescription, and delivery process from home.

Telemedicine also makes the entire process seamless, from diagnosis to delivery. NovaGenix partners with reliable pharmacies, ensuring that you receive genuine medication without the risks associated with disreputable online vendors and typically get the medication at a substantially lower cost without sacrificing quality or access to pharmacists or provider alike.



Why NovaGenix Stands Out

If you're seeking a provider to help you obtain Semaglutide, NovaGenix is an ideal choice. Located in Jupiter, Florida, and accessible online with telemedicine consultations available, NovaGenix has earned a reputation for providing top-tier health and wellness services, particularly in the fields of weight management and hormone therapy. Their team of experienced healthcare providers are committed to patient satisfaction and safety with a record of success that speaks for itself.

Here’s why NovaGenix should be your go-to option for Semaglutide, Tirzepatide and Weight Loss Programs:

  • Trusted Medical Expertise: NovaGenix’s licensed practitioners are experts in weight management and wellness, ensuring you receive the best possible care from experienced professionals. With over 30 years’ experience helping patients deal with issues like obesity, get their lives back on track.
  • Comprehensive Care: In addition to Wegovy, NovaGenix offers a wide range of wellness treatments, from hormone therapy to nutritional counseling, making them a full-service anti-aging clinic focused on the benefits of holistic health and treating the whole person.
  • Patient-Centered Approach: NovaGenix emphasizes personalized care, tailoring treatment plans to meet the individual needs of each patient. We are all different and have different needs, goals and should be treated uniquely with an approach that is tailored specifically to each patient weighing out both the benefits and risks of any weight loss treatment.


Start Your Weight loss Journey with NovaGenix

Finding a trusted source for Semaglutide doesn’t have to be a challenge. With NovaGenix, you’ll experience a smooth, supportive, and expert-led process to achieve your weight loss goals. Whether you prefer the convenience of telemedicine or need the support of ongoing consultations, NovaGenix is here to guide you every step of the way.



Start your weight loss journey today by contacting NovaGenix and see if medically supervised weight loss is the right solution for you. Reach out to their team online at www.NovaGenix.org or visit their Jupiter, Florida location at 609 N. Hepburn Ave Suite 106, Jupiter, Florida 33458 for more information. Your path to better health starts now! Call or Text us at 561-277-8260 to learn more.



Monday, October 14, 2024

FDA Lifts Tirzepatide Shortage Status: What It Means for Patients Relying on Compounded Versions and why they reversed their decision

FDA Removes Tirzepatide (Mounjaro, Zepbound) from Drug Shortage List: What It Means for Patients Using Compounded Versions and Reasons Behind There Sudden Reversal

Tirzepatide No Longer in Short Supply: Impact on Compounded Medications for Weight Loss


Tirzepatide No Longer in Short Supply: Impact on Compounded Medications for Weight Loss

As of October 2024, the FDA has officially removed tirzepatide  (the active ingredient in Mounjaro and Zepbound) from its drug shortage list. This change follows months of high demand for tirzepatide, which is used for both diabetes and weight-loss treatments. Due to the rising popularity of GLP-1 medications for weight loss, many patients experienced difficulties obtaining them. Eli Lilly, the manufacturer, increased production capacity, restoring full availability in pharmacies. Lilly's drugs  have recently taken the world of weight loss by storm, however, this has impacted providers and patients who relied on affordable, effective compounded versions of the drug. The good news is that due to pressure from advocacy groups, they reversed their decision...for now.

Impact on Compounded Tirzepatide

During the shortage, compounded tirzepatide provided a legal and accessible alternative, allowing pharmacies to create versions by combining drug ingredients or altering the dose, sometimes with added vitamins like B-12. Now that the shortage has been resolved, compounding pharmacies are no longer permitted to produce and sell new tirzepatide compounds, which will affect many patients currently using compounded versions for weight loss.

This change will likely raise the cost of tirzepatide for patients who found the compounded version to be a more affordable option. The FDA’s  decision may impact tirzepatide costs in two main ways:






Higher Costs for Brand-Name Versions

Mounjaro and Zepbound, the FDA-approved brands, are considerably more expensive than compounded medications. Brand-name drugs often have higher prices due to research, development, and marketing costs, as well as corporate pricing strategies. Without compounded versions, pharmaceutical companies can set higher prices due to lack of competition. The potential for significant profits makes it worthwhile for companies to defend these price points in court.

For example, Mounjaro for diabetes can cost patients without insurance $1,000 to $1,200 per month, with Zepbound similarly priced for weight loss. Insurance may cover part of the cost, but most insurance plans exclude weight-loss medications, despite evidence supporting their health benefits, like reducing obesity-related comorbidities.




Lower Costs for Compounded Versions

Compounded tirzepatide, produced during the shortage, was often significantly cheaper because compounding pharmacies are not bound by major pharmaceutical pricing. Patients could save hundreds of dollars monthly through compounded alternatives, particularly when obtained through specialty clinics or anti-aging and weight-loss providers.

Now, with compounded tirzepatide unavailable, patients must switch to the pricier brand-name options, which could strain budgets for those previously using compounded forms for affordability.


Future Pricing Trends

With Eli Lilly increasing production, there’s hope that the higher availability may eventually influence prices through competition or expanded insurance coverage. However, in the near term, the cost gap between compounded and brand-name versions will remain substantial. As a profit-driven company, Eli Lilly will likely aim to maintain high pricing to maximize returns.

Patients transitioning to branded medications should consult their healthcare providers and check with insurance companies for rebates, discounts, or generic alternatives if available. Semaglutide is a generic medication, a similar medication to tirzepatide, and might remain a more affordable choice for some patients.


Temporary Access for Compounded Tirzepatide

Fortunately, the FDA has granted a 60-day grace period during which compounded pharmacies can fulfill pre-existing tirzepatide orders. After this period, compounded tirzepatide will no longer be legally available unless a new shortage occurs. In response to public demand, the FDA has agreed to review its decision, which was prompted by a lawsuit from the Outsourcing Facilities Association. The U.S. FDA agreed on October 11, 2024, to reconsider its decision barring compounding pharmacies from producing their own versions of Eli Lilly's popular weight loss and diabetes drugs, Mounjaro and Zepbound due to the outsourcing facilities association. This association represents the compounding industry and argues that compounded options provide a cheaper, essential alternative for weight loss, especially given limited insurance coverage.



The lawsuit, now on hold by U.S. District Judge Mark Pittman, highlights ongoing shortages and the demand for compounded alternatives, which offer solutions for patients unable to access or afford brand-name options. For now, some pharmacies can still fill compounded tirzepatide prescriptions, and we’ll monitor the FDA’s and courts' actions to see what the future holds for patients, providers, and pharmacies.

What This Means for Patients

For those relying on compounded tirzepatide, this change means switching to the FDA-approved options—Mounjaro (for diabetes) and Zepbound (for weight management). Patients using compounded versions should consult with their healthcare providers to facilitate a smooth transition and explore potential insurance coverage for the brand-name medications.

Although compounded medications may offer more affordable alternatives, FDA-approved options are rigorously regulated for safety and efficacy. Now that Eli Lilly can meet demand, brand-name availability should improve, reducing the need for compounded alternatives.

 


Future Outlook for GLP-1 Agonists and FDA Regulations

The resolution signals improved supply and manufacturing, making tirzepatide widely available for diabetes and weight management. Eli Lilly’s continued investment in new production facilities aims to prevent future shortages, a positive development for patients relying on these medications. The more hopeful news is the FDA’s willingness to reconsider its decision, potentially allowing for compounded options to help combat obesity, one of the nation’s leading health risks.

If you’re interested in a consultation to discuss weight loss programs with Dr. Mackey and learning more about GLP-1 medications or discussing other options, Contact us at 561-277-8260 to set up an initial consultation.

 

Foley & Lardner LLP   BioSpace

Tuesday, October 8, 2024

Balancing Weight Loss Success with Potential Side Effects of Wegovy and Mounjaro

Exploring the Possible Side Effects of GLP-1 Agonists:Wegovy, Mounjaro, and More—Balancing Risks with Weight Loss Benefits



GLP-1 (glucagon-like peptide-1) agonists, including popular medications like Wegovy (semaglutide), Mounjaro (tirzepatide), and Ozempic, have revolutionized the field of weight management. Originally developed for managing type 2 diabetes, these medications have now gained popularity for their remarkable ability to promote weight loss in individuals with obesity or weight-related conditions. Several celebrities like Oprah have come out and discussed their success with these weight loss medications making them much more socially acceptable than they used to be. While their benefits in terms of weight loss and overall health improvement are extraordinary, it’s important to understand what some of the possible side effects that could happen to some patients with their use. Importantly, the benefits of these medications—particularly in terms of reducing some of the serious health risks associated with obesity—typically will outweigh the potential risks experienced by a small percentage of the population.



How GLP-1 Agonists Like Wegovy and Mounjaro Work for Weight Loss

GLP-1 agonists are drugs/peptides that mimic the action of a natural hormone called glucagon-like peptide-1, which helps regulate appetite as well as insulin production, and blood sugar levels. These medications work by slowing down the process of gastric emptying (the rate at which food leaves the stomach), by sending signals to the brain that increase satiety, and promotes insulin release in response to eating. This leads to a reduction in hunger, making it easier for individuals to consume fewer calories and lose weight.

Clinical trials have shown that people taking medications like Wegovy or Mounjaro, along with lifestyle modifications, can lose up to 15-20% of their body weight, a pretty big accomplishment for those who have struggled to lose weight through diet and exercise alone. This degree of weight loss is associated with substantial improvements in metabolic health, including reduced risks of type 2 diabetes, heart disease, and even certain cancers. For those that criticize others for taking medications to lose weight, it should be noted that the risks of obesity related health conditions make the outcome justify any method that achieves results, and that not everyone is able to lose weight through diet and exercise alone.


Common Side Effects of GLP-1 Agonists

All medications have the possibility of side effects. Even commonly taken over the counter drugs like aspirin or cold medicines could cause side effects. Having said that it’s important for a medical practitioner to discuss all possible side effects that may occur. While these GLP-1 medications are effective, they can come with some side effects for some patients, especially when the body is first adjusting to the medicine. The most commonly reported side effects for Wegovy, Mounjaro, and other GLP-1 agonists include gastrointestinal issues:

Nausea: This is one of the most common side effects, particularly when starting the treatments or increasing the dose. Nausea generally subsides after the body adjusts to the medication, but it can be managed by eating smaller meals and avoiding fatty or rich foods. Also starting the medication by taking lower doses and gradually increasing the amount of medication taken can help to mitigate the feeling of nausea that some people might experience.

Vomiting: Less commonly, some patients could experience vomiting, particularly if their dose has been increased too quickly. This side effect is often temporary but can also be mitigated by slowly titrating the dosage and adjusting the diet.

Diarrhea: Changes in the body’s digestion patterns from taking GLP-1 medications could result in diarrhea for some individuals. Maintaining adequate hydration and eating fiber-rich foods can help alleviate this symptom which like the others is often temporary upon first starting treatment and not very common.

Constipation: Alternatively, constipation could also be a possibility, but again is a fairly rare side effect. Increasing your fiber intake and staying hydrated can help reduce constipation if it were to occur. There are also other OTC options which can be useful for those who may experience this side effect.

Abdominal Pain: Some patients report discomfort or pain in the abdominal area, often due to the slowing of gastric emptying. Like the other side effects, this usually diminishes over time and can be reduced by having a schedule that slowly increases the dose and strength of the medication. An experienced physician will know this and be able to help deal with these potential side effects.



Less Common but Serious Side Effects

Though rare, GLP-1 agonists like Wegovy, Mounjaro, and Ozempic have been associated with some more serious side effects. Although these may be extremely rare, it’s important to discuss ALL possible side effects that can occur.

Pancreatitis: There have been reports of GLP-1 agonists being linked to pancreatitis (inflammation of the pancreas). Symptoms include severe abdominal pain, nausea, and vomiting. Patients experiencing these symptoms should seek medical attention immediately. Pancreatitis has been reported in a small percentage of patients. In clinical trials, the incidence has generally been around 0.1% to 0.2%, which means it affects about 1-2 out of every 1,000 people on these medications.

Gallbladder Issues: Rapid weight loss, which can occur with these medications, may lead to gallbladder problems like gallstones. Although these complications are more often linked to the weight loss process itself rather than the medication, it’s still an important factor to consider. The incidence of gallbladder-related problems varies across studies but has been reported to be around 1-2% in clinical trials of GLP-1 receptor agonists, such as semaglutide and liraglutide. In particular, gallbladder-related side effects are more commonly seen in patients using these medications for weight loss. Although the overall risk of gallbladder issues on GLP-1 receptor agonists is low, it can become more of a concern in patients experiencing significant weight loss. Doctors may monitor patients, especially those with a history of gallbladder disease or those who are losing weight rapidly, for symptoms of gallbladder issues during treatment.

Kidney Problems: In some cases, particularly in patients with pre-existing kidney issues, GLP-1 agonists have been associated with worsening kidney function. Reduced urine output or swelling are symptoms that should be reported to a healthcare provider. Overall, while kidney issues are not very common, they can occur, particularly in vulnerable patients or those with pre-existing kidney conditions. Regular monitoring and management of side effects like dehydration can help mitigate these risks.

Thyroid Tumors: Animal studies have suggested that semaglutide, the active ingredient in Wegovy, may increase the risk of thyroid tumors, including cancer. Although this has not been definitively shown in humans, individuals with a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should avoid these medications as they are contraindicated for patients wishing to start GLP-1 treatment.

Allergic Reactions: Like any medication, GLP-1 agonists can cause allergic reactions to occur in some people, including rash, itching, or difficulty breathing. If any of these occur, stop taking the medication and call your physician immediately. If they are not available, seek medical help immediately.



Weight Loss Benefits Outweigh the Risks

Despite these potential side effects, which are rare, the benefits of significant weight loss far outweigh the risks for most individuals. Obesity has been positively linked with numerous life-threatening  medical conditions, including type 2 diabetes, heart disease, stroke, and certain cancers. For those struggling with obesity, losing even a small amount of weight can dramatically improve one’s overall health and significantly reduce the risk of these conditions.

1. Reduced Risk of Type 2 Diabetes

Weight loss achieved through GLP-1 agonists has been shown to improve insulin sensitivity and reduce blood sugar levels, which is especially beneficial for those individuals who are at risk of developing type 2 diabetes. For those already managing diabetes, these medications can offer improved glycemic control and improve overall health.

2. Improved Cardiovascular Health

Obesity is a major risk factor for cardiovascular disease which is one of the number one killers in America. Weight loss can improve cholesterol levels as well as lower blood pressure and reduce the risk of heart attacks and strokes. By helping people lose a significant amount of weight, GLP-1 agonists contribute to better cardiovascular health and improve quality of life.

3. Enhanced Mobility and Joint Health

Carrying excess weight puts additional stress on the joints, increasing the risk of conditions like osteoarthritis. Losing weight helps alleviate this strain, improving mobility and reducing the need for joint surgeries. We have seen many patients with knee injuries and inflammation due to their being obese. When this happens, the reduction in mobility will cause an increase in weight gain leading to a cycle of weight gain and furthers health complications. Losing weight will help reverse and improve these conditions.

4. Mental Health Improvements

Obesity is often linked to mental health conditions for many people. Things like depression and anxiety, due to both physical and societal factors can be crippling to some individuals. The weight loss facilitated by GLP-1 agonists can improve self-esteem, enhance body image, and lead to an overall better quality of life. People who are more comfortable with their body are able to go out and enjoy life as compared to those who are limited by their low self-esteem.

5. Lower Cancer Risk

Obesity has been shown to be a risk factor for several types of cancer, including breast, colon, and pancreatic cancer. These are all life threatening and weight loss can significantly reduce the risk of developing these cancers, making it a crucial preventive measure for long-term health and wellness.



Mitigating the Side Effects of Wegovy, Mounjaro, and Other GLP-1 Agonists

While the side effects of GLP-1 agonists can be concerning, most can be managed or mitigated through careful dosing and lifestyle changes. Fortunately, these risks are relatively rare but either way, here are some strategies to minimize risks to even further the likelihood of them occurring:

Slow Dose Titration: Starting with a low dose and gradually increasing it allows the body to adjust, reducing the risk of nausea, vomiting, and other gastrointestinal issues. Patients who start on a full dose are more likely to experience some form of a side effect, whereas the patients that slowly increase their dose are more likely to avoid them.

Diet Adjustments: Eating smaller, more frequent meals and avoiding fatty or rich foods can help prevent nausea and vomiting. Plus, there is an additional weight loss benefit of eating healthier low-calorie meals which will only increase the weight loss and improve overall health.

Hydration and Fiber: Drinking plenty of water and incorporating fiber-rich foods into your diet can help alleviate constipation and diarrhea and has been shown to also help improve cholesterol levels.

Regular Monitoring: Regular check-ups with a healthcare provider can ensure that any serious side effects, like pancreatitis or kidney problems, are caught early and can be mitigated.



Lifelong Use of GLP-1 Agonists: Is It Necessary?

One of the most common concerns patients ask us about medications like Wegovy and Mounjaro is whether they will need to take them for life. The answer to that depends on individual circumstances. While some patients may be able to achieve their weight loss goals and maintain them through lifestyle changes like improved diet and regular exercise after discontinuing the medication, others may require long-term treatment to keep the weight off. Also, genetic factors and other underlying health conditions can play a major role in how well a patient can maintain a healthy weight. Obesity is a chronic condition, and for many individuals, maintaining weight loss requires ongoing medical intervention.

Much like medications for diabetes or hypertension, GLP-1 agonists may be necessary for long-term management of obesity in some patients. The underlying factors that contribute to weight gain, including genetics, hormones, and environmental influences, do not disappear after weight loss and need to be considered. As a result, some people may need to continue taking these medications, even at a lower maintenance dose to prevent weight regain and sustain their health improvements.

The Balance Between Benefits and Risks

In the end, GLP-1 agonists like Wegovy, Mounjaro, and Ozempic offer a powerful tool for weight management, especially for individuals who have struggled with obesity and have difficulty in losing weight. While these medications can come with potential side effects, most are both rare and manageable and tend to subside as the body adjusts. More importantly, the health risks associated with obesity—such as type 2 diabetes, heart disease, and certain cancers—are far more severe than the possible side effects of the medications.

For many people, the benefits of significant weight loss, improved mobility, reduced cardiovascular risk, and better mental health far outweigh the potential risks associated with GLP-1 agonists which is why so many people are turning to them as a solution to what has been a lifelong problem. Working closely with an experienced healthcare provider to monitor the possibility of side effects and adjust dosages when needed can help ensure a safe and effective weight loss journey.

Ultimately, achieving and maintaining a healthy weight is a lifelong commitment, and GLP-1 agonists offer an invaluable tool in the fight against obesity. With careful management, the risks are minimal, and the rewards—better health, enhanced quality of life, and longevity—are well worth it. For more information or to schedule an initial consultation to discuss whether any of these medications are right for you and the benefits and risks of GLP-1 medications, feel free to visit our website or call to learn more.