Wegovy is used as an aid for weight management in conjunction with a reduced calorie-controlled diet and increased physical activity. It is licensed for use as a weight loss tool for those adults with an initial Body Mass Index (BMI) of

≥30kg/m² (which is defined as obesity), or

≥ 27kg/m² to <30kg/m² (defined as being overweight) in the presence of at least one weight-related comorbidity such as high blood pressure, high cholesterol or cardiovascular disease.

Wegovy dose escalation

When you start to take Wegovy, you gradually increase the dose to allow your body to become accustomed to it. There are several gastrointestinal side effects associated with Wegovy, and by slowly titrating the dose over several weeks, you mitigate these side effects.

The maintenance dose of Wegovy is 2.4mg once weekly, which is achieved by starting with a dose of 0.25mg and gradually increasing over 16 weeks. If the gastrointestinal symptoms are significant before you reach the maintenance dose, you should delay a dose escalation or even drop to a lower dose. Weekly doses greater than 2.4mg are not recommended.

How to Administer Wegovy

Prepare for your injection.

• You will the following supplies to administer your Wegovy injection: your Wegovy pen, one alcohol swab or soap and water, one gauze pad or cotton ball, and one sharps disposable container for used Wegovy pens- Do not throw your used pen in household rubbish
• Wash your hands
• Check your Wegovy pen

Do not use your Wegovy® pen if:

• The pen appears to have been used or appears broken or damaged.
• The Wegovy medicine is not clear and colourless through the pen window
• The expiration date (EXP) has passed

Choose your injection site

APC Labs Wegovy injection sites

Injection site

• Your healthcare provider can help advise on an injection site suitable for you
• You may inject into your upper legs (front of the thighs), lower stomach (keep 2 inches away from your belly button), or upper arm
• Do not inject into an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks
• You may inject in the same body area each week but make sure it is not in the same spot each time

Clean the injection site with an alcohol swab or soap and water. Do not touch the injection site after cleaning.

Remove pen cap

Pull the pen cap straight off your pen

Removing pen cap from Wegovy Pen

Inject Wegovy®

Push the pen firmly against your skin and apply pressure until the yellow bar stops moving.

If the yellow bar does not start moving, apply greater pressure and press the pen more firmly against your skin.

Injecting Wegovy

During the injection you will hear two clicks

Click 1 indicates that the injection has started

Click 2 indicates that the injection is ongoing

The steps during injecting Wegovy

Troubleshooting

• If you have problems injecting, change to a firmer injection site, such as the upper leg or upper arm or consider standing up while injecting into the lower stomach
• If medicine appears on the skin or squirts from the needle, ensure you keep applying pressure until the yellow bar has stopped moving the next time you inject. Then, you can lift the pen slowly from your skin

Throw away (dispose of) the pen.

• Dispose of the used Wegovy pen safely after use.
• Do not throw the pen away in your household rubbish.
• Use a sharps disposal container, and when full, return to your local community pharmacy.

Dispose of used Wegovy pens in a sharps bin

What if blood appears after injection?

Sometimes you may see some blood appear after injecting the Wegovy. If this occurs then press lightly with a gauze pad or cotton ball if blood appears at the injection site.

The post How to take Wegovy appeared first on APC Labs.

The post Semaglutide Transmucosal Film appeared first on APC Labs.

However, researchers started noticing strange side effects once it was widely used. They began to see cases of hypertrichosis or Ambras syndrome or, to use a more politically incorrect name, werewolf syndrome (if there are any fans of Father Ted, they will know what this condition means….it was the episode when the jungle music priest came to replace Father Jack). This serendipitous discovery of hypertrichosis or the Ambras syndrome when using minoxidil (Zappacosta, A.R., 1980) opened the doors for more researchers to work on the elusive cure for “baldness”. Guinter Kahn and his colleague Paul J Grant started to work on testing subjects with a minoxidil 1% solution. In contrast, other physicians began prescribing Loniten “off-label” as a hair loss remedy.

Fortunately, the side effect of hypertrichosis caused hair growth, mainly on the head. In these cases, the side effect was warmly welcomed. However, in some instances, hair growth was triggered in other parts of the body, such as the arms, back, and chest. As a result of this unexpected side effect, researchers all over the world began experimenting with minoxidil and found that it demonstrated impressive hair growth, especially in conditions such as androgenetic alopecia (male pattern baldness) and alopecia areata.

The work of the researchers eventually bore fruit with the formulation of a topical minoxidil solution for treating androgenetic alopecia in men, with the licence later being extended to include women. Initially, a 2% minoxidil solution was marketed to stimulate hair regrowth in men in 1986 in the USA, with the 5% solution appearing in 1993 (Messenger & RUndegren, 2004). Finally, in 1986, the US FDA approved Rogaine topical lotion for treating genetic hair loss. In the UK, we know this product as Regaine, and eventually, both would move from the prescription-only status to the less restrictive over-the-counter form in 1995.

Once Rogaine’s patent expired, other cheaper generic and compounded versions entered the market. In the UK, Regina is available for hair loss for both men and women and is available in two different strengths: 2% and 5%, with the lower strength usually recommended for women.

The reason that a lower strength was initially recommended for women was that it was found that women were more susceptible to other side effects of minoxidil. These included a significant reduction in blood pressure, leading to other symptoms such as lightheadedness or dizziness. Other side effects that were experienced more so by women included allergic reactions such as dermatitis. It is interesting to note that women generally tend to have a more robust immune system than men. It seems that nature has decided that the female species is more valuable than the extra males and thus has given it a weaker immune system. It appears that nature somehow knew men would engage in risky activities to impress their friends on a Friday night and thus thought an efficient immune system would be wasted on them. However, there is no such thing as a free lunch; one consequence of this superior immune system is an increased risk of allergies and autoimmune conditions, which is when the immune system starts to attack the body when it has nothing to do,

For these reasons, women were recommended to use the 2% solution. Another unfortunate consequence of using minoxidil was that it could encourage facial hair growth, which would not be wanted in women if it ran down the temples. However, it was found that this problem usually resolved itself once the women stopped using the solution (Peluso, A.M., Misciali, C 1997). It was also found that facial hair growth in women occurred more frequently when the 5% solution was used. The development of a foam dispenser has made the application of minoxidil easier without any solution running down the sides of the temple. Also, unwanted hair growth can be mitigated by using a lower concentration of the minoxidil solution.

With regards to allergic dermatitis, which has previously been mentioned, this manifests itself as itching, burning, the appearance of papules or pustules, scalp tension, scalp pain, scaling or seborrheic dermatitis-like symptoms. However, the true allergy is usually associated with the propylene glycol in topical solution preparations. The propylene glycol content is more significant in the 5% solution than the 2% solution. Hence, switching to lower concentrations can sometimes alleviate the severity of the allergic response (Rogers, N.E. and Avram, M.R., 2008). The other way to mitigate the effects of propylene glycol allergy is to use the foam preparation. This is one of the reasons that we at APC Labs advocate using the foam solution; it’s easier to apply and causes less irritation. In other rare instances, there is an allergic reaction to the minoxidil.

A landmark study by Lucky et al. (2004) found that the use of the 5% solution produced better results than the 2% minoxidil solution in a cohort of women suffering from androgenetic alopecia or female-pattern hair loss. Both strengths were equally well tolerated, and as a result, minoxidil 5% foam became available for women’s use.

Minoxidil has become firmly established in treating hair loss and is included in many of the preparations we now prepare at APC Labs. If you do not see the strength you require or want to try a combination of hair loss ingredients that is not available on the market, please contact us, and we will see if we can formulate an original solution for you. This is because, at APC Labs, we know that everyone is different.

References:

Acelajado, M.C., Pisoni, R., Dudenbostel, T., Dell’Italia, L.J., Cartmill, F., Zhang, B., Cofield, S.S., Oparil, S. and Calhoun, D.A., 2012. Refractory hypertension: definition, prevalence, and patient characteristics. The Journal of Clinical Hypertension, 14(1), pp.7-12.

Messenger, A.G. and Rundegren, J., 2004. Minoxidil: mechanisms of action on hair growth. British Journal of Dermatology, 150(2), pp.186-194.

Peluso, A.M., Misciali, C., Vincenzi, C. and Tosti, A., 1997. Diffuse hypertrichosis during treatment with 5% topical minoxidil. British Journal of Dermatology, 136(1), pp.118-120.

Rogers, N.E. and Avram, M.R., 2008. Medical treatments for male and female pattern hair loss. Journal of the American Academy of Dermatology, 59(4), pp.547-566.

Zappacosta, A.R., 1980. Reversal of baldness in a patient receiving minoxidil for hypertension. The New England Journal of Medicine, 303(25), pp.1480-1481.

The post Minoxidil, an Introduction appeared first on APC Labs.

The recent ruling by the Minnesota Court of Appeals has ignited discussions surrounding religious beliefs, access to reproductive healthcare, and discrimination. At the heart of the matter is pharmacist George Badeaux’s refusal to provide emergency contraceptives to a customer in 2019, citing personal beliefs. This decision has sparked legal proceedings and prompted broader conversations about individual rights, professional obligations, and the intersection of faith and healthcare.

The three-judge panel’s ruling declared that Badeaux’s refusal to dispense a prescription for emergency contraception constituted business discrimination. The customer, Andrea Anderson, who sought the prescription, travelled significantly to obtain it elsewhere. Anderson later filed a lawsuit under Minnesota’s Human Rights Act, alleging discrimination.

Failure to Supply Emergency Contraception Amounts to Sex Discrimination

In the ruling, Judge Jeanne Cochran stated that Badeaux’s refusal to dispense emergency contraception because it might interfere with a pregnancy amounted to sex discrimination. This decision challenges the notion that religious beliefs can justify actions that deny individuals access to necessary healthcare services.

The implications of this ruling extend beyond the immediate legal case. It sets a precedent that refusal to provide certain medications based on personal beliefs can be considered discriminatory, particularly in reproductive healthcare. The ruling suggests that businesses must prioritize patients’ needs over personal convictions, especially in matters of healthcare where timely access is critical.

Religious Freedom Versus Individual Rights

This case raises complex ethical and legal questions about balancing religious freedom and individual rights. Badeaux’s representation by Alliance Defending Freedom, a Christian advocacy group, underscores the tension between religious convictions and professional obligations. While Badeaux’s counsel argues for the protection of religious liberties, Anderson’s legal team contends that denying access to emergency contraception constitutes discrimination.

Access to Reproductive Healthcare in the US- a Volatile Landscape

Moreover, this ruling may have broader implications for reproductive healthcare access nationwide. The decision aligns with efforts to ensure equitable access to contraception and abortion services, particularly as states grapple with changing legal landscapes. In recent years, some states have expanded access to emergency contraceptives and birth control, while others have enacted restrictive abortion laws. This case will undoubtedly add to the growing discussions.

Pharmacy First in the UK

The case also highlights the role of pharmacies in providing healthcare services and the responsibilities that come with that role. Pharmacies play a crucial role in ensuring access to essential medications, and pharmacists are expected to prioritise patients’ health needs above personal beliefs. The ruling underscores the importance of upholding professional standards and ethical principles in healthcare practice. This is especially the case in the UK, which saw pharmacists taking on an ever more significant role in patient care with the introduction of the Pharmacy First Scheme. This scheme allows pharmacists to dispense prescription-only medicines against a patient group directive for seven common conditions, including:

• sinusitis,
• sore throat,
• otitis media (earache),
• infected insect bite,
• impetigo,
• shingles, and
• uncomplicated urinary tract infections in women.

Reproductive Healthcare and Gender Equality

Additionally, the ruling sheds light on broader societal attitudes toward reproductive healthcare and gender equity. By recognising Badeaux’s refusal as a form of discrimination, the court affirms the importance of ensuring equal access to healthcare services for all individuals, regardless of gender or religious beliefs.

The case may catalyse further discussions and policy changes surrounding reproductive healthcare access and religious freedoms. It underscores the need for clear guidelines and regulations to address conflicts between personal beliefs and professional responsibilities in healthcare settings.

Summary

In conclusion, the Minnesota Court of Appeals’ ruling in George Badeaux’s refusal to provide emergency contraceptives represents a significant development in the ongoing debate over reproductive healthcare access and religious freedoms. The decision highlights the importance of prioritising patients’ health needs and upholding principles of equity and non-discrimination in healthcare practice.

The post Pharmacist’s Contraceptive Denial Ruled Discriminatory appeared first on APC Labs.

What is Alzheimer’s disease (AD)?

Alzheimer’s disease (AD) is a progressive neurodegenerative condition marked by memory loss, cognitive decline, and difficulties with visuospatial tasks¹. The neurological alterations in Alzheimer’s disease (AD) entail the accumulation of amyloid-β (Aβ) plaques and the hyperphosphorylation of tau proteins, forming neurofibrillary tangles, leading to eventual neurodegeneration.²

Sildenafil and its effects on AD

Sildenafil, a selective PDE5 inhibitor, has shown promising effects in various preclinical models of Alzheimer’s disease (AD), including modulating neuronal plasticity, reducing tau phosphorylation, improving cognitive impairment, decreasing amyloid-β (Aβ) plaque accumulation, and enhancing the level of brain-derived neurotrophic factor (BDNF).³

In a recent large-scale analysis of patient data from two databases, researchers found a 30%-54% reduced prevalence of AD among sildenafil users compared to non-users, even after adjusting for potential confounding factors. Mechanistic studies also showed decreased levels of neurotoxic proteins in brain cells exposed to sildenafil, supporting its potential neuroprotective effects.⁴

Feixiong Cheng, PhD, director of the Cleveland Clinic Genome Center and lead researcher of the study, highlighted the significance of these findings, emphasising the need for new therapies for AD. Using artificial intelligence to analyse data across multiple domains, the study provides further support for repurposing sildenafil as a treatment for AD.

The study published in March 2024 utilized real-world patient data from two databases, MarketScan Medicare Supplemental and Clinformatics, spanning different time periods. Propensity score-stratified analyses showed that sildenafil use was associated with a reduced likelihood of AD compared to control drugs.

Specifically, sildenafil demonstrated a 54% reduced incidence of AD in the MarketScan database and a 30% reduced prevalence in the Clinformatics database compared to control drugs like spironolactone.

These findings align with previous research indicating a potential protective effect of PDE5i treatment on AD risk. However, they contradict an earlier study published in Brain Communications in 2022, which found no link between ED medications and reduced AD risk.

The study also revealed that sildenafil reduced tau hyperphosphorylation in AD patient-induced pluripotent stem cell (iPSC)-derived neurons in a dose-dependent manner. RNA-sequencing data analysis further supported sildenafil’s targeting of AD-related genes and pathways, providing mechanistic insights into its beneficial effects on AD.

A previous study demonstrated that sildenafil increased neurite growth and decreased phospho-tau in AD patient iPSC-derived neurons, supporting its potential beneficial effect in AD.⁵ In vivo studies in mouse models have also shown improvements in memory, amyloid plaque load, inflammation, and neurogenesis with sildenafil treatment.⁶ Additionally, pilot trials have indicated beneficial effects of sildenafil in AD treatment, showing reduced neural activity in the hippocampus and improved cerebral metabolic rate and blood flow.⁷

The results indicate that sildenafil could be a promising candidate for repurposing in Alzheimer’s disease treatment, backed by evidence from both iPSC-derived neuron models and real-world patient data. However, Cheng emphasised the need for clinical trials to investigate sildenafil’s effectiveness in AD patients further.

References:

1. DeTure MA , Dickson DW ((2019) ) The neuropathological diagnosis of Alzheimer’s disease. Mol Neurodegener 14: , 32.
2. Rajmohan R , Reddy PH ((2017) ) Amyloid-beta and phosphorylated tau accumulations cause abnormalities at synapses of Alzheimer’s disease neurons. J Alzheimers Dis 57: , 975–999.
3. Cuadrado-Tejedor M , Hervias I , Ricobaraza A , Puerta E , Pérez-Roldán JM , García-Barroso C , Franco R , Aguirre N, García-Osta A ((2011) ) Sildenafil restores cognitive function without affecting β-amyloid burden in a mouse model of Alzheimer’s disease. Br J Pharmacol 164: 2029–2041.
4. Gohel, Dhruv et al. ‘Sildenafil as a Candidate Drug for Alzheimer’s Disease: Real-World Patient Data Observation and Mechanistic Observations from Patient-Induced Pluripotent Stem Cell-Derived Neurons’. 1 Jan. 2024 : 643 – 657.
5. Fang J, Zhang P, Zhou Y, Chiang CW, Tan J, Hou Y, Stauffer S, Li L, Pieper AA, Cummings J, Cheng F ((2021) ) Endophenotype-based in silico network medicine discovery combined with insurance record data mining identifies sildenafil as a candidate drug for Alzheimer’s disease. Nat Aging 1: 1175–1188.
6. García-Barroso C, Ricobaraza A, Pascual-Lucas M, Unceta N, Rico AJ, Goicolea MA, Sallés J, Lanciego JL, Oyarzabal J, Franco R, Cuadrado-Tejedor M, García-Osta A ((2013) ) Tadalafil crosses the blood-brain barrier. It reverses cognitive dysfunction in a mouse model of AD. Neuropharmacology 64: , 114–123.
7. Samudra N, Motes M, Lu H, Sheng M, Diaz-Arrastia R, Devous M, Hart J, Womack KB ((2019) ) A pilot study of changes in medial temporal lobe fractional amplitude of low-frequency fluctuations after sildenafil administration in patients with Alzheimer’s disease. J Alzheimers Dis 70: 163–170.

The post New Data Could Support the Role Of Viagra for Alzheimer’s Prevention. appeared first on APC Labs.

What is Rybelsus?

Rybelsus is the oral form of the once-weekly injection, Ozempic. People taking Ozempic have to inject themselves once a week, while those taking Rybelsus have to take one tablet daily.

Ozempic and Rybelsus are made by Novo Nordisk, the same manufacturer, and contain the same active ingredient, semaglutide.

What is Semaglutide?

The main ingredient in Rybelsus and Ozempic is semaglutide, a GLP-1 receptor agonist. This family of drugs mimic the effects of a hormone that both stimulates insulin and decreases the feeling of hunger.

Originally, semaglutide was developed to treat type II diabetes, but subsequently, it was found to be the greatest-ever weight loss drug. The story is similar to the development of Viagra, which was initially developed to treat pulmonary arterial hypertension but was discovered to treat symptoms of erectile dysfunction. Such is the serendipitous nature of drug discovery!

Users of semaglutide find that they can shed weight relatively effortlessly. This is because the semaglutide makes them feel less hungry, so they consume fewer calories.

Although Ozempic is used for weight loss, its primary licensed use is treating type II diabetes. The massive demand for the drug has led to shortages, which led to the development of Wegovy, a semaglutide injection that can be used to lose weight for people without type II diabetes.

At present, Rybelsus is the only oral form of semaglutide. It has been demonstrated to cause weight loss and improvements in blood sugars when used alone or in combination with other diabetic drugs.

Is Rybelsus as Effective as Ozempic?

Studies have demonstrated that Rybelsus is just as effective as Ozempic; however, higher doses must be given to achieve similar results. Whenever we take a capsule or a pill, the medicine has to pass from the digestive tract, through the liver, and finally into the blood, so not all the drugs reach the bloodstream.

Studies have been carried out to test the equivalent doses, and they have found that the maximum 14mg dose of Rybelsus is equivalent to the 0.5mg weekly dose of Ozempic. Hence, when a switch from injection is required, if someone is taking Ozempic 0.5mg weekly, this would correspond to a daily dose of 14mg Rybelsus.

How Effective is Rybelsus?

A study called the PIONEER 2 trial looked at its effectiveness in treating type II diabetes in people who took the antidiabetic metformin. The study found that after six months on the maximum dose, the trial participants found their average HBA1c levels reduced by 1.3%, and after one year, they lost 10 pounds.

A similar study, the SUSTAIN2 trial, carried out a similar study in a similar cohort of diabetics who were either taking metformin or a different class of antidiabetics called TZD. However, this time, the study focused on Ozempic rather than Rybelsus. The study found that the Ozempic produced an HBA1c reduction of 1.3% and a weight loss of 9.5 pounds.

Hence, the results of the PIONEER 2 and SUSTAIN 2 trials produced very similar outcomes, suggesting that these two drugs are equally effective.

However, Ozempic is also available in more potent doses. When Ozempic is used at the maximum dose of 2mg, it produced a reduction of HBA1c levels in type II diabetics who were taking metformin 2.2%, and the participants lost 15 pounds of weight. Wegovy is available at even higher doses of 2.4mg, and at present, Rybelsus is not available in these higher strengths and, to date, has not been tested as a weight loss drug for people who don’t have type II diabetes.

How to Take Rybelsus

Another potential reason that Rybelsus has not taken off is that it is a bit of a pain to take the drug. Let me explain. According to the FDA, you must take Rybelsus on an empty stomach every morning for 30 minutes before eating, drinking or taking any other medicines. You are only recommended to drink 4 ounces of plain water now. If you have your breakfast too early, this will impact the effectiveness of the Rybelsus. So, it is advised to wait longer than 30 minutes after taking the Rybelsus to start eating for best results. This delay in eating will enhance the absorption of Rybelsus.

In contrast, the dosing regimen for Ozempic is far less demanding. It involves one weekly injection that can be taken at any time of the day, with or without meals.

Is a Higher Dose of Rybelsus on the Way?

Even though higher doses for Rybelsus are not currently available unless you use a compounding pharmacy, Novo Nordisk is currently pushing for approval for these higher doses.

The PIONEER PLUS trial looked at larger doses of semaglutide, 25mg and 50mg daily, to confirm that these higher doses will be effective. The trial ran for 68 weeks and was tested on over 1,000 participants with type II diabetes.

The results found that the 14mg tablet produced a 1.5% reduction in HBA1c and a 9.9 lb weight loss. The 25mg tablet produced a 2.2% reduction in HBA1c and a 15.4 lb weight loss. Finally, the 50mg tablet also produced a 2.2% reduction in HBA1c but a massive 20.3lb weight loss. Hence, the 50mg tablet would be on par with the current maximum dose of 2.0mg in Ozempic.

Rybelsus and Side Effects

One of the main side effects that people experience when taking Rybelsus is gastrointestinal issues such as nausea, vomiting, or diarrhoea. However, these side effects begin to subside once the body gets accustomed to the drug. However, for others, these effects prove to be too much for them, and they are unable to continue the drug.

This is another benefit that compounding can play an active role. As we have mentioned, the Rybelsus has to be absorbed across the digestive tract, and when it is in contact with the intestines, it can cause these side effects. However, by formulating the Rybelsus in an oral adhesive buccal formulation, you effectively bypass the gut and eliminate these side effects. So, for this reason, if you cannot take Rybelsus due to the gastrointestinal side effects, talk to us at APC labs to see if we can formulate a suitable preparation for you.

However, sometimes, side effects still occur even when compounded in a form that bypasses the gut since Ozempic has similar effects. The side effect profiles of both Rybelsus and Ozempic were compared and found to be identical at equivalent doses.

Rybelsus has a pretty similar side-effect profile. Here’s the number of people who experience intestinal troubles, according to the data that the FDA lists on its official labels for the two drugs at equivalent doses:

Side Effect: Nausea

Ozempic: 20%

Rybelsus: 20%

Side Effect: Abdominal Pain

Ozempic: 7%

Rybelsus: 11%

Side Effect: Diarrhoea

Ozempic: 9%

Rybelsus: 10%

Side Effect: Vomiting

Ozempic: 5%

Rybelsus: 8%

Side Effect: Constipation

Ozempic: 5%

Rybelsus: 5%

The PIONEER PLUS trial also found that the gastrointestinal side effects were more familiar with larger doses.

As with all medications, there are also some more severe side effects you should watch out for, such as pancreatitis. Some people should not take Rybelsus, so it is important to always discuss it with your doctor before starting It.

Summary

• Rybelsus is semaglutide in oral form.
• Rybelsus is relatively more complicated to take than the weekly injection, i.e., a daily dose on an empty stomach
• Rybelsus has less powerful doses than Ozempic, but compounding can solve this.
• Rybelsus is an excellent option for needle-phobic people.
• Rybelsus is an effective therapy for improving glycaemic control and weight loss.

Compounded Semaglutide

At APC Labs, we pride ourselves on being pioneers in the field of compounding pharmacy. We are the first and only compounding pharmacy in the UK to offer transmucosal semaglutide formulations. This is where compounding can have a significant effect. We can compound a semaglutide formulation absorbed via the buccal mucosa, avoiding absorption through the gastrointestinal tract. As a result, a more substantial portion of the medication is absorbed directly into the bloodstream, reducing loss and reducing gastrointestinal side effects. Consequently, the dosage can be customised for each person. These are just a few advantages of selecting a compounding pharmacy; it offers you the flexibility to optimise your medications. If you are interested, please get in touch with APC Labs for more information.

References:

Aroda, V.R., Aberle, J., Bardtrum, L., Christiansen, E., Knop, F.K., Gabery, S., Pedersen, S.D. and Buse, J.B., 2023. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. The Lancet, 402(10403), pp.693-704.

Aroda, V.R., Ahmann, A., Cariou, B., Chow, F., Davies, M.J., Jódar, E., Mehta, R., Woo, V. and Lingvay, I., 2019. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in treating type 2 diabetes: insights from the SUSTAIN 1–7 trials. Diabetes & metabolism, 45(5), pp.409-418.

Zinman, B., Bhosekar, V., Busch, R., Holst, I., Ludvik, B., Thielke, D., Thrasher, J., Woo, V. and Philis-Tsimikas, A., 2019. Semaglutide once weekly as an add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. The Lancet Diabetes & endocrinology, 7(5), pp.356-367.

The post Is Rybelsus the Same as Ozempic? appeared first on APC Labs.

 Although fibromyalgia is not considered an inflammatory condition and does not respond well to anti-inflammatories (Clauw DJ, Arnold LM et al. 2011), there may still be an element of the inflammatory process involved (Wallace DJ. 2006).

Clinical Trials of LDN Treatment for Fibromyalgia

 Two small clinical trials have demonstrated that low-dose naltrexone, or LDN, can be an effective treatment for fibromyalgia. In both trials, LDN was administered at 4.5mg at night before bed. In the first crossover trial, where the participants received either LDN or placebo to start and then swapped midway through the trial, LDN reduced the pain associated with fibromyalgia in 6 out of 10 women compared to placebo (Younger J, Mackey S. 2009).

To help consolidate these findings, a second study was conducted on 30 women who had fibromyalgia (Younger J, Noor N, et al. 2013). This was a double-blind, crossover, counterbalanced study that found that 57 % of the participants exhibited a significant reduction of pain during the low-dose naltrexone arm of the trial. The trial participants stated that they felt “very much improved”.

 These two trials add to the growing evidence that LDN or low-dose naltrexone is an effective treatment for reducing pain in fibromyalgia. 

Low Dose Naltrexone and Compounding Pharmacies

Low-dose naltrexone (LDN) is not commercially available, meaning it is not widely manufactured. As a result, LDN can only be obtained from compounding pharmacies that specialise in customising such formulations. These pharmacies prepare LDN individually, offering it in liquid form or as capsules.

A recent advancement in the compounding pharmacy industry in the UK is the introduction of transmucosal LDN film tablets. APC Labs is the exclusive compounding pharmacy in the UK, offering Low Dose Naltrexone in this innovative format. These film tablets are placed on the inner cheek, where they dissolve and allow for rapid absorption of LDN into the bloodstream. Bypassing the liver’s first-pass metabolism ensures a quicker onset of action and increased drug absorption.

If you’re interested in trying the new transmucosal LDN film tablets, please get in touch with APC Labs today for further details.

  References:

Clauw DJ, Arnold LM, McCarberg BH, FibroCollaborative The science of fibromyalgia. Mayo Clin Proc. 2011;86(9):907–911.

 Wallace DJ. Is there a role for cytokine-based therapies in fibromyalgia? Curr Pharm Des. 2006;12(1):17–22.

 Younger J, Mackey S. Low-dose naltrexone reduces Fibromyalgia symptoms: a pilot study. Pain Med. 2009;10(4):663–672.

 Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for treating fibromyalgia: findings of a small, randomised, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013;65(2):529–538.

The post Fibromyalgia and LDN appeared first on APC Labs.

Some men using TRT experience a decrease in sperm count, which can pose issues for those who are trying to conceive. Does TRT make you infertile, and what can you do to improve your odds of having a baby? There are several steps you can take before starting TRT which may help preserve your fertility, including freezing sperm, using clomiphene alone, and combining Testosterone with HCG. Keep reading to learn more about low testosterone, infertility, TRT, and a few ways you can minimize its impact on your fertility.

The Impact Of Low Testosterone

Everyone’s bodies produce testosterone, a hormone responsible for playing a role in puberty, libido, and fertility. It can also impact physical traits including body hair, muscle mass, strength, and bone mass. For men, the testes produce most of the body’s testosterone.

Men typically have higher testosterone levels than women, but T levels fluctuate frequently based on your body’s needs. Overall testosterone levels change over time too, decreasing with age and causing unwanted side effects. Low testosterone can reduce your quality of life and result in symptoms like:

Erectile dysfunction (ED)

Decreased libido

Diminished muscle mass

Less body hair growth

Fatigue

Irritability

Depressed symptoms

If you suspect your testosterone levels may be low, talk to a medical provider at Alpha Hormones. They can test your T levels or recommend an at-home test, analyze the results, and let you know how to proceed. They may suggest making lifestyle changes, like a healthy diet and increased exercise, or trying a treatment like testosterone replacement therapy to help increase your testosterone levels.

The Relationship Between Low Testosterone And Fertility

If you’re trying to have a baby, you may believe that low testosterone levels are to blame. In reality, the reason may be more complicated than that. For some, low testosterone levels can lead to a decrease in sperm production and fertility. Testosterone is just one of the hormones that stimulate sperm production, but there are a few other hormones that play a role too. As such, low testosterone does not necessarily mean you are infertile, and it doesn’t cause infertility. Testosterone levels in the testes are usually high enough to produce enough effective sperm to allow you to conceive normally, even if you have low T.

However, low testosterone levels can still impact your ability to conceive a child. Why? Because low T can cause ED and decrease your sex drive–two factors that are essential when trying for a baby. So, even if your sperm levels are normal, low T can still affect your ability to conceive and make it more difficult.

When you are diagnosed with low T, your medical provider will often recommend that you start hormone therapy as soon as possible. If you’re having fertility issues, they may run tests to check your sperm levels as well. With this information, they’ll be able to address the two separate—yet interconnected—problems.

How Can TRT Affect Your Fertility?

While TRT can be effective at raising your testosterone levels, it can lead to other issues especially when it comes to your fertility. One of the most common side effects of testosterone replacement therapy is a decreased sperm count.

To understand why this occurs, we must first look at how the body produces sperm in the first place. A complicated collection of hormones triggers sperm production. Ordinarily, when your body registers that testosterone levels are low, it sends a signal to the pituitary gland. This prompts the production of two essential hormones: luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This process triggers the testes to begin producing sperm.

When your brain registers an influx of testosterone from TRT treatment, it disrupts the standard sperm production process. Since the body doesn’t register low T levels, the pituitary gland doesn’t produce the necessary hormones and sperm production decreases. So, does TRT make you infertile? A lower sperm count does not necessarily equate to infertility, but it can make it harder for you to conceive.

There is no singular timeline to suggest when you’ll notice a drop in sperm count while on TRT. Everyone’s body is different; some may experience the effect on their fertility faster than others. Other people may experience a gradual decline in sperm count. When you will experience this side effect depends largely on how quickly and how well your body reacts to the new inflow of testosterone.

Is The Impact Of Testosterone On Your Sperm Count Permanent?

Does TRT make you infertile forever? It shouldn’t–while testosterone replacement therapy can often cause infertility, in most cases, it is not permanent. Infertility is reversible but it will be very costly to fix it. Fertility treatment cost can sometime be in the tens or hundreds of thousands of dollars so it’s best to try and prevent it whenever possible. When TRT is stopped, infertility (and your testosterone levels) usually reverts back to where it was when you began treatment. However, for a very small percentage of TRT users, fertility does not return after stopping TRT. Keep in mind that you should only discontinue TRT under medical guidance.

Usually, sperm levels return to pre-testosterone replacement therapy levels within one year of ceasing TRT. Typically, the less time you’ve been on TRT, the more likely you’ll be able to reverse its effects. The amount of time needed for fertility to be regained also depends on factors like how long you were on TRT, what type of dose you were on, and how old you are. A younger man who was using TRT for a short period will bounce back faster than an older person who has been receiving treatment for a long time.

Should You Stop Using TRT If You Want Children?

First, you should never discontinue your TRT without first talking to a medical professional. They can help you determine the best course of action to address your low T while protecting your fertility.

While stopping TRT is one way to protect your fertility, it’s not the only option. There are a few methods you can use to ensure you’ll be able to have kids when you’re ready. This may include freezing sperm before starting treatment, trying a different kind of treatment for low T, or combining Testosterone with HCG to protect your fertility. You can read a bit more about your options below.

Discuss Long-Term Goals With Your Doctor Before Starting TRT

Before starting testosterone replacement therapy, it’s important to discuss your long-term goals with your doctor or a hormone expert. Consider whether you want to become a father relatively soon or only several years in the future. Whether you’re heterosexual or homosexual considering intra-vitro fertilization (IVF), intrauterine insemination (IUI) or surrogacy, talk to a medical provider at Alpha Hormones about the risks of TRT for infertility and how it might affect sperm production, and possible treatment options.

The medical provider may run some tests to check your current sperm levels and discover the root cause of your low T and infertility. With this information, they’ll be better able to meet your needs. If you are planning to have children or unsure about fatherhood, they can help you find the best way to address your low testosterone while ensuring you’ll be able to conceive without difficulty.

Cryopreservation And Freeze Your Sperm

Freezing sperm is a great way to ensure you’ll be able to have a child when you’re ready to and protect your family’s future or want to leave a legacy. This process is also sometimes referred to as cryopreservation. Hopeful fathers can preserve a sperm sample before starting testosterone replacement therapy or, if your levels are still healthy and viable, after starting TRT.

Experts recommend freezing at least two samples in multi vials. These samples are analyzed by healthcare professionals and specialized labs to ensure they’re healthy and that there is enough to freeze. Once frozen, your samples will remain viable indefinitely– as long as the freezing conditions remain constant. When freezing sperm, you can store your samples for as long as you need to until you’re ready to start a family. You may consider storing your sperm with multiple companies to ensure there is no mishap in the process of withdrawing your samples for fertilization.

Use HCG With TRT

When you combine TRT with other treatments, you can combat the negative side effects of TRT (like low sperm counts and testicular shrinkage). One such treatment is HCG. HCG, or human chorionic gonadotropin, stimulates the testicles to produce more testosterone. HCG acts similarly to a luteinizing hormone (LH), which is vital to sperm production. HCG usually comes in two vials: one is a diluent usually consists of bacteriostatic water or one is powder. It’s mixed together and inject subcutaneously with a small insulin syringe. HCG needs to be refrigerated after each usage or it can lose its potency or efficacy. The dosage varies depending on the patient.

Testosterone and HCG can be used to treat low testosterone levels in men with hypogonadism. This is a condition where the body doesn’t make enough natural hormones to function normally. Men with low T can use Testosterone and HCG together to improve their testosterone levels, increase testicular size, and maintain fertility. HCG is not 100% in preventing infertility, but it’s better than not using it at all with TRT. Hence, it’s better to freeze your sperm and use testosterone with HCG at the same time for your low testosterone treatment to decrease your infertility risk.

Try Clomiphene Instead Of TRT

Testosterone replacement therapy isn’t your only option for increasing your testosterone levels. Your doctor may recommend an alternative treatment like clomiphene citrate instead. Clomiphene is a fertility drug that can treat infertility in men and women. The drug works by regulating the estrogen system and prompting your body to produce more LH and FSH to promote sperm production. This medicine can also boost testosterone and treat low T symptoms like low libido and erectile dysfunction. It’s taken oral unlike HCG which is mainly administered via subcutaneously injections. Clomiphene is also very affordable and not a controlled substance like testosterone and HCG so your medical provider can easily e-prescribe to your local pharmacy if indicated.

Because clomiphene isn’t a steroid or hormone, it won’t cause the same side effects as TRT while you’re taking it. In fact, this pill has very few side effects, most of which can be avoided with the right dose. If you’re concerned about the risks associated with TRT, this alternative option could be right for you!

It’s important to note that clomiphene doesn’t work for everyone. It may also take longer to work than regular TRT. Some men have found it to be less effective than TRT, especially for older men and those with compounding health problems. It can be used alone or in conjunction with HCG. Using both at the same time can increase your testosterone levels higher and increase sperm production than used alone. If you’re planning on trying any other fertility drugs (i.e., recombinant FSH or even gonadorelin), talk to a medical provider at Alpha Hormones first!

Treat The Cause Of Your Infertility

Does TRT make you infertile? Yes, it could possibly have that effect on some men. However, it’s possible that your fertility problems are unrelated to your low testosterone levels or TRT. Along with aging, low testosterone can be caused by a variety of health conditions, including:

Hypothalamic disease

Pituitary disease

Delayed puberty

Testicular damage

Noncancerous pituitary tumor

Genetic conditions like Klinefelter syndrome, myotonic dystrophy, and Kallmann syndrome

If your low T is caused by something other than aging, your medical provider may be able to treat the underlying cause, improve your T levels without TRT, and protect your fertility. It’s best to talk to a physician that specializes in TRT or a reproductive specialist.

Preventing Infertility Risk With TRT

You can take steps to preserve fertility while undergoing TRT, such as freezing sperm samples ahead of time or asking your doctor about possible side effects before starting treatment. If you have concerns about the possibility of infertility from taking TRT, talk to one of Alpha Hormones medical providers before starting hormone therapy.

As we’ve seen, there are many reasons why infertility can develop, and the causes are different for each person. In some cases, low T and TRT can make it harder to get pregnant because it causes erectile dysfunction, low libido, or decreased sperm counts. If you want to start TRT but don’t want this risk, there are still options available: freezing samples of sperm before starting treatment or taking clomiphene citrate and/or HCG instead of testosterone. Just remember that they won’t work if your underlying medical cause isn’t diagnosed first!

To get started with hormone therapy and to decrease your infertility risk while on TRT, consult with one of Alpha Hormones medical providers.

The post Can TRT Make you Infertile? appeared first on APC Labs.

LDN in Clinical Use 

In the 1980s, the pioneering work of Dr Bihari saw the first use of low-dose naltrexone in doses ranging from 1.3mg to 3mg in helping to treat patients who have HIV (Bihari, B 2013). However, the use of low-dose naltrexone (LDN) remains an off-label use since there have not yet been any large-scale clinical trials to authorise its widespread use; this is despite the success that many doctors have witnessed in their patients suffering from autoimmune conditions. 

Despite the reluctance of widespread uptake in conventional medical circles, the evidence is slowly mounting as more people find success with LDN. In particular, the uptake has drastically increased in Norway following positive results that have been widely circulated, causing more patients and doctors to become more educated about the benefits of LDN(Raknes, G.; Småbrekke, 2017).

 Naltrexone 

Naltrexone is a well-known opioid antagonist used in chronic or acute states of abuse (Schumacher, M.; Basbaum, A., 2014). So, if naltrexone blocks the opioid receptor, then how does this explain the effects of LDN? When researchers started to experiment with lowered doses of naltrexone, they found that it changed the way it acted on the body. In other words, low doses changed the drug’s pharmacodynamic properties. 

Endorphins 

It is well known that opiates such as morphine are potent painkillers, but the body is also capable of producing similar substances called endorphins. The name “endorphin” is derived from “endogenous morphine.” 

These endorphins are produced by most cells in the body and play an essential role in regulating cell growth. As a consequence of this action, they can exert a positive influence on the immune system. It is found that immune system disorders are associated with lower levels of these endorphins. 

Opioid Cell Growth Factor 

Opioid cell growth factor (OGF) or Met-Enkephalin is an endorphin that can influence cell growth and the immune system. It has to “dock” with the zeta receptor on the cell’s surface to exert its action on the cell. So, for the beneficial actions to occur, both opioids and receptors are required. 

How LDN works 

When LDN is administered, they occupy these zeta or OGF receptors and displace the natural endorphins. When this displacement occurs, it causes the body to try and compensate by: 

• Increasing production of OGF receptors means there is an increased chance of interacting with a stray OGF molecule.
• The receptor sensitivity increases.
• Production of OGF is increased. 

LDN only blocks the OGF receptors for a few hours before it is excreted from the body. This causes a rebound effect, in which OGF production and utilisation are significantly increased. LDN upregulates opioid signalling (Rahn, K.A.; McLaughlin, 2011). 

So, while the LDN blocks the OGF receptor, the body is busy preparing a counterattack. When the LDN is metabolised and excreted by the body, the reinforcements arrive in the form of more OGF molecules and OGF receptors. The body has also increased the sensitivity of these receptors, making interactions between OGF and receptors easier. In this way, LDN has primed the immune system, thus preparing the body to heal itself. 

Metabolism of LDN and the rebound effect Different people metabolise LDN at different rates, and the resulting “rebound effect” can also vary between people. However, this positive aftereffect of LDN generally lasts for about a day. 

To maximize this rebound effect, a low dose is required. Using a high dose of Naltrexone or a timed-release formulation will result in continuous blockade of OGF receptors. The LDN only causes intermittent blockade, thus allowing for a rebound effect.

Low-Dose Naltrexone Preparations

Low-dose naltrexone (LDN) is not a commercially licensed medication, meaning it is not mass-produced. Therefore, LDN is exclusively available from compounding pharmacies specialising in preparing such formulations. These pharmacies create LDN on a personalised basis, offering it in liquid form or as capsules. A recent advancement in the compounding pharmacy field in the UK is the introduction of transmucosal LDN film tablets. APC Labs is currently the sole compounding pharmacy in the UK, offering LDN in this innovative format. These film tablets are placed on the inner cheek, where they dissolve and allow for rapid absorption of LDN into the bloodstream. This bypasses the liver’s first-pass metabolism, ensuring a quicker onset of action and enhanced drug absorption. If you want to try the new transmucosal LDN film tablets, please contact APC Labs today for more information. 

References: 

Bihari, B. Low-dose naltrexone for normalising immune system function. Altern. Ther. Health Med. 2013, 19, 56–65. 

Rahn, K.A.; McLaughlin, P.J.; Zagon, I.S. Prevention and diminished expression of experimental autoimmune encephalomyelitis by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period: Therapeutic implications for multiple sclerosis. Brain Res. 2011, 1381, 243–253. 

Raknes, G.; Småbrekke, L. A sudden and unprecedented increase in low-dose naltrexone (LDN) prescribing in Norway. Patient and prescriber characteristics and dispense patterns. A drug utilisation cohort study. Pharmacoepidemiol. Drug Saf. 2017, 26, 136–142. 

Schumacher, M.; Basbaum, A.; Ramana, N. Opioid Agonists & Antagonists. In Basic & Clinical Pharmacology & Toxicology, 13th ed.; Katzung, B., Trevor, A., Eds.; Wiley: Hoboken, NJ, USA, 2014; p. 531

 Sudakin, D. Naltrexone: Not Just for Opioids Anymore. J. Med. Toxicol. 2016, 12, 71–75.

The post What is Low Dose Naltrexone or LDN? appeared first on APC Labs.

Rapid weight loss in and of itself can cause temporary telogen effluvium, which is a form of hair shedding which can further contribute to hair loss in susceptible individuals. However, AHLA have also hypothesized that the hormonal shifts caused by the semaglutide, and other similar medications can produce hormonal shifts that can trigger not only the temporary telogen effluvium but also early onset male and female pattern hair loss, also known as androgenic alopecia.

Hair loss associated with androgenic alopecia is progressive and permanent however the progression can be delayed by using compounded medicines that contain something to prevent the hair loss, DHT receptor antagonists, such as finasteride combined with a hair growth promoter, such as minoxidil. APC labs are specialists at compounded such combination products, if you require further information, please contact us.

Hence, the AHLA recommends that the semaglutide be used only in accordance with its licensed indications, type II diabetes and weight loss and under the supervision of an experienced prescriber.

Researchers had observed as early as 1975 that when the rapid weight loss did not include supplemented protein, it led to a negative nitrogen balance and hair loss. However, with an increase in protein intake during fasting to preserve the nitrogen balance, the hair loss is eliminated.

Hence, it has been suggested that when mobilized body protein plus dietary protein are insufficient to meet requirements, the low priority of hair growth for available protein accounts for the telogen effluvium and not the rapidity of weight loss per se.

This brings up an important point when using products such as semaglutide, weight loss will occur due a decrease in the caloric intake which in turn means that the intake of nutrients and proteins will decrease. Thus, will taking the semaglutide it is important to supplement your reduced diet with proteins and essential vitamins and minerals. If you are concerned about whether you are getting enough proteins along with the necessary vitamins and minerals contact us at APC Labs for more advice.

Reference

Blackburn GL, Bistrian BR. Hair loss with rapid weight loss. Arch Dermatol. 1977;113(2):234.

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