Understanding and Managing Epidiolex Side Effects

Written by: Hunter Podell, Subject Matter Expert and Website Founder
Published: March 15, 2024; Last updated: April 6, 2024

Evaluating Epidiolex side effects is critical whether you’re considering treatment or already using it. This article details the spectrum of expected side effects, equipping you with the knowledge to navigate them and collaborate with your healthcare provider for the best treatment experience.

Key Takeaways

• Epidiolex, containing CBD, is FDA approved for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients 1 year and older, and is not a controlled substance.

• Common side effects of Epidiolex include sleepiness, decreased appetite, diarrhea, and infections, with liver damage being a serious side effect requiring regular monitoring.

• While the initial recommended Epidiolex dosage is 5 mg/kg/day, gradual titration is essential to mitigate side effects and maintain safety, particularly when considering drug interactions with substances like clobazam and valproate.

Epidiolex Overview

Imagine a medication so innovative that it becomes the first of its kind to gain FDA approval. Epidiolex is a pioneering medication tailored to address seizures linked to Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged 1 year and older. It is specifically designed to cater to the medical needs of these conditions..

Interestingly, the active ingredient in Epidiolex is cannabidiol (CBD), a substance derived from marijuana. However, it’s worth noting that despite its origins, Epidiolex, or cannabidiol oral solution CX as it’s also known, is not considered a controlled substance.

This revolutionary medication is indicated for use in patients aged 1 year and older, providing a lifeline for those suffering from seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. It is pivotal to comprehend the impact of Epidiolex on the body and be cognizant of its potential side effects when initiating the treatment.

While on Epidiolex, maintaining open communication with your healthcare provider about any concerns or queries is imperative. They are well-equipped to provide insightful advice and guidance, ensuring the safety and efficacy of Epidiolex for you. After all, the goal of any treatment is to improve your quality of life, and that’s what we hope Epidiolex can do for those who need it.

Common Side Effects of Epidiolex

As with any medication, Epidiolex may have some side effects. These can range from mild to severe, depending on various factors such as an individual’s health status, age, and how their body reacts to the medication. In clinical trials, some of the common side effects reported include:

• Sleepiness

• Decreased appetite

• Diarrhea

• Fever

• Vomiting

• Fatigue

• Rash

• Sleep problems

• Infections

Gastrointestinal issues such as diarrhea were reported by up to 31% of individuals in clinical studies of Epidiolex, and vomiting is also a known side effect. Comprehending the impact of Epidiolex on the body is key to managing these side effects and fostering a positive treatment experience.

Drowsiness, fatigue, and sleeping difficulties occur more frequently in people taking Epidiolex compared to those taking a placebo. While these side effects may appear intimidating, bear in mind that they are manageable and often lessen over time as the body acclimates to the medication.

Other side effects of Epidiolex may include:

• Unusual lack of energy

• Decreased weight

• Fever

• Instances of skin rashes

• Mild infections like UTIs or ear infections

If you’re on Epidiolex, you should closely monitor your health and promptly report any changes to your healthcare provider.

Managing Common Side Effects

Managing the side effects of Epidiolex can seem challenging, but with the right strategies in place, it is entirely feasible. One approach is to consider dosage adjustments based on patient response to Epidiolex, including the presence of sedation when used with clobazam. This would, of course, warrant an evaluation by the doctor.

Gradual dosage increments, as directed by a doctor, play a crucial role in mitigating the occurrence of side effects during the onset of Epidiolex treatment. This approach helps the body gradually adjust to the medication, reducing the risk of severe side effects.

Another important tip to manage sleepiness caused by Epidiolex is to avoid driving or operating heavy machinery and refrain from consuming alcohol to prevent increased sleepiness. These precautions can help ensure safety while managing the side effects of the medication.

Lastly, here are some tips for managing the side effects of Epidiolex:

• Maintain similar amounts of fat and calories in each meal

• This can help reduce the risk of gastrointestinal side effects

• It can ensure a smoother treatment journey

Serious Side Effects of Epidiolex

Now, let’s explore some of the potentially serious side effects of Epidiolex. While these are less common, it’s important to be cognizant of them due to their potential significant implications. One such serious side effect is liver damage, which can manifest with symptoms such as loss of appetite, abdominal pain, and jaundice.

Epidiolex clinical trials have frequently reported the following side effects:

• High liver enzyme levels as an indication of liver problems

• Drowsiness

• Diarrhea

• Decreased appetite

• Fatigue

This highlights the importance of regular blood tests and liver function monitoring during Epidiolex treatment.

The risk of liver problems increases when Epidiolex is used in higher doses or in combination with certain medications known to impact liver function, such as valproate sodium, valproic acid, or divalproex sodium. Hence, meticulous dose management and continual monitoring become paramount when these medications are used concurrently with Epidiolex.

Another serious side effect to be aware of is an allergic reaction, which can include severe symptoms such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Additionally, there is an increased risk of suicidal thoughts and behavior by 80% in patients taking Epidiolex compared to those not on the medication, indicating possible adverse effects.

Recognizing and Responding to Serious Side Effects

Recognition and appropriate response to serious side effects are vital in ensuring safety during Epidiolex treatment. For instance, symptoms of a severe allergic reaction to Epidiolex can include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.

If someone has an allergic reaction to Epidiolex, they should seek emergency medical help immediately. This is a critical step as severe allergic reactions can be life-threatening if not treated promptly.

In case of serious side effects from Epidiolex, one should call their doctor immediately or call 911, the local emergency number, or the poison control center in the case of a medical emergency. It’s always better to err on the side of caution when it comes to potential serious side effects.

Patients are also encouraged to:

• Report any side effects of Epidiolex to the FDA or their healthcare provider

• Contribute to the safety monitoring of the medication

• Help inform future treatment protocols

• Ensure the safety of all patients who use Epidiolex.

Epidiolex Interactions and Precautions

While on Epidiolex, being aware of potential drug interactions and precautions is necessary. This is because Epidiolex, or cannabidiol, has been reported to have 592 known drug interactions, including 16 major, 523 moderate, and 53 minor interactions.

Significant interactions occur between Epidiolex and certain medications, such as clobazam and valproate. For instance, concurrent use of Epidiolex and clobazam has shown a marked increase in clobazam levels, potentially leading to more severe sedation and a need for dose adjustments. Similarly, combining Epidiolex with valproate has been associated with an increased likelihood of liver enzyme elevations.

The significance of drug interactions and potential side effects necessitates:

• careful patient screening

• involvement of healthcare providers in decisions to start or stop any concomitant medication

• regular monitoring of serum antiepileptic drug levels and liver function tests

This is emphasized due to potential drug interactions with Epidiolex, which impact these parameters.

Patients should also be cautious about alcohol and certain foods during Epidiolex treatment, as there are known alcohol/food interactions that may influence the effects of the medication. Increased sleepiness has been noted in patients who use Epidiolex in combination with substances like alcohol or marijuana.

Dosage and Administration

Correct dosage and administration of Epidiolex are fundamental to a successful treatment experience. The recommended dosage and administration for Epidiolex treatment are as follows:

• Initial dose: 5 mg/kg/day for the first week, divided into 2.5 mg/kg twice daily

• Subsequent weekly titration increases: 5 mg/kg/day

• Maintenance dose: Individualized based on patient response and tolerability

It is important to follow the prescribed dosage and administration instructions for your prescription medicine, provided by your healthcare professional, such as a doctor or pharmacist, as per the guidelines of the Food and Drug Administration. In case of a missed dose, it is crucial to consult your healthcare professional for guidance on when to take your next dose.

Epidiolex is administered orally and can be taken with or without food to maintain stable drug levels. It is available as a strawberry-flavored oral solution, making it easy to ingest even for young patients. For tube administration, such as through an NG-tube or G-tube, specific instructions are provided.

Dose adjustments for Epidiolex may be necessary based on body weight, medical condition, and liver function. The maintenance dose for conditions like Lennox-Gastaut syndrome (LGS) or Dravet syndrome typically falls around 10 mg/kg/day, but some patients may benefit from higher doses up to 20 mg/kg/day.

Patients and caregivers can utilize practical tools such as downloadable dosing worksheets and provided oral syringes to assist with dosage management, ensuring accurate measurement and consistent administration of Epidiolex. These aids can make a significant difference in maintaining the appropriate dosage and getting the most out of the treatment.

Off-Label Uses and Ongoing Research

Epidiolex’s potential doesn’t stop at treating Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. There are off-label uses and ongoing research that are exploring its potential in treating other conditions. For instance, Greenwich Biosciences is pursuing FDA approval for Epidiolex for tuberous sclerosis based on promising results from research.

Some potential off-label uses and ongoing research for Epidiolex include:

• Epilepsy in other forms

• Autism spectrum disorder

• Multiple sclerosis

• Parkinson’s disease

• Anxiety disorders

• Sleep disorders

These are just a few examples, and more research is needed to fully understand the potential of Epidiolex in treating these conditions.

Research indicates potential for Epidiolex use in epileptic syndromes beyond Dravet syndrome and Lennox-Gastaut syndrome. This opens up the possibility of Epidiolex being a game-changer for many patients who struggle with different types of seizure disorders.

The active component of Epidiolex, CBD, may have anti-inflammatory and antioxidant properties, albeit with low affinity for cannabinoid receptors. This suggests that Epidiolex might have potential benefits beyond seizure control, which is a promising prospect. Understanding how Epidiolex affects various conditions is essential for future research and potential therapeutic applications.

However, prescribing off-label uses of Epidiolex is encumbered by authorization and insurance challenges, limiting it to the two approved epilepsy conditions. Nonetheless, numerous studies are exploring alternative medical treatments that could leverage CBD’s therapeutic properties.

Epidiolex During Pregnancy and Breastfeeding

Pregnancy and breastfeeding are special periods in a woman’s life when medication use requires careful consideration. Animal studies have documented potential risks associated with the use of Epidiolex during pregnancy, including increased embryofetal mortality in rats and adverse fetal development effects in rabbits.

Epidiolex has not been assigned a specific pregnancy category by the FDA due to insufficient data in humans, but animal studies suggest potential risks to the fetus. Hence, if you’re pregnant or planning to conceive while on Epidiolex, it’s vital to have a discussion with your healthcare provider.

Similarly, no definitive studies have determined whether Epidiolex is excreted into human milk, and its impact on breastfed infants or milk production is not well-known. As such, nursing mothers on Epidiolex should engage in comprehensive discussions with their healthcare providers to understand the potential risks and benefits.

Women taking Epidiolex who are pregnant or planning on becoming pregnant are encouraged to participate in the North American AED Pregnancy Registry, which aims to gather information on the drug’s safety during pregnancy. This initiative can help inform future guidelines on the use of Epidiolex during pregnancy and ensure the safety of both mother and child.

Comparing Epidiolex to Alternative Treatments

Epidiolex emerges as a viable treatment option for certain seizure disorders, but how does it measure up against traditional antiepileptic drugs (AEDs) and other alternative treatments? Epidiolex has a different adverse drug reaction (ADR) profile compared to traditional AEDs, which can have serious ADRs leading to limited treatment options.

Traditional AEDs for Dravet syndrome include valproate derivatives and clobazam, among other drugs, which work differently from Epidiolex, a plant-derived treatment with a unique mechanism of action. This difference in mechanism of action could potentially offer unique benefits that traditional AEDs do not provide.

Clinical trials have shown that Epidiolex is both safe and effective for the treatment of Dravet and Lennox-Gastaut syndromes, suggesting a beneficial role as part of therapy regimens for these conditions. This further emphasizes Epidiolex’s potential as a viable treatment option.

While the ketogenic diet is a non-drug therapy recommended for cases of refractory epilepsy, it may not be suitable for all patients due to its complications. This contrasts with the pharmacological treatment offered by Epidiolex, which can be tailored to individual needs.

Summary

Epidiolex, the first FDA-approved CBD-based medication, has revolutionized the treatment of certain seizure disorders. It offers a new hope for patients with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. However, like any medication, it comes with potential side effects, both common and serious, and can interact with other medications.

The key to a successful Epidiolex treatment lies in understanding these effects, taking necessary precautions, adhering to the prescribed regimen, and maintaining open communication with healthcare providers. With ongoing research and off-label uses, the future of Epidiolex looks promising, potentially extending its benefits to a wider range of conditions. As we continue to explore the potential of this groundbreaking medication, we move one step closer to a world where every patient has access to effective treatment.

Frequently Asked Questions

What is the most troubling side effect of Epidiolex?

The most troubling side effect of Epidiolex is the potential for high liver enzyme levels, which may indicate liver problems and could lead to symptoms such as loss of appetite, abdominal pain, and jaundice. It’s important to monitor liver enzyme levels through regular blood tests.

What is the difference between Epidiolex and CBD oil?

Epidiolex is a pharmaceutical-grade CBD oil, purified and at a higher potency of 100mg/ML, while regular CBD oil from a collective or dispensary is typically whole plant CBD oil at a lower potency of 25 to 50 mg per ML. This difference in potency and purification sets Epidiolex apart from regular CBD oil.

Does Epidiolex cause liver damage?

Yes, liver damage has occurred in some people taking EPIDIOLEX, with between 8% and 25% of users experiencing high levels of liver enzymes, indicating potential liver issues.

What is the controversy with Epidiolex?

In rare cases, Epidiolex, a treatment for seizures in Dravet syndrome, may cause side effects such as clusters of seizures, vision impairment, and speech problems.

What is Epidiolex used for?

Epidiolex is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged 1 year and older.

References

Abu-Sawwa R, Scutt B, Park Y. Emerging Use of Epidiolex (Cannabidiol) in Epilepsy. J Pediatr Pharmacol Ther. 2020;25(6):485-499. doi: 10.5863/1551-6776-25.6.485. PMID: 32839652; PMCID: PMC7439947.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7439947/

Pauli, C. S., Conroy, M., Vanden Heuvel, B. D., & Park, S.-H. (2020, January 22). Cannabidiol drugs clinical trial outcomes and adverse effects. Frontiers.

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00063/full

Sholler DJ, Schoene L, Spindle TR. Therapeutic Efficacy of Cannabidiol (CBD): A Review of the Evidence from Clinical Trials and Human Laboratory Studies. Curr Addict Rep. 2020 Sep;7(3):405-412. doi: 10.1007/s40429-020-00326-8. Epub 2020 Jul 25. PMID: 33585159; PMCID: PMC7880228.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880228/

Written by Hunter Podell - Subject Matter Expert and Website Founder

Hunter has 8+ years of experience as a content writer and digital marketer. Earning his chops marketing in the healthcare space for over 5 years, Hunter is extremely familiar with the rules and regulations required to deliver high quality content that answers the user's needs while adhering to strict guidelines.