Epidiolex (Cannabidiol) - Oral

What Is Epidiolex?

Epidiolex (cannabidiol) is a prescription medicine that prevents seizures from neurological syndromes. It's available as a solution taken by mouth (oral), usually twice daily. While Epidiolex (cannabidiol) was a controlled substance (Schedule V), it is now no longer a scheduled substance as of 2020.

The marijuana (Cannabis sativa) plant contains both cannabidiol and tetrahydrocannabinol (THC) and other components. Cannabidiol interacts with cannabinoid receptors in the brain. THC is the main psychoactive chemical in marijuana. While cannabidiol and THC are both used medically and recreationally, this article focuses on the medical use of the prescription product Epidiolex (cannabidiol).

The way that Epidiolex prevents seizures is not known. According to the manufacturer, the anti-seizure effect is unrelated to its interaction with cannabinoid receptors in the brain. Research suggests that cannabidiol decreases overactive nerves in different ways.

What Is Epidiolex Used For?

This medicine is approved for adults and children 1-year-old and older. It’s used for preventing seizures that occur due to:

• Lennox-Gastaut syndrome
• Dravet syndrome
• Tuberous sclerosis complex 

These conditions often cause refractory epilepsy with seizures that aren’t easily prevented with other anticonvulsants (anti-seizure drugs [AEDs]). Often, Epidiolex is taken with other AEDs to prevent seizures.

How to Take Epidiolex

Epidiolex comes in a bottle with a measuring device and a syringe. You should use the measuring device to measure the oral solution. Use the syringe to take or give the medicine to your child by mouth. If your child is very young or unable to take care of themselves, they may need assistance taking this medicine.

Food can affect the concentration of the medicine in your body. It can be taken with or without food, but it’s essential always to take it in the same way (for example, either always before meals or always after meals), so the drug concentration will stay the same.

Storage

Epidiolex comes in a bottle. It should be stored upright. Keep your medications tightly closed and out of the reach of children and pets, ideally locked in a cabinet or closet. Do not store your medicines in the bathroom.

It should be kept at a standard room temperature of 20 to 25 degrees Celsius (C), 68 to 77 degrees Fahrenheit (F), with excursions permitted between 15 to 30 degrees C (59 to 86 degrees F). Do not freeze.

You should use it within 12 weeks of opening the bottle. Avoid using any of the solution past 12 weeks after opening. Ask your pharmacist how to discard any remaining solution and if there are any medicine take-back programs in your area.

Avoid pouring unused and expired drugs down the drain or in the toilet. Ask your pharmacist or healthcare provider about the best ways to dispose of this medicine. Visit the Food and Drug Administration's (FDA) website to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area. Ask your pharmacist or healthcare provider if you have any questions about the best ways to dispose of your medications.

If you travel with Epidiolex, get familiar with your final destination's regulations. In general, be sure to make a copy of your Epidiolex prescription. Keep your medication in its original container from your pharmacy with your name on the label. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.

Off-Label Uses

Cannabidiol has been used off-label to treat several conditions. These uses are mostly considered “investigational” (i.e., not well-established).

A few of the off-label uses are:

• Anxiety disorders
• Behavioral or developmental disorders in children and adolescents
• Protection from nerve damage in neurological (brain) diseases, including Parkinson’s disease 

The dosing and side effects may be different when it’s used for treating these conditions than when it’s used for treating epilepsy.

What Are the Side Effects of Epidiolex?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common side effects for people who have Lennox-Gastaut Syndrome and Dravet Syndrome:

• Tiredness, lack of energy
• Decreased appetite
• Diarrhea
• Feeling sick
• Rash
• Trouble sleeping
• Infections

The most common side effects for people who have tuberous sclerosis:

• Diarrhea, vomiting
• Decreased appetite
• Tiredness
• Fevers

Be sure to tell your healthcare provider if you or your child have been experiencing these side effects. If the medicine causes them, they can often be treated, or your treatment may need to be changed. However, these symptoms may also be due to other causes which should be diagnosed and treated. Be sure to reach out to your healthcare provider.

Severe Side Effects

This medicine may cause harmful side effects. Your healthcare provider may monitor for serious side effects.

Severe side effects:

• Liver damage may cause jaundice (yellow discoloration of the skin and eyes) or enlargement of your stomach area (abdomen). 
• Severe tiredness: It can be dangerous to operate machinery using Epidiolex, leading to injuries, such as falls.
• Suicidal ideation or actions: Thinking, planning, or taking action to commit suicide may occur while taking this medicine.
• Hypersensitivity reaction: Epidiolex may cause a rash, swelling of the face or body, difficulty breathing, and/or passing out.

Get medical attention immediately if you have any of the severe side effects of Epidiolex.

Long-Term Side Effects

This medicine may cause lasting problems even after it is discontinued. These include:

• Neurological or behavior changes.
  

Dosage: How Much Epidiolex Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Epidiolex:

Severe allergic reaction: Avoid using Epidiolex if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: We don't know enough about the safety and effectiveness of Epidiolex in pregnant people and their unborn fetuses. Discuss with your healthcare provider if you plan to become pregnant or are pregnant, and weigh the benefits and risks of taking Epidiolex during your pregnancy.

Breastfeeding: There's not enough data about how much Epidiolex can be found in breast milk. We don't know enough about the safety of Epidiolex in human breast milk and nursing babies. Talk with your healthcare provider if you plan to breastfeed, to weigh the benefits and risks of taking Epidiolex while nursing and the different ways to feed your baby.

Adults over 65: Some older adults may be more sensitive to Epidiolex's side effects. The general guidance is to start at a lower dose and modify as needed.

Children: For children, the dose is typically weight-based and taken by mouth twice a day.

Liver problems: For people with liver disease, the dose should be increased slowly to a target dose lower than the standard dose.

Missed Dose

If you accidentally forgot your Epidiolex dose, take it as soon as you remember. If it's already close to your next scheduled dose, skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways that work for you to help yourself remember to keep your appointments and take your medication routinely. If you miss too many doses, Epidiolex might be less effective at treating your condition.

Overdose: What Happens If I Take Too Much Epidiolex?

Taking too much Epidiolex can cause serious effects, including vomiting, sleepiness (somnolence), and loss of consciousness. If you have taken too much, seek medical attention. You will likely need close medical observation, and you may need to be treated for symptoms of an overdose.

Precautions

What Are Reasons I Shouldn’t Take Epidiolex?

You should not take Epidiolex if you have ever been allergic to this medicine. You may be prescribed this medicine with caution if you have liver failure, are pregnant, or are breastfeeding.

What Other Medications Interact With Epidiolex?

Epidiolex can interact with several medications, sometimes causing changes in the concentration of one or both drugs and increasing the risk of specific side effects.

• Rifampin lowers the concentration of Epidiolex.
• Using Epidiolex with clobazam, diazepam, or phenytoin may increase the risk of adverse reactions.
• Using Epidiolex with valproate increases the possibility of high liver enzymes (markers of possible liver damage).
• Using Epidiolex with alcohol or any other sedatives increases the risk of sedation.

What Medications Are Similar?

There are several medical and therapeutic forms of cannabidiol. Epidiolex is the only cannabidiol medication that is approved for treating epilepsy. Do not take other forms of cannabidiol while taking Epidiolex, and do not take any other forms of cannabidiol for treating seizures—they are not formulated for seizure treatment.

How Can I Stay Healthy While Taking Epidiolex?

There are several strategies for staying healthy while taking Epidiolex.

• Sometimes, people prescribed this medicine also have underlying problems or may not understand the need for treatment. Have a plan for communicating and navigating challenges in administering the medication if you need to. Speak with your healthcare provider.
• It is essential to avoid driving, using machinery, climbing ladders, or other activities that require concentration or balance until you know whether this medicine makes you sleepy.
• Avoid seizure triggers, such as alcohol, drugs, skipping medicine, skipping meals, lack of sleep, and bright lights.
• Have an emergency plan in place in case a seizure occurs.
• Be aware of this drug's mild and severe side effects, and get prompt medical attention if you experience any dangerous side effects.