Epidiolex

Generic name: cannabidiol
Drug class: Miscellaneous anticonvulsants

\Medically reviewed by  A Ras MD.

What is Epidiolex?

Epidiolex is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in people 1 year of age and older.

It is not known if Epidiolex is safe and effective in children under 1 year of age.

Description

Cannabidiol is a cannabinoid designated chemically as 2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol (IUPAC/CAS).  Its empirical formula is C21H30O2 and its molecular weight is 314.46.  The chemical structure is:

Cannabidiol, the active ingredient in EPIDIOLEX, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant.

Cannabidiol is a white to pale yellow crystalline solid.  It is insoluble in water and is soluble in organic solvents.

EPIDIOLEX (cannabidiol) oral solution is a clear, colorless to yellow liquid containing cannabidiol at a concentration of 100 mg/mL.  Inactive ingredients include dehydrated alcohol (7.9% w/v), sesame seed oil, strawberry flavor, and sucralose.  EPIDIOLEX contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Mechanism of Action

The precise mechanisms by which EPIDIOLEX exerts its anticonvulsant effect in humans are unknown.  Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.

What is the most important information I should know about Epidiolex?

Epidiolex can cause serious side effects, including:

1. Epidiolex may cause liver problems. Your healthcare provider may order blood tests to check your liver before you start taking Epidiolex and during treatment. In some cases, Epidiolex treatment may need to be stopped. Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment with Epidiolex:

• loss of appetite, nausea, vomiting
• itching
• fever, feeling unwell, unusual tiredness
• unusual darkening of the urine
• yellowing of the skin or the whites of the eyes (jaundice)
• right upper stomach area pain or discomfort

2. Epidiolex may cause you to feel sleepy, which may get better over time. Using certain medicines with Epidiolex such as clobazam or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you.
3. Like other antiepileptic drugs, Epidiolex may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• trouble sleeping (insomnia)
• attempt to commit suicide
• new or worse irritability
• new or worse depression
• acting aggressive, being angry, or violent
• new or worse anxiety
• acting on dangerous impulses
• feeling agitated or restless
• an extreme increase in activity and talking (mania)
• panic attacks
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

4. Do not stop taking Epidiolex without first talking to your healthcare provider. Stopping a seizure medicine such as Epidiolex suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus).

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Who should not take Epidiolex?

Do not take Epidiolex if you are allergic to cannabidiol or any of the ingredients in Epidiolex. See the end of this Medication Guide for a complete list of ingredients in Epidiolex.

What should I tell my healthcare provider before taking Epidiolex?

Before taking Epidiolex, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have liver problems.
• have abused or been dependent on prescription medicines, street drugs or alcohol.
• are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Epidiolex. You and your healthcare provider will decide if you should take Epidiolex while you are pregnant.
  • If you become pregnant while taking Epidiolex, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Epidiolex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Epidiolex.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any cannabis-based products.

Epidiolex may affect the way other medicines work, and other medicines may affect how Epidiolex works. Do not start or stop taking other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider if you are planning to have a cannabis drug screen because Epidiolex may affect your test results. Tell the person giving the drug test that you are taking Epidiolex.

How should I take Epidiolex?

• Read the Instructions for Use at the end of this Medication Guide for information on the right way to use Epidiolex.
• Take Epidiolex exactly as your healthcare provider tells you.
• Your healthcare provider will tell you how much Epidiolex to take and when to take it.
• Measure each dose of Epidiolex using the bottle adapter and 5 mL dosing syringes that come with Epidiolex. If your dose of Epidiolex is less than 1 mL, your pharmacist will provide you with 1 mL syringes to take your medicine.
• Use a dry syringe each time you take Epidiolex. If water is inside the syringe, it could cause the oil based medicine to look cloudy.

What should I avoid while taking Epidiolex?

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you. Epidiolex may cause you to feel sleepy.

What are the possible side effects of Epidiolex?

Epidiolex can cause serious side effects, including:

• See “What is the most important information I should know about Epidiolex?”

The most common side effects of Epidiolex include:

• sleepiness
• rash
• decreased appetite
• sleep problems
• diarrhea
• fever
• increase in liver enzymes
• vomiting
• feeling very tired and weak
• infections

These are not all of the possible side effects of Epidiolex. For more information ask your healthcare provider or pharmacist.

Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also contact Greenwich Biosciences at 1-833-424-6724 (1-833-GBIOSCI).

General Information about the safe and effective use of Epidiolex

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Epidiolex for a condition for which it was not prescribed. Do not give Epidiolex to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Epidiolex that is written for health professionals.

How should I store Epidiolex?

• Store Epidiolex at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Always store Epidiolex in an upright position.
• Do not freeze.
• Keep the child-resistant cap tightly closed.
• Use Epidiolex within 12 weeks of first opening the bottle. Throw away (dispose of) any unused medicine after 12 weeks.

Keep Epidiolex and all medicines out of the reach of children.

What are the ingredients in Epidiolex?

Active ingredient: cannabidiol

Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose

Epidiolex does not contain gluten (wheat, barley or rye).

For more information, go to www.EPIDIOLEX.com or call 1-833-424-6724 (1-833-GBIOSCI).

Instructions for use for Epidiolex

Epidiolex (EH-peh-DYE-oh-lex)

(cannabidiol)

oral solution

100 mg/mL

Be sure that you read, understand and follow these instructions carefully to ensure proper dosing of the oral solution.

Important:

• Follow your healthcare provider’s instructions for the dose of Epidiolex to take or give.
• Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose of Epidiolex.
• Always use the oral syringe provided with Epidiolex to make sure you measure the right amount of Epidiolex.
• Do not use Epidiolex after the expiration date on the package and each bottle.
• Use Epidiolex within 12 weeks of first opening the bottle.
• After 12 weeks, safely throw away (dispose of) any Epidiolex that has not been used.

Each package contains:

Child-resistant cap

Bottle adapter

1 bottle of Epidiolex oral solution (100 mg/mL)

2 reusable 5 mL oral syringes:

• 1 syringe to take or give the dose of Epidiolex
• 1 extra syringe (included as a spare if needed)

Supplies not included in the package:

• If your dose of Epidiolex is less than 1 mL, your pharmacist will provide you with 1 mL syringes to take your medicine.
• Call your pharmacist right away if your dose of Epidiolex is less than 1 mL and you do not receive 1 mL syringes with your medicine.

Note: If you lose or damage an oral syringe, or cannot read the markings, use the spare syringe.

Prepare The Bottle- to use Epidiolex for the first time

1. Remove the child-resistant cap by pushing down while turning the cap to the left (counter-clockwise).

2. Push the bottle adapter firmly into the bottle. Make sure the bottle adapter is fully inserted. If not fully inserted, small parts such as the bottle adapter may become a choking hazard for children and pets.

Note: Do not remove the bottle adapter from the bottle after it is inserted.

Prepare The Dose

Your healthcare provider will tell you how much Epidiolex to take or give.

3. Use this table to measure the total dose of Epidiolex to be given.

4. Push the plunger all the way down and insert the tip of the oral syringe fully into the bottle adapter. With the oral syringe in place, turn the bottle upside down.

5. Slowly pull the plunger of the oral syringe to withdraw the dose of Epidiolex needed. See Step 3 for how to measure the total dose of Epidiolex.

Line up the end of the plunger with the marking for your dose of Epidiolex.

What to do if you see air bubbles:

If there are air bubbles in the oral syringe, keep the bottle upside down and push the plunger so that all of the liquid flows back into the bottle. Repeat Step 5 until the air bubbles are gone.

6. When you have measured the correct dose of Epidiolex, leave the oral syringe in the bottle adapter and turn the bottle right side up.

7. Carefully remove the oral syringe from the bottle adapter.

Give Epidiolex

8. Place the tip of the oral syringe against the inside of the cheek and gently push the plunger until all the Epidiolex in the syringe is given.

Do not forcefully push on the plunger.

Do not direct the medicine to the back of the mouth or throat. This may cause choking.

If the dose of Epidiolex prescribed by the healthcare provider is more than 5 mL, repeat steps 4 through 8 to complete the dose.

For example:

If your dose of Epidiolex is 8 mL, withdraw 5 mL of medicine into the syringe and give the medicine. Insert the tip of the oral syringe back into the bottle adapter and withdraw 3 mL of medicine. Give the medicine to receive a total dose of 8 mL.

Clean Up

9. Screw the child-resistant cap back on the bottle tightly by turning the cap to the right (clockwise).

Do not remove the bottle adapter. The cap will fit over it.

10. Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out of the syringe using the plunger.

11. Remove the plunger from the barrel of the oral syringe and rinse both parts under tap water.

Do not wash the oral syringe in the dishwasher.

12. Shake off any extra water from the plunger and oral syringe barrel, and allow them to air dry until next use.

Make sure the oral syringe is completely dry before the next use. If water is inside the syringe, it could cause the oil based medicine to look cloudy.

Do not throw away the oral syringe.

How should I store Epidiolex?

• Store Epidiolex at room temperature between 68°F to 77°F (20°C to 25°C).
• Always store Epidiolex in an upright position.
• Do not freeze.
• Keep the child-resistant cap tightly closed.
• Use Epidiolex within 12 weeks of first opening the bottle. Dispose of any unused Epidiolex after 12 weeks.
• Keep Epidiolex and all medicines out of the reach of children.

Helpline Details

For additional assistance, call the toll-free helpline at 1-833-426-4243 (1-833-GBNGAGE).

Hours: Monday-Friday 08:00am – 08:00pm EST

Frequently Asked Questions

Q: What if there are air bubbles in the oral syringe?

A: Push the liquid back into the bottle and repeat Step 5 until the air bubbles are gone.

Q: What should I do if the liquid in the bottle has turned cloudy?

A: The liquid in the bottle may turn cloudy if water gets in the bottle. This does not change the safety or how well the medicine works. Continue to use the cloudy liquid as prescribed by your healthcare provider.

Always make sure the oral syringes are completely dry before each use.

Q: What should I do if the oral syringe is not completely dry before use?

A: If the oral syringe is not completely dry, use the spare syringe provided in the pack.

Label

PRINCIPAL DISPLAY PANEL

• NDC 70127-100-10
  EPIDIOLEX
  (cannabidiol)
  100 mg/mL
  oral solution

• PRINCIPAL DISPLAY PANEL

   

  NDC 70127-100-06
  EPIDIOLEX
  (cannabidiol)
  100 mg/mL
  oral solution

  

  SRC: NLM .