Epidiolex

Epidiolex is a prescription medication used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Epidiolex belongs to a group of drugs called cannabinoids. It is believed to work differently from other prescription seizure medicines, but the exact mechanisms of action (how it works) are unknown.

This medication comes in oral solution form and is taken 2 times a day with or without food.

Epidiolex can cause sleepiness. Do not drive or operate heavy machinery until you know how Epidiolex affects you. Other common side effects include decreased appetite, diarrhea, and increased liver enzymes.

Epidiolex is a prescription medication used to used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Epidiolex. See the “Epidiolex Precautions” section.

Common side effects of Epidiolex include the following:

• Sleepiness
• Decreased appetite
• Diarrhea
• Increase in liver enzymes
• Feeling tired and weak
• Rash
• Sleep problems
• Infections

This is not a complete list of Epidiolex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the activity of the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St. John's wort
• medications that block the activity of the enzyme CYP2C19 such as some  antidepressants (moclobemide, fluvoxamine, fluoxetine) and some bacteriostatic antimicrobials (chloramphenicol).
• medications that increase the activity of the enzyme CYP2C19 such as some anticonvulsants (carbamazepine, phenytoin), some bactericidals (rifampicin), and St. John’s wort

This is not a complete list of Epidiolex drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Epidiolex including the following:

• Liver injury. 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. Tell your healthcare provider right away if you have some or all of the following symptoms of liver injury:
  • Unexplained nausea
  • Vomiting
  • Right upper quadrant abdominal pain
  • Fatigue
  • Anorexia
  • Yellowing of the skin
  • Dark urine

• Epidiolex may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you.

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

• 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.

Do not take Epidiolex if you:

• are allergic to Epidiolex or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epidiolex, high-fat/high-calorie meals should be avoided because they can greatly increase the concentration of the medication. Talk to your health care provider about the best way to take this medication.

Before taking Epidiolex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Epidiolex or to any of its ingredients
• 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
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Epidiolex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Epidiolex.

Take Epidiolex exactly as prescribed.

Epidiolex comes in liquid form and is taken two times a day.

Take Epidiolex at the same time each day with or without food.

Measure each dose of Epidiolex using the bottle adapter and 5 mL dosing syringes that come with it. 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication 

• The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).

• Based on individual clinical response and tolerability, Epidiolex can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day).

• Dosage adjustment is recommended for patients with moderate or severe liver impairment.

If you take too much Epidiolex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Epidiolex at room temperature room temperature between 68ºF to 77ºF (20ºC to 25ºC). Always store Epidiolex in its original bottle in an upright position. DO NOT refrigerate or freeze.
• Use Epidiolex within 12 weeks of first opening the bottle. Throw away any unused medication after 12 weeks.
• Keep this and all medicines out of the reach of children.