By admin August 26, 2023 Tuberous sclerosis complex 0

Epilepsia. 2022 Feb; 63(2): 426–439

Trial and study design: An open‐label extension trial

Sample size: N=201

Dosage and duration: CBD (100 mg/mL oral solution). The initial target dose was 25 mg/kg/day, which, based on response and tolerability, could be decreased or increased up to 50 mg/kg/day, median treatment time was 267 days (range, 18–910) at a 27 mg/kg/day mean modal dose.

Results:

  • Median percentage reductions in seizure frequency (12-week windows across 48 weeks) were 54%–68%. Seizure responder rates (≥50%, ≥75%, 100% reduction) were 53%–61%, 29%–45%, and 6%–11% across 12-week windows for 48 weeks. Improvement on the S/CGIC scale was reported by 87% of patients/ caregivers at 26 weeks.

Safety and side effects:

  • Most patients (92%) had an adverse event (AE); the most common AEs were diarrhea, seizure, and decreased appetite, and they were mostly mild or moderate in severity.

Conclusion:

  • In patients with TSC, long-term add-on CBD treatment was well tolerated and sustainably reduced seizures through 48 weeks, with most patients/caregivers reporting global improvement.
Important safety information while taking CLASEPI

What is the Most Important Information I Should Know About CLASEPI (cannabidiol)?

Do not take if you are allergic to cannabidiol or any of the ingredients in CLASEPI (cannabidiol).

CLASEPI (cannabidiol) may cause liver problems. Your doctor may order blood tests to check your liver before you start taking CLASEPI (cannabidiol) and during treatment. In some cases, CLASEPI (cannabidiol) treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with CLASEPI (cannabidiol):

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

Side effects-

1. Hepatocellular Injury

Cannabidiol can cause dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]).

2. Somnolence and Sedation

Cannabidiol can cause somnolence and sedation. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on Cannabidiol to gauge whether it adversely affects their ability to drive or operate machinery.

3. Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Cannabidiol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behaviour.

4. Hypersensitivity Reactions

Cannabidiol can cause hypersensitivity reactions. Cannabidiol is contraindicated in patients with a prior hypersensitivity reaction to cannabidiol or any of the ingredients in the product, which includes sesame seed oil.

5. Withdrawal of Antiepileptic Drugs (AEDs)

As with most antiepileptic drugs, Cannabidiol should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

Precautions

  • Can cause hepatic transaminase elevations
  • Monitor for Somnolence and sedation.
  • Monitor patients for suicidal behavior and thoughts
  • Hypersensitivity Reactions
  • For Withdrawal of Antiepileptic Drugs Cannabidiol should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
 

Effects on ability to drive and use machines:

Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation. Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities.

Use in Specific Population:

  • Paediatrics: Safety and effectiveness of cannabdiol in children aged below 1 year have not been established.
  • Pregnancy: There are no adequate data on the developmental risks associated with the use of cannabidiol in pregnant women.
  • Breast-feeding: There are no data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • Hepatic Impairment: Because of an increase in exposure to cannabididol, dosage adjustments are necessary in patients with moderate or severe hepatic impairment.
  • Renal impairment: Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment. There is no experience in patients with end-stage renal disease. It is not known if cannabidiol is dialysable.

Contraindication:

Cannabidiol is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product.

 

Overdose

Symptoms

Experience with doses higher than the recommended therapeutic dose is limited. Mild to moderate diarrhoea and somnolence have been reported in healthy adult subjects taking a single dose of 6000 mg; this equates to a dose of over 85 mg/kg for a 70 kg adult. These adverse reactions resolved upon study completion.

Management of overdose

In the event of overdose, the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs