EPIDIOLEX Oral solution (2023)

Βιβλιογραφική αναφορά

Συγγραφείς

Greenwich Biosciences, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

EPIDIOLEX is indicated for the treatment of seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

2. Dosage and Administration

2.1 Assessments Prior to Initiating EPIDIOLEX Because of the risk of hepatocellular injury, obtain serum transaminases (ALT and AST) and total bilirubin levels in all patients prior to starting treatment ...

3. Dosage Forms and Strengths

Cannabidiol oral solution: 100 mg/mL of a strawberry-flavored, clear, colorless to yellow solution.

4. Contraindications

EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product [see Description (11) and Warnings and Precautions (5.4)]. ...

5. Warnings and Precautions

5.1 Hepatocellular Injury EPIDIOLEX can cause dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]). In controlled studies for LGS and ...

6. Adverse Reactions

The following important adverse reactions are described elsewhere in labeling: Hepatocellular Injury [see Warnings and Precautions (5.1)] Somnolence and Sedation [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Effect of Other Drugs on EPIDIOLEX Strong CYP3A4 or CYP2C19 Inducers Coadministration with a strong CYP3A4 and CYP2C19 inducer (rifampin 600 mg once daily) decreased cannabidiol and 7-OH-CBD plasma ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as EPIDIOLEX, during pregnancy. Encourage women ...

8.2. Lactation

Risk Summary 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. The developmental and health benefits ...

8.4. Pediatric Use

Safety and effectiveness of EPIDIOLEX for the treatment of seizures associated with LGS, DS, or TSC have been established in patients 1 year of age and older. The use of EPIDIOLEX in these indications ...

8.5. Geriatric Use

Clinical trials of EPIDIOLEX in the treatment of LGS, DS, and TSC did not include a sufficient number of patients aged above 55 years to determine whether or not they respond differently from younger patients. ...

8.6. Hepatic Impairment

Because of an increase in exposure to EPIDIOLEX, dosage adjustments are necessary in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.6), Warnings and Precautions ...

9.1. Controlled Substance

EPIDIOLEX is not a controlled substance.

9.2. Abuse

Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioral responses, including generalization to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study. ...

9.3. Dependence

In a human physical dependence study, administration of cannabidiol 1500 mg/day (750 mg twice daily) to adults for 28 days did not produce signs or symptoms of withdrawal over a 6-week assessment period ...

11. 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 C21H30 ...

12.1. 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. ...

12.2. Pharmacodynamics

There are no relevant data on the pharmacodynamic effects of cannabidiol.

12.3. Pharmacokinetics

Cannabidiol demonstrated an increase in exposure that was less than dose-proportional over the range of 5 to 25 mg/kg/day in patients. Absorption Cannabidiol has a time to maximum plasma concentration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a carcinogenicity study in mice, oral administration of cannabidiol (0 [water], 0 [vehicle], 30, 100, or 300 mg/kg/day) for 2 years resulted in an increased incidence of hepatocellular ...

14. Clinical Studies

14.1 Lennox-Gastaut Syndrome The effectiveness of EPIDIOLEX for the treatment of seizures associated with LGS was established in two randomized, double-blind, placebo-controlled trials in patients aged ...

16.1. How Supplied

EPIDIOLEX is a strawberry-flavored, clear, colorless to yellow solution supplied in an amber glass bottle with a child-resistant closure. EPIDIOLEX is available in bottles containing 60 mL (NDC 70127-100-06) ...

16.2. Storage and Handling

Store EPIDIOLEX in an upright position at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep the ...

17. Patient Counseling Information

Advise the caregiver or patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Information Advise patients who are prescribed EPIDIOLEX to use the ...