Co-administration can cause ALT and/or AST elevation.
Source: NLP:divalproex sodium
Brand names: Epidiolex
Cytochrome P450 2C8 Inhibitors · Cytochrome P450 2C9 Inhibitors · Cytochrome P450 2C19 Inhibitors · UGT1A9 Inhibitors · UGT2B7 Inhibitors · Cytochrome P450 1A2 Inhibitors · Cytochrome P450 2B6 Inhibitors · Cytochrome P450 2B6 Inducers
Route: Oral
Contraindications
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 )]. Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Pregnancy Surveillance Program and Pregnancy Exposure Registry There are two programs, an EPIDIOLEX pregnancy surveillance program and an antiepileptic drug (AED) pregnancy exposure registry, that monitor pregnancy outcomes. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in both, by calling the toll free numbers or visiting the websites below: • EPIDIOLEX Pregnancy Surveillance Program o 1-855-272-7158 o https://www.epidiolexpregnancystudy.com • North American Antiepileptic Drug (NAAED) Pregnancy Registry o 1-888-233-2334 o https://www.aedpregnancyregistry.org/ Risk Summary There are no adequate data on the developmental risks associated with the use of EPIDIOLEX in pregnant women. Administration of cannabidiol to pregnant animals produced evidence of developmental toxicity (increased embryofetal mortality in rats and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, long-term neurobehavioral changes, and adverse effects on the reproductive system in rat offspring) at maternal plasma exposures similar to (rabbit) or greater than (rat) that in humans at therapeutic doses (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. The background risks of major birth defects and miscarriage for the indicated populations are unknown. Data Animal Data Oral administration of cannabidiol (0, 75, 150, or 250 mg/kg/day) to pregnant rats throughout the period of organogenesis resulted in embryofetal mortality at the highest dose tested. There were no other drug-related maternal or developmental effects. The highest no-effect dose for embryofetal toxicity in rats was associated with maternal plasma cannabidiol exposures (AUC) approximately 16 and 9 times that in humans at the recommended human doses (RHD) of 20 and 25 mg/kg/day, respectively. Oral administration of cannabidiol
12 interactions on record
Co-administration can cause ALT and/or AST elevation.
Source: NLP:divalproex sodium
Therapeutic drug monitoring and dose reduction for everolimus should be considered when coadministered.
Source: NLP:everolimus
Therapeutic drug monitoring and dose reduction for everolimus should be considered when co-administered with cannabidiol.
Source: NLP:everolimus tablets
May increase sirolimus blood levels. Therapeutic drug monitoring and sirolimus dose reduction should be considered.
Source: NLP:sirolimus
Concomitant use increases plasma concentrations of N-desmethylclobazam (active metabolite), which may increase risk of clobazam-related adverse reactions.
Source: NLP:cannabidiol
Increases in exposure may be observed when concomitantly used with EPIDIOLEX. Consider therapeutic drug monitoring and dosage reduction.
Source: NLP:cannabidiol
Strong CYP3A4 and CYP2C19 inducer decreases cannabidiol and 7-OH-CBD plasma concentrations by approximately 32% and 63%, potentially reducing EPIDIOLEX efficacy.
Source: NLP:cannabidiol
Concomitant use increases plasma exposures of stiripentol. Monitor for stiripentol-related adverse reactions.
Source: NLP:cannabidiol
Therapeutic drug monitoring and dose reduction for tacrolimus should be considered when co-administered with cannabidiol.
Source: NLP:tacrolimus
Therapeutic drug monitoring and tacrolimus dose reduction should be considered when co-administered with cannabidiol.
Source: NLP:tacrolimus extended-release capsules
Increases in exposure may be observed as cannabidiol is a weak CYP1A2 inhibitor. Consider dosage reduction where minimal concentration changes may lead to serious adverse reactions.
Source: NLP:cannabidiol
Increases in exposure may be observed as cannabidiol is a weak CYP1A2 inhibitor. Consider dosage reduction where minimal concentration changes may lead to serious adverse reactions.
Source: NLP:cannabidiol