EPIDIOLEX cannabidiol (CBD) ORAL SOLUTION 100 MG/ML SOL KIT 10

NDC No.70127-0100-10 70127-100-10 7012710010 70127010010 UPC/GTIN No. 8-16060-02000-7 816060-020007 816060-020007 MPN No. Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

mFor: Lennox-Gastaut Syndrome, Dravet Syndrome

EPIDIOLEX  DOSAGE:

Epidiolex Dosage (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. Furthermore, Epidiolex is a strawberry flavor clear, colorless to a yellow solution supplied in a 105 mL amber glass bottle with a child-resistant closure containing 100 mL of oral solution (NDC 70127-100-01). In fact, each mL contains 100 mg of cannabidiol. Besides this, Epidiolex is packaged in a carton with two 5 mL calibrated oral dosing syringes and a bottle adapter (NDC 70127-100-10). The pharmacy will provide 1 mL calibrated oral dosing syringes when doses less than 1 mL are required.

STORAGE AND HANDLING:

Store Epidiolex in an upright position at 20C to 25C (68F to 77F), excursions are permitted between 15C to 30C (59F to 86F). [See USP Controlled Room Temperature]. Furthermore, do not freeze it. Besides this, keep the cap tightly closed. More importantly, use within 12 weeks of first opening the bottle, then discard any remainder. Furthermore, these highlights do not include all the information needed to use Epidiolex safely and effectively. See full prescribing information for Epidiolex.

EPIDIOLEX (cannabidiol) oral solution, CV
Initial U.S. Approval: 2018

INDICATIONS AND USAGE OF EPIDIOLEX:

EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older (1)

DOSAGE AND ADMINISTRATION:

Obtain serum transaminases (ALT and AST) and total bilirubin levels in all patients before starting treatment. (2.1, 5.1)
EPIDIOLEX is to be administered orally. (2.2)
The recommending starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). Also after one week, the dosage is  increase to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day) (2.2
Furthermore, 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). Also, see Full Prescribing Information for titration. (2.2)
Also, dosage adjustments are recommending for patients with moderate or severe hepatic impairment. (2.5, 8.6)

DOSAGE FORMS AND STRENGTHS:

Oral solution: 100 mg/mL (3)

CONTRAINDICATIONS:

Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX (4)

WARNINGS AND PRECAUTIONS OF EPIDIOLEX DOSAGE:

Hepatocellular Injury:

Epidiolex can cause transaminase elevations. Furthermore, concurrent use of valproate and higher doses of Epidiolex increase the risk of transaminase elevations. Also, see Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations. (5.1)

Somnolence and Sedation:

Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on Epidiolex. (5.2)

Suicidal Behavior and Ideation:

Monitor patients for suicidal behavior and thoughts. (5.3)

Hypersensitivity Reactions:

Advise patients to seek immediate medical care. Furthermore, discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. (5.4)

Withdrawal of Antiepileptic Drugs:

EPIDIOLEX withdrew to minimize the risk of increasing seizure frequency and status epilepticus. (5.5)

ADVERSE REACTIONS:

The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) are somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder, and poor quality sleep, and infections. (6.1)

Furthermore, to report SUSPECTED ADVERSE REACTIONS, contact Greenwich Biosciences at 1-833-424-6724 (1-833-GBIOSCI) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

Moderate or strong inhibitors of CYP3A4 or CYP2C19: Consider dose reduction of EPIDIOLEX. (7.1)
Strong inducer of CYP3A4 or CYP2C19: Consider dose increase of EPIDIOLEX. (7.1)
Consider a dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, and CYP2C19 (e.g., clobazam).  Substrates of CYP1A2 and CYP2B6 may also require dose adjustment. (7.2)

USE IN SPECIFIC POPULATIONS:

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

Furthermore, see 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2018

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