HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HORIZANT safely and effectively. See full prescribing information for HORIZANT.
HORIZANT(gabapentin enacarbil) Extended-Release Tablets for oral use
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on Driving (5.1) 03/2013
INDICATIONS AND USAGE
HORIZANT is indicated for:
treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. (1.1)
management of postherpetic neuralgia (PHN) in adults. (1.2)
DOSAGE AND ADMINISTRATION
Instruct patients to swallow tablets whole and not to cut, crush, or chew tablets. Take with food. (2)
RLS: 600 mg once daily taken at about 5 PM. (2.1)
A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions. (2.1)
If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed. (2.1)
PHN: The starting dose is 600 mg in the morning for 3 days, then increase to 600 mg twice daily beginning on day 4. (2.2)
A daily dose greater than 1,200 mg provided no additional benefit. (2.2)
If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of next scheduled dose. (2.2)
Patients with renal impairment: Doses of HORIZANT must be adjusted in accordance with renal function. (2.3)
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 300 mg and 600 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Driving impairment: Warn patients not to drive until they have gained sufficient experience with HORIZANT to assess whether it will impair their ability to drive. (5.1)
Somnolence/sedation and dizziness: May impair the patient’s ability to operate complex machinery. (5.2)
HORIZANT is not interchangeable with other gabapentin products. (5.3)
Suicidal thoughts or behaviors: HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behaviors. Monitor for suicidal thoughts or behaviors. (5.4)
ADVERSE REACTIONS
RLS: Most common adverse reactions (≥10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness. (6.1)
PHN: Most common adverse reactions (≥10% and greater than placebo) were dizziness, somnolence, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact XenoPort at 1-877-XENOPRT (1-877-936-6778) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Restless Legs Syndrome 1.2 Management of Postherpetic Neuralgia 2 DOSAGE AND ADMINISTRATION
2.1 Restless Legs Syndrome 2.2 Postherpetic Neuralgia 2.3 Renal Impairment 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Effects on Driving 5.2 Somnolence/Sedation and Dizziness 5.3 Lack of Interchangeability With Gabapentin 5.4 Suicidal Behavior and Ideation 5.5 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity 5.6 Discontinuation of HORIZANT 5.7 Tumorigenic Potential 6 ADVERSE REACTIONS
6.1 Clinical Trial