Restless legs syndrome (RLS)

USE IN SPECIFIC POPULATIONS
Pregnancy: based on animal data, may cause fetal harm.
Renal impairment: Dosage adjustments necessary. HORIZANT is not recommended for use in patients with creatinine clearance (CrCl) <30 mL/min or in patients on hemodialysis.

DOSAGE AND ADMINISTRATION
Restless Legs Syndrome
The recommended dosage for HORIZANT is 600 mg once daily taken with food at about 5 PM. A daily dose of 1,200 mg provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions.

If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.

Tablets should be swallowed whole and should not be cut, crushed, or chewed.

Renal Impairment and Hemodialysis
In patients with compromised renal function (creatinine clearance [CrCl] 30 to 59 mL/min), 600 mg of HORIZANT should be administered on Day 1, Day 3, and every day thereafter.

In patients with stable renal function, CrCl can be estimated using the equation of Cockcroft and Gault:

for males: CrCl = (140-age)(weight) / [(72)(SCr)]

for females: CrCl = (0.85)(140-age)(weight) / [(72)(SCr)]

where age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.

HORIZANT is not recommended for use in patients with a CrCl <30 mL/min or on hemodialysis because the dose cannot be reduced below 600 mg.

HOW SUPPLIED
HORIZANT Extended-Release Tablets, 600 mg, are white to off-white, oval-shaped tablets debossed with “GS LFG”. HORIZANT Extended-Release Tablets may contain occasional black/grey spots.

NDC 0173-0806-01: Bottles of 30