Horizant

HORIZANT- gabapentin enacarbil tablet, extended release
Arbor Pharmaceuticals

1 INDICATIONS AND USAGE

1.1 Treatment of Restless Legs Syndrome

HORIZANT® is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.

HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.

1.2 Management of Postherpetic Neuralgia

HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults.

2 DOSAGE AND ADMINISTRATION

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

Tablets should be taken with food.

HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles [see Warnings and Precautions (5.3)].

2.1 Restless Legs Syndrome

The recommended dosage for HORIZANT is 600 mg once daily 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 [see Adverse Reactions (6.1)].

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

2.2 Postherpetic Neuralgia

The recommended dosage of HORIZANT is 600 mg twice daily. HORIZANT should be initiated at a dose of 600 mg in the morning for 3 days of therapy, then increased to 600 mg twice daily (1,200 mg/day) on day four. In the 12-week principal efficacy study, additional benefit of using doses greater than 1,200 mg a day was not demonstrated, and these higher doses resulted in an increase in adverse reactions [see Adverse Reactions (6.1)].

If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of the next scheduled dose.

2.3 Renal Impairment

Dosing of HORIZANT is adjusted in accordance with renal function, as represented by creatinine clearance [see Clinical Pharmacology (12.3)]. Target dose regimens are listed in Table 1 and Table 2.

Table 1. Dosage of HORIZANT for Patients With Restless Legs Syndrome in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min) Target Dose Regimen
≥60 600 mg per day
30 – 59 Start at 300 mg per day and increase to 600 mg as needed
15 – 29 300 mg per day
<15 300 mg every other day
<15 on hemodialysis Not recommended
Table 2. Dosage of HORIZANT for Patients With Postherpetic Neuralgia in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min) Titration Maintenance Tapering
*
Based on tolerability and efficacy
≥60 600 mg in AM for 3 days 600 mg twice daily 600 mg in AM for 1 week
30 – 59 300 mg in AM for 3 days 300 mg twice daily. Increase to 600 mg twice daily as needed * Reduce current maintenance dose to once daily in AM for 1 week
15 – 29 300 mg in AM on Day 1 and Day 3 300 mg in AM. Increase to 300 mg twice daily if needed * If taking 300 mg twice daily, reduce to 300 mg once daily in AM for 1 week. If taking 300 mg once daily, no taper needed.
<15 None 300 mg every other day in AM. Increase to 300 mg once daily in AM if needed * None
<15 on hemodialysis None 300 mg following every dialysis. Increase to 600 mg following every dialysis if needed * None

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.

3 DOSAGE FORMS AND STRENGTHS

HORIZANT Extended-Release Tablets, 300 mg, are white to off-white, oval-shaped tablets debossed with “GS TF7” and 600 mg, are white to off-white, oval-shaped tablets debossed with “GS LFG”. Both the 300 mg and 600 mg tablets may contain occasional black/grey spots.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Driving

HORIZANT may cause significant driving impairment [see Clinical Studies (14.3)]. The duration of driving impairment after starting therapy with HORIZANT is unknown. Patients taking HORIZANT should not drive until they have gained sufficient experience to assess whether HORIZANT impairs their ability to drive. However, prescribers and patients should be aware that patients’ ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by HORIZANT, can be imperfect. Whether the impairment is related to somnolence [see Warnings and Precautions (5.2)] or other effects of HORIZANT is unknown.

5.2 Somnolence/Sedation and Dizziness

HORIZANT causes somnolence/sedation and dizziness (see Tables 4 and 5). Patients should be advised not to drive a car or operate other complex machinery until they have gained sufficient experience on HORIZANT to assess whether HORIZANT impairs their ability to perform these tasks.

During the controlled trials in patients with RLS, somnolence/sedation was reported in 20% of patients treated with 600 mg of HORIZANT per day compared with 6% of patients receiving placebo. In those patients treated with HORIZANT who reported somnolence, the somnolence persisted during treatment in about 30%. In the remaining patients, symptoms resolved within 3 to 4 weeks. Dizziness was reported in 13% of patients receiving 600 mg of HORIZANT per day compared with 4% of patients receiving placebo. In those patients treated with HORIZANT who reported dizziness, symptoms persisted during treatment in about 20%. Somnolence/sedation led to withdrawal in 2% of patients receiving 600 mg of HORIZANT per day. Dizziness led to withdrawal in 1% of patients receiving 600 mg of HORIZANT per day. The incidence of these adverse reactions was greater in the patients receiving 1,200 mg per day.

During the 12-week, controlled study in patients with PHN, somnolence was reported in 10% of patients treated with 1,200 mg of HORIZANT per day compared with 8% of patients receiving placebo. Fatigue/asthenia was reported in 6% of patients treated with 1,200 mg of HORIZANT per day compared with 1% of patients receiving placebo. In those patients treated with 1,200 mg of HORIZANT per day who reported somnolence (10%), the somnolence persisted during treatment in about 27%. In the remaining patients, symptoms resolved within 4 to 5 weeks. Dizziness was reported in 17% of patients receiving 1,200 mg of HORIZANT per day compared with 15% of patients receiving placebo. In those patients treated with 1,200 mg of HORIZANT per day who reported dizziness, symptoms persisted during treatment in about 6%. Somnolence led to withdrawal in <1% of patients receiving 1,200 mg of HORIZANT per day compared with 2% of patients receiving placebo. Dizziness led to withdrawal in 2% of patients receiving 1,200 mg of HORIZANT per day compared with 3% of patients receiving placebo.

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