Supernus

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2.1 Important Administration Instructions

Administer Oxtellar XR™ as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals) [see Clinical Pharmacology (12.3)]. If Oxtellar XR™ is taken with food, adverse reactions are more likely to occur because of increased peak levels [see Clinical Pharmacology (12.3)].

Swallow Oxtellar XR™ tablets whole. Do not cut, crush, or chew the tablets. For ease of swallowing in pediatric patients or patients with difficulty swallowing, achieve daily dosages with multiples of appropriate lower strength tablets (e.g., 150 mg tablets).

2.2 Dosing for Adults in Adjunctive Therapy

The recommended daily dose of Oxtellar XR™ is 1,200 mg to 2,400 mg per day, given once daily. The dose of 2,400 mg per day showed slightly greater efficacy than 1,200 mg per day, but was associated with an increase in adverse reactions.

Initiate treatment at a dose of 600 mg per day given once daily for one week. Subsequent dose increases can be made at weekly intervals in 600 mg per day increments to achieve the recommended daily dose.

2.3 Dosing for Children (6 to 17 years of age) in Adjunctive Therapy

In pediatric patients 6 years to 17 years of age, initiate treatment at a daily dose of 8 mg/kg to 10 mg/kg once daily, not to exceed 600 mg per day in the first week.

Subsequent dose increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dose. The target maintenance dose, achieved over two to three weeks, is displayed in Table 1.

Table 1: Target Daily Dose in Pediatric Patients Aged 6 to 17 Years Old Weight Target Daily Dose 20 kg to 29 kg 900 mg per day 29.1 kg to 39 kg 1200 mg per day Greater than 39 kg 1800 mg per day

2.4 Dosage Modifications in Patients with Renal Impairment

In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), initiate Oxtellar XR™ at one-half the usual starting dose (300 mg per day). Subsequent dose increases can be made at weekly intervals in increments of 300 mg to 450 mg per day to achieve the desired clinical response. [see Use in Specific Populations (8.5)].

2.5 Dosage Modifications in Geriatric Patients

In geriatric patients, consider starting at a lower dose (300 mg or 450 mg per day). Subsequent dose increases can be made at weekly intervals in increments of 300 mg to 450 mg per day to achieve the desired clinical effect [see Use in Specific Populations (8.4)].

2.6 Dosage Modification for use with Concomitant Antiepileptic Drugs

Enzyme inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin decrease exposure to 10-monohydroxy derivative (MHD), the active metabolite. Dosage increases may be necessary. Consider initiating dose at 900 mg once per day [see Drug Interactions (7.1)].

2.7 Withdrawal of AEDs

As with all antiepileptic drugs, Oxtellar XR™ should be withdrawn gradually to minimize the potential of increased seizure frequency [see Warnings and Precautions (5.6)].

2.8 Conversion from Immediate-Release Oxcarbazepine to Oxtellar XR™

In conversion of oxcarbazepine immediate-release to Oxtellar XR™, higher doses of Oxtellar XR™ may be necessary [see Clinical Pharmacology (12.3)].