Xcopri Titration Pack

XCOPRI TITRATION PACK- cenobamate
XCOPRI- cenobamate tablet, film coated
XCOPRI MAINTENANCE PACK- cenobamate
SK Life Science, Inc.

1 INDICATIONS AND USAGE

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

XCOPRI may be taken any time with or without food. Swallow tablets whole with liquid. Do not crush or chew.

2.2 General Dosing Recommendations

Monotherapy and Adjunctive Therapy

XCOPRI is administered orally once daily. The recommended dosage and titration, which should not be exceeded because of the potential for serious adverse reactions [see Warnings and Precautions (5.2)] , is included in Table 1.

Table 1: Recommended Dosage for Partial-Onset Seizures in Adults
Initial Dosage
Week 1 and 2 12.5 mg once daily
Titration Regimen
Week 3 and 4 25 mg once daily
Week 5 and 6 50 mg once daily
Week 7 and 8 100 mg once daily
Week 9 and 10 150 mg once daily
Maintenance Dosage
Week 11 and thereafter 200 mg once daily
Maximum Dosage
If needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to 400 mg. 400 mg once daily

2.3 Dosage Modifications in Patients with Hepatic Impairment

For patients with mild to moderate (5-9 points on Child-Pugh assessment) hepatic impairment, the maximum recommended dosage is 200 mg once daily [see Use in Specific Populations (8.7)]. XCOPRI is not recommended for use in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

2.4 Discontinuation of XCOPRI

If XCOPRI is discontinued, the dosage should be gradually reduced over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal [see Warnings and Precautions (5.1, 5.5)].

3 DOSAGE FORMS AND STRENGTHS

XCOPRI tablets are available in the following strengths, shapes, colors, and tablet markings (Table 2).

Table 2: TRADENAME Tablet Presentations
Tablet Strength Tablet Color/Shape Tablet Markings
12.5 mg Uncoated round white to off-white tablets SK on one side and 12 on the other side
25 mg Film coated round brown tablets SK on one side and 25 on the other side
50 mg Film coated round yellow tablets SK on one side and 50 on the other side
100 mg Film coated round brown tablets SK on one side and 100 on the other side
150 mg Film coated round light orange tablets SK on one side and 150 on the other side
200 mg Film coated modified oval light orange tablets SK on one side and 200 on the other side

4 CONTRAINDICATIONS

XCOPRI is contraindicated in patients with:

  • Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI [see Warnings and Precautions (5.1) and Description (11)]
  • Familial Short QT syndrome [see Warnings and Precautions (5.2)]

5 WARNINGS AND PRECAUTIONS

5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking XCOPRI. DRESS has occurred, including one fatality, when XCOPRI was titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1339 partial-onset seizure patients when XCOPRI was initiated at 12.5 mg once daily and titrated every two weeks. This finding does not establish that the risk of DRESS is prevented by a slower titration; however, XCOPRI should be initiated at 12.5 mg once daily and titrated every two weeks [see Dosage and Administration (2.2)]. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. XCOPRI should be discontinued immediately and not restarted if an alternative etiology for the signs or symptoms cannot be established [see Contraindications (4)].

5.2 QT Shortening

In a placebo-controlled study of the QT interval, a higher percentage of subjects who took XCOPRI (31% at 200 mg and 66% at 500 mg) had a QT shortening of greater than 20 msec compared to placebo (6-17%). Reductions of the QTc interval below 300 msec were not observed [see Clinical Pharmacology (12.2)]. Familial Short QT syndrome is associated with an increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation. Such events in this syndrome are believed to occur primarily when the corrected QT interval falls below 300 msec. Nonclinical data also indicate that QT shortening is associated with ventricular fibrillation. Patients with Familial Short QT syndrome should not be treated with XCOPRI [see Contraindications (4)]. Caution should be used when administering XCOPRI and other drugs that shorten the QT interval as there may be a synergistic effect on the QT interval that would increase the QT shortening risk.

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