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References: 1. Paladin data on file. 2. XCOPRI Product Monograph. Paladin Pharma Inc. May 15, 2024. 3. Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):522-530.

Study C017 data are based on a starting dose of 50 mg/day and a titration of 50 mg/day every week until 100 mg/day or 200 mg/day was reached, and then increased by 100 mg/day every week in patients randomized to 400 mg/day. This differs from the recommended starting dose and titration schedule in the XCOPRI Product Monograph.

XCOPRI is recommended at a starting dose of 12.5 mg/day for 2 weeks, then 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks, then increased by 50 mg every 2 weeks until 200 mg/day. If needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg/day every 2 weeks to a maximum daily dose of 400 mg.

Rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including one fatality, have been reported following treatment with XCOPRI. These events appear to have occurred at high initial dose (50-200 mg) and at a faster-than-recommended titration of XCOPRI to target maintenance dose. XCOPRI should be initiated at a daily dose of 12.5 mg and slowly titrated to the target maintenance dose over several weeks.

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Important Safety Information

Indications and clinical use:
XCOPRI is indicated as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

Clinical experience with XCOPRI in elderly patients with epilepsy (≥65 years of age) is limited. Dose selection for an elderly patient should start at the low end of the dosing range and be maintained at the lowest effective dose.

Contraindications:
Patients with or with family history of Familial Short QT syndrome, presence or history of short QT interval.

Most serious warnings and precautions:
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): rare cases have been reported following treatment with XCOPRI, including one fatality. These events appear to have occurred at high initial dose (50-200 mg) and at a faster-than-recommended titration schedule to target maintenance dose. No cases were reported in patients following the recommended titration schedule during the clinical trials. XCOPRI should be initiated at a daily dose of 12.5 mg and slowly titrated to the target maintenance dose over several weeks. Caution should be taken when using XCOPRI in patients with medical history of DRESS or using concomitant drugs, including other anti-seizure medications (ASMs), that are associated with such hypersensitivity reactions.

Other relevant warnings and precautions:

• Withdrawal of ASMs
• QT shortening
• Drug abuse and dependence
• Driving and operating machinery
• Use in patients with hepatic impairment
• Somnolence and fatigue; dizziness and disturbance in gait and coordination, cognitive dysfunction-related events
• Visual changes including diplopia, blurred vision, and impaired vision
• Behavioural abnormalities, suicidal ideation and behaviour in patients treated with ASMs
• Use in patients with renal impairment
• Use during pregnancy and/or breastfeeding
• Oral contraceptives: women relying on hormonal therapy for contraception should employ at least one other reliable
• non-hormonal method of contraception while on XCOPRI and for at least 21 days after discontinuing treatment

For more information:
Consult the Product Monograph for important information relating to adverse reactions, interactions, and dosing instructions, which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-867-7426.

ASM=anti-seizure medication; DRESS=Drug Reaction with Eosinophilia and Systemic Symptoms.

StudIES C017 & C013

C017 STUDY DESIGN

C013 STUDY DESIGN

C013 STUDY DESIGN

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)¹

Rare cases of DRESS have been reported following treatment with XCOPRI, including one fatality. These events appear to have occurred at high initial dose (50-200 mg) and at a faster-than-recommended titration schedule to target maintenance dose.

No cases were reported in patients following the recommended titration schedule during the clinical trials. XCOPRI should be initiated at a daily dose of 12.5 mg and slowly titrated to the target maintenance dose over several weeks. Caution should be taken when using XCOPRI in patients with medical history of DRESS or using concomitant drugs, including other anti-seizure medications (ASMs), that are associated with such hypersensitivity reactions.

In two randomized, double-blind, placebo-controlled trials

XCOPRI was generally well tolerated¹

Study design

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As an adjunct to other ASMs:

≥50% responder rate was significantly higher for XCOPRI vs. placebo^1,2

Secondary Endpoint:

Proportion of patients who achieved ≥50% seizure frequency reduction during the double-blind treatment period

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Study C017 data are based on a starting dose of 50 mg/day and a titration of 50 mg/day every week until 100 mg/day or 200 mg/day was reached, and then increased by 100 mg/day every week in patients randomized to 400 mg/day. This differs from the recommended starting dose and titration schedule in the XCOPRI Product Monograph.

XCOPRI is recommended at a starting dose of 12.5 mg/day for 2 weeks, then 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks, then increased by 50 mg every 2 weeks until 200 mg/day. If needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg/day every 2 weeks to a maximum daily dose of 400 mg.

Rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including one fatality, have been reported following treatment with XCOPRI. These events appear to have occurred at high initial dose (50-200 mg) and at a faster-than-recommended titration of XCOPRI to target maintenance dose. XCOPRI should be initiated at a daily dose of 12.5 mg and slowly titrated to the target maintenance dose over several weeks.

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• Patient Support Program
• Patient Support Program

HOME

Study C017 data are based on a starting dose of 50 mg/day and a titration of 50 mg/day every week until 100 mg/day or 200 mg/day was reached, and then increased by 100 mg/day every week in patients randomized to 400 mg/day. This differs from the recommended starting dose and titration schedule in the XCOPRI Product Monograph.

XCOPRI is recommended at a starting dose of 12.5 mg/day for 2 weeks, then 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks, then increased by 50 mg every 2 weeks until 200 mg/day. If needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg/day every 2 weeks to a maximum daily dose of 400 mg.

Rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including one fatality, have been reported following treatment with XCOPRI. These events appear to have occurred at high initial dose (50-200 mg) and at a faster-than-recommended titration of XCOPRI to target maintenance dose. XCOPRI should be initiated at a daily dose of 12.5 mg and slowly titrated to the target maintenance dose over several weeks.

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