Relgaabi

INDICATIONS & USAGE

RELGAABI is indicated for:

• Management of postherpetic neuralgia in adults
• Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

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DOSAGE AND ADMINISTRATION

Dosage for Postherpetic Neuralgia

In adults with postherpetic neuralgia, RELGAABI may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Dosage for Epilepsy with Partial Onset Seizures

Patients 12 Years of Age and Above

The starting dose is 300 mg three times a day. The recommended maintenance dose of RELGAABI is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been administered in long-term clinical studies. Doses of 3,600 mg/day have also been administered to a small number of patients for a relatively short duration. Administer RELGAABI three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours.

Pediatric Patients Age 3 to 11 Years

The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of RELGAABI in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of RELGAABI in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. RELGAABI may be administered as capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

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CONTRAINDICATIONS

Known hypersensitivity to RELGAABI or its ingredients

WARNINGS AND PRECAUTIONS

• Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established
• Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately
• Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired
• Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior
• Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms, or suicidal behavior and ideation have been observed after discontinuation
• Respiratory Depression: May occur with RELGAABI when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate
• Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were:

• Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema
• Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus
• Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility

To report SUSPECTED ADVERSE REACTIONS, Method Pharmaceuticals, Inc. at 1-877-250-3427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Prescribing Information: DailyMed