Treatment should be initiated and supervised by physicians with experience in the treatment of epilepsy. Posology Children and adolescents ZTALMY should be titrated gradually to achieve individual clinical response and tolerability.
Any patient not tolerating the dosing steps shown in the tables below, can be maintained at the lower dose for additional days before advancing to the next dose. If the next dose is still not tolerated, patients can drop back to the previous lower dose.
It is recommended that the total daily dose is administered in 3 equal doses throughout the day. , somnolence), provided that the total daily dose is administered. Patients weighing ≤ 28 kg The recommended maximum daily dose is 63 mg/kg/day given in three separate doses (every 8 hours).
A minimum dose of 33 mg/kg/day is generally required. 42 63 mg/kg Patients weighing > 28 kg The recommended maximum daily dose is 1 800 mg per day given in three separate doses (every 8 hours). A minimum dose of 900 mg/day is generally required.
The recommended titration schedule for patients weighing more than 28 kg is shown below: Week Dose (given 3 times a day) mL per single dose Total daily dose Week 1 150 mg 3 450 mg Week 2 300 mg 6 900 mg Week 3 450 mg 9 1 350 mg Week 4 – ongoing 600 mg 12 1 800 mg Adults The efficacy and safety of treatment initiation with ZTALMY in patients aged over 17 years have not yet been established.
In adolescents in whom a clear treatment benefit has been demonstrated, treatment may be continued into adulthood. 2) Discontinuation If ZTALMY must be discontinued, the dose should be decreased gradually. For patients weighing 28 kg or less, the decrease in total daily dose should be 15 mg/kg every four days.
For patients weighing more than 28 kg, the decrease in total daily dose should be 450 mg every four days. ZTALMY may be stopped immediately and without down-titration in the case of an emergency, however, a down-titration is recommended to minimize the risk of increased seizure frequency and status epilepticus.
Missed doses Missed doses may be taken up to 4 hours before the next scheduled dose. When the next dose is due in less than 4 hours, it is recommended to skip the dose and to continue with the next scheduled dose. Special populations Elderly There is no information on the use of ZTALMY in patients with CDD who are 65 years of age and over.
Doses in elderly patients should be chosen carefully based on clinical status and concomitant medicinal products. Close clinical monitoring is recommended when initiating treatment in the elderly. Renal impairment ZTALMY can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment.
There is no experience in patients with end-stage renal disease. 2). 4). For patients with severe hepatic impairment (Child-Pugh C) the initial target dose should be one-third the recommended target dose. The dose titration should be performed as detailed in the table(s) below.
14 21 mg/kg The dose in patients with severe hepatic impairment weighing more than 28 kg is shown below: Week Dose (given 3 times a day) mL per single dose Total daily dose Week 1 50 mg 1 150 mg Week 2 100 mg 2 300 mg Week 3 150 mg 3 450 mg Week 4 – ongoing 200 mg 4 600 mg Higher or lower doses may be considered in patients with severe hepatic impairment based on individual clinical response and tolerability.
Paediatric population There is no relevant use of ZTALMY in infants below 6 months of age. The safety and efficacy of ZTALMY in children aged less than 2 years have not yet been established. No data are available. Method of administration Oral use only.
No data are available on the feasibility of administration through an enteral feeding tube. 2). Do not mix with food or drinks prior to administration. ZTALMY should only be administered using the reusable oral dosing syringes provided in each pack for a more accurate dose administration.
1 mL increment corresponds to 5 mg ganaxolone). The calculated dose should be rounded to the nearest graduated increment. If the calculated dose is 3 mL (150 mg) or less, the smaller 3 mL oral syringe should be used. If the calculated dose is more than 3 mL (150 mg) the larger 12 mL oral syringe should be used.