ZTALMY is a liquid formulation administered orally1

Keto friendly

Cherry-flavored, sugar-free suspension suitable for ketogenic diets1,2

Given with food

ZTALMY must be administered with food1

No refrigeration

Can be stored at room temperature1

Titrate ZTALMY gradually and administer 3 times daily1

Titrate based on tolerability1

Titrate based on tolerability1

  • Increase dosages no more frequently than every 7 days to reach
    maintenance dose1
  • Dosages are calculated by weight for patients ≤28 kg1
  • Dosages are set for patients weighing >28 kg1

Administer orally TID with food1

Administer orally TID with food1

  • Total daily dose is given in 3 doses throughout the day1
  • Cherry-flavored suspension (50 mg/mL ganaxolone) is administered by oral syringe1
  • ZTALMY must be given with food1

TID=3 times daily.

Recommended titration schedule1

Dosages by patient weight1

Days Patients ≤28 kg Patients >28 kg
Dosage Total Daily Dosage Dosage Total Daily Dosage
Titration Week 1
Days 1-7
6 mg/kg TID 18 mg/kg/day 150 mg TID 450 mg/day
Titration Week 2
Days 8-14
11 mg/kg TID 33 mg/kg/day 300 mg TID 900 mg/day
Titration Week 3
Days 15-21
16 mg/kg TID 48 mg/kg/day 450 mg TID 1350 mg/day
Maintenance
Day 22 + ongoing
21 mg/kg TID 63 mg/kg/day 600 mg TID 1800 mg/day
Days Patients ≤28 kg
Dosage Total Daily Dosage
Titration Week 1
Days 1-7
6 mg/kg TID 18 mg/kg/day
Titration Week 2
Days 8-14
11 mg/kg TID 33 mg/kg/day
Titration Week 3
Days 15-21
16 mg/kg TID 48 mg/kg/day
Maintenance
Day 22 + ongoing
21 mg/kg TID 63 mg/kg/day
Days Patients >28 kg
Dosage Total Daily Dosage
Titration Week 1
Days 1-7
150 mg TID 450 mg/day
Titration Week 2
Days 8-14
300 mg TID 900 mg/day
Titration Week 3
Days 15-21
450 mg TID 1350 mg/day
Maintenance
Day 22 + ongoing
600 mg TID 1800 mg/day

TID=3 times per day.

Calculate a patient dose in mg and mL for patients 2 years of age and older

Recommended maintenance dosage is 63 mg/kg/day divided TID, up to a maximum of 1800 mg/day.1

Each mL of ZTALMY oral suspension contains 50 mg of ganaxolone.1

See dosing section of Prescribing Information for more information.

Titration and maintenance dosing schedule in mg and mL
Select one
SEE RESULTS
Dosage in mg to mL conversion mg 3 times a day SEE RESULTS

Dosage information

Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in the recommended titration schedule table.1

Dosage adjustments in the pivotal trial

In the pivotal trial, 22% of patients taking ZTALMY had a dose interruption or reduction due to an adverse reaction—most frequently somnolence (10%) and sedation (2%)—compared with 16% of patients taking placebo.1

Drug Interactions

Coadministration of ZTALMY with CYP450 inducers, such as strong or moderate CYP3A4 inducers, will decrease ganaxolone exposure, which can lower the efficacy of ZTALMY. It is recommended to avoid concomitant use. If unavoidable, consider an increase in the dosage of ZTALMY; however, do not exceed the maximum daily dosage.1

Discontinuation of ZTALMY

Decrease the dose of ZTALMY gradually when discontinuing treatment. As with all antiepileptic drugs, abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.1

dipping a syringe into a bottle dipping a syringe into a bottle

Instructions for caregivers administering ZTALMY

dipping a syringe into a bottle dipping a syringe into a bottle

See the Medication Guide for Instructions for Use for complete instructions on how to properly prepare and administer ZTALMY.

Shake the bottle thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose.1

Measure and administer the prescribed dose using the oral syringe(s) provided by your pharmacist. A household teaspoon or tablespoon is not an adequate measuring device and should not be used.1

Discard any unused ZTALMY oral suspension after 30 days of first opening the bottle.1

Download How to Give ZTALMY for illustrated steps on preparation and administration.

HOW TO GIVE ZTALMY
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PRESCRIBING RESOURCES
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IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

  • Somnolence and Sedation: ZTALMY can cause somnolence and sedation. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. Monitor patients for these effects and advise them not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery.

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION AND USAGE

ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (incidence of at least 5% and at least twice the rate of placebo) were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy.

DRUG INTERACTIONS

Cytochrome P450 inducers will decrease ganaxolone exposure. Avoid concomitant use with strong or moderate CYP3A4 inducers; if unavoidable, consider a dosage increase of ZTALMY, but do not exceed the maximum recommended dosage.

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

ZTALMY contains ganaxolone, a Schedule V controlled substance (CV). Advise patients of the potential for abuse and dependence. It is recommended that ZTALMY be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation.

Please see full Prescribing Information.

References:

  1. ZTALMY [package insert]. Radnor, PA: Marinus Pharmaceuticals, Inc.; 2022.
  2. Leone A, De Amicis R, Lessa C, et al. Food and food products on the Italian market for ketogenic dietary treatment of neurological diseases. Nutrients. 2019;11(5):1104.