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
  • Dosage adjustments are required for patients with severe hepatic impairment1

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 Standard Dosage Severe Hepatic Impairment*
Patients ≤28 kg Patients >28 kg Patients ≤28 kg Patients >28 kg
Titration Week 1
Days 1-7 		6 mg/kg TID
(18 mg/kg/day)		 150 mg TID
(450 mg/day)		 2 mg/kg TID
(6 mg/kg/day)		 50 mg TID
(150 mg/day)
Titration Week 2
Days 8-14 		11 mg/kg TID
(33 mg/kg/day)		 300 mg TID
(900 mg/day)		 3.66 mg/kg TID
(11 mg/kg/day)		 100 mg TID
(300 mg/day)
Titration Week 3
Days 15-21 		16 mg/kg TID
(48 mg/kg/day)		 450 mg TID
(1350 mg/day)		 5.33 mg/kg TID
(16 mg/kg/day)		 150 mg TID
(450 mg/day)
Maintenance
Day 22 + Ongoing 		21 mg/kg TID
(63 mg/kg/day)		 600 mg TID
(1800 mg/day)		 7 mg/kg TID
(21 mg/kg/day)		 200 mg TID
(600 mg/day)
Days Standard Dosage
Patients ≤28 kg Patients >28 kg
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 Severe Hepatic Impariment*
Patients ≤28 kg Patients >28 kg
Titration Week 1
Days 1-7 		2 mg/kg TID
(6 mg/kg/day)		 50 mg TID
(150 mg/day)
Titration Week 2
Days 8-14 		3.66 mg/kg TID
(11 mg/kg/day)		 100 mg TID
(300 mg/day)
Titration Week 3
Days 15-21 		5.33 mg/kg TID
(16 mg/kg/day)		 150 mg TID
(450 mg/day)
Maintenance
Day 22 + Ongoing 		7 mg/kg TID
(21 mg/kg/day)		 200 mg TID
(600 mg/day)

*Dosage adjustments are required for patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustments are necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.1

TID=3 times per day.

Calculate a patient dose in mg and mL for patients 2 years of age and older1

  • The recommended maintenance dosage for patients with normal, mild, or moderate hepatic impairment is 63 mg/kg/day, divided TID
  • The maximum dosage is 1800 mg/day

For patients with severe hepatic impairment, dosage adjustments are required during titration and maintenance.

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

See dosing section of Prescribing Information for more information.

Titration and maintenance dosing schedule in mg and mL
Standard dosage
Adjusted dosage for
severe hepatic impairment
Select one
SEE RESULTS

†Dosage adjustments are required for patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustments are necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.1

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

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 the specialty pharmacy. 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 (38%), pyrexia (18%), salivary hypersecretion (6%), and seasonal allergy (6%).

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.; 2023.
  2. Leone A, De Amicis R, Lessa C, et al. Nutrients. 2019;11(5):1104.