ZTALMY recommended titration schedule — click here to access the latest prescribing information

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

  • 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

  • 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

Dosage by patient weight1

DaysStandard Dosage
Patients ≤28 kgPatients >28 kg
Titration Week 1
Days 1-7 		2 mg/kg three times daily (6 mg/kg/day)50 mg three times daily (150 mg)
Titration Week 2
Days 8-14 		4 mg/kg three times daily (12 mg/kg/day)100 mg three times daily (300 mg)
Titration Week 3
Days 15-21 		8 mg/kg three times daily (24 mg/kg/day)200 mg three times daily (600 mg)
Titration Week 4
Days 22-28 		14 mg/kg three times daily (42 mg/kg/day)400 mg three times daily (1,200 mg)
Maintenance
Day 29 and thereafter 		21 mg/kg three times daily (63 mg/kg/day)600 mg three times daily (1,800 mg)
DaysSevere Hepatic Impariment*
Patients ≤28 kgPatients >28 kg
Titration Week 1
Days 1-7 		0.66 mg/kg three times daily (2 mg/kg/day)17 mg three times daily (50 mg)
Titration Week 2
Days 8-14 		1.33 mg/kg three times daily (4 mg/kg/day)33 mg three times daily (100 mg)
Titration Week 3
Days 15-21 		2.66 mg/kg three times daily (8 mg/kg/day)67 mg three times daily (200 mg)
Titration Week 4
Days 22-28 		4.66 mg/kg three times daily (14 mg/kg/day)133 mg three times daily (400 mg)
Maintenance
Day 29 and thereafter 		7 mg/kg three times daily (21 mg/kg/day)200 mg three times daily (600 mg)

*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 Total daily dose is an approximation.

Calculate a patient dose in mg and mL for patients 2 years 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 1,800 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.

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

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.

UGT inhibitors may increase ganaxolone exposure. Consider a reduction of ZTALMY maintenance dose when initiating UGT inhibitors.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

See the Medication Guide and 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.

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 and older.

IMPORTANT SAFETY INFORMATION

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.

  • Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. Monitor patients taking ZTALMY for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. When considering ZTALMY, or any other AED, balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness.

  • Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

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.

UGT inhibitors may increase ganaxolone exposure. Consider a reduction of ZTALMY maintenance dose when initiating UGT inhibitors.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Use caution when ZTALMY is administered to pregnant women as there are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, developmental adverse effects were observed following exposure during organogenesis or throughout gestation and lactation.

  • Lactation: ZTALMY is excreted in human milk at concentrations resulting in a dose to the breastfed infant of less than 1% maternal dose. The effects of ZTALMY on milk production and the breastfed infant are unknown.

  • Hepatic Impairment: Administration of ZTALMY in patients with severe hepatic impairment (Child‑Pugh class C) results in elevated ganaxolone plasma concentrations. Therefore, dosage adjustment in these patients during titration and maintenance is required. No dosage adjustment is necessary in patients with mild (Child‑Pugh class A) or moderate (Child‑Pugh class B) hepatic impairment.

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.

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 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.

UGT inhibitors may increase ganaxolone exposure. Consider a reduction of ZTALMY maintenance dose when initiating UGT inhibitors.

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