Cherry-flavored, sugar-free suspension suitable for ketogenic diets^1,2

ZTALMY must be administered with food¹

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

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

Days	Standard Dosage
Days	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*
Days	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 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.

Titration and maintenance dosing schedule in mg and mL

Select one (required):

Standard dosage
Adjusted dosage for
severe hepatic impairment†

PATIENT WEIGHT

Select one

kg lb

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. Total daily dose is an approximation.¹

Dosage in mg to mL conversion DOSAGE 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

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

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

FORMULATED WITH
THE NEEDS OF PATIENTS 2 YEARS AND OLDER WITH CDKL5 DEFICIENCY DISORDER (CDD) IN MIND

ZTALMY is a liquid formulation administered orally¹

Keto friendly

Given with food

No refrigeration

Titrate ZTALMY gradually and administer 3 times daily¹

Titrate based on tolerability¹

Titrate based on tolerability¹

Administer orally TID with food¹

Administer orally TID with food¹

Recommended titration schedule¹

Dosage by patient weight¹

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

Discontinuation of ZTALMY

Instructions for caregivers administering ZTALMY

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

Get patients started on ZTALMY

Questions? Sign up to stay informed or speak with a ZTALMY representative

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION AND USAGE

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

Healthcare provider website for ZTALMY® (ganaxolone) oral suspension CV

FORMULATED WITH THE NEEDS OF PATIENTS 2 YEARS AND OLDER WITH CDKL5 DEFICIENCY DISORDER (CDD) IN MIND

ZTALMY is a liquid formulation administered orally1

Keto friendly

Given with food

No refrigeration

Titrate ZTALMY gradually and administer 3 times daily1

Titrate based on tolerability1

Titrate based on tolerability1

Administer orally TID with food1

Administer orally TID with food1

Recommended titration schedule1

Dosage by patient weight1

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

Discontinuation of ZTALMY

Instructions for caregivers administering ZTALMY

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

Get patients started on ZTALMY

Questions? Sign up to stay informed or speak with a ZTALMY representative

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION AND USAGE

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

Healthcare provider website for ZTALMY® (ganaxolone)
oral suspension CV

FORMULATED WITH
THE NEEDS OF PATIENTS 2 YEARS AND OLDER WITH CDKL5 DEFICIENCY DISORDER (CDD) IN MIND

ZTALMY is a liquid formulation administered orally¹

Titrate ZTALMY gradually and administer 3 times daily¹

Titrate based on tolerability¹

Titrate based on tolerability¹

Administer orally TID with food¹

Administer orally TID with food¹

Recommended titration schedule¹

Dosage by patient weight¹

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