Ztalmy
(Ganaxolone)Dosage & Administration
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Ztalmy Prescribing Information
Dosage and Administration (ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3)] .The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.
ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3)] .The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients with severe hepatic impairment and weighing 28 kg or less are included in Table 3, and dosage recommendations for patients with severe hepatic impairment (Child-Pugh class C) weighing more than 28 kg are included in Table 4. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 3 and Table 4. No dosage adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
| 10/2025 |
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.
- Administer ZTALMY orally three times daily with food. ()
2.1 Dosage InformationZTALMY is administered by mouth three times daily and must be taken with food
[see Clinical Pharmacology (12.3)].The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.
Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily6 mg/kg/day 1 to 7 4 mg/kg three times daily12 mg/kg/day 8 to 14 8 mg/kg three times daily24 mg/kg/day 15 to 21 14 mg/kg three times daily42 mg/kg/day 22 to 28 21 mg/kg three times daily63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily150 mg 1 to 7 100 mg three times daily300 mg 8 to 14 200 mg three times daily600 mg 15 to 21 400 mg three times daily1,200 mg 22 to 28 600 mg three times daily1,800 mg 29 and thereafter - Titrate ZTALMY gradually according to the recommended schedules. See full prescribing information. ()
2.1 Dosage InformationZTALMY is administered by mouth three times daily and must be taken with food
[see Clinical Pharmacology (12.3)].The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.
Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily6 mg/kg/day 1 to 7 4 mg/kg three times daily12 mg/kg/day 8 to 14 8 mg/kg three times daily24 mg/kg/day 15 to 21 14 mg/kg three times daily42 mg/kg/day 22 to 28 21 mg/kg three times daily63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily150 mg 1 to 7 100 mg three times daily300 mg 8 to 14 200 mg three times daily600 mg 15 to 21 400 mg three times daily1,200 mg 22 to 28 600 mg three times daily1,800 mg 29 and thereafter - Dosage for patients weighing 28 kg or less ():
2.1 Dosage InformationZTALMY is administered by mouth three times daily and must be taken with food
[see Clinical Pharmacology (12.3)].The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.
Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily6 mg/kg/day 1 to 7 4 mg/kg three times daily12 mg/kg/day 8 to 14 8 mg/kg three times daily24 mg/kg/day 15 to 21 14 mg/kg three times daily42 mg/kg/day 22 to 28 21 mg/kg three times daily63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily150 mg 1 to 7 100 mg three times daily300 mg 8 to 14 200 mg three times daily600 mg 15 to 21 400 mg three times daily1,200 mg 22 to 28 600 mg three times daily1,800 mg 29 and thereafter - the starting dosage is 2 mg/kg three times daily (6 mg/kg/day)
- the maximum dosage is 21 mg/kg three times daily (63 mg/kg/day).
- Dosage for patients weighing over 28 kg ():
2.1 Dosage InformationZTALMY is administered by mouth three times daily and must be taken with food
[see Clinical Pharmacology (12.3)].The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.
Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily6 mg/kg/day 1 to 7 4 mg/kg three times daily12 mg/kg/day 8 to 14 8 mg/kg three times daily24 mg/kg/day 15 to 21 14 mg/kg three times daily42 mg/kg/day 22 to 28 21 mg/kg three times daily63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily150 mg 1 to 7 100 mg three times daily300 mg 8 to 14 200 mg three times daily600 mg 15 to 21 400 mg three times daily1,200 mg 22 to 28 600 mg three times daily1,800 mg 29 and thereafter - the starting dosage is 50 mg three times daily (150 mg daily)
- the maximum dosage is 600 mg three times daily (1800 mg daily).
- Patients with severe hepatic impairment: see full prescribing information for dosage recommendation. ()
2.3 Dosage in Patients with Severe Hepatic ImpairmentZTALMY is administered by mouth three times daily and must be taken with food
[see Clinical Pharmacology (12.3)].The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients with severe hepatic impairment and weighing 28 kg or less are included in Table 3, and dosage recommendations for patients with severe hepatic impairment (Child-Pugh class C) weighing more than 28 kg are included in Table 4. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 3 and Table 4.
No dosage adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Table 3 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing 28 kg or Less Dosage Total Daily DoseApproximate daily dose. Days 0.66 mg/kg three times daily2 mg/kg/day 1 to 7 1.33 mg/kg three times daily4 mg/kg/day 8 to 14 2.66 mg/kg three times daily8 mg/kg/day 15 to 21 4.66 mg/kg three times daily14 mg/kg/day 22 to 28 7 mg/kg three times daily21 mg/kg/day 29 and thereafter Table 4 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing More Than 28 kg Dosage Total Daily DoseApproximate daily dose. Days 17 mg three times daily50 mg 1 to 7 33 mg three times daily100 mg 8 to 14 67 mg three times daily200 mg 15 to 21 133 mg three times daily400 mg 22 to 28 200 mg three times daily600 mg 29 and thereafter
Oral suspension: 50 mg/mL ganaxolone. Each bottle contains 110 mL of white to off-white cherry flavored suspension.
- Pregnancy: Based on animal data, may cause fetal harm. ()
8.1 PregnancyPregnancy Exposure RegistryThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as ZTALMY, during pregnancy. Encourage women who are taking ZTALMY during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Risk SummaryThere are no available data on ZTALMY use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal studies, adverse effects on development were observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the maximum recommended human dose (MRHD) of 1800 mg. In addition, neuronal death was observed in rats exposed to ganaxolone during a period of brain development that begins during the third trimester of pregnancy in humans and continues during the first few years after birth.
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated populations are unknown.
Clinical Considerations
Disease-associated Maternal and/or Embryofetal Risk
Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality. The risk of maternal or fetal injury may be greatest for patients with untreated or poorly controlled convulsive seizures. Women with epilepsy who become pregnant should not abruptly discontinue antiepileptic drugs, including ZTALMY, due to the risk of status epilepticus or severe seizures, which may be life-threatening
[see Warnings and Precautions (5.3)].DataAnimal DataIn an embryofetal development study in mice, oral administration of ganaxolone (0, 50, 175, or 300 mg/kg/day) throughout the period of organogenesis resulted in increased incidences of fetal malformations (external and/or visceral) at all doses in the absence of maternal toxicity. Maternal plasma drug exposures (AUC) at the low-effect dose (50 mg/kg/day) for embryofetal developmental toxicity in the mouse were approximately 10-fold lower than that in humans at the MRHD.
In a combined embryofetal development and pre- and postnatal development study in rats, ganaxolone (0, 10, 20, or 40 mg/kg/day) was administered orally to females throughout gestation and lactation. There were no effects on embryofetal growth, survival, or morphology; however, adverse effects on offspring growth (delayed reflex development, decreased body weight gain) were observed during the postnatal period (prior to and after weaning) at the high dose, and neurobehavioral impairment (decreased locomotor activity) was observed in the offspring at the two highest doses. The no-effect dose (10 mg/kg/day) for pre- and postnatal developmental toxicity in rats was associated with maternal drug exposures less than that in humans at the MRHD.
Oral administration of ganaxolone (0, 20, 45, or 90 mg/kg/day) to rats on postnatal day (PND) 7 resulted in widespread apoptotic neurodegeneration in the brain (cortex, thalamus, and hippocampus) at all doses; a no-effect dose was not identified. Brain development on PND 7 in rat corresponds to that beginning in humans during the third trimester of pregnancy and continuing for the first several months to years after birth
[see Use in Specific Populations (8.4)].
None.