Ztalmy

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Ztalmy Generic Name & Formulations

General Description

Ganaxolone 50mg/mL; oral susp; cherry flavor.

Pharmacological Class

GABAA receptor modulator.

How Supplied

Oral susp (135mL)—1, 5

Generic Availability

NO

Mechanism of Action

The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS.

Ztalmy Indications

Indications

Seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Ztalmy Dosage and Administration

Adults and Children

<2yrs: not established. Take with food. Give 3 times daily in equally divided doses using oral syringe. ≥2yrs (≤28kg; dose based on body wt.): initially 18mg/kg/day for Days 1–7; 33mg/kg/day for Days 8–14; 48mg/kg/day for Days 15–21; then 63mg/kg/day thereafter; (>28kg): initially 450mg/day for Days 1–7; 900mg/day for Days 8–14; 1350mg/day for Days 15–21; then 1800mg/day thereafter. Severe hepatic impairment (Child-Pugh class C): (≤28kg; dose based on body wt.): initially 6mg/kg/day for Days 1–7; 11mg/kg/day for Days 8–14; 16mg/kg/day for Days 15–21; then 21mg/kg/day thereafter; (>28kg): initially 150mg/day for Days 1–7; 300mg/day for Days 8–14; 450mg/day for Days 15–21; then 600mg/day thereafter.

Ztalmy Contraindications

Not Applicable

Ztalmy Boxed Warnings

Not Applicable

Ztalmy Warnings/Precautions

Warnings/Precautions

Monitor for somnolence and sedation. Monitor for depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Avoid abrupt cessation. Withdraw gradually. Severe hepatic impairment (Child-Pugh class C): dose adjustment needed. Pregnancy. Nursing mothers.

Ztalmy Pharmacokinetics

Absorption

Time to maximum plasma concentration (Tmax): 2–3 hours.

Distribution

Plasma protein bound: ~99%.

Metabolism

Hepatic (CYP3A4/5, CYP2B6, CYP2C19, CYP2D6). 

Elimination

Fecal (55%), renal (18%). Half-life: 34 hours.

Ztalmy Interactions

Interactions

Avoid concomitant strong or moderate CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital, primidone); if unavoidable, consider increasing Ztalmy dose (up to max daily dose). May increase the risk of somnolence and sedation with concomitant other CNS depressants (eg, opioids, antidepressants, alcohol).

Ztalmy Adverse Reactions

Adverse Reactions

Somnolence, pyrexia, upper respiratory tract infection, salivary hypersecretion, seasonal allergy, sedation, bronchitis, influenza, gait disturbance, nasal congestion.

Ztalmy Clinical Trials

See Literature

Ztalmy Note

Not Applicable

Ztalmy Patient Counseling

See Literature