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Ztalmy
Ztalmy (ganaxolone) is a neuroactive steroid used to treat seizures associated with CDKL5 deficiency disorder (CDD), a rare genetic disorder that affects brain development and leads to severe developmental delays and drug-resistant epilepsy. Ztalmy works by enhancing the activity of GABA-A receptors in the brain, which helps reduce the occurrence and severity of seizures. Ztalmy is the first FDA-approved treatment specifically for seizures in CDKL5 deficiency disorder.
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Frequently Asked Questions
How long does it take for Ztalmy to start working?
The effects of Ztalmy on reducing seizures may be seen within a few weeks of starting treatment, but it may take longer to see the full benefit, especially as the dose is gradually increased.
Can Ztalmy be used with other anti-seizure medications?
Yes, Ztalmy is often used in combination with other anti-seizure medications to help manage seizures, particularly in patients with refractory epilepsy. Always consult your healthcare provider to ensure safe and effective use with other medications.
What should I do if I miss a dose of Ztalmy?
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Can Ztalmy be used for conditions other than CDKL5 deficiency disorder?
Ztalmy is specifically approved for the treatment of seizures associated with CDKL5 deficiency disorder. It is not approved for other seizure disorders or conditions, though research is ongoing into other potential uses.
Is Ztalmy safe for long-term use?
Yes, Ztalmy is designed for long-term use in managing seizures in patients with CDKL5 deficiency disorder, but regular monitoring by a healthcare provider is required to ensure it remains safe and effective.
Comprehensive Drug Guide
How Does Ztalmy Work?
Ztalmy works by binding to and enhancing the activity of GABA-A receptors, which are involved in inhibitory neurotransmission in the brain. By increasing the effects of GABA, the brain's main inhibitory neurotransmitter, Ztalmy helps reduce neuronal excitability, leading to fewer and less severe seizures in patients with CDKL5 deficiency disorder.
Common Dosages
- Oral suspension 50 mg/mL
Typical Dosing
- For CDKL5 deficiency disorder (CDD): The recommended starting dose is 5 mg/kg taken orally three times daily, with the dose gradually increased over several weeks based on the patient's response. The maximum recommended dose is 21 mg/kg taken three times daily.
Typical Dosing
FDA Approved Indications
- Seizures associated with CDKL5 deficiency disorder (CDD) in patients aged 2 years and older.
Who Shouldn't Take Ztalmy?
- Known hypersensitivity to ganaxolone or any components of the formulation.
Advice From The Pharmacist
- Shake the bottle well before each dose of Ztalmy to ensure the medication is evenly distributed.
- Ztalmy can be taken with or without food, but it is recommended to take it with food to enhance absorption.
- Use the provided oral syringe to measure each dose accurately. Administer the dose directly into the mouth or mix it with a small amount of liquid or soft food.
- Store Ztalmy in the refrigerator and discard any unused portion after 30 days.
- Regular follow-up visits with your healthcare provider are necessary to adjust the dose and monitor for side effects.
Side Effects of Ztalmy
Common Side Effects
- Drowsiness
- Dizziness
- Fatigue
- Increased risk of infections (e.g., colds, respiratory infections)
Uncommon/Severe Side Effects
- Severe drowsiness or excessive sedation
- Suicidal thoughts or behaviors
- Severe allergic reactions (rash, swelling, difficulty breathing)
Risks and Warnings of Ztalmy
- Sedation and Drowsiness: Ztalmy can cause significant drowsiness, which may affect your ability to perform activities requiring mental alertness, such as driving or operating heavy machinery. Monitor for signs of excessive sedation and report them to your healthcare provider.
- Suicidal Thoughts: Like other anti-seizure medications, Ztalmy may increase the risk of suicidal thoughts or behaviors. Patients and caregivers should monitor for any signs of mood changes, depression, or suicidal ideation and seek medical help if these occur.
- Withdrawal Symptoms: Abruptly stopping Ztalmy may lead to withdrawal symptoms or an increase in seizure frequency. Always taper the dose under the supervision of your healthcare provider.
Interactions with Ztalmy
Common Drug Interactions
- CNS depressants (e.g., benzodiazepines, opioids): Combining Ztalmy with other medications that depress the central nervous system can increase the risk of sedation, respiratory depression, or other serious side effects.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): These drugs may decrease the effectiveness of Ztalmy by increasing its metabolism, leading to reduced blood levels.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): These drugs can increase the levels of Ztalmy in the blood, potentially increasing the risk of side effects.
Alternatives to Ztalmy
- Valproic acid (Depakote): An antiepileptic drug used for managing various types of seizures, including those associated with genetic disorders.
- Clobazam (Onfi): A benzodiazepine used as an adjunctive therapy for certain seizure disorders, including Lennox-Gastaut syndrome.
- Vigabatrin (Sabril): Another antiepileptic drug that is used for treating drug-resistant epilepsy in certain conditions, though it comes with risks of vision loss.
- Cannabidiol (CBD): Approved for the treatment of seizure disorders such as Dravet syndrome and Lennox-Gastaut syndrome.