Ztalmy (ganaxolone) is an oral suspension used to treat seizures in people ages 2 and older with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD), a rare genetic condition that causes seizures and other developmental problems. It's the first and currently only FDA-approved medication to treat this condition.
Seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years and older
It's not exactly known how Ztalmy (ganaxolone) works to treat CDD, but it's thought to work by raising the activity of gamma-aminobutyric acid (GABA), an important chemical in the body that slows down brain activity. So, Ztalmy (ganaxolone) works to calm down the brain to reduce the frequency of seizures.
Ztalmy (ganaxolone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Higher dose of Ztalmy (ganaxolone) | Alcohol use | Taking other medications that cause sleepiness
Ztalmy (ganaxolone) can make you or your child very sleepy, which can affect the ability to focus, think, or react. This side effect is more likely to happen or be more intense if you drink alcohol while taking this medication or take other medications that cause sleepiness (like opioids, benzodiazepines, or sleep medications). Don't drive or operate machinery until you know how this medication affects you.
Seizure medications, like Ztalmy (ganaxolone), might raise your risk for thoughts of suicide or harming yourself. If you or your child experiences suicidal thoughts or unusual behavior (e.g., anxiety, panic attacks, difficulty sleeping, feeling angry or irritated) while taking Ztalmy (ganaxolone), call the provider right away.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Works well to treat CDD-related seizures
Available as a cherry-flavored suspension to make it easier to take
Dose can be adjusted based on how you respond
Needs to be taken 3 times per day with food
Brand name only, which can be expensive
Unknown if safe or works well in children younger than 2 years old
You'll need an adapter and syringe to prepare a dose of Ztalmy (ganaxolone). Ask your pharmacist for those supplies if you don't have them. Don't use household spoons to measure the medication because they're not accurate and might cause you to take the wrong dose.
Before drawing up the dose of Ztalmy (ganaxolone), make sure to shake the bottle for at least 1 minute and then wait 1 minute to draw up the dose. This will make sure you're getting the correct amount of medication.
Make sure you understand how to properly give your child Ztalmy (ganaxolone) so you don't waste any of the medication. Read the instructions for use and contact your child's provider if you have any questions.
Throw away any unused Ztalmy (ganaxolone) after 30 days of opening the bottle, since it might not work well after this time.
Ztalmy (ganaxolone) can interact with a lot of commonly used medications, including over-the-counter (OTC) medications and supplements. Make sure to tell your provider about all of the medications you're taking before starting Ztalmy (ganaxolone).
Ztalmy (ganaxolone) can make you sleepy during the day, which can affect your ability to focus, think, or react. Don't drive or operate machinery until you know how this medication affects you.
Store Ztalmy (ganaxolone) at room temperature and out of reach of children.
Ztalmy (ganaxolone) is dosed based on you or your child's weight.
More than 28 kg (62 lbs): The typical starting dose is 150 mg by mouth with food 3 times a day for 1 week. Your provider will then slowly raise the dose over time up to 600 mg 3 times a day depending on how you tolerate the medication.
28 kg (62 lbs) or less: The typical starting dose is 6 mg/kg by mouth with food 3 times a day for 1 week. Your provider will then slowly raise the dose over time up to 21 mg/kg 3 times a day depending on how you tolerate the medication.
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