Ztalmy
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.
What is Ztalmy (ganaxolone)?
What is Ztalmy (ganaxolone) used for?
- Seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years and older
How Ztalmy (ganaxolone) works
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.
Drug facts
Risks and warnings for Ztalmy (ganaxolone)
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.
Sleepiness
- 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.
Suicidal thoughts and behaviors
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.
Side effects of Ztalmy (ganaxolone)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low energy/sleepy during the day (38%)
- Fever (18%)
- Upper respiratory tract infection (10%)
- Sleepiness (6%)
- Excessive drooling (6%)
- Allergies (6%)
Less Common Side Effects
- Bronchitis
- Walking abnormally
- Stuffy nose
Ztalmy (ganaxolone) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Suicidal thoughts and behaviors: anxiety, panic attacks, difficulty sleeping, feeling angry or irritated, restlessness
The following Ztalmy (ganaxolone) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Drowsiness
- Excessive drooling
- Fever
- Runny or stuffy nose
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Pros and cons of Ztalmy (ganaxolone)
Pros
- 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
Cons
- 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
Pharmacist tips for Ztalmy (ganaxolone)
- 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.
Common questions about Ztalmy (ganaxolone)
Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a rare genetic problem that causes seizures at a young age, usually around the time of birth. It also causes problems with brain development, motor, speech, and vision. This happens because your body is missing important proteins that are responsible for brain function and development due to problems with the CDKL5 gene. Ztalmy (ganaxolone) helps by slowing down brain activity, which helps to lower the frequency of seizures.
No. If you wish to stop taking Ztalmy (ganaxolone), talk to your provider first about a plan to slowly lower the dose before stopping it completely. This is because suddenly stopping Ztalmy (ganaxolone) can raise your risk for seizures.
Yes, Ztalmy (ganaxolone) should be taken with food. This will allow most of the medication to be absorbed into your body so it can work well for you. It's not clear how well Ztalmy (ganaxolone) will work for you if you take it on an empty stomach.
Ztalmy (ganaxolone) is a controlled medication that's categorized as Schedule V because it has a risk of abuse. Abuse is when a medication is used for non-medical reasons for its desirable physical or emotional effects. Although unknown, long-term Ztalmy (ganaxolone) use might also lead to dependence (when your body depends on the medication to function normally). For this reason, it's recommended to have your provider slowly lower the dose before stopping it completely.
Ztalmy (ganaxolone) hasn't been studied in human pregnancy, so it's not known if it's safe for you and your baby. In animal studies, Ztalmy (ganaxolone) caused harm to unborn babies when mothers were exposed to it. If you're pregnant or thinking of getting pregnant, talk to your provider to see if there are safer options for you. If you do become pregnant during Ztalmy (ganaxolone) treatment, let your provider know. You're encouraged to enroll in a pregnancy exposure registry called the North American Antiepileptic Drug Pregnancy Registry by visiting their website or calling 1-888-233-2334. This registry monitors the health outcomes of both you and your baby during pregnancy.
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Ztalmy (ganaxolone) dosage
Bottle of oral suspension| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 110ml of 50mg/ml | 8 bottles | $22,331.92 | $2,791.49 |
Typical dosage for Ztalmy (ganaxolone)
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.
How much does Ztalmy (ganaxolone) cost?
$22,331.92
Ztalmy (ganaxolone) images
