What is Ztalmy?
- Ztalmy is a prescription medicine that is used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years of age and older.
- [There is a pending DEA decision for control of Ztalmy (ganaxolone) under the Controlled Substances Act. A statement for patients about abuse and dependence risks cannot be completed at this time.]
- It is not known if this medicine is safe and effective in children under 2 years of age.
Ztalmy can cause serious side effects, including:
- Ztalmy may cause sleepiness. Taking Ztalmy with central nervous system (CNS) depressants including alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ztalmy affects you or your child.
- Like other antiepileptic drugs, Ztalmy may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Do not stop treatment without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause you or your child to have seizures more often or seizures that do not stop (status epilepticus).
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Before taking Ztalmy
Before you start treatment, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
- drink alcohol.
- have or have had depression, mood problems, or suicidal thoughts or behavior.
- have abused or been dependent on prescription medicines, street drugs, or alcohol.
- have liver problems.
- are pregnant or plan to become pregnant. Tell your healthcare provider right away if you or your child become pregnant while taking Ztalmy. You and your healthcare provider will decide if you or your child should take Ztalmy while pregnant.
- if you or your child become pregnant while taking Ztalmy, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to http://www. aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
- are breastfeeding or plan to breastfeed. Ztalmy may pass into breast milk. Talk to your healthcare provider about the best way to feed your or your child’s baby while taking Ztalmy.
What other drugs will affect Ztalmy?
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ztalmy may affect the way other medicines work, and other medicines may affect how Ztalmy works. Do not stop or start taking other medicines without talking to your healthcare provider.
Especially tell your healthcare provider if you or your child take:
Know the medicines you or your child take. Keep a list of them to show your healthcare provider or pharmacist when you or your child get a new medicine.
How should I take Ztalmy?
- Read the Instructions for Use that comes with your prescription for information on the right way to use Ztalmy.
- Take or give Ztalmy exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much to take or give and when to take or give it.
- Measure each dose using the bottle adapter and oral dosing syringes provided by your pharmacist. Do not use a household teaspoon or tablespoon. If your dose of Ztalmy is less than 1 mL, your pharmacist will provide you with an appropriately sized syringe to take or give Ztalmy.
- Take or give Ztalmy with food.
- In case of overdose, get medical help or contact a live Poison Center expert right away.
What should I avoid while taking Ztalmy?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ztalmy affects you or your child. Ztalmy may cause you or your child to feel sleepy.
Usual Adult and Pediatric Dose for Seizures Associated with CDKL5 Deficiency Disorder
- Dosage for patients weighing 28 kg or less: the starting dosage is 6 mg/kg three times daily (18 mg/kg/day) and the maximum dosage is 21 mg/kg three times daily (63 mg/kg/daily).
-Dosage for patients weighing over 28 kg: the starting dosage is 150 mg three times daily (450 mg daily) and the maximum dosage is 600 mg three times daily (1800 mg daily)
- Ztalmy is administered by mouth three times daily and must be taken with food.
Recommended Titration Schedule for Patients Weighing 28 kg or Less
|Dosage||Total Daily Dosage||Days|
|6 mg/kg three times daily||18 mg/kg/day||1 to 7|
|11 mg/kg three times daily||33 mg/kg/day||8 to 14|
|16 mg/kg three times daily||48 mg/kg/day||15 to 21|
|21 mg/kg three times daily||63 mg/kg/day||22 to ongoing|
Recommended Titration Schedule for Patients Weighing More Than 28 kg
|Dosage||mL per Dose||Total daily dosage||Days|
|150 mg three times daily||3||450 mg||1 to 7|
|300 mg three times daily||6||900 mg||8 to 14|
|450 mg three times daily||9||1350 mg||15 to 21|
|600 mg three times daily||12||1800 mg||22 to ongoing|
- Use: treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
Ztalmy side effects
Ztalmy can cause serious side effects, including:
- See Important information.
The most common side effects include:
- excessive saliva or drooling
- seasonal allergy
These are not all of the possible side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or your child, or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also contact Marinus Pharmaceuticals at 844-627-4687.
How should I store Ztalmy?
- Store Ztalmy oral suspension between 59°F to 86°F (15°C to 30°C).
- Always store the oral suspension in its original bottle in an upright position.
- Keep the child-resistant cap tightly closed.
- Use the oral suspension within 30 days of first opening the bottle. Throw away (dispose of) any unused medicine after 30 days.
Keep all medicines out of the reach of children and pets.
General Information about the safe and effective use of Ztalmy.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist of healthcare provider for information that is written for health professionals.
What are the ingredients in Ztalmy?
Active ingredient: ganaxolone
Inactive ingredients: artificial cherry flavor, citric acid, hypromellose, methylparaben, polyvinyl alcohol, propylparaben,
purified water, simethicone emulsion, sodium benzoate, sodium citrate, sodium lauryl sulfate and sucralose.
INSTRUCTIONS FOR USE
- Follow your healthcare provider’s instructions for how to take or give Ztalmy.
- Ztalmy oral suspension should always be given with food.
- Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose.
- Always use the oral syringe provided by your pharmacist to make sure you measure the right amount.
- Do not use the oral suspension after the expiration date on the package and each bottle.
- Use the oral suspension within 30 days of first opening the bottle.
- After 30 days of first opening the bottle, safely throw away (dispose of) any oral suspension that has not been used.
Each package contains:
- 1 bottle of Ztalmy with a child resistant cap:
Supplies not included in the package:
- press-in bottle adapter
- oral syringe
You can get a press-in bottle adapter and oral syringes from your pharmacy. Your pharmacist can help you choose the right press-in bottle adapter and oral syringe to use with Ztalmy.
Call your pharmacist right away if you do not have a press-in bottle adapter and the right sized oral syringe to use with your medicine.
Note: If you lose or damage an oral syringe, or cannot read the markings, contact your pharmacist for a new oral syringe.
Follow the instructions below to use the press-in bottle adapter and oral syringe to measure and take or give Ztalmy.
Prepare the bottle
1. Hold the bottle in your hand and shake it up and down well for 1 minute.
Always shake the bottle well for 1 minute then let the bottle stand for 1 minute so that any foam build up during shaking can settle before measuring and giving each dose of Ztalmy. This helps you measure the correct amount of medicine.
Note: This step is for each dose of the medicine.
2. Remove the child-resistant cap by pushing down while turning the cap to the left (counter-clockwise).
3. Puncture and peel off the induction seal from the bottle.
Note: This step is only for the first use of the bottle.
4. Push the press-in-bottle adapter firmly into the bottle. Firmly grasp the bottle in one hand and insert the press-in bottle adapter all the way in the bottle with the other hand using constant pressure. Make sure the press-in bottle adaptor is fully inserted. If not fully inserted, small parts such as the press-in bottle adaptor may become a choking hazard for children and pets.
Note: Do not remove the press-in bottle adapter from the bottle after it is inserted.
Prepare the dose
Your healthcare provider will tell you how much Ztalmy to take or give.
5. Gather the oral syringe, push the plunger all the way down then insert the tip of the oral syringe fully into the press-in bottle adapter. With the oral syringe in place, turn the bottle upside down.
6. Slowly pull the plunger of the oral syringe to withdraw the dose needed. Line up the end of the plunger with the marking for your dose.
What to do if you see air bubbles:
If there are air bubbles in the oral syringe, keep the bottle upside down and slowly push the plunger so that all of the liquid flows back into the bottle.
7. When you have measured the correct amount, leave the oral syringe in the press-in bottle adapter and turn the bottle right side up.
8. Carefully remove the oral syringe from the press-in bottle adapter.
Take or give Ztalmy
9. Place the tip of the oral syringe against the inside of the cheek and gently push the plunger until all of the Ztalmy in the oral syringe is taken or given. Do not forcefully push the plunger. Do not direct the medicine to the back of the mouth or throat. This may cause choking.
10. Screw the child-resistant cap back on the bottle tightly by turning the cap to the right (clockwise). Do not remove the press-in bottle adapter. The child-resistant cap will fit over it.
Frequently asked Questions:
Q: What if there are air bubbles in the oral syringe?
A: Slowly push the liquid back into the bottle and repeat step 7 until the air bubbles are gone.
More about Ztalmy (ganaxolone)
- Check interactions
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: gamma-aminobutyric acid analogs
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.