What is the most important information I should know about ZTALMY?
ZTALMY can cause serious side effects, including:
- 1.
- 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.
- 2.
- 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.
|
- 3.
- Do not stop taking ZTALMY without first talking to your healthcare provider. Stopping a seizure medicine such as ZTALMY 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. |
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.
- ZTALMY is a federally controlled substance (CV) because it contains ganaxolone that can be abused and lead to dependence. Keep ZTALMY in a safe place to prevent misuse and abuse. Selling or giving away ZTALMY may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- It is not known if ZTALMY is safe and effective in children under 2 years of age.
|
Before taking ZTALMY, 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.
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:
- alcohol
- opioids
- antidepressants
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 at the end of this Medication Guide 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 ZTALMY to take or give and when to take or give it.
- Measure each dose of ZTALMY 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.
|
What are the possible side effects of ZTALMY?
ZTALMY can cause serious side effects, including:
The most common side effects of ZTALMY include:
- sleepiness
- fever
- excessive saliva or drooling
- seasonal allergy
These are not all of the possible side effects of ZTALMY. 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 at 68°F to 77°F (20°C to 25°C).
- Always store ZTALMY in its original bottle in an upright position.
- Keep the child-resistant cap tightly closed.
- Use ZTALMY within 30 days of first opening the bottle. Throw away (dispose of) any unused medicine after 30 days.
Keep ZTALMY and all medicines out of the reach of children. |
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 ZTALMY for a condition for which it was not prescribed. Do not give ZTALMY to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ZTALMY 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.
Marketed by Marinus Pharmaceuticals, Inc. Radnor, PA 19087 USA
For more information, go to www. ZTALMY.com or call 844-MARINUS (844-627-4687).
© 2022 Marinus Pharmaceuticals, Inc. All rights reserved.
ZTALMY is a registered trademark of Marinus Pharmaceuticals, Inc. |