INDICATION

What is ZTALMY?

• ZTALMY is a prescription medicine 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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZTALMY?

ZTALMY can cause serious side effects, including:

Sleepiness: 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.

Suicidal Thoughts or Actions: Like all other antiepileptic drugs, ZTALMY may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you:

Pay attention to changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.

Stopping ZTALMY: Do not stop taking ZTALMY without first talking to your healthcare provider. Stopping ZTALMY suddenly can cause you or your child to have seizures more often or seizures that do not stop (status epilepticus).

What should I tell my healthcare provider?

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.
• 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.

What should be avoided 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 side effects of ZTALMY?

See "What is the most important information I should know about ZTALMY?"

The most common side effects of ZTALMY include:

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 the FDA at www.fda.gov/medwatch, or 1-800-FDA-1088. You may also contact Marinus Pharmaceuticals directly at 844-627-4687.

For additional safety information, please click here for Medication Guide and Instructions for Use and discuss with your doctor.