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See how ZTALMY can fit into your child's treatment plan

About ZTALMY

Learn about support from ZTALMY One^TM

Starting ZTALMY

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

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.

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:

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:

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

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:

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

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

Program Eligibility and Terms and Conditions

The copay savings program requires a valid prescription for ZTALMY® (ganaxolone) oral suspension, CV consistent with the Prescribing Information.
Patient must have commercial insurance. Offer is not valid for cash-paying patients.
Patient must reside in the U.S. or U.S. Territory.
Patients are responsible for as low as a zero-dollar copayment for a ZTALMY prescription for a maximum 30-day supply per fill. The value of the copay savings program offer is limited to an annual maximum per calendar year. For maximum annual benefit limit information, please contact ZTALMY One™ (1‑844‑982‑5691).
Patients are not eligible to use this offer if they are eligible for or enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care or a state prescription drug assistance program.
You are responsible for reporting use of the copay savings program to any commercial insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the copay savings program, as may be required. You should not use the copay savings program if your insurer or health plan prohibits use of manufacturer copay programs.
Offer not valid where prohibited by law.
Copay Savings Program accepted only by the ZTALMY One designated specialty pharmacy.
If patient’s insurance changes, the pharmacy must be notified immediately. Based on patient’s insurance change, patient may no longer be able to participate in the copay savings program.
Offer is not health insurance.
Offer good only in the U.S.
Offer is limited to one per person during this offering period and is not transferable.
Offer is not conditioned on any past, present, or future purchase, including refills.
Marinus reserves the right to rescind, revoke or amend this offer and program eligibility requirements at any time without notice.

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IMPORTANT SAFETY INFORMATION

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

What is ZTALMY?

IMPORTANT SAFETY INFORMATION

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

What should I tell my healthcare provider?

What should be avoided while taking ZTALMY?

What are the side effects of ZTALMY?