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A FIRST FOR CDKL5 DEFICIENCY DISORDER
ZTALMY is the first FDA-approved prescription medicine indicated specifically
for seizures associated with CDKL5 deficiency disorder (CDD)
in people 2 years of age and older
Available in July 2022
ZTALMY will be available following controlled substance scheduling by the US Drug Enforcement Administration.
For caregivers of people with CDKL5 deficiency disorder
What is ZTALMY?
ZTALMY is a prescription medicine used to treat
seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in
people 2 years of age and older. It is not known if ZTALMY is safe
and effective in children under 2 years of age. ZTALMY is a sugar-free cherry-flavored oral suspension suitable for ketogenic diets.
What is CDKL5 deficiency disorder?
CDKL5 deficiency disorder, or CDD, is a rare genetic disorder characterized by treatment-resistant
seizures that start in infancy and significant developmental delays.
What does FDA approval mean?
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research has reviewed data on
ZTALMY and has decided that the benefits outweigh the risks for the treatment of seizures associated
with CDD in people 2 years of age and older.
When will ZTALMY be available?
ZTALMY is expected to be available in July 2022.
Why is there a delay between FDA approval and prescription availability?
The FDA has recommended that ZTALMY be classified as a controlled substance. This recommendation has been
submitted to the US Drug Enforcement Administration (DEA). ZTALMY will be available following
controlled substance scheduling by the DEA.
What is a controlled substance?
Any newly developed medicine that has a possibility for abuse or dependence is classified as a controlled substance and
is scheduled by the DEA. Schedule I (one) drugs have the highest potential for abuse, and Schedule V (five)
drugs have a lower potential for abuse. Like some other seizure medicines, ZTALMY is a controlled substance.
How can I stay informed about ZTALMY?
Ask your child’s healthcare team about ZTALMY at your next appointment. Your
healthcare team can help you stay informed about when ZTALMY will be available.
IMPORTANT SAFETY INFORMATION
What warnings should I know about ZTALMY?
ZTALMY may cause sleepiness which may get better over time. 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.
[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 ZTALMY is safe and effective in children under 2 years of age.
IMPORTANT SAFETY INFORMATION
What warnings should I know about ZTALMY?
ZTALMY may cause sleepiness which may get better over time. 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 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 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
Do not stop taking ZTALMY without first talking to your healthcare provider.
Stopping ZTALMY suddenly can cause the person 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 warnings should I 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.
Thank you for signing up. A representative will be in touch with you.
ZTALMY is a federally controlled substance (CV) because it contains ganaxolone. Keep ZTALMY in a safe place to prevent misuse, abuse, and protect it from theft. Never give your ZTALMY to anyone else, because it may harm them. Selling or giving away this medicine is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines, or street drugs. Please see full Prescribing Information for Important Safety Information on ZTALMY.
