Ztalmy

Generic name: Ganaxolone
Dosage form: oral suspension
Drug class: Gamma-aminobutyric acid analogs

Usage of 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 side effects

Ztalmy can cause serious side effects, including:

See Important information.

The most common side effects include:

sleepiness

fever

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.

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.

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How to use Ztalmy

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.

Warnings

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.

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:

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.