ZTALMY ganaxolone 50 mg/mL Suspension — NDC 81583-100-01 (Billing 81583-0100-01)

1 INDICATIONS AND USAGE ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. ZTALMY is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Administer ZTALMY orally three times daily with food. ( 2.1 ) Titrate ZTALMY gradually according to the recommended schedules. See full prescribing information.

( 2.1 ) Dosage for patients weighing 28 kg or less ( 2.1 ): the starting dosage is 2 mg/kg three times daily (6 mg/kg/day) the maximum dosage is 21 mg/kg three times daily (63 mg/kg/day). Dosage for patients weighing over 28 kg ( 2.1 ): the starting dosage is 50 mg three times daily (150 mg daily) the maximum dosage is 600 mg three times daily (1800 mg daily). Patients with severe hepatic impairment: see full prescribing information for dosage recommendation.

( 2.3 )

2.1Dosage Information ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3) ] . The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2.

Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2. Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily 6 mg/kg/day 1 to 7 4 mg/kg three times daily 12 mg/kg/day 8 to 14 8 mg/kg three times daily 24 mg/kg/day 15 to 21 14 mg/kg three times daily 42 mg/kg/day 22 to 28 21 mg/kg three times daily 63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily 150 mg 1 to 7 100 mg three times daily 300 mg 8 to 14 200 mg three times daily 600 mg 15 to 21 400 mg three times daily 1,200 mg 22 to 28 600 mg three times daily 1,800 mg 29 and thereafter

2.2Administration Instructions See the Instructions for Use for complete instructions on how to properly prepare and administer ZTALMY. Shake the bottle thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose. Measure and administer the prescribed dose using the oral syringe(s) provided by your pharmacist.

A household teaspoon or tablespoon is not an adequate measuring device and should not be used. ZTALMY must be administered with food [see Clinical Pharmacology (12.3) ] . Discard any unused ZTALMY oral suspension after 30 days of first opening the bottle [see How Supplied/Storage and Handling (16.2) ] .

2.3Dosage in Patients with Severe Hepatic Impairment ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3) ] . The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients with severe hepatic impairment and weighing 28 kg or less are included in Table 3, and dosage recommendations for patients with severe hepatic impairment (Child-Pugh class C) weighing more than 28 kg are included in Table 4.

Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 3 and Table 4. No dosage adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

Table 3 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing 28 kg or Less Dosage Total Daily Dose Approximate daily dose. Days 0.66 mg/kg three times daily 2 mg/kg/day 1 to 7 1.33 mg/kg three times daily 4 mg/kg/day 8 to 14 2.66 mg/kg three times daily 8 mg/kg/day 15 to 21 4.66 mg/kg three times daily 14 mg/kg/day 22 to 28 7 mg/kg three times daily 21 mg/kg/day 29 and thereafter Table 4 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing More Than 28 kg Dosage Tota… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Oral suspension: 50 mg/mL ganaxolone. Each bottle contains 110 mL of white to off-white cherry flavored suspension. Oral suspension 50 mg/mL ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Somnolence and Sedation Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that ZTALMY does not affect them adversely (e.g., impair judgment, thinking, or motor skills) [see Warnings and Precautions (5.1) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and their families that antiepileptic drugs, including ZTALMY, may increase the risk of suicidal thoughts and behavior and advise them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.

Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.2) ] . Withdrawal of Antiepileptic Drugs (AEDs) Advise patients not to discontinue use of ZTALMY without consulting with their healthcare provider. ZTALMY should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Dosage and Administration (2.4) and Warnings and Precautions (5.3) ] .

Administration information Advise patients who are prescribed ZTALMY to use the adapter and oral dosing syringes provided by their pharmacist [see Dosage and Administration (2.2) and Instructions for Use ] . Instruct patients to take ZTALMY with food [see Dosage and Administration (2.1) ] . Instruct patients to shake ZTALMY thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose [see Dosage and Administration (2.2) and Instructions for Use ] .

Instruct patients to discard any unused ZTALMY oral suspension after 30 days of first opening the bottle [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16.2) ] . Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during ZTALMY therapy. Encourage women who are taking ZTALMY to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1) ] . Potential for Abuse Advise patients that ZTALMY can be abused or lead to dependence [see Drug Abuse and Dependence (9) ] .

MEDICATION GUIDE ZTALMY ® (zuh tal' mee) (ganaxolone) oral suspension, CV This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: Issued: 11/2025 What is the most important information I should know about ZTALMY? 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 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: alco… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE ZTALMY ® ( zuh-tal' mee ) (ganaxolone) oral suspension, CV 50 mg/mL Be sure that you read, understand, and follow these instructions carefully to ensure proper dosing of the oral suspension. Important: Follow your healthcare provider's instructions for how to take or give ZTALMY. ZTALMY should always be given with food.

Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose of ZTALMY. Always use the oral syringe provided by your pharmacist to make sure you measure the right amount of ZTALMY. Do not use ZTALMY after the expiration date on the package and each bottle.

Use ZTALMY within 30 days of first opening the bottle. After 30 days of first opening the bottle, safely throw away (dispose of) any ZTALMY that has not been used. Each package contains: 1 bottle of ZTALMY with a child resistant cap: Supplies not included in the package: press-in bottle adapter oral syringe You can get a press-in bottle adapter and oral syringes from your pharmacy.

Your pharmacist can help you choose the right press-in bottle adapter and oral syringe to use with ZTALMY. Call your pharmacist right away if you do not have a press-in bottle adapter and the right sized oral syringe to use with your medicine. Note: If you lose or damage an oral syringe, or cannot read the markings, contact your pharmacist for a new oral syringe.

Follow the instructions below to use the press-in bottle adapter and oral syringe to measure and take or give ZTALMY. Prepare the bottle Hold the bottle in your hand and shake it up and down well for 1 minute. Always shake the bottle well for 1 minute then let the bottle stand for 1 minute so that any foam build up during shaking can settle before measuring and giving each dose of ZTALMY.

This helps you measure the correct amount of medicine. Note: This step is for each dose of the medicine. Remove the child-resistant cap by pushing down while turning the cap to the left (counter-clockwise).

Puncture and peel off the induction seal from the bottle. Note: This step is only for the first use of the bottle. Push the press-in-bottle adapter firmly into the bottle.

Firmly grasp the bottle in one hand and insert the press-in bottle adapter all the way in the bottle with the other hand using constant pressure. Make sure the press-in bottle adaptor is fully inserted. If not fully inserted, small parts such as the press-in bottle adaptor may become a choking hazard for children and pets.

Note : Do not remove the press-in bottle adapter from the bottle after it is inserted. Prepare the dose Your healthcare provider will tell you how much ZTALMY to take or give. Gather the oral syringe, push the plunger all the way down then insert the tip of the oral syringe fully into the press-in bottle adapter.

With the oral syringe in place, turn the bottle upside down. Slowly pull the plunger of the oral syringe to withdraw the dose of ZTALMY needed. Line up the end of the plunger with the marking for your dose of ZTALMY.

What to do if you see air bubbles : If there are air bubbles in the oral syringe, keep the bottle upside down and slowly push the plunger so that all of the liquid flows back into the bottle. Repeat step 6 until air bubbles are gone. When you have measured the correct amount of ZTALMY, leave the oral syringe in the press-in bottle adapter and turn the bottle right side up.

Carefully remove the oral syringe from the press-in bottle adapter. Take or give ZTALMY Place the tip of the oral syringe against the inside of the cheek and gently push the plunger until all of the ZTALMY in the oral syringe is taken or given. Do not forcefully push the plunger.

Do not direct the medicine to the back of the mouth or throat. This may cause choking. Screw the child-resistant cap back on the bottle tightly by turning the cap to the right (clockwise).

Do not remove the press-in bottle adapter. The child-resistant cap will fit over it. How should I store ZTALMY?

Store ZTALM… [Excerpted — this section continues on DailyMed.]