Ganaxolone (ga-NAX-oh-lone)

Treats seizures in patients with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Brand Name(s):

Ztalmy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Shake the bottle well for at least 1 minute before each use. Let the bottle stand for 1 minute before measuring and taking each dose.
• Measure the oral liquid medicine with the provided oral dosing syringe.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Use this medicine within 30 days of first opening the bottle. Throw away any unused medicine after 30 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ganaxolone works. Tell your doctor if you are using carbamazepine, phenobarbital, phenytoin, primidone, or rifampin.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, or a history of alcohol or drug abuse, depression, or a mood disorder.
• This medicine may cause changes in behavior or mood, including thoughts of suicide.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Depression, anxiety, irritability, hallucinations, trouble sleeping, unusual behavior, thoughts of hurting yourself or others
• Unusual drowsiness or sleepiness

If you notice these less serious side effects, talk with your doctor:

• Fever, headache, runny or stuffy nose, sneezing
• Increased watering of mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088