Ganaxolone is used to treat seizures associated with a disorder called cyclin-dependent kinase-like 5 deficiency disorder (CDD) in people 2 years and older.

Ganaxolone may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking ganaxolone. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take ganaxolone with food.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Seizures may increase if you stop using ganaxolone suddenly. Ask your doctor before stopping the medicine.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store tightly closed in the original container at room temperature, away from moisture and heat. Throw away any unused medicine after 30 days.

Usual Adult Dose for Seizures:

Weight greater than 28 kg:
-Days 1 to 7: 150 mg orally 3 times a day
-Days 8 to 14: 300 mg orally 3 times a day
-Days 15 to 21: 450 mg orally 3 times a day
-Days 22 to ongoing: 600 mg orally 3 times a day

Comments:
-Dosage should be increased based on tolerability no more frequently than every 7 days.
-Titration increments should not exceed those shown above.
-When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Use: For the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)

Usual Pediatric Dose for Seizures:

2 years or older:
Weight up to 28 kg:
-Days 1 to 7: 6 mg/kg orally 3 times a day
-Days 8 to 14: 11 mg/kg orally 3 times a day
-Days 15 to 21: 16 mg/kg orally 3 times a day
-Days 22 to ongoing: 21 mg/kg orally 3 times a day

Weight greater than 28 kg:
-Days 1 to 7: 150 mg orally 3 times a day
-Days 8 to 14: 300 mg orally 3 times a day
-Days 15 to 21: 450 mg orally 3 times a day
-Days 22 to ongoing: 600 mg orally 3 times a day

Comments:
-Dosage should be increased based on tolerability no more frequently than every 7 days.
-Titration increments should not exceed those shown above.
-When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Use: For the treatment of seizures associated with CDD

Tell your doctor if you have ever had:

• liver disease;

• depression, or suicidal thoughts or behavior; or

• alcohol or drug addiction.

Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ganaxolone on the baby.

Ask a doctor if it is safe to breastfeed while using ganaxolone.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, in an upright position, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused medication 30 days after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how ganaxolone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Common side effects of ganaxolone may include:

• drowsiness;

• fever;

• excessive saliva or drooling; or

• seasonal allergy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• drink alcohol;

• opioids; or

• antidepressants.

This list is not complete. Other drugs may affect ganaxolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ganaxolone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.