Ganaxolone

Ganaxolone is used to treat seizures related to a condition called cyclin-dependent kinase-like 5 deficiency disorder (CDD) in individuals aged 2 years and older.

Ganaxolone may also be used for other reasons that are not mentioned in this medication guide.

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.

Some people may have thoughts about suicide while using ganaxolone. Contact your doctor immediately if you notice any sudden changes in your mood or behavior, or if you have thoughts about suicide.

Tell your doctor if you have ever had:

• liver disease;
• depression, or thoughts or behavior related to suicide; or
• alcohol or drug addiction.

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

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

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

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

Call your doctor immediately if you experience new or sudden changes in mood or behavior, including new or worsening 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 harming 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.

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 dayComments:-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 dayWeight 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 dayComments:-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

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

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

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

Avoid driving or doing risky activities until you understand how ganaxolone will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Tell your doctor about all your other medicines, especially:

• 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.