Ganaxolone

Generic name: ganaxolone [ gan-AX-oh-lone ]
Brand name: Ztalmy
Dosage form: oral suspension (50 mg/mL)
Drug class: Gamma-aminobutyric acid analogs

Medically reviewed by Drugs.com on Sep 13, 2022. Written by Cerner Multum.

What is ganaxolone?

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.

Ganaxolone side effects

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.

Warnings

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.

Before taking this medicine

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.

How should I take ganaxolone?

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.

Ganaxolone dosing information

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

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking ganaxolone?

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.

What other drugs will affect ganaxolone?

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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