What is Ganaxolone?
Ganaxolone can be used to treat seizures in patients 2 years of age and older with a disorder known as cyclin-dependent kinase-like 5 deficiency (CDD). This medication guide does not list all possible uses of ganaxolone.
Side effects of Ganaxolone
If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of your lips, face, tongue, or throat. Contact your doctor immediately if there are any sudden or new changes in your mood or behavior. This includes new depression, anxiety, or panic attacks.
Ganaxolone can cause a number of side effects.
- Drowsiness;
- Fever;
- Excessive salivation or drooling.
- Allergy seasonal.
There may be other side effects. For medical advice on side effects, call your doctor. Contact the FDA by dialing 1-800-FDA-1088 in order to report side effects.
Warnings
Some people experience thoughts of suicide when taking ganaxolone. Should you experience sudden shifts in mood or behavior or any thoughts of suicide, notify your physician as soon as possible.
Before you take this drug
Tell your doctor immediately of any of the following symptoms:
- Liver disease
- Depression or suicidal behavior or thoughts;
- Alcohol or drug abuse.
Notify your doctor of any pregnancy or plans to become pregnant. You may find your name on a registry for pregnant women to monitor the effects of ganaxolone. Ask your doctor if you can safely breastfeed if you are using ganaxolone.
How to take Ganaxolone?
Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label. Take ganaxolone along with your food. Shake the shakension. Use the measuring device provided (not a spoon). If you suddenly stop taking ganaxolone, seizures may increase. Before stopping ganaxolone, consult your doctor. It should not be shared with anyone, even if their symptoms match those of another. Store tightly sealed in the original container at room temperature, away from moisture and warmth. After 30 days, throw away any medicine that has not been used.
Details on dosage
Usual Adult Dose for Seizures:
Weight greater than 28 kg
Days 1–7: Orally take 150 mg 3 times per day.
Days 15 to 21: 300 mg 3 times daily
Days 22 to 28: 450mg orally, 3 times per day
Days 22 and onwards: 600 mg 3 times daily orally
Comments:
The dosage should be adjusted based on tolerance, but not more than once every seven days.
The titration increments shown above should not be exceeded.
When discontinuing treatment, it is important to reduce the dose gradually. It is best to avoid abrupt discontinuation, if possible, in order to minimize the risk of increased seizure frequencies and status epilepticus.
Use: To treat seizures caused by cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
Usual Pediatric Dose for Seizures:
Two years old or older
Weights up to 28 kg
Days 1–7: 6 mg/kg 3 times daily
Days 15 to 21: Orally, 11 mg/kg 3 times per day
Days 22 to 28: 16 mg/kg 3 times daily orally
Days 22 and onwards: Orally, 3x21 mg/kg
Weight greater than 28 kg
Days 1–7: Orally take 150 mg 3 times per day.
Days 15 to 21: 300 mg 3 times daily
Days 22 to 28: 450mg orally, 3 times per day
Days 22 and onward: 600 mg 3 times daily orally
Comments:
The dosage should be adjusted based on tolerance, but not more than once every seven days.
The titration increments shown above should not be exceeded.
When discontinuing treatment, it is best to reduce the dose gradually. It is better to avoid abrupt discontinuation, if possible, in order to minimize the risk of increased seizure frequencies and status epilepticus.
Use: To treat seizures caused by CDD
What happens if I miss the dose?
If it's nearly time for your next dose, skip any missed ones and wait. Never take two doses at the same time of a similar medication.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
Avoid alcohol. Alcohol can cause death or have dangerous side effects. Do not drive or engage in hazardous activities until you have a better understanding of how ganaxolone affects you. Dizziness and fatigue may result in accidents or more serious injuries, potentially leading to accidents and more serious consequences.
Interaction with other drug
Tell your doctor about your other medications, including:
- Drink alcohol
- Opioids;
- Antidepressants.
This list is incomplete. Other drugs, such as vitamins and herbs, may also affect ganaxolone. This list does not include all possible interactions with other drugs.
