Nurses Compass
Drug Guide
Ganaxolone
Classification
Therapeutic: Anticonvulsant / Neurologic
Pharmacological: Neuron 3α,5α,17β-Pregnanolone analog (GABA-A receptor modulator)
FDA Approved Indications
- Treatment of seizures associated with CDKL5 deficiency disorder in patients 2 years of age and older
Mechanism of Action
Ganaxolone is a synthetic neurosteroid that modulates GABA-A receptors, enhancing GABAergic inhibitory neurotransmission, which helps to reduce neuronal excitability and seizure activity.
Dosage and Administration
Adult: Typically, 300 mg to 600 mg twice daily, titrated based on response and tolerability.
Pediatric: Dosing based on weight; specific dosing guidelines should be provided by the prescribing information.
Geriatric: No specific dosage adjustments recommended; monitor for increased sensitivity.
Renal Impairment: No specific adjustment recommended; use with caution.
Hepatic Impairment: No specific adjustment recommended; evaluate hepatic function prior to initiation.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Widely distributed; crosses blood-brain barrier.
Metabolism: Primarily via hepatic glucuronidation and reduction pathways.
Excretion: Excreted mainly in urine as inactive metabolites.
Half Life: Approximately 16-18 hours.
Contraindications
- Known hypersensitivity to ganaxolone or any component of the formulation
Precautions
- Use caution in patients with hepatic impairment.
- Potential for central nervous system depression; caution when operating machinery or driving.
- Pregnancy Category C; benefits must outweigh risks during pregnancy.
- Lactation: Discontinue or exercise caution as drug may pass into breast milk.
Adverse Reactions - Common
- Dizziness (Common)
- Somnolence (Common)
- Fatigue (Common)
Adverse Reactions - Serious
- Hypersensitivity reactions (Serious but rare)
- Seizure worsening (Rare)
Drug-Drug Interactions
- CNS depressants (increase sedation risk)
Drug-Food Interactions
- No specific food interactions identified
Drug-Herb Interactions
- Potential interactions with herbs affecting CYP enzymes; consult guidelines
Nursing Implications
Assessment: Monitor seizure frequency, neurological status, and hepatic function.
Diagnoses:
- Risk for ineffective cerebral tissue perfusion
- Risk for CNS depression
Implementation: Administer as prescribed; monitor for adverse effects; educate patient about signs of hypersensitivity.
Evaluation: Assess seizure control and adverse reactions regularly.
Patient/Family Teaching
- Take medication exactly as prescribed and not to discontinue without medical advice.
- Report signs of hypersensitivity or adverse reactions.
- Be cautious when performing tasks requiring alertness.
- Inform healthcare provider of all medications being taken.
Special Considerations
Black Box Warnings:
- No black box warnings reported to date
Genetic Factors: Genetic variations in metabolism may affect response; specific testing not routinely required.
Lab Test Interference: No known interference.
Overdose Management
Signs/Symptoms: Dizziness, confusion, somnolence, respiratory depression.
Treatment: Supportive care; maintain airway; activated charcoal if ingestion was recent; call poison control or emergency services.
Storage and Handling
Storage: Store at room temperature between 20°C to 25°C (68°F to 77°F).
Stability: Stable according to manufacturer specifications.