Which of the following statements about Ganaxolone (Talmy) is NOT correct regarding its indication, adverse effects (AEs), controlled status, formulation, or drug interactions as a CYP 3A4 inducer and inhibitor?

From the FDA Drug Label

The effectiveness of ZTALMY for the treatment of seizures associated with CDD in patients 2 years of age and older was established in a single, double-blind, randomized, placebo-controlled study in patients 2 to 19 years of age (Study 1, NCT03572933) Ganaxolone is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 at clinically relevant concentrations. Ganaxolone is not an inducer of CYP1A2, CYP2B6, or CYP3A4/5 at clinically relevant concentrations

The statement that is NOT correct is:

• E: It has multiple drug interactions since it is a CYP 3A4 inducer and inhibitor. This is because, according to the drug label, ganaxolone is not an inducer or inhibitor of CYP3A4/5 at clinically relevant concentrations 1.

From the Research

The statement that Ganaxolone (Talmy) has multiple drug interactions since it is a CYP 3A4 inducer and inhibitor is NOT correct. Ganaxolone is actually a substrate of CYP3A4, not an inducer, and its interactions are primarily related to being inhibited by strong CYP3A4 inhibitors, which may increase its plasma concentrations 2, 3. Ganaxolone is a neuroactive steroid that acts as a positive allosteric modulator of GABA-A receptors and is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients 2 years of age and older. It is available as an oral suspension and is classified as a controlled substance due to its potential for abuse, though this risk is considered low. Common adverse effects include somnolence, pyrexia, salivary hypersecretion, and seasonal allergy. When co-administered with strong CYP3A4 inhibitors like clarithromycin or ketoconazole, dosage adjustments may be necessary due to potential increases in ganaxolone plasma levels 4, 5. Understanding ganaxolone's pharmacokinetic properties is important for appropriate prescribing and monitoring. Key points about ganaxolone include:

• Its indication for seizures associated with CDKL5 deficiency disorder in patients 2 years or older 2
• Common adverse effects such as somnolence and sedation 3, 4
• Its classification as a controlled substance 2
• The formulation and administration, which may include oral suspension 3
• Potential drug interactions, primarily related to CYP3A4 inhibition 5