Adult and pediatric patients 1 year and older with diffuse midline glioma harboring an H3 K27M mutation with disease progression following prior therapy.
Adults: 625 mg orally once weekly. Pediatric: weight-based (125-625 mg weekly). Take on empty stomach.
Tablets: 125 mg; Oral Suspension
None listed in the prescribing information.
Nausea (42%), Vomiting (38%), Fatigue (32%), Headache (28%), Decreased Appetite (26%), Constipation (22%), Diarrhea (18%), QTc Prolongation (12%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
QTc Prolonging Drugs: Avoid where feasible.
Strong CYP3A4 Inhibitors: Avoid.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Dordaviprone activates the mitochondrial protease ClpP, leading to impaired mitochondrial function and selective toxicity in cells harboring H3 K27M mutations.
Tmax: 4-6 hours. Protein binding: ~98%. Half-life: ~24 hours.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Modeyso has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Modeyso (dordaviprone) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Dordaviprone activates the mitochondrial protease ClpP, leading to impaired mitochondrial function and selective toxicity in cells harboring H3 K27M mutations.
Nausea (42%), Vomiting (38%), Fatigue (32%), Headache (28%), Decreased Appetite (26%), Constipation (22%), Diarrhea (18%), QTc Prolongation (12%) Nausea 42% Vomiting 38% Fatigue 32% Headache 28% Decreased Appetite 26% Constipation 22% Diarrhea 18% QTc Prolongation 12%