Medical Uses
Modeyso (dordaviprone) is a protease activator used for the treatment of adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Recommended Dosage:
Dosage for Adults: The recommended dosage of Dordaviprone is 625 mg orally once weekly. Take the dosage on an empty stomach (at least 1 hour before or 3 hours after food intake).
Dosage for Children (1 to <17 years old): The dose of Dordaviprone for children depends on their body weight. This medicinal product is not recommended for children who weigh less than 10 kg. Recommended weekly dose by weight:
- 10 to <12.5 kg → 125 mg once a week
- 12.5 to <27.5 kg → 250 mg once a week
- 27.5 to <42.5 kg → 375 mg once a week
- 42.5 to <52.5 kg → 500 mg once a week
- 52.5 kg or more → 625 mg once a week
Continue taking this medicine until the doctor tells you to stop (for example, if the disease gets worse or side effects become too strong). Swallow the oral capsules whole with water.
If your child cannot swallow capsules, open the capsule and mix the contents in 15–30 mL of liquid (such as sports drink, apple juice, lemonade, or water). Give the mixture right away, within 2 hours. If not used in time, throw it away and prepare a new one.