Modeyso Dosage
Generic name: DORDAVIPRONE 125mg
Dosage form: capsules
Medically reviewed by Drugs.com. Last updated on Aug 8, 2025.
Patient Selection
Select patients for treatment with MODEYSO based on the presence of an H3 K27M mutation from tumor specimens. An FDA-approved test for the detection of this mutation is not currently available.
Recommended Testing Before Starting MODEYSO
Monitor electrocardiograms (ECG) and electrolytes before starting MODEYSO and periodically during treatment as clinically indicated.
Recommended Dosage and Administration
Take MODEYSO on an empty stomach (at least 1 hour before or 3 hours after food intake).
Adults
The recommended dosage of MODEYSO is 625 mg orally once weekly.
Pediatrics
The recommended dosage of MODEYSO in pediatric patients aged 1 to <17 years who weigh at least 10 kg is based on body weight (Table 1). A recommended dosage of MODEYSO has not been established in pediatric patients who weigh less than 10 kg.
|
Body Weight (kg) |
Recommended Dosage |
|
10 kg to <12.5 kg |
125 mg Once Weekly |
|
12.5 kg to <27.5 kg |
250 mg Once Weekly |
|
27.5 kg to <42.5 kg |
375 mg Once Weekly |
|
42.5 kg to <52.5 kg |
500 mg Once Weekly |
|
≥52.5 kg |
625 mg Once Weekly |
Continue MODEYSO until disease progression or unacceptable toxicity.
Swallow capsules whole. For patients unable to swallow capsules whole, open each capsule, mix contents with approximately 15 to 30 mL of liquid (sports drink, apple juice, lemonade, or water) before administration, and administer orally as a liquid. Once mixed, administer within 2 hours of preparation, or discard and mix a new dose.
Vomiting
If vomiting occurs after taking a dose, do not take an additional dose and take the next dose at the regularly scheduled time.
Missed Dose
If a dose is missed within 2 days, take the missed dose as soon as possible. If a dose is missed by more than 2 days, skip the missed dose and take the next dose at the scheduled time.
Dosage Modifications for Adverse Reactions
The recommended dosage reductions for adverse reactions for MODEYSO are provided in Table 2.
|
Patient’s Weight (kg) |
First Dosage Reduction |
Second Dosage Reduction |
|
Pediatric patients 10 kg to <12.5 kg |
Permanently discontinue |
N/A |
|
Pediatric patients 12.5 kg to <27.5 kg |
125 mg once weekly |
Permanently discontinue |
|
Pediatric patients 27.5 kg to <42.5 kg |
250 mg once weekly |
125 mg once weekly |
|
Pediatric patients 42.5 kg to <52.5 kg |
375 mg once weekly |
250 mg once weekly |
|
Pediatric patients ≥52.5 kg and adult patients |
500 mg once weekly |
375 mg once weekly |
The recommended dosage modifications for adverse reactions are provided in Table 3.
|
Adverse Reaction |
Severitya |
Dosage Modificationb |
|
Hypersensitivity |
Any grade |
If hypersensitivity is suspected based on clinical judgement, interrupt MODEYSO until resolution of the event. Permanently discontinue MODEYSO in patients who develop serious hypersensitivity reactions. |
|
QTc Interval Prolongation |
QTc absolute value >500 ms or An increase of >60 ms from baseline |
Interrupt MODEYSO until QTc interval ≤480 ms or return to baseline. Resume MODEYSO at the next lower dose level. |
|
Torsades de pointes, polymorphic ventricular tachycardia or signs or symptoms of serious or |
Permanently discontinue MODEYSO. |
|
|
Other Adverse Reactions |
Grade 3 or 4 |
Interrupt MODEYSO until ≤Grade 1 or return to baseline. Resume MODEYSO at the next lower dose level. |
|
Recurrent Grade 4 |
Permanently discontinue MODEYSO. |
a. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
b. See Table 2 for recommended dosage reductions.
Dosage Modifications for CYP3A4 Inhibitors
Avoid concomitant use of strong and moderate CYP3A4 inhibitors with MODEYSO.
- •
- If concomitant use of a strong CYP3A4 inhibitor cannot be avoided for adult and pediatric patients who weigh at least 52.5 kg, reduce the dose of MODEYSO from 625 mg to 375 mg once weekly.
- •
- If concomitant use of a moderate CYP3A4 inhibitor cannot be avoided for adult and pediatric patients who weigh at least 52.5 kg, reduce the dose of MODEYSO from 625 mg to 500 mg once weekly.
- •
- The recommended dosage for pediatric patients weighing less than 52.5 kg who are receiving strong or moderate CYP3A4 inhibitors has not been established.
Upon discontinuation of the CYP3A4 inhibitor, wait for 3 to 5 plasma half-lives of the CYP3A4 inhibitor, then increase MODEYSO to the dose that was taken before starting the CYP3A4 inhibitor.
More about Modeyso (dordaviprone)
Patient resources
Professional resources
Related treatment guides
See also:
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
