Source: FDA, National Drug Code (US) Revision Year: 2025
MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age 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 overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Select patients for treatment with MODEYSO based on the presence of an H3 K27M mutation from tumor specimens [see Clinical Studies (14)]. An FDA-approved test for the detection of this mutation is not currently available.
Monitor electrocardiograms (ECG) and electrolytes before starting MODEYSO and periodically during treatment as clinically indicated [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].
Take MODEYSO on an empty stomach (at least 1 hour before or 3 hours after food intake) [see Clinical Pharmacology (12.3)].
The recommended dosage of MODEYSO is 625 mg orally once weekly.
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.
Table 1. Recommended Body Weight-Based Dosage for Pediatric Patients:
| 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 [see Patient Counseling Information (17)]. Once mixed, administer within 2 hours of preparation, or discard and mix a new dose.
If vomiting occurs after taking a dose, do not take an additional dose and take the next dose at the regularly scheduled time.
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.
The recommended dosage reductions for adverse reactions for MODEYSO are provided in Table 2.
Table 2. Recommended Dosage Reductions for Adverse Reactions:
| 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.
Table 3. Recommended Dosage Modifications for Adverse Reactions:
| Adverse Reaction | Severitya | Dosage Modificationb |
|---|---|---|
| Hypersensitivity [see Warnings and Precautions (5.1)] | 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 [see Warnings and Precautions (5.2)] | 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 life-threatening arrhythmia | Permanently discontinue MODEYSO. | |
| Other Adverse Reactions [see Adverse Reactions (6.1)] | 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.
Avoid concomitant use of strong and moderate CYP3A4 inhibitors with MODEYSO.
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 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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