MODEYSO offers once-weekly oral dosing1

ADMINISTRATION

Calendar icon signifying once weekly dosing

Once-weekly dosing1

MODEYSO is taken once a week, with a recommended dose of 625 mg (five 125-mg capsules) for patients weighing ≥52.5 kg (≥115.7 lb).1

See full Prescribing Information

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Oral administration1

MODEYSO comes in capsules that patients take anywhere.1

  • MODEYSO should be taken on an empty stomach, at least 1 hour prior to or 3 hours after a meal
  • The prescribed dose of MODEYSO should be taken at the same time and on the same day each week

See full Instructions for Use

For patients unable to swallow capsules, the capsule contents may be dissolved in approximately 15 mL to 30 mL of liquid (sports drink, apple juice, lemonade, or water) before administration1

Refer to the Instructions for Use on how to prepare a dose of MODEYSO for patients unable to swallow the capsules.

DOSE MODIFICATIONS

Dose reductions and modifications are recommended for patients on strong or moderate CYP3A4 inhibitors and patients experiencing adverse reactions.1

See modification details for patients on CYP3A4 inhibitors.

RECOMMENDED DOSAGE REDUCTIONS FOR ADVERSE REACTIONS1

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

RECOMMENDED DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS1

Adverse Reaction
Severity*
Dosage Modification
Hypersensitivity
Any grade
If hypersensitivity is suspected based on clinical judgment, interrupt MODEYSO until resolution of the event. Permanently discontinue MODEYSO in patients who develop serious hypersensitivity reactions
QT 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 life-threatening arrhythmia
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

QTc, corrected interval from Q wave to T wave, adjusted for heart rate.

*Severity as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

PATIENT COUNSELING

Before prescribing MODEYSO1

  • Confirm the presence of the H3 K27M mutation

  • Perform pregnancy testing in appropriate patients, advise patients to avoid pregnancy by using effective contraception during treatment and for 1 month after the final dose, and inform all patients about reproductive risk

  • Advise patients not to breastfeed during treatment with MODEYSO and for 1 week after the final dose

  • Monitor ECGs and electrolytes before initiating and periodically during treatment as clinically indicated

  • Educate patients on the signs and symptoms of hypersensitivity reactions and QTc interval prolongation, and instruct them to seek immediate medical attention if symptoms occur

  • Inform patients of potential drug interactions, and instruct patients to inform their healthcare provider before initiating any new medications, including prescription and over-the-counter drugs, vitamins, and herbal products

See full Prescribing Information, including patient counseling information, for additional details on getting started.

Missed dose guidance1

  • If vomiting occurs after taking MODEYSO, the patient should not be re-dosed until the next scheduled dose

  • If a dose is missed, it may be taken up to 2 days after the scheduled administration day

  • If more than 2 days have passed, skip the missed dose and take the next scheduled dose

ECGs, electrocardiograms; H3, histone 3.

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Reference: 1. MODEYSO™. Package insert. Chimerix, Inc; 2025.