Dordaviprone-Modeyso instruction manual Chinese introduction

1. Name:dordaviprone, dordaviprone (transliteration)

Product name:Modeyso

2. Indications:

Dordaviprone - Modeyso is indicated for the treatment of adult and pediatric patients 1 year and older with diffuse midline glioma harboring the H3 K27M mutation and whose disease has progressed after prior therapy.

3. Usage and dosage:

1. Before taking medicine:

(1)Patient selection: Patients treated with Modeyso are selected based on the presence of the H3 K27M mutation in tumor specimens. There are currently no FDA-approved tests for detecting this mutation.

(2) Medication monitoring:Monitor electrocardiogram (ECG) and electrolytes before initiating treatment, and periodically during treatment as clinically indicated.

2. Recommended dosage and usage

(1) Adult patients: The recommended dose of Modeyso is 625 mg orally once weekly with continued use until disease progression or unacceptable toxicity.

(2) Pediatric patients: The recommended dose of Modeyso in pediatric patients 1 to <17 years of age who weigh at least 10 kg is based on body weight. The dosage for patients 10kg to <12.5kg is 125 mg orally once a week; for patients 12.5kg to <27.5kg, the dosage is 250 mg orally once a week; for 27.5kg to <4 The dosage for patients weighing 2.5 kg is 375 mg orally once a week; the dosage for patients 42.5 kg to <52.5 kg is 500 mg orally once a week; the dosage for patients ≥52.5 kg is 625 mg orally once a week.

(3)Take Modeyso capsules on an empty stomach or at least 1 hour before or 3 hours after eating. Swallow capsule whole. For patients who are unable to swallow the entire capsule, open each capsule before taking, mix the contents with approximately 15 to 30 mL of liquid (sports drink, apple juice, lemonade, or water) and take it orally as a liquid. Once mixed, administer within 2 hours of preparation, or discard and mix a new dose.

4. Adverse reactions:

In clinical studies of Modeyso, the most common adverse reactions (≥20%) were fatigue, headache, vomiting, nausea, and musculoskeletal pain. The most common (≥2%) grade 3 or 4 laboratory abnormalities were lymphopenia, decreased calcium, and increased alanine aminotransferase.

5. Supply and storage:

Modeysois available primarily as125 mg capsules, which can be stored at 20°C to 25°C (68°F to 77°F); permitted excursions are 15°C to 30°C (59°F to 86°F).

6. Special groups:

1. Women: According to animal research results and its mechanism of action, pregnant women taking MODEYSO may cause harm to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the last dose; to not breastfeed during treatment and for 1 week after the last dose.

2. Men: It is recommended that male patients with female partners of reproductive potential use effective contraceptive measures during treatment with MODEYSO and within 1 month after the last dose.

7. Mechanism of action:

Dordaviprone is a protease activator of mitochondrial caseinolytic protease P (ClpP). Dordaviprone also inhibits dopamine D2 receptors. Diffuse midline gliomas with H3 K27M mutations are associated with loss of H3 K27 trimethylation. In vitro, in an H3 K27M mutant diffuse glioma model, dordaviprone activated an integrated stress response, induced apoptosis, and altered mitochondrial metabolism, leading to restoration of histone H3 K27 trimethylation. Dordaviprone demonstrated antitumor activity in cell-based assays and in vivo models of H3 K27M-mutant diffuse glioma. xa0xa0

Reference materials:https://www.drugs.com/modeyso.html