Lucius LuciDorda Dordaviprone 125mg For Progressive H3 K27M-Mutant Diffuse Midline Glioma Intervention

LuciDorda is a mitochondrial ClpP protease agonist and dopamine D2 receptor (DRD2) antagonist. It is indicated for adults and pediatric patients aged ≥1 year with H3 K27M-mutant diffuse midline glioma who have experienced disease progression following prior multimodal therapeutic interventions.

Genetic testing of tumor tissue to confirm the presence of the H3 K27M mutation is mandatory before initiating treatment.

Administration: Take on an empty stomach — at least 1 hour before or 3 hours after a meal. Swallow capsules whole with lukewarm water. Do not open or chew the capsules.

Standard Adult Dose: 625 mg (five 125 mg capsules) orally, once weekly.

Dose Reduction Steps for Toxicity Management:

• First dose reduction: 500 mg once weekly
• Second dose reduction: 375 mg once weekly

Missed Dose Rule: A missed dose may be taken within 2 days of the scheduled dosing day. If more than 2 days have passed, skip the missed dose and resume at the next scheduled dose. Do not take a double dose.

1. Severe hypersensitivity to Dordaviprone or any excipients in the formulation.
2. Pregnancy: contraindicated. Women of childbearing potential must use effective contraception throughout the treatment period and for at least 1 month after the last dose.

1. QT Interval Monitoring: Perform baseline ECG and electrolyte assessment prior to initiation, with periodic follow-up during treatment. If QTc prolongation exceeds 60 ms or the absolute QTc exceeds 500 ms, suspend treatment.
2. Severe Hypersensitivity Risk: Seek emergency medical attention for rash, dyspnea, or swelling of the face/lips/tongue. Permanently discontinue in the event of anaphylactic shock.
3. Drug-Drug Interactions: Metabolized via hepatic enzymes. Co-administration with potent CYP3A modulators requires professional dose evaluation.
4. Lactation Advisory: The active ingredient may be excreted in breast milk. Discontinue breastfeeding for the entire duration of treatment.

This product information is for B2B reference only. Always consult the full prescribing information and a qualified healthcare professional before use.