Lucius LuciDorda Dordaviprone 125mg

Product Information

• Product name: LuciDorda Dordaviprone125mg Dordaviprone 125mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Dordaviprone
• Current strength: 125mg
• SKU: Product ID 3122
• Site category: general medicines

Product Summary

LuciDorda Dordaviprone125mg Dordaviprone 125mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Dordaviprone is the active ingredient used for this product page. Public prescribing information for Dordaviprone was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P (ClpP). Dordaviprone also inhibits the dopamine D2 receptor. Diffuse midline gliomas harboring an H3 K27M mutation are associated with the loss of H3 K27 trimethylation. Dordaviprone exhibited antitumor activity in cell-based assays and in vivo models of H3 K27M-mutant diffuse glioma.

Reference Indications

Dordaviprone 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 . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Dordaviprone is a protease activator 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 response rate and duration of response .

Reference Dosage and Administration

Recommended dose in adult patients is 625 mg orally once weekly. Take Dordaviprone orally once weekly on an empty stomach, at least 1 hour before or 3 hours after food intake.

With this 125mg product, that corresponds to 5 x 125mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Hypersensitivity: If clinically significant hypersensitivity or anaphylaxis occur, immediately discontinue Dordaviprone and initiate appropriate medical treatment and supportive care. QTc Interval Prolongation: Dordaviprone causes concentration dependent QTc interval prolongation. Interrupt or reduce the dose of Dordaviprone in patients who develop QT prolongation, and permanently discontinue Dordaviprone in patients with signs of life-threatening arrhythmias. ( 5.2 , 12.2 ) Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) 5.1 Hypersensitivity Dordaviprone can cause severe hypersensitivity reactions. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

Common Adverse Reactions and Monitoring

QTc Interval Prolongation . The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase. The pooled safety population described in and below reflects exposure to Dordaviprone at the recommended weight-based dose taken until disease progression or unacceptable toxicity in 376 adult and pediatric patients with glioma across four open-label clinical studies (ONC006, ONC013, ONC014, and ONC018) . The median age was 23 years (range: 3 to 80): 30% were 2 to 11 years old, 11% were 12 to 17 years old, 55% were 18 to 64 years old, and 3.7% were 65 years or older.

Drug Interactions and Special Populations

CYP3A4 Inhibitors: Avoid concomitant use of strong and moderate CYP3A4 inhibitors with Dordaviprone. If concomitant use cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the dose of Dordaviprone as recommended. ( 2.5 , 7.1 ) CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers with Dordaviprone. Drugs Known to Prolong QTc Interval: Avoid concomitant use of Dordaviprone with products known to prolong the QTc interval. If concomitant use cannot be avoided, separate administration of Dordaviprone and the QT-prolonging product. Table 6: Effect of Other Drugs on Dordaviprone Strong and Moderate CYP3A4 Inhibitors Prevention or Management Avoid concomitant use of strong and moderate CYP3A4 inhibitors with Dordaviprone.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: MODEYSO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.