Dordaviprone
Generic Name: dordaviprone
Brand Names:
Modeyso
11 DESCRIPTION Dordaviprone is a protease activator. Dordaviprone is present as dordaviprone hydrochloride with the molecular formula C 24 H 26 N 4 O•2HCl. The molecular weight is 459.41. The full chemical name for dordaviprone hydrochloride is 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo[1,2- a ]pyrido[3,4-e]pyrimidin-5(4 H )-one dihydrochloride.
Overview
11 DESCRIPTION Dordaviprone is a protease activator. Dordaviprone is present as dordaviprone hydrochloride with the molecular formula C 24 H 26 N 4 O•2HCl. The molecular weight is 459.41. The full chemical name for dordaviprone hydrochloride is 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo[1,2- a ]pyrido[3,4-e]pyrimidin-5(4 H )-one dihydrochloride.
Uses
1 INDICATIONS AND USAGE 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). MODEYSO 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.
Dosage
2 DOSAGE AND ADMINISTRATION • Select patients for treatment with MODEYSO based on the presence of an H3 K27M mutation from tumor specimens. ( 2.1 ) • Monitor ECG and electrolytes before starting MODEYSO and periodically during treatment as clinically indicated. ( 2.2 ) • The recommended dose in adult patients is 625 mg orally once weekly. ( 2.3 ) • The recommended dose in pediatric patients weighing ≥10 kg is based on body weight (see Table 1). ( 2.3 ) • Take MODEYSO orally once weekly on an empty stomach, at least 1 hour before or 3 hours after food intake. ( 2.3 ) • Continue MODEYSO until disease progression or unacceptable toxicity.
Side Effects
6 ADVERSE REACTIONS The following potential clinically significant adverse reactions are described elsewhere in the labelling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] . • QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] . The most common (≥20%) adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chimerix at toll-free phone # 1-866-662-2679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS • CYP3A4 Inhibitors: Avoid concomitant use of strong and moderate CYP3A4 inhibitors with MODEYSO. If concomitant use cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the dose of MODEYSO as recommended. ( 2.5 , 7.1 ) • CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO. ( 7.1 ) • Drugs Known to Prolong QTc Interval: Avoid concomitant use of MODEYSO with products known to prolong the QTc interval. If concomitant use cannot be avoided, separate administration of MODEYSO and the QT-prolonging product. ( 5.2 , 7.2 , 12.2 ) 7.1 Effect of Other Drugs on MODEYSO Table 6 describes drug interactions where concomitant use of another drug affects MODEYSO.
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity: If clinically significant hypersensitivity or anaphylaxis occur, immediately discontinue MODEYSO and initiate appropriate medical treatment and supportive care. ( 5.1 ) • QTc Interval Prolongation: MODEYSO causes concentration dependent QTc interval prolongation. Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation, and permanently discontinue MODEYSO 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 MODEYSO can cause severe hypersensitivity reactions. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , MODEYSO can cause fetal harm when administered to a pregnant woman. There are no available data on MODEYSO use in pregnant women to inform a drug‑associated risk.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Strength Description Package Configuration NDC Number 125 mg White, opaque, hard capsules printed with “DDP” and “125” on the body and “CMRX” on the cap of the capsule. Each bottle contains 10 capsules and desiccant with a child‑resistant closure.
Frequently Asked Questions
What is Dordaviprone used for?▼
1 INDICATIONS AND USAGE 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). MODEYSO 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.
What are the side effects of Dordaviprone?▼
6 ADVERSE REACTIONS The following potential clinically significant adverse reactions are described elsewhere in the labelling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] . • QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] . The most common (≥20%) adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chimerix at toll-free phone # 1-866-662-2679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Dordaviprone during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , MODEYSO can cause fetal harm when administered to a pregnant woman. There are no available data on MODEYSO use in pregnant women to inform a drug‑associated risk.
What are the important warnings for Dordaviprone?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity: If clinically significant hypersensitivity or anaphylaxis occur, immediately discontinue MODEYSO and initiate appropriate medical treatment and supportive care. ( 5.1 ) • QTc Interval Prolongation: MODEYSO causes concentration dependent QTc interval prolongation. Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation, and permanently discontinue MODEYSO 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 MODEYSO can cause severe hypersensitivity reactions. 4 CONTRAINDICATIONS None. None. ( 4 )
Related Medications
Agaricus Albus 30x
agaricus albus 30x
For temporary relief of headache, cough. May also be used for standard homeopathic indications or as directed by your physician.
Miconazole Nitrate Antifungal Powder
miconazole nitrate antifungal powder
Purpose Antifungal
Carprofen
carprofen
Dosage form: POWDER. Active ingredients: CARPROFEN (1 kg/kg). Category: BULK INGREDIENT.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.