Key facts about Dordaviprone
What dosages is Dordaviprone available in?
Dordaviprone is available as oral capsules in the following strengths:
- 125 mg
What is Dordaviprone used for?
Dordaviprone is indicated for use in adult and pediatric patients aged 1 year and older with diffuse midline glioma that harbors an H3 K27M mutation and has progressed following prior therapy. This approval was granted under the FDA’s accelerated approval pathway, making Dordaviprone the first, and currently only, systemic treatment option for this rare and aggressive form of brain tumor.
How does Dordaviprone work?
Dordaviprone works by inhibiting specific pathways that drive tumor growth in diffuse midline glioma with the H3 K27M mutation. It targets cancer cells to slow or stop their proliferation, helping manage disease progression in patients whose tumors have continued to grow following prior therapy. Dordaviprone works by activating the mitochondrial protease ClpP and inhibiting the dopamine D2 receptor, helping to slow tumour growth and induce cancer cell death.
How do I take Dordaviprone?
Dordaviprone is administered as an oral capsule once weekly. The recommended dosage is:
- Adults and pediatric patients weighing ≥52.5 kg: 625 mg orally once weekly.
- Pediatric patients aged 1 year and older weighing between 10 kg and <52.5 kg: The dosage varies based on body weight, ranging from 125 mg to 500 mg once weekly.
Dordaviprone should be taken on an empty stomach, at least 1 hour before or 3 hours after eating. If swallowing capsules is not possible, the contents can be mixed with approximately 15 to 30 mL of liquid (such as water, apple juice, lemonade, or a sports drink) before ingestion.
Always follow your healthcare provider’s instructions regarding how and when to take Dordaviprone.
Is it safe for me to take Dordaviprone?
Dordaviprone is generally safe and effective for most patients when used as directed. However, it may not be suitable if you have certain health conditions or are taking specific medications.
Do not take Dordaviprone if you have:
- Severe hypersensitivity to Dordaviprone or any of its ingredients.
- QTc interval prolongation or a history of arrhythmias.
- Severe liver impairment.
- Known hypersensitivity to Dordaviprone or any of its ingredients.
- Used another protease activator or similar medication within the last 24 hours.
Dordaviprone Common Side Effects
Common side effects of Dordaviprone include:
- Fatigue
- Headache
- Nausea
- Vomiting
- Musculoskeletal pain
These side effects occurred in more than 20% of patients during clinical trials.
Dordaviprone Serious Side Effects
Serious side effects of Dordaviprone are not common. However, you should seek immediate medical attention if you experience:
- Allergic reactions: Rash, itching, swelling, difficulty breathing
- Heart rhythm problems: Palpitations, dizziness, or fainting
- Neurological symptoms: Seizures, confusion, sudden numbness or weakness
Effects of other drugs, drug classes and over-the-counter products on Dordaviprone
Dordaviprone may be affected by certain drug classes. You should inform your doctor if you are taking:
- Strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): These can increase Dordaviprone exposure, potentially increasing the risk of Dordaviprone-related adverse reactions.
- Strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): These can decrease Dordaviprone exposure, potentially reducing its anti-tumor activity.
- Medications that prolong the QTc interval (e.g., certain antiarrhythmics, antipsychotics): Concomitant use with Dordaviprone may increase the risk of QTc-associated arrhythmias.
Always discuss all medications, including over-the-counter products, with your healthcare provider before starting Dordaviprone.
Who makes Dordaviprone?
Various FDA-approved generic manufacturers
Is Dordaviprone safe in pregnancy?
Dordaviprone is not recommended during pregnancy. Animal studies showed risk of fetal harm, and the FDA classifies it as a drug with known fetal risk.
Women of reproductive potential should have a pregnancy test before starting treatment and use effective contraception during treatment and for 1 month after the last dose. Men with female partners of reproductive potential should also use contraception.
If you become pregnant while taking Dordaviprone, contact your doctor immediately to discuss risks and options.
