ONC201 is an investigational anti-cancer medication being studied for its potential to treat certain types of tumors, particularly diffuse midline glioma with an H3 K27M mutation. As with any medication, ONC201 can cause side effects. Understanding these potential effects is important for patients and their caregivers to be informed throughout the treatment journey.
Common Side Effects of ONC201
Clinical trials evaluating ONC201 have identified several commonly reported side effects, typically mild to moderate. Fatigue is frequently observed, affecting around 34-46% of patients. This tiredness generally does not severely impact daily activities.
Nausea is another common side effect, occurring in approximately 36% of patients. It is usually mild and can sometimes be accompanied by vomiting. Headaches are also reported by about 32% of patients during treatment with ONC201. These headaches are generally not severe.
Other common effects include changes in appetite and mild dizziness. These side effects tend to appear early in treatment and may lessen over time as the body adjusts to the medication.
Less Common and Serious Side Effects
While ONC201 is generally well-tolerated, some less common side effects can be serious and require close medical attention. Severe adverse events (Grade 3 or higher) have occurred in a small percentage of patients, typically less than 10%. These events are often not directly related to the drug.
Significant fatigue, sometimes reaching Grade 3 severity, has occurred in about 10% of patients. This severe form can significantly impact a patient’s ability to function. Increases in serum amylase have been noted, though these were mild and quickly reversible.
Changes in liver function, such as elevated ALT levels, have also been reported, though typically mild (Grade 1-2). Any significant changes in blood counts or neurological effects, like unusual weakness or confusion, are serious and require immediate evaluation. These effects highlight the need for continuous monitoring by healthcare professionals during ONC201 treatment.
Managing Side Effects
Managing common, less severe side effects of ONC201 involves practical strategies. For fatigue, patients can incorporate short rest periods and prioritize sleep. Gentle physical activity, if tolerated, may also help.
To address nausea, eating smaller, more frequent meals and avoiding rich, greasy, or spicy foods can be beneficial. Staying well-hydrated by sipping water or clear broths may also help alleviate mild nausea. Headaches can often be managed with over-the-counter pain relievers and adequate fluid intake.
If a patient experiences a mild rash, keeping the skin moisturized and avoiding harsh soaps can be helpful. Patients should discuss any side effects with their healthcare provider for individualized guidance.
When to Seek Medical Attention
Knowing when to seek immediate medical attention is important for patients receiving ONC201. Certain symptoms indicate a serious issue requiring prompt professional evaluation.
Patients should contact their healthcare provider right away if they experience a sudden, severe headache different from usual, or accompanied by changes in vision or confusion. A high fever (above 100.4°F / 38°C), especially with chills or body aches, warrants immediate medical consultation.
Any signs of a severe allergic reaction, such as difficulty breathing, swelling of the face or throat, or a widespread, itchy rash, require emergency medical attention. Unexplained bleeding or bruising, severe abdominal pain, or new, persistent neurological changes like extreme weakness or difficulty speaking should also prompt immediate contact with the healthcare team.