From the Guidelines
Momelotinib is associated with a significant risk of peripheral neuropathy, which occurs in approximately 44% of patients, and is a major side effect that clinicians should be aware of when prescribing this medication. The side effects of momelotinib can be significant and impact a patient's quality of life. According to the study by Bose and Verstovsek 1, common side effects of momelotinib include peripheral neuropathy, which can be sensory in nature and may not improve even after dose reduction or discontinuation of the medication. Other side effects may include diarrhea, nausea, and fatigue, although these are not as prominently featured in the study as peripheral neuropathy.
Key Side Effects
- Peripheral neuropathy: occurs in approximately 44% of patients, with a median time to onset of 32 weeks, and may not improve with dose reduction or discontinuation 1
- Diarrhea and nausea: may occur, but are less prominently featured in the study as major side effects
- Fatigue, headache, and dizziness: may also occur, but are not as well-documented in the study as peripheral neuropathy
Management of Side Effects
It is essential for clinicians to monitor patients closely for signs of peripheral neuropathy and other side effects when prescribing momelotinib. Regular follow-up appointments and blood tests can help identify potential issues early on. Patients should also be educated on the potential side effects of momelotinib and instructed to contact their healthcare provider immediately if they experience any severe or persistent side effects. By being aware of the potential side effects of momelotinib, clinicians can provide better care and improve patient outcomes.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Momelotinib Side-Effects
- The most common grade 3 or worse adverse events associated with momelotinib were anaemia, thrombocytopenia, and abdominal pain 2.
- Peripheral neuropathy occurred in 11% of patients receiving momelotinib, with one case being grade 3 2.
- Serious events were reported for 35% of patients in the momelotinib group, including deaths due to adverse events such as acute myeloid leukaemia, respiratory failure, cardiac arrest, and bacterial sepsis 2.
- A long-term analysis of momelotinib found that the most common nonhematologic treatment-emergent adverse event was diarrhea, occurring in 27% of patients 3.
- Hematologic adverse events, including thrombocytopenia, anemia, and neutropenia, occurred in 25%, 23%, and 7% of patients, respectively 3.
- The most common reason for momelotinib discontinuation was thrombocytopenia, with a discontinuation rate of 4% 3.
- Post hoc analyses found that momelotinib maintained a consistent safety profile in patients with myelofibrosis and thrombocytopenia, with no increased risk of adverse events over time 4.
- A subgroup analysis of the SIMPLIFY-2 trial found that momelotinib improved transfusion independence rates and mean hemoglobin levels in patients with anemia, compared to continued ruxolitinib or best available therapy 5.
Specific Adverse Events
- Anaemia: occurred in 14% of patients in the momelotinib group and 14% of patients in the best available therapy group 2.
- Thrombocytopenia: occurred in 7% of patients in the momelotinib group and 6% of patients in the best available therapy group 2.
- Abdominal pain: occurred in 1% of patients in the momelotinib group and 6% of patients in the best available therapy group 2.
- Peripheral neuropathy: occurred in 11% of patients receiving momelotinib, with one case being grade 3 2.
- Diarrhea: occurred in 27% of patients, with 3% being grade 3 or worse 3.