What are Ninlaro side effects?
The most common side effects seen in a clinical study with Ninlaro® (ixazomib, Takeda Oncology) in combination with Revlimid® (lenalidomide, Celgene) and dexamethasone included:
- Gastrointestinal effects (diarrhea, constipation, nausea, or vomiting)
- Low platelet count (thrombocytopenia)
- Peripheral neuropathy
- Peripheral edema (swelling of the hands or feet)
- Back pain
In this study, the most common serious side effects included:
- Low platelet count
Patients have also experienced low numbers of white blood cells known as neutrophils (neutropenia).
Women should avoid becoming pregnant while taking Ninlaro, as it caused fetal harm in animal studies.
How are side effects of Ninlaro managed?
If you experience any new or worsening side effects, contact your health care provider. Most side effects can be managed with supportive care measures, other medications, temporarily stopping treatment, or dose modifications.
Patients who experience low platelet or neutrophil counts may have their next dose of Ninlaro and Revlimid held until their counts go back up. At that point, Revlimid is resumed at a lower dose and the same dose of Ninlaro is taken. Patients experiencing neutropenia may also receive a colony-stimulating factor, a medication to stimulate the production of neutrophils.
If the platelet or neutrophil counts fall again, both Ninlaro and Revlimid are again withheld until the counts go up. Then, Ninlaro is resumed at a lower dose and Revlimid is resumed at its most recent dose. For any subsequent instances of low platelet or neutrophil counts, any dosing modifications will alternate between Revlimid and Ninlaro.
Patients who experience side effects such as rash, peripheral neuropathy, or other severe toxicities may also have their next dose of Ninlaro and Revlimid held until the symptoms improve. When dosing is resumed, one agent may be administered at a lower dose, depending on the side effect seen. Ninlaro-Revlimid-dexamethasone may be stopped in cases of life-threatening or disabling side effects.