Active Ingredient: Rilzabrutinib
Rilzabrutinib is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 400 milligrams rilzabrutinib, 2 times daily.
The recommended dose of rilzabrutinib is 400 mg twice daily.
Recommended use with cytochrome P450 enzyme 3A (CYP3A) inhibitors or inducers and gastric acid reducing agents are provided in the following table.
Use with CYP3A inhibitors or inducers and gastric acid reducing agents:
| Co-administered medicinal product | Recommended use | |
| CYP3A inhibitors | Strong and moderate CYP3A inhibitor | Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inhibitors. If these inhibitors will be used short-term (such as anti- infectives for up to seven days), interrupt rilzabrutinib. |
| Avoid co-administration of grapefruit, starfruit and products containing these fruits, and Seville oranges with rilzabrutinib, as these are moderate or strong inhibitors of CYP3A. | ||
| Weak CYP3A inhibitor | No dose adjustment. | |
| CYP3A inducers | Strong and moderate CYP3A inducers | Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inducers. |
| Weak CYP3A inducer | No dose adjustment. | |
| Gastric acid reducing agents | Proton pump inhibitors (PPIs) | Avoid co-administration of rilzabrutinib with PPIs. |
| H2-receptor antagonists or antacid | If treatment with a gastric acid reducing agent is required, consider using a H2-receptor antagonist (H2RA) or antacid. Take rilzabrutinib at least 2 hours before taking the H2RA or antacid. |
If a dose of rilzabrutinib is missed, patients should take the missed dose as soon as possible on the same day with a return to the regular schedule the following day. The missed dose and the next regular scheduled dose must be taken more than 2 hours apart. Extra doses should not be taken to make up for the missed dose.
Treatment with rilzabrutinib should be discontinued after 12 weeks of rilzabrutinib therapy if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.
The tablets can be taken at approximately the same time each day with or without food. In patients who experience gastrointestinal symptoms, taking rilzabrutinib with food may improve tolerability.
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