Imbruvica is a medicine for treating adult patients with the following blood cancers: - mantle cell lymphoma (MCL) in patients whose disease does not respond to or has come back after previous treatment; - chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients; - Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma). For the treatment of MCL, Imbruvica is taken on its own. For CLL, Imbruvica can be taken on its own but can also be taken with bendamustine and rituximab, or with either obinutuzumab, rituximab or venetoclax. For patients with Waldenström’s macroglobulinaemia, Imbruvica is taken on its own or with rituximab. Imbruvica contains the active substance ibrutinib.
Therapeutic Indication
### Therapeutic indication IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Therapeutic Area (MeSH)
ATC Code
L01EL01
ATC Item
ibrutinib
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Ibrutinib | N/A | 伊布替尼 |
EMA Name
Imbruvica
Medicine Name
Imbruvica
Aliases
N/ANo risk management plan link.