Imbruvica

What Imbruvica is used for

Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory 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.

Approved use, as published by the European Medicines Agency.

Key facts

Brand

Imbruvica

Active substance

ibrutinib

Disease area

Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Medicine group

Antineoplastic agents;Protein kinase inhibitors

ATC code

L01EL01

Marketing authorisation holder

Janssen-Cilag International NV

Authorised in the EU since

2014

Official information

• Imbruvica: European public assessment report (EPAR), product information and package leaflet, on the EMA website

In the USA

Same active substance: Imbruvica

In India

• Ibrutinib: 10 brands in India