Imbruvica
Imbruvica ingredients
| Active ingredient | Strength |
|---|---|
| Ibrutinib | 140 mg/1, 420 mg/1, 70 mg/mL, 70 mg/1, 280 mg/1 |
What Imbruvica is used for
The FDA lists the approved uses on the official label (below). In the EU, ibrutinib is approved as Imbruvica 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…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Imbruvica
- Generic name
- Ibrutinib
- Made by
- Pharmacyclics LLC
- Forms
- Capsule, Suspension, Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA210563
- On the US market since
- 2013
Official information
- Imbruvica prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Ibrutinib)
In India
- Ibrutinib: 10 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Imbruvica?
Imbruvica (Ibrutinib) is a cancer medicine made by Pharmacyclics LLC, approved by the US FDA.
What are the ingredients of Imbruvica?
Imbruvica contains Ibrutinib (140 mg/1, 420 mg/1, 70 mg/mL, 70 mg/1, 280 mg/1).
Is Imbruvica approved in Europe?
The same active substance is approved in the EU as Imbruvica.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA