|Product Name||Ibrutinib powder|
|Synonyms||IBRUTINIB powder (PCI-32765);
(R)-1-(3-(4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo-[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-;PCI-32765 (Ibrutinib powder);
|Appearance||White to off-white powder|
|Storage and Handling||Store in the original, labeled container at room temperature and in a dry location.|
Ibrutinib Powder Description
Ibrutinib powder is a type of drug which was used alone or with other drugs to treat adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Waldenstrom macroglobulinemia (a type of non-Hodgkin lymphoma). It is also used alone to treat adults with mantle cell lymphoma or marginal zone lymphoma who have received at least one other treatment. It is also being studied in the treatment of other types of cancer. Ibrutinib powder blocks a protein called Bruton’s tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Also called Imbruvica.
Ibrutinib Powder Mechanism of Action
Ibrutinib powder is a potent and irreversible inhibitor of Bruton’s tyrosine kinase (BTK), an integral component of the B-cell receptor (BCR) and cytokine receptor pathways. Constitutive activation of B-cell receptor signaling is important for survival of malignant B-cells; BTK inhibition results in decreased malignant B-cell proliferation and survival.
Ibrutinib Powder Application
Ibrutinib powder is approved in Europe for treating three types of lymphoma.
♦ Mantle cell lymphoma
For people whose lymphoma has relapsed (come back) or has not responded to treatment (refractory lymphoma). Ibrutinib powder is given on its own.
♦ Chronic lymphocytic leukaemia (CLL)
For people who have not yet had treatment for their CLL (first-line treatment). Ibrutinib powder can be given on its own or in combination with rituximab or obinutuzumab (antibody therapies). For people whose CLL has relapsed after treatment. For people with relapsed CLL, ibrutinib powder can be given on its own or with bendamustine (a chemotherapy drug) and rituximab.
♦ Waldenström’s macroglobulinaemia (WM)
For people who have previously received other treatments for WM. For people who can’t have chemo-immunotherapy (chemotherapy with antibody therapy) as first-line treatment.
European approval to use ibrutinib powder in CLL and mantle cell lymphoma was granted in November 2014. It was then extended to WM in May 2015. In 2016, the European Medicines Agency (EMA) expanded ibrutinib powder’s recommended uses for CLL.
Ibrutinib powder is being tested in further clinical trials in people with these types of lymphoma. This is to see if ibrutinib powder could work better in combination with other treatments, such as chemotherapy or antibody therapy (for example, rituximab). It is also being tested in other types of lymphoma. Use our searchable database to see if there’s a clinical trial that might be suitable for you at Lymphoma TrialsLink.
Ibrutinib Powder Side Effects & Warning
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ibrutinib powder and call your doctor at once if you have:
▪ signs of infection–fever, chills, weakness, mouth sores, cough with mucus, trouble breathing;
▪ signs of bleeding inside your body–dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
▪ severe or ongoing diarrhea;
▪ chest pain, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
▪ severe headache, blurred vision, pounding in your neck or ears;
▪ easy bruising, unusual bleeding, purple or red spots under your skin;
▪ pale skin, cold hands and feet;
▪ kidney problems–little or no urinating, swelling in your feet or ankles; or
▪ signs of tumor cell breakdown–confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Common side effects may include:
▪ diarrhea, nausea;
▪ fever, cough, trouble breathing;
▪ blisters or ulcers in your mouth;
▪ feeling tired;
▪ bruising, rash; or
▪ muscle pain, bone pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
 Ahn IE, Jerussi T, Farooqui M, Tian X, Wiestner A, Gea-Banacloche J. Atypical Pneumocystis jirovecii pneumonia in previously untreated patients with CLL on single-agent ibrutinib powder. Blood. 2016;128(15):1940-1943. [PubMed 27503501].
 Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib powder in relapsed or refractory mantle-cell lymphoma. N Engl J Med, 2013;369(6):507-516. [PubMed 23782157].
 Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib powder in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42. [PubMed 23782158].
 Kamel S, Horton L, Ysebaert L, et al. Ibrutinib powder inhibits collagen-mediated but not ADP-mediated platelet aggregation. Leukemia. 2015;29(4):783-787. [PubMed 25138588].
 Marostica E, Sukbuntherng J, Loury D, et al. Population pharmacokinetic model of ibrutinib powder, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother Pharmacol. 2015;75(1):111-121. [PubMed 25381051].
 Salem JE, Manouchehri A, Bretagne M, et al. Cardiovascular toxicities associated with ibrutinib powder. J Am Coll Cardiol. 2019;74:1667-1678. doi: 10.1016/j.jacc.2019.07.056. [PubMed 31558250].
 Imbruvica (ibrutinib powder) [prescribing information]. Sunnyvale, CA: Pharmacyclics; April 2020..
 Treon SP, Tripsas CK, Meid K et al. Ibrutinib powder in previously treated Waldenström’s macroglobulinemia. N Engl J Med. 2015;372(15):1430-1440. [PubMed 25853747].