Ibruxen (Ibrutinib 140mg)

ndication

Ibrutinib, is a kinase inhibitor indicated for the treatment of patients with: • Mantle cell lymphoma (MCL), who have received at least one prior therapy Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. • Chronic lymphocytic leukemia (CLL), who have received at least one prior therapy • Chronic lymphocytic leukemia with 17p deletion • Waldenström’s macroglobulinemia (WM)

Administration

Administer once daily at approximately the same time each day. Capsules should be taken orally with a glass of water. The capsules should not be opened, broke, or chewed.

Side Effect

>10% (MCL) Increased serum creatinine, 1.5 x ULN (67%) Platelets decreased, all grades (57%) Diarrhea (51%) Hemorrhage (48%) Neutrophils decreased, all grades (47%) Hemoglobin decreased, all grades (41%) Fatigue (41%) Musculoskeletal pain (37%) Peripheral edema (35%) URI infection (34%) Nausea (31%) Bruising (30%) Neutropenia, grades 3 or 4 (29%) Dyspnea (27%) Constipation (25%) Rash (25%) Abdominal pain (24%) Vomiting (23%) Decreased appetite (221%) Cough (19%) Pyrexia (18%) Stomatitis (17%) Thrombocytopenia, grades 3 or 4 (17%) UTI infection (14%) Pneumonia (14%) Skin infections (14%) Asthenia (14%) Muscle spasms (14%) Dizziness (14%) Sinusitis (13%) Headache (13%) Dehydration (12%) Dyspepsia (11%) Petechiae (11%) Arthralgia (11%) Epistaxis (11%) >10% (CLL) Platelets decreased, all grades (71%) Diarrhea (63%) Bruising (54%) Neutrophils decreased, all grades (54%) URT infection (48%) Hemoglobin decreased, all grades (44%) Fatigue (31%) Rash (27%) Musculoskeletal pain (27%) Neutropenia, grades 3 or 4 (27%) Pyrexia (25%) Peripheral edema (23%) Constipation (23%) Arthralgia (23%) Nausea (21%) Stomatitis (21%) Sinusitis (21%) Dizziness (21%) Vomiting (19%) Cough (19%) Muscle spasms (19%) Headache (19%) Skin infection (17%) Petechiae (17%) Decreased appetite (17%) Hypertension (17% Abdominal pain (15%) Oropharyngeal pain (15%) Dyspepsia (13%) Asthenia (13%) Chills (13%) 1-10% (MCL) Anemia, grades 3 or 4 (9%) Increased serum creatinine, 1.5-3 x ULN (9%) Hemorrhage, grades 3 or 4 (5%) Secondary primary malignancies (5%) 1-10% (CLL) Pneumonia (10%) UTI (10%) Dyspnea (10%) Peripheral neuropathy (10%) Second malignancies (10%) Anxiety (10%) Insomnia (10%) Thrombocytopenia, grades 3 or 4 (10%)