hat were 2-20 times higher than those reported in patients with hematologic malignancies. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
Hemorrhage [see Warnings and Precautions (5.1)]
Infections [see Warnings and Precautions (5.2)]
Cytopenias [see Warnings and Precautions (5.3)]
Cardiac Arrhythmias [see Warnings and Precautions (5.4)]
Hypertension [see Warnings and Precautions (5.5)]
Second Primary Malignancies [see Warnings and Precautions (5.6)]
Tumor Lysis Syndrome [see Warnings and Precautions (5.7)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.
Mantle Cell Lymphoma
The data described below reflect exposure to IMBRUVICA in a clinical trial (Study 1104) that included 111 patients with previously treated MCL treated with 560 mg daily with a median treatment duration of 8.3 months.
The most commonly occurring adverse reactions (≥ 20%) were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting and decreased appetite (see TABLES 1 and 2).
The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) were pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue, and skin infections.
Fatal and serious cases of renal failure have occurred with IMBRUVICA therapy. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 9% of patients.
Adverse reactions from the MCL trial (N=111) using single agent IMBRUVICA 560 mg daily occurring at a rate of ≥ 10% are presented in TABLE 1.
Table 1: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with MCL (N=111)
Body System Adverse Reaction All Grades (%) Grade 3 or 4 (%)
Gastrointestinal disorders Diarrhea 51 5
Nausea 31 0
Constipation 25 0
Abdominal pain 24 5
Vomiting 23 0
Stomatitis 17 1
Dyspepsia 11 0
Infections and infestations Upper respiratory tract infection 34 0
Urinary tract infection 14 3
Pneumonia 14 7
Skin infections 14 5
Sinusitis 13 1
General disorders and administration site conditions Fatigue 41 5
Peripheral edema 35 3
Pyrexia 18 1
Asthenia 14 3
Skin and subcutaneous tissue disorders Bruising 30 0
Rash 25 3
Petechiae 11 0
Musculoskeletal and connective tissue disorders Musculoskeletal pain 37 1
Muscle spasms 14 0
Arthralgia 11 0
Respiratory, thoracic and mediastinal disorders Dyspnea 27 |
