BRUKINSA patients can call the myBeiGene® patient support program to talk to a dedicated nurse: 1-833-BEIGENE (1-833-234-4363)
Safety in MZL: | Pooled Safety Population (N=1550)*2 | |||
---|---|---|---|---|
Adverse Reaction | All Grades (%) | Grade ≥3 (%) | All Grades (%) | Grade ≥3 (%) |
Upper respiratory tract infection | 26 | 3.4 | 39 | 2 |
Urinary tract infection | 11 | 2.3 | 13 | 2 |
Pneumonia | 10 | 6 | 20 | 11 |
Diarrhea | 25 | 3.4 | 19 | 2 |
Abdominal pain | 14 | 2.3 | 10 | 0.6 |
Nausea | 13 | 0 | 11 | 0.2 |
Bruising | 24 | 0 | 23 | 0.1 |
Rash | 21 | 0 | 28 | 0.9 |
Musculoskeletal pain | 27 | 1.1 | 30 | 2 |
Hemorrhage | 23 | 1.1 | 30 | 4 |
Fatigue | 21 | 2.3 | 17 | 1 |
Cough | 10 | 0 | 19 | 0.1 |
*Chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, hairy cell leukemia, diffuse large B-cell lymphoma, and Richter’s transformation.2
Select Laboratory Abnormalities (≥20%) That Worsened | ||
---|---|---|
Laboratory Abnormality†1 | BRUKINSA | |
All Grades (%) | Grade 3 or 4 (%) | |
Hematologic abnormalities | ||
Neutrophils decreased | 43 | 15 |
Platelets decreased | 33 | 10 |
Lymphocytes decreased | 32 | 8 |
Hemoglobin decreased | 26 | 6 |
Chemistry abnormalities | ||
Glucose increased‡ | 54 | 4.6 |
Creatinine increased | 34 | 1.1 |
Phosphate decreased | 27 | 2.3 |
Calcium decreased | 23 | 0 |
ALT increased | 22 | 1.1 |
Patients on study received growth factor support as needed.2
†The denominator used to calculate the rate varied from 87 to 88 based on the number of patients with a baseline value and at least one post-treatment value.
‡Patients on study were not required to fast for lab tests.
ARs of Special Interest in the Pooled Safety Population (N=1550)§2 | ||
---|---|---|
Adverse Reaction | Percent of Patients (N=1550) | |
All Grades (%) | Grade ≥3 (%) | |
Hypertension | 14 | 7 |
Atrial fibrillation and flutter | 4 | 2 |
In the (N=1550) pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients included neutrophil count decreased (42%), upper respiratory tract infection (39%), platelet count decreased (34%), hemorrhage (30%), and musculoskeletal pain (30%).1
§Chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, hairy cell leukemia, diffuse large B-cell lymphoma, and Richter’s transformation.2
Atrial fibrillation
Hypertension
¶Atrial fibrillation resolved 1 day after onset and patient had a history of Grade 1 atrial fibrillation.
ALT=alanine aminotransferase; ARs=adverse reactions; MZL=marginal zone lymphoma; R/R=relapsed/refractory.
Dose reductions
due to ARs1
2.3%
(2/88)
of patients
Discontinuation
rate due to ARs1
6%
(5/88)
of patients
Median duration of treatment:
14.5 months (range: 0.9-58.6 months)2
#Dose reduction and discontinuation rates represent combined data from MAGNOLIA (Study 214) and Study 003.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.
These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
BRUKINSA is a prescription medicine used to treat adults with:
It is not known if BRUKINSA is safe and effective in children.
Please see full Prescribing Information including Patient Information.