UP FRONT
G:.5”
perform an assessment individualized
to each patient and the dynamics within
his or her support system.
Obviously, that’s not to say that the
caregiver’s role is unimportant; caregivers
are indispensable, particularly at the time
when patients are first diagnosed and
overwhelmed by the changes in their lives.
As their cancer is treated and they are
starting to feel better, patients may be able
S:7”
to take on more ownership
of their care. It’s
or other caregiver; while that’s
certainly fine, we can’t automatically
assume that the caregiver is running
everything. We have to involve patients
in discussions about their treatment –
not just the caregiver. Only in certain
circumstances, when the patient has
expressly handed over control to a
caregiver, can we defer to him or her.
Rather than assuming that the caregiver
is handling everything, we should
Adverse Reactions (10% or Greater) in Patients with CML in Study 1 (cont’d)
Chronic Phase CML
N=406
Back pain
Asthenia
Pruritus
Dizziness
Dyspnea
Advanced Phase CML
N=140
All Grades
(%)
Grade 3/4
(%)
All Grades
(%)
Grade 3/4
(%)
12
11
11
10
10
1
1
1
0
1
7
10
8
13
19
1
1
0
1
6
Advanced phase (AdvP) CML includes patients with accelerated phase and blast phase CML
a. Abdominal pain includes the following preferred terms: abdominal pain, upper abdominal pain, lower abdominal pain,
abdominal tenderness, gastrointestinal pain, abdominal discomfort
b. Rash includes the following preferred terms: rash, macular rash, pruritic rash, generalized rash, papular rash,
maculo-papular rash
c. Fatigue includes the following preferred terms: fatigue, malaise
d. Edema includes the following preferred terms: edema, peripheral edema, localized edema, face edema
e. Respiratory tract infection includes the following preferred terms: respiratory tract infection, upper respiratory tract infection,
lower respiratory tract infection, viral upper respiratory tract infection, viral respiratory tract infection
In the single-arm, Phase 1/2 clinical trial, one patient (0.2%) experienced QTcF interval of greater than
500 ms. Patients with uncontrolled or significant cardiovascular disease, including QT interval
prolongation, were excluded by protocol.
Number (%) of Patients with Clinically Relevant or Severe Grade 3/4 Laboratory Test
Abnormalities in Patients with CML in Study 1, Safety Population
Chronic Phase CML
N=406
n (%)
102 (25)
80 (57)
182 (33)
74 (18)
52 (37)
126 (23)
53 (13)
49 (35)
102 (19)
39 (10)
17 (4)
33 (8)
8 (6)
4 (3)
4 (3)
47 (9)
21 (4)
37 (7)
30 (7)
10 (7)
40 (7)
3 (1)
2 (1)
5 (1)
Additional Adverse Reactions from Multiple Clinical Trials:
The following adverse reactions were reported in patients in clinical trials with BOSULIF (less than 10% of
BOSULIF-treated patients). They represent an evaluation of the adverse reaction data from 870 patients
with Ph+ leukemia who received at least 1 dose of single-agent BOSULIF. These adverse reactions are
presented by system organ class and are ranked by frequency. These adverse reactions are included
based on clinical relevance and ranked in order of decreasing seriousness within each category.
Blood and Lymphatic System Disorders: 1% and less than 10% - febrile neutropenia
Cardiac Disorders: 1% and less than 10% - pericardial effusion; 0.1% and less than 1% - pericarditis
Ear and Labyrinth Disorders: 1% and less than 10% - tinnitus
Gastrointestinal Disorders: 1% and less than 10% - gastritis; 0.1% and less than 1% - acute pancreatitis,
gastrointestinal hemorrhagea
General Disorders and Administrative Site Conditions: 1% and less than 10% - chest pain,b pain
Hepatobiliary Disorders: 1% and less than 10% - hepatotoxicity,c abnormal hepatic functiond; 0.1% and less
than 1% - liver injury
Immune System Disorders: 1% and less than 10% - drug hypersensitivity; 0.1% and less than 1% anaphylactic shock
Infections and Infestations: 1% and less than 10% - pneumonia,e influenza, bronchitis
Investigations: 1% and less than 10% - electrocardiogram QT prolonged, increased blood creatine
phosphokinase, increased blood creatinine
Metabolism and Nutrition Disorder: 1% and less than 10% - hyperkalemia, dehydration
Musculoskeletal and Connective Tissue Disorder: 1% and less than 10% - myalgia
Nervous System Disorders: 1% and less than 10% - dysgeusia
Renal and Urinary Disorders: 1% and less than 10% - acute renal failure, renal failure
Respiratory, Thoracic, and Mediastinal Disorders: 1% and less than 10% - pleural effusion; 0.1% and less than
1% - acute pulmonary edema, respiratory failure, pulmonary hypertension
Skin and Subcutaneous Disorders: 1% and less than 10% - urticaria, pruritus, acne; 0.1% and less than 1% erythema multiforme, exfoliative rash, drug eruption
a. Gastrointestinal hemorrhage includes the following preferred terms: gastrointestinal hemorrhage, gastric hemorrhage,
upper gastrointestinal hemorrhage
b. Chest pain includes the following preferred terms: chest pain, chest discomfort
c. Hepatotoxicity includes the following preferred terms: hepatotoxicity, toxic hepatitis, cytolytic hepatitis
d. Abnormal hepatic function includes the following preferred terms: abnormal hepatic function, liver disorder
e. Pneumonia includes the following preferred terms: pneumonia, bronchopneumonia, lobar pneumonia, primary
atypical pneumonia
DRUG INTERACTIONS
Drugs That May Increase Bosutinib Plasma Concentrations: CYP3A inhibitors: Avoid the concomitant use
of strong or moderate CYP3A inhibitors with BOSULIF as an increase in bosutinib plasma concentration
is expected. In a dedicated cross-over drug-interaction trial in healthy volunteers (N=24), concomitant
ketoconazole (strong CYP3A inhibitor) increased bosutinib Cmax 5.2-fold and AUC 8.6-fold compared to
BOSULIF alone. Drugs That May Decrease Bosutinib Plasma Concentrations: CYP3A Inducers: Avoid the
How to Help Without Hurting
To help our patients navigate the healthcare system, we have to know who they
are and how proactive they are. It is our
responsibility to understand our patients
and how much of our help they