July 25, 2016
Recommended Topic Related To:

Bosulif

"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

CLL is a rare blood and bone marrow disease"...

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Bosulif




Bosulif Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/18/2016

Bosulif (bosutinib) is a kinase inhibitor used to treat adult patients with chronic accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. Common side effects of Bosulif include:

The recommended dose and schedule of Bosulif is 500 mg orally once daily with food. Bosulif may interact with ketoconazole, rifampin, proton pump inhibitors, St. John's wort, and digoxin. Tell your doctor all medications and supplements you use. Bosulif is not recommended for use during pregnancy. It may harm a fetus. Women should use contraception to prevent pregnancy during and for at least 30 days after completing treatment with Bosulif. Because of potential risk to a nursing infant, breastfeeding is not recommended; consult your doctor.

Our Bosulif (bosutinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Bosulif in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bosutinib and call your doctor at once if you have:

  • severe or ongoing nausea, vomiting, stomach pain, or diarrhea;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands or feet, rapid weight gain;
  • pain in your chest, on your left side, or behind your breastbone;
  • pain when you breathe, fast or uneven heart rate, feeling short of breath (especially when lying down);
  • anxiety, sweating, wheezing, gasping for breath, cough with foamy mucus; or
  • feeling weak, tired, dizzy, or light-headed.

Common side effects may include:

  • headache, dizziness, tired feeling;
  • mild stomach discomfort;
  • joint pain, back pain;
  • mild itching or rash; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Read the entire detailed patient monograph for Bosulif (Bosutinib Tablets)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Bosulif FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Serious adverse reactions reported include anaphylactic shock [see CONTRAINDICATIONS], myelosuppression, gastrointestinal toxicity (diarrhea), fluid retention, hepatotoxicity and rash.

Adverse reactions of any toxicity grade reported for greater than 20% of patients in the Phase ½ safety population (n=546) were diarrhea (82%), nausea (46%), thrombocytopenia (41%), vomiting (39%), abdominal pain (37%), rash (35%), anemia (27%), pyrexia (26%), and fatigue (24%) [see Clinical Studies].

Adverse Reactions in Patients with Imatinib-Resistant or -Intolerant Ph+ Chronic Phase (CP), Accelerated Phase (AP), and Blast Phase (BP) CML

The single-arm Phase ½ clinical trial (Study 1) enrolled patients with Ph+ chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) and with resistance or intolerance to prior therapy [see Clinical Studies]. The safety population (received at least 1 dose of BOSULIF) included 546 CML patients:

  • 287 patients with CP CML previously treated with imatinib only who had a median duration of BOSULIF treatment of 24 months, and a median dose intensity of 484 mg/day.
  • 119 patients with CP CML previously treated with both imatinib and at least 1 additional TKI who had a median duration of BOSULIF treatment of 9 months and a median dose intensity of 475 mg/day.
  • 140 patients with advanced phase CML including 76 patients with AP CML and 64 patients with BP CML. In the patients with AP CML and BP CML, the median duration of BOSULIF treatment was 10 months and 3 months, respectively. The median dose intensity was 483 mg/day, and 500 mg/day, in the AP CML and BP CML cohorts, respectively.

Table 3 identifies adverse reactions greater than or equal to 10% for all grades and grades 3 or 4 for the Phase ½ CML safety population.

Table 3: Adverse Reactions (10% or Greater) in Patients with CML in Study 1

  Chronic Phase CML
N=406
Advanced Phase CML
N=140
All Grades (%) Grade 3/4 (%) All Grades (%) Grade 3/4 (%)
Diarrhea 84 9 76 5
Nausea 46 1 47 2
Abdominal Paina 40 1 29 5
Thrombocytopenia 40 26 42 37
Vomiting 37 3 42 4
Rashb 34 8 35 4
Fatiguec 26 1 20 4
Anemia 23 9 37 26
Pyrexia 22 < 1 36 3
Increased alanine 20 7 10 5
aminotransferase
Headache 20 1 18 4
Cough 20 0 21 0
Increased aspartate aminotransferase 16 4 11 3
Neutropenia 16 11 19 18
Edemad 14 < 1 14 1
Arthralgia 14 < 1 13 0
Decreased appetite 13 1 14 0
Respiratory tract infectione 12 < 1 10 0
Nasopharyngitis 12 0 5 0
Back pain 12 1 7 1
Asthenia 11 1 10 1
Pruritus 11 1 8 0
Dizziness 10 0 13 1
Dyspnea 10 1 19 6
Advanced Phase CML includes patients with Accelerated Phase and Blast Phase CML
aAbdominal pain includes the following terms: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal tenderness, gastrointestinal pain, abdominal discomfort
bRash includes the following terms: rash, macular rash, pruritic rash, generalized rash, popular rash, maculo-papular rash
cFatigue includes the following terms: fatigue, malaise
dEdema includes the following terms: edema, peripheral edema, localized edema, face edema
eRespiratory tract infection includes the following 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 ½ clinical trial, one patient (0.2%) experienced QTcF interval of greater than 500 milliseconds. Patients with uncontrolled or significant cardiovascular disease including QT interval prolongation were excluded by protocol.

Table 4 identifies the clinically relevant or severe Grade 3/4 laboratory test abnormalities for the Phase ½ CML safety population.

Table 4: 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 (%)
Advanced Phase CML
N=140
n (%)
All CP and AdvP CML
N=546
n (%)
Hematology Parameters
  Platelet Count (Low) less than 50 x109/L 102 (25) 80 (57) 182 (33)
  Absolute Neutrophil Count less than 1 x 109/L 74 (18) 52 (37) 126 (23)
  Hemoglobin (Low) less than 80 g/L 53 (13) 49 (35) 102 (19)
Biochemistry Parameters
  SGPT/ALT greater than 5.0 x ULN 39 (10) 8 (6) 47 (9)
  SGOT/AST greater than 5.0 x ULN 17 (4) 4 (3) 21 (4)
  Lipase greater than 2 x ULN 33 (8) 4 (3) 37 (7)
  Phosphorus (Low) less than 0.6 mmol/L 30 (7) 10 (7) 40 (7)
  Total Bilirubin greater than 3.0 x ULN 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 hemorrhage (includes gastrointestinal hemorrhage, gastric hemorrhage, upper gastrointestinal hemorrhage)

General Disorders and Administrative Site Conditions: 1% and less than 10% -chest pain (includes chest pain and chest discomfort), pain

Hepatobiliary Disorders: 1% and less than 10% -hepatotoxicity (includes hepatotoxicity, toxic hepatitis, and cytolytic hepatitis), abnormal hepatic function (includes abnormal hepatic function, liver disorder); 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 (includes pneumonia, bronchopneumonia, lobar pneumonia, primary atypical pneumonia), 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

Read the entire FDA prescribing information for Bosulif (Bosutinib Tablets)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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