Bosulif

Last reviewed on RxList: 5/27/2021
Bosulif Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Bosulif?

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.

What Are Side Effects of Bosulif?

Common side effects of Bosulif include:

Dosage for Bosulif

The recommended dose and schedule of Bosulif is 500 mg orally once daily with food.

What Drugs, Substances, or Supplements Interact with Bosulif?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Bosulif Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, itching; dizziness; back pain, joint pain; 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;
  • blood in your stools;
  • urinating more or less than usual;
  • feeling light-headed or short of breath;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet;
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • swelling or fluid build-up in the lungs--anxiety, sweating, pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • headache, feeling tired;
  • nausea, vomiting, diarrhea, stomach pain;
  • fever, cough;
  • abnormal liver function tests;
  • swelling;
  • rash; or
  • low blood cell counts.

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)

QUESTION

What is leukemia? See Answer
Bosulif Professional Information

SIDE EFFECTS

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

  • Gastrointestinal toxicity [see WARNINGS AND PRECAUTIONS].
  • Myelosuppression [see WARNINGS AND PRECAUTIONS].
  • Hepatic toxicity [see WARNINGS AND PRECAUTIONS].
  • Cardiovascular toxicity [see WARNINGS AND PRECAUTIONS]
  • Fluid retention [see WARNINGS AND PRECAUTIONS].
  • Renal toxicity [see WARNINGS AND PRECAUTIONS].

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.

The most common adverse reactions, in ≥20% of patients with newly diagnosed CP Ph+ CML or CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy (N=814) were diarrhea (80%), rash (44%), nausea (44%), abdominal pain (43%), vomiting (33%), fatigue (33%), hepatic dysfunction (33%), respiratory tract infection (25%), pyrexia (24%), and headache (21%).

The most common laboratory abnormalities that worsened from baseline in ≥20% of patients were creatinine increased (93%), hemoglobin decreased (90%), lymphocyte count decreased (72%), platelets decreased (69%), ALT increased (58%), calcium decreased (53%), white blood cell count decreased (52%), absolute neutrophils count decreased (50%), AST increased (50%), glucose increased (46%), phosphorus decreased (44%), urate increased (41%), alkaline phosphatase increased (40%), lipase increased (36%), creatine kinase increased (29%), and amylase increased (24%).

Adverse Reactions In Patients With Newly-Diagnosed CP CML

The clinical trial randomized and treated 533 patients with newly-diagnosed CP CML to receive BOSULIF 400 mg daily or imatinib 400 mg daily as single agents (Newly-Diagnosed CP CML Study) [see Clinical Studies]. The safety population (received at least 1 dose of BOSULIF) included:

  • two hundred sixty-eight (268) patients with newly-diagnosed CP CML had a median duration of BOSULIF treatment of 55 months (range: 0.3 to 60 months) and a median dose intensity of 394 mg/day.

Serious adverse reactions occurred in 22% of patients with newly-diagnosed CP CML who received bosutinib. Serious adverse reactions reported in >2% of patients included hepatic dysfunction (4.1%), pneumonia (3.4%), coronary artery disease (3.4%), and gastroenteritis (2.2%). Fatal adverse reactions occurred in 3 patients (1.1%) due to coronary artery disease (0.4%), cardiac failure acute (0.4%), and renal failure (0.4%).

Permanent discontinuation of bosutinib due to an adverse reaction occurred in 20% of patients with newly-diagnosed CP CML who received bosutinib. Adverse reactions which resulted in permanent discontinuation in > 2% of patients included hepatic dysfunction (9%).

Permanent discontinuation of bosutinib due to an adverse reaction occurred in 20% of patients with newly-diagnosed CP CML who received bosutinib. Adverse reactions which resulted in permanent discontinuation in > 2% of patients included hepatic dysfunction (9%).

Dose modifications (dose interruption or reductions) of bosutinib due to an adverse reaction occurred in 68% of patients with newly-diagnosed CP CML. Adverse reactions which required dose interruptions or reductions in >5% of patients included hepatic dysfunction (27%), thrombocytopenia (16%), diarrhea (16%), lipase increased (10%), neutropenia (7%), abdominal pain (6%), rash (5%).

The most common adverse reactions, in >20% of bosutinib-treated patients with newly-diagnosed CML (N=268) were diarrhea (75%), hepatic dysfunction (45%), rash (40%), abdominal pain (39%), nausea (37%), fatigue (33%), respiratory tract infection (27%), headache (22%), and vomiting (21%).

The most common laboratory abnormalities that worsened from baseline in ≥20% of patients were creatinine increased (94%), hemoglobin decreased (89%), lymphocyte count decreased (84%), ALT increased (68%), platelet count decreased (68%), glucose increased (57%), AST increased (56%), calcium decreased (55%), phosphorus decreased (54%), lipase increased (53%), white blood cell count decreased (50%), absolute neutrophil count decreased (42%), alkaline phosphatase increased (41%), creatine kinase increased (36%), and amylase increased (32%).

Table 4 identifies adverse reactions greater than or equal to 10% for All Grades and Grades 3 or 4 (3/4) for the Phase 3 CP CML safety population.

Table 4: Adverse Reactions (10% or Greater) in Patients With Newly-Diagnosed CML in Bosutinib 400 mg Study*

System Organ Class Preferred Term Bosutinib 400 mg Chronic Phase CML
(N=268)
Imatinib 400 mg Chronic Phase CML
(N=265)
All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Gastrointestinal disorders Diarrhea 75 9 40 1
Abdominal paina 39 2 27 1
Nausea 37 0 42 0
Vomiting 21 1 20 0
Constipation 13 0 6 0
Hepatobiliary disorders Hepatic dysfunctionf 45 27 15 4
Skin and subcutaneous tissue disorders Rashd 40 2 30 2
Pruritus 11 <1 4 0
General disorders and administration-site conditions Fatigueb 33 1 30 <1
Pyrexia 17 1 11 0
Edemag 15 0 46 2
Infections and infestations Respiratory tract infectione 27 1 25 <1
Nervous system disorders Headache 22 1 15 1
Musculoskeletal and connective tissue disorders Arthralgia 18 1 18 <1
Back pain 12 <1 9 <1
Respiratory, thoracic, and mediastinal disorders Cough 11 0 10 0
Dyspnea 11 1 6 1
Metabolism and nutrition disorders Decreased appetite 11 <1 6 0
Vascular disorders Hypertensionc 10 5 11 5
*Based on a Minimum of 57 Months of Follow-up. Adverse drug reactions are based on all-causality treatment-emergent adverse events. The commonality stratification is based on 'All Grades' under Total column. 'Grade 3', 'Grade 4' columns indicate maximum toxicity.
aAbdominal pain includes the following preferred terms: Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness, Dyspepsia, Epigastric discomfort, Gastrointestinal pain.
bFatigue includes the following preferred terms: Asthenia, Fatigue, Malaise.
cHypertension* includes the preferred terms: Blood pressure systolic increased, Hypertension, Hypertensive crisis, Hypertensive heart disease, Retinopathy hypertensive.
fHepatic dysfunction includes the preferred terms: Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Drug-induced liver injury, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Hepatic steatosis, Hepatitis, Hepatitis toxic, Hepatocellular injury, Hepatotoxicity, Hyperbilirubinemia, Jaundice, Liver disorder, Liver function test increased, Ocular icterus, Transaminases increased.
gEdema includes the following preferred terms: Eye edema, Eyelid edema, Face edema, Edema, Edema peripheral, Orbital edema, Periorbital edema, Periorbital swelling, Peripheral swelling, Swelling, Swelling face, Swelling of eyelid, Swollen tongue.
dRash includes the following preferred terms: Acne, Blister, Dermatitis, Dermatitis acneiform, Dermatitis bullous, Dermatitis exfoliative generalized, Drug reaction with eosinophilia and systemic symptoms, Dyshidrotic eczema, Eczema, Eczema asteatotic, Erythema, Erythema nodosum, Genital rash, Lichen planus, Perivascular dermatitis, Photosensitivity reaction, Psoriasis, Rash, Rash erythematous, Rash macular, Rash maculo-papular, Rash papular, Rash pruritic, Rash pustular, Rash vesicular, Seborrhoeic keratosis, Skin discoloration, Skin exfoliation, Skin hypopigmentation, Skin irritation, Skin lesion, Stasis dermatitis. eRespiratory tract infection includes the following preferred terms: Nasopharyngitis, Respiratory tract congestion, Respiratory tract infection, Respiratory tract infection viral, Upper respiratory tract infection.

In the randomized study in patients with newly-diagnosed CP CML, one patient in the group treated with BOSULIF experienced a Grade 3 QTcF prolongation (>500 msec). Patients with uncontrolled or significant cardiovascular disease including QT interval prolongation were excluded by protocol.

Table 5 identifies the clinically relevant or severe Grade 3/4 laboratory test abnormalities for the Phase 3 newly-diagnosed CML safety population.

Table 5: Select Laboratory Abnormalities (≥20%) That Worsened From Baseline in Patients with Newly-Diagnosed CML in Bosutinib 400 mg Study*

Bosutinib
N=268 %
Imatinib
N=265 %
All Grade Grade 3-4 All Grade Grade 3-4
Hematology Parameters
Platelet Count decreased 68 14 60 6
Absolute Neutrophil Count decreased 42 9 65 20
Hemoglobin decreased 89 9 90 7
White Blood Cell Count decreased 50 6 70 8
Lymphocyte Count decreased 84 12 82 14
Biochemistry Parameters
SGPT/ALT increased 68 26 28 3
SGOT/AST increased 56 13 29 3.4
Lipase increased 53 19 35 8
Phosphorus decreased 54 9 69 21
Amylase increased 32 3.4 18 2.3
Alkaline Phosphatase increased 41 0 43 0.4
Calcium decreased 55 1.5 57 1.1
Glucose increased 57 3 65 3.4
Creatine Kinase increased 36 3 65 5
Creatinine increased 94 1.1 98 0.8
*Based on a Minimum of 57 Months of Follow-up.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; CML=chronic myelogenous leukemia; SGPT=serum glutamic-pyruvic transaminase; SGOT=serum glutamic-oxaloacetic transaminase; N/n=number of patients; ULN=upper limit of normal
Graded using CTCAE v 4.03

Adverse Reactions In Patients With Imatinib-Resistant Or -Intolerant Ph+ CP, AP, And BP CML

The single-arm clinical trial enrolled patients with Ph+ CP, AP, or BP 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:

  • two hundred eighty-four (284) patients with CP CML previously treated with imatinib only who had a median duration of BOSULIF treatment of 26 months (range: 0.2 to 155 months), and a median dose intensity of 437 mg/day.
  • one hundred nineteen (119) patients with CP CML previously treated with both imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) who had a median duration of BOSULIF treatment of 9 months (range: 0.2 to 148 months) and a median dose intensity of 427 mg/day.
  • one hundred forty-three (143) patients with advanced phase (AdvP) CML including 79 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 (range: 0.1 to 140 months) and 3 months (range: 0.03 to 71 months), respectively. The median dose intensity was 406 mg/day, and 456 mg/day, in the AP CML and BP CML cohorts, respectively.

Serious adverse reactions occurred in 30% of patients in the safety population of the single-arm trial in patients with CML (N=546) who were resistant or intolerant to prior therapy. Serious adverse reactions reported in >2% of patients included pneumonia (7%), pleural effusion (6%), pyrexia (3.7%), coronary artery disease (3.5%), dyspnea (2.6%), rash (2.2%), thrombocytopenia (2%), abdominal pain (2%), and diarrhea (2%).

Fatal adverse reactions occurred in 12 patients (2.2%) due to coronary artery disease (0.9%), pneumonia (0.4%), respiratory failure (0.4%), gastrointestinal hemorrhage (0.2%), acute kidney injury (0.2%), and acute pulmonary edema (0.2%).

Permanent discontinuation of bosutinib due to an adverse reaction occurred in 22% of patients with CML who were resistant or intolerant to prior therapy. Adverse reactions which resulted in permanent discontinuation in >2% of patients included thrombocytopenia (6%), hepatic dysfunction (3.3%), and neutropenia (2%).

Dose modifications (dose interruption or reductions) of bosutinib due to an adverse reaction occurred in 66% of patients with CML who were resistant or intolerant to prior therapy. Adverse reactions which required dose interruptions or reductions in >5% of patients included thrombocytopenia (24%), diarrhea (14%), rash (13%), hepatic dysfunction (10%), neutropenia (9%), pleural effusion (8%), vomiting (7%), anemia (6%), and abdominal pain (6%).

The most common adverse reactions, in ≥20% of patients in the safety population of the single-arm trial in patients with CML (N=546) who were resistant or intolerant to prior therapy were diarrhea (83%), nausea (47%), rash (46%), abdominal pain (45%), vomiting (39%), fatigue (33%), pyrexia (28%), hepatic dysfunction (27%), respiratory tract infection (24%), cough (23%), and headache (21%).

The most common laboratory abnormalities that worsened from baseline in ≥20% were creatinine increased (93%), hemoglobin decreased (91%), lymphocyte decreased (80%), platelets decreased (69%), absolute neutrophil count (54%), ALT increased (53%), calcium decreased (53%), white blood cell count decreased (52%), urate increased (48%), AST increased (47%), phosphorus decreased (39%), alkaline phosphatase increased (39%), lipase increased (28%), magnesium increased (25%), potassium decreased (24%), potassium increased (23%). See Table 7 for Grade 3/4 laboratory abnormalities.

Table 6 identifies adverse reactions greater than or equal to 10% for All Grades and Grades 3 or 4 for the Phase ½ CML safety population based on long-term follow-up.

Table 6: Adverse Reactions (10% or Greater) in Patients With CML Who Were Resistant or Intolerant to Prior Therapy in Single-Arm Trial*

System Organ Class Preferred Term CP CML
(N=403)
AdvP CML
(N=143)
All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Gastrointestinal disorders Diarrhea 85 10 76 4
Abdominal paina 49 2 36 7
Nausea 47 1 48 2
Vomiting 38 3 43 3
Constipation 15 <1 17 1
Skin and subcutaneous tissue disorders Rashe 48 9 42 5
Pruritus 12 1 7 0
General disorders and administration-site conditions Fatigue 35 3 27 6
Pyrexia 25 1 37 3
Edemac 19 <1 17 1
Chest paing 8 1 12 1
Hepatobiliary disorders Hepatic dysfunctionh 29 11 21 10
Infections and infestations Respiratory tract infectionf 27 <1 17 0
Influenzai 11 1 3 0
Pneumoniad 10 4 18 12
Respiratory, thoracic, and mediastinal disorders Cough 24 0 22 0
Pleural effusion 14 4 9 4
Dyspnea 12 2 20 6
Nervous system disorders Headache 21 1 18 4
Dizziness 11 0 14 1
Musculoskeletal and connective tissue disorders Arthralgia 19 1 15 0
Back pain 14 1 8 1
Metabolism and nutrition disorders Decreased appetite 14 1 14 0
Vascular disorders Hypertensionb 11 3 8 3
ADR Definition
*Based on a Minimum of 105 Months of Follow-up. Adverse drug reactions are based on all-causality treatment-emergent adverse events. The commonality stratification is based on 'All Grades' under Total column. 'Grade 3', 'Grade 4' columns indicate maximum toxicity.
aAbdominal pain includes the following preferred terms: Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness, Dyspepsia, Epigastric discomfort, Gastrointestinal pain, Hepatic pain.
gChest pain includes the following preferred terms: Chest discomfort, Chest pain.
hHepatic dysfunction includes the following preferred terms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood bilirubin unconjugated increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Hepatic function abnormal, Hepatic steatosis, Hepatitis toxic, Hepatomegaly, Hepatotoxicity, Hyperbilirubinemia, Liver disorder, Liver function test abnormal, Liver function test increased, Transaminases increased.
bHypertension* includes the following preferred terms: Blood pressure increased, Blood pressure systolic increased, Essential hypertension, Hypertension, Hypertensive crisis, Retinopathy hypertensive.
iInfluenza includes the following preferred terms: H1N1 influenza, Influenza.
cEdema includes the following preferred terms: Eye edema, Eyelid edema, Face edema, Generalized edema, Localized edema, Edema, Edema peripheral, Penile edema, Periorbital edema, Periorbital swelling, Peripheral swelling, Scrotal edema, Scrotal swelling, Swelling, Swelling face, Swelling of eyelid, Testicular edema, Tongue edema.
dPneumonia includes the following preferred terms: Atypical pneumonia, Lower respiratory tract congestion, Lower respiratory tract infection, Pneumonia, Pneumonia aspiration, Pneumonia bacterial, Pneumonia fungal, Pneumonia necrotising, Pneumonia streptococcal.
eRash includes the following preferred terms: Acarodermatitis, Acne, Angular cheilitis, Blister, Dermatitis, Dermatitis acneiform, Dermatitis psoriasiform, Drug eruption, Eczema, Eczema asteatotic, Erythema, Erythema annulare, Exfoliative rash, Lichenoid keratosis, Palmar erythema, Photosensitivity reaction, Pigmentation disorder, Psoriasis, Pyoderma gangrenosum, Pyogenic granuloma, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash pruritic, Rash pustular, Seborrhoeic dermatitis, Seborrhoeic keratosis, Skin depigmentation, Skin discoloration, Skin disorder, Skin exfoliation, Skin hyperpigmentation, Skin hypopigmentation, Skin irritation, Skin lesion, Skin plaque, Skin toxicity, Stasis dermatitis.
fRespiratory tract infection includes the following preferred terms: Nasopharyngitis, Respiratory tract congestion, Respiratory tract infection, Respiratory tract infection viral, Upper respiratory tract infection, Viral upper respiratory tract infection.
* ADR identified post-marketing.

In the single-arm study in patients with CML who were resistant or intolerant to prior therapy, 2 patients (0.4%) experienced QTcF interval of greater than 500 milliseconds. Patients with uncontrolled or significant cardiovascular disease including QT interval prolongation were excluded by protocol.

Table 7 identifies the clinically relevant or severe Grade 3/4 laboratory test abnormalities for the safety population of the study in patients with CML who were resistant or intolerant to prior therapy based on long-term follow-up.

Table 7: Number (%) of Patients With Clinically Relevant All Grade or Grade 3/4 Laboratory Test Abnormalities in the Safety Population of the Study of Patients With CML Who Were Resistant or Intolerant to Prior Therapy*

CP CML
N=403 %
AdvP CML
N=143 %
All grade Grade 3/4 All grade Grade 3/4
Hematology Parameters
Platelet Count decreased 66 26 80 57
Absolute Neutrophil Count decreased 50 16 66 39
Hemoglobin decreased 89 13 97 38
Lymphocyte decreased 79 14 82 21
White Blood Cell Count decreased 51 7 57 27
Biochemistry Parameters
SGPT/ALT increased 58 11 39 6
SGOT/AST increased 50 5 37 3.5
Lipase increased 32 12 19 6
Phosphorus decreased 41 8 33 7
Total Bilirubin increased 16 0.7 22 2.8
Creatinine increased 95 3 87 1.4
Alkaline Phosphatase increased 39 0 39 1.4
Glucose increased 42 2.7 39 6
Sodium increased 23 0.5 11 0
Sodium decreased 18 2.2 27 6
Calcium decreased 55 4.7 45 3.5
Urate increased 49 6 43 6
Magnesium increased 27 7 18 4.9
Potassium decreased 22 1.7 29 4.9
Potassium increased 25 2.7 19 2.1
*Based on a Minimum of 105 Months of Follow-up. Abbreviations: AdvP=advanced phase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CML=chronic myelogenous leukemia; CP=chronic phase; N/n=number of patients; SGPT=serum glutamate-pyruvate transaminase; SGOT=serum glutamate-oxaloacetate aminotransferase; ULN=upper limit of normal.

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 all 1372 patients with 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: 0.1% and less than 1% - 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

Endocrine Disorders: 1% and less than 10% - Hypothyroidism; 0.1% and less than 1% - Hyperthyroidism

Gastrointestinal Disorders: 1% and less than 10% - Gastritis, Pancreatitis (includes Edematous pancreatitis, Pancreatic enzymes increased, Pancreatitis, Pancreatitis acute, Pancreatitis chronic), Gastrointestinal hemorrhage (includes Anal hemorrhage, Gastric hemorrhage, Gastrointestinal hemorrhage, Intestinal hemorrhage, Lower gastrointestinal hemorrhage, Rectal hemorrhage, Upper gastrointestinal hemorrhage)

General Disorders and Administrative Site Conditions: 1% and less than 10% - Pain

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% - Bronchitis

Investigations: 1% and less than 10% - Electrocardiogram QT prolonged (includes Electrocardiogram QT prolonged, Long QT syndrome)

Metabolism and Nutrition Disorders: 1% and less than 10% - Dehydration

Musculoskeletal and Connective Tissue Disorders: 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 kidney injury, Renal impairment, Renal failure

Respiratory, Thoracic and Mediastinal Disorders: 1% and less than 10% - Pulmonary hypertension (includes Pulmonary hypertension, Pulmonary arterial hypertension, Pulmonary arterial pressure increased); 0.1% and less than 1% - Acute pulmonary edema (includes Acute pulmonary edema, Pulmonary edema), Respiratory failure

Skin and Subcutaneous Disorders: 0.1% and less than 1% - Erythema multiforme

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of BOSULIF. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Thrombotic microangiopathy

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome

DRUG INTERACTIONS

Effect Of Other Drugs On BOSULIF

Strong Or Moderate CYP3A Inhibitors

Concomitant use with a strong or moderate CYP3A inhibitor increased bosutinib Cmax and AUC compared to BOSULIF alone [see CLINICAL PHARMACOLOGY] which may increase the risk of toxicities. Avoid the concomitant use of strong or moderate CYP3A inhibitors with BOSULIF.

Strong CYP3A Inducers

Concomitant use with a strong CYP3A inducer decreased bosutinib Cmax and AUC compared to BOSULIF alone [see CLINICAL PHARMACOLOGY] which may reduce BOSULIF efficacy. Avoid the concomitant use of strong CYP3A inducers with BOSULIF.

Proton Pump Inhibitors (PPI)

Concomitant use with a PPI decreased bosutinib Cmax and AUC compared to BOSULIF alone [see CLINICAL PHARMACOLOGY] which may reduce BOSULIF efficacy. As an alternative to PPIs, use short-acting antacids or H2 blockers and separate dosing by more than 2 hours from BOSULIF dosing.

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

© Bosulif Patient Information is supplied by Cerner Multum, Inc. and Bosulif Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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