DRUG INTERACTION

Contraindicated  

Serious Use Alternative  

Monitor Closely  

Minor  

Adverse drug reactions:  

Frequency defined   

>10%   

Newly diagnosed CP CML   

All grades   

Creatinine increased (94%)   

Hemoglobin decreased (89%)   

Lymphocyte count decreased (84%)   

Lipase increased (53%)   

WBC decreased (50%)   

Hepatic dysfunction (45%)   

ANC decreased (42%)   

Alkaline phosphatase increased (41%)   

Diarrhea (75%)   

Platelet count decreased (68%)   

Serum glutamic-pyruvic transaminase (SGPT)/ALT increased (68%)   

Glucose increased (57%)   

Calcium decreased (55%)   

Phosphorus decreased (54%)   

Rash (40%)   

Abdominal pain (39%)   

Nausea (37%)   

Creatine kinase increased (36%)   

Fatigue (33%)   

Amylase increased (32%)   

Dyspnea (11%)   

Decreased appetite (11%)   

Respiratory tract infection (27%)   

Headache (22%)   

Vomiting (21%)   

Arthralgia (18%)   

Pyrexia (17%)   

Edema (15%)   

Constipation (13%)   

Back pain (12%)   

Pruritus (11%)   

Cough (11%)   

Grade 3 or 4   

Lipase increased (19%)   

Platelet count (14%)   

SGOT/AST increased (13%)   

Lymphocyte count (12%)   

SGPT/ALT increased (26%)   

Hepatic dysfunction (27%)   

Pruritus (11%)   

Hypertension (11%)   

Imatinib-resistant or -intolerant Ph+ CP, AP, and BP CML   

All grades   

SGPT/ALT increased (39-58%)   

WBC decreased (51-57%)   

Calcium decreased (45-55%)   

SGOT/AST increased (37-50%)   

Abdominal pain (36-49%)

Pregnancy warnings:     

•      US FDA pregnancy category: not assigned 

Breastfeeding warnings:  

•      The release of the drug into the human breastmilk is unknown  

Pregnancy Categories:       

Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first trimester or the later trimester.       

Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women       

Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women       

Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits       

Category X: Drugs listed in this category outweigh risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.       

Category N: There is no data available for the drug under this category 

Patient Information Leaflet  

Generic Name: bosutinib (Rx) 

Pronounced: boe-SUE-tin-ib 

  

Why do we use bosutinib? 

bosutinib is an anticancer drug belonging to the sub-class of Tyrosine Kinase inhibitors used to treat a blood cancer known as chronic myeloid leukemia. It helps in inhibiting the growth and spread of cancer cells.