Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
May 4, 2016
Health Canada has issued new restrictions concerning the use of Bosulif (bosutinib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, , moxifloxacin, mefloquine, pentamidine, arsenic trioxide, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with bosutinib. You are more at risk for this type of abnormal heart rhythm and its complications if you:
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have diabetes
- have had a stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Anemia: Bosutinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Bleeding: Bosutinib may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Drowsiness/reduced alertness: This medication is not expected to make you drowsy and impair your ability to drive or use machinery. However, it may make some people feel weak. Do not drive or use machinery until you know how this medication affects you.
Dehydration: Severe dehydration can occur with the use of bosutinib. This may be due to severe or persistent diarrhea, vomiting, or decreased fluid intake. Dehydration can lead to kidney failure, if it is severe enough. While you are taking bosutinib, you may be encouraged to drink extra water. Your doctor will do blood tests to check the function of your kidneys.
Fluid retention: This medication can cause serious fluid retention. If you experience unexpected rapid weight gain or swelling in your feet, ankles, lower legs, or hands, contact your doctor immediately. Your doctor will weigh and monitor you regularly for signs of fluid retention while you are taking this medication.
Gastrointestinal bleeding: Bosutinib can cause bleeding in the digestive system. This is very serious and sometimes fatal. If you experience signs of bleeding from the stomach or intestines, such as vomiting blood or material that looks like coffee grounds, or stools that are black and tarry get immediate medical attention.
Grapefruit juice: Grapefruit and grapefruit juice, star fruit, and pomegranate all affect how bosutinib is removed from the body and may cause too much of the medication to build up in the body. Avoid these foods and juices while you are taking bosutinib.
Heart problems and heart failure: People at risk for heart problems such as heart failure (e.g., people with high blood pressure, diabetes, and coronary artery disease) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor immediately if you have symptoms of heart failure such as leg swelling, chest pain, or shortness of breath.
Infection: As well as killing cancer cells, bosutinib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Kidney function: If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Rarely, bosutinib has been reported to cause kidney failure. If you experience signs of decreasing kidney function such as decreased urine production, swelling, fatigue or abdominal pain, contact your doctor immediately.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Bosutinib has been reported to cause liver failure which can cause death.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Pancreatitis: Bosutinib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.
If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.
Skin reactions: Severe skin reactions have been linked to bosutinib use. Although rare, they are considered medical emergencies and require immediate medical attention.
If you experience skin blistering or peeling, a rash that covers a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort, seek medical attention immediately.
Pregnancy: There are no adequate studies of use of this medication by pregnant women. This medication should not be taken during pregnancy. Female partners of men taking this medication should not become pregnant. Both females and males must use a reliable method of birth control (e.g., condoms, birth control pill) during treatment and for at least 4 weeks after treatment is finished. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if bosutinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Due to the potential for serious harm to a baby if they are exposed to this medication, breast-feeding mothers are advised not use this medication.
Children: The safety and effectiveness of this medication have not been established for children.