Bosulif

The recommended adult dose of Bosulif (Bosutinib) is 500 mg taken by mouth, once a day. It should be swallowed whole with water, and taken with a meal. Do not crush or cut the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Bosulif (Bosutinib) be taken exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Bosulif (Bosutinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

100 mg
Each yellow, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "100" on the other, contains 103.40 mg of Bosulif (Bosutinib) monohydrate, equivalent to 100 mg of Bosulif (Bosutinib). Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow.

500 mg
Each red, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "500" on the other, contains 516.98 mg of Bosulif (Bosutinib) monohydrate, equivalent to 500 mg of Bosulif (Bosutinib). Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.

Do not take Bosulif (Bosutinib) if you:

• are allergic to Bosulif (Bosutinib) or any ingredients of the medication
• have a history of irregular heartbeat, particularly long QT syndrome
• have untreated low potassium or low magnesium in your blood
• have reduced liver function

There may be an interaction between Bosulif (Bosutinib) and any of the following:

• Abiraterone acetate
• Amiodarone
• Anagrelide
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• Atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• Bicalutamide
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• Carvedilol
• chloroquine
• conivaptan
• Cyclosporine
• Deferasirox
• Desipramine
• Dipyridamole
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• Enzalutamide
• Flecainide
• grapefruit juice
• H2 antagonists (e.g., Famotidine, Ranitidine)
• hepatitis medications (e.g., boceprevir, daclatasvir, ledipasvir, simeprevir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mefloquine
• Methadone
• mifepristone
• Mirabegron
• Modafinil
• nefazodone
• Norfloxacin
• other protein kinase inhibitors (e.g., Crizotinib, Dabrafenib, Dasatinib, idealisib, imatinib)
• pentamidine
• procainamide
• Progesterone
• Propranolol
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• reserpine
• rifabutin
• rifampin
• rifapentine
• Romidepsin
• St. John's wort
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• sotalol
• tacrolimus
• Tamoxifen
• Tetrabenazine
• Tocilizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Bosulif (Bosutinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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 Bosulif (Bosutinib).

HEALTH CANADA ADVISORY

May 4, 2016

Health Canada has issued new restrictions concerning the use of Bosulif (Bosulif (Bosutinib)). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abnormal heart rhythms: Bosulif (Bosutinib) 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 Bosulif (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 Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), and whether any special monitoring is needed.

Anemia: Bosulif (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.

Birth control: Effective birth control should be practiced while using Bosulif (Bosutinib) as Bosulif (Bosutinib) may harm the baby if used during pregnancy. Both men and women should use effective birth control (e.g., condoms, birth control pill) during treatment and for at least 4 weeks after treatment is finished. If you or your partner become pregnant while taking Bosulif (Bosutinib), contact your doctor immediately.

Bleeding: Bosulif (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.

Bone health: People who take Bosulif (Bosutinib) may be at an increased risk of bone fractures as a result of a decrease in the density and strength of bones. This effect is more likely to occur with people who have Osteoporosis or have changes in minerals in the blood or hormones that affect how the body retains calcium. If you have osteoporosis or risk factors for osteoporosis (female, small stature, over age 65, long-term use of corticosteroids or certain other medications), discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), and whether any special monitoring is needed.

Drowsiness/reduced alertness: Bosulif (Bosutinib) 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 Bosulif (Bosutinib) affects you.

Dehydration: Severe dehydration can occur with the use of Bosulif (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 Bosulif (Bosutinib), you may be encouraged to drink extra water. Your doctor will do blood tests to check the function of your kidneys.

Fluid retention: Bosulif (Bosutinib) 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 Bosulif (Bosutinib).

Gastrointestinal bleeding: Bosulif (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, star fruit, and pomegranate: Grapefruit and grapefruit juice, star fruit, and pomegranate all affect how Bosulif (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 Bosulif (Bosutinib).

Heart problems and heart failure: If you are at risk for heart problems such as heart failure (e.g., if you have high blood pressure, diabetes, or Coronary Artery Disease), discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), 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.

Hepatitis B: People who have chronic (long-term) hepatitis B may experience a flare-up of hepatitis B symptoms when they take Bosulif (Bosutinib). In severe cases, this can cause liver failure, may necessitate a liver transplant, or may even be fatal. If you have a history of hepatitis B, discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), and whether any special monitoring is needed.

Infection: As well as killing cancer cells, Bosulif (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: Decreased kidney function or Kidney Disease may cause Bosulif (Bosutinib) to build up in the body, causing side effects. If you have reduced kidney function, discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), and whether any special monitoring is needed.

Rarely, Bosulif (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 Bosulif (Bosutinib) to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), and whether any special monitoring is needed.

Bosulif (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: Bosulif (Bosutinib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Bosulif (Bosutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bosulif (Bosutinib), 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 Bosulif (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.

Tumour lysis syndrome: Bosulif (Bosutinib), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may have nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Bosulif (Bosutinib) should not be taken during pregnancy. Bosulif (Bosutinib) may cause severe harm to a developing baby if it is taken by the mother while she is pregnant. Female partners of men taking Bosulif (Bosutinib) 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 Bosulif (Bosutinib), contact your doctor immediately.

Breast-feeding: Bosulif (Bosutinib) passes into breast milk. If you are a breast-feeding mother and are taking Bosulif (Bosutinib), it may affect your baby. Due to the potential for serious harm to a baby if they are exposed to Bosulif (Bosutinib), breast-feeding mothers are advised not use Bosulif (Bosutinib).

Children: The safety and effectiveness of Bosulif (Bosutinib) have not been established for children.