What Bosulif is used for and how to use it
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Bosulif - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Chronic Myelogenous Leukemia
Class: BCR-ABL tyrosine kinase inhibitors
Form: Tablets
Ingredients: bosutinib, microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow (for 100 mg tablet) and iron oxide red (for 500 mg tablet)

(bosutinib tablets)

About This Medication

What the Medication is Used For

BOSULIF (bosutinib) is used to treat a certain type of cancer called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adult patients for whom previous medicines have not worked and for whom subsequent treatment with the following medicines, imatinib, nilotinib and dasatinib, is not an option.

BOSULIF should be prescribed by a qualified healthcare professional who is experienced in the used of anticancer therapies and in the treatment of chronic myeloid leukemia.

BOSULIF has not been studied in children.

What it Does

BOSULIF works by slowing down the growth and spread of leukemia cells in patients with CML.

When it Should not Be Used

Do not use BOSULIF if you:

  • are allergic (hypersensitive) to BOSULIF or any of the other ingredients of BOSULIF, listed under "What the important nonmedicinal ingredients are:"
  • have an abnormal electrical signal of the heart (prolongation of QT interval)
  • have uncorrectable low levels of potassium or magnesium
  • have liver failure
  • please refer to Serious Side Effects, How Often they Happen and What to Do About Them

What the Medicinal Ingredient Is

bosutinib

What the Important Nonmedicinal Ingredients Are

microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow (for 100 mg tablet) and iron oxide red (for 500 mg tablet)

What Dosage Forms it Comes In

BOSULIF is available as oral tablets containing 100 mg or 500 mg of bosutinib.

BOSULIF 100 mg tablets are yellow film-coated with "Pfizer" on one side and "100" on the other side.

BOSULIF 500 mg tablets are red film-coated with "Pfizer" on one side and "500" on the other side.

Warnings and Precautions

Serious Warnings and Precautions

Serious side effects with BOSULIF include:

  • Drug interactions with inhibitors or inducers of CYP3A4. Concomitant use of BOSULIF with medicines belonging to a special group called potent and moderate CYP3A4 inhibitors should be avoided.
  • Gastrointestinal problems (vomiting and diarrhea)
  • Liver problems
  • Heart problems that may lead to death
  • Fluid in the lungs and around the heart (fluid retention)
  • Bleeding
  • Abnormal electrical signal of the heart (QT prolongation)

BEFORE you use BOSULIF talk to your doctor or pharmacist if:

  • have or have had in the past, a liver, heart, pancreas or kidney problem.
  • are pregnant, or plan to become pregnant. As BOSULIF could harm an unborn baby. Discuss contraception with your doctor if there is any possibility that you may become pregnant. BOSULIF must not be used during pregnancy.
  • are breastfeeding or planning to breast-feed. Do not breast-feed during treatment with BOSULIF as it could harm your baby.
  • have gastrointestinal problems (vomiting and diarrhea).

BOSULIF may cause harm to your unborn child. Both male and female patients must use an effective birth control method such as a condom while taking BOSULIF, during interruptions of treatment and for at least 4 weeks after the last dose. This must be done even if you have undergone a successful vasectomy. If you or your partner become pregnant, tell your doctor right away.

Male and female fertility may be affected by treatment with BOSULIF.

Do not drive or operate machinery if you feel tired or dizzy, or experience any change in vision while taking BOSULIF.

Interactions with this Medication

Serious Drug and Drug-Food Interactions

Do not take any products or juice containing grapefruit, star fruit, pomegranate, Seville oranges or similar fruits while taking BOSULIF. They may change the amount of BOSULIF in your body.

While taking BOSULIF, avoid taking drugs that:

  • Are used to treat fungal infections such as ketoconazole, itraconazole, voriconazole, posaconazole, and fluconazole
  • Are used to treat human immunodeficiency virus (HIV) infections such as ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, darunavir, amprenavir, efavirenz, and etravirine
  • Are used to treat high blood pressure such as dialtizem, verapamil, bosentan and mibefradil
  • Are used to treat depression such as nefazodone and St. John's wort (a herbal preparation obtained without a prescription)
  • Are used to treat bacterial infections such as erythromycin, clarithromycin, and ciprofloxacin
  • Are used to treat tuberculosis such as rifampicin, and rifabutin
  • Are used to treat epilepsy such as phenytoin, carbamazepine, and phenobarbital
  • Are used to treat irregular heart beat (anti-arrhythmic drugs) such as dronedarone
  • Are used to prevent and control nausea (feeling sick) and vomiting, such as aprepitant
  • Are used to treat a type of leukaemia, such as imatinib
  • Are used in the treatment of heartburn and peptic ulcers due to too much acid in the stomach, such as cimetidine
  • Are used to treat certain types of sleep disorders, such as modafinil

Tell your doctor about the medicines you take, including prescription medicines, non-prescription medicines, vitamins, and herbal supplements. BOSULIF and certain other medicines can interact with each other and cause serious side effects. Especially tell your doctor if you take:

  • Other cancer medicine such as vandetanib, sunitinib, nilotinib, lapatinib.
  • Quinidine, amiodarone and other medicines for heart rhythm problems (anti-arrhythmic drugs).
  • Lansoprazole, dexlansoprazole, omeprazole, esomeprazole, pantoprazole, rabeprazole.
  • Digoxin, used to treat irregular heart beat or heart failure.
  • Amitryptiline and imipramine (medicine for depression).
  • Pimozide, ziprasidone, haloperidol (medicine for psychoses).
  • Quinine and chloroquine (medicine to treat malaria).
  • Domperidone, dolasetron and ondansetron (medicine for nausea and vomiting).
  • Formoterol and salmeterol (asthma drugs).
  • Water pills, laxatives (medicine that decrease electrolyte levels).

Know the medicines you take. Keep a list of your medicines, both prescription and non-prescription, and show it to your doctor and pharmacist when you get a new medicine. Do not take other medicines with BOSULIF until you have talked with your doctor.

Proper Use of This Medication

Usual Dose

The starting dose is 500 mg once daily. Your doctor may adjust the dose.

BOSULIF should be taken with a meal. Swallow BOSULIF tablets whole in water. Do not cut crush or dissolve the tablets.

Do not drink grapefruit juice or eat grapefruit, grapefruit products, star fruit, pomegranate, Seville oranges and other similar fruits. They may change the amount of BOSULIF in your body.

Always take BOSULIF exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Overdose

If you accidentally take too many BOSULIF tablets or a higher dose than you need, contact a doctor for advice right away. If possible, show the doctor the pack, or this leaflet. You may require medical attention.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Side Effects and What to Do About Them

BOSULIF may cause serious side effects, such as:

Liver problems - Your doctor may do blood tests to check your liver function during treatment with BOSULIF:

  • your skin or the whites of your eyes turn yellow
  • your urine turns dark or brown (tea color)

Kidney problems – Your doctor may do blood and/or urine tests to check your kidney function before and during treatment with BOSULIF

Gastrointestinal problems:

  • you have abdominal pain, nausea, diarrhea, or vomiting
  • you have blood in your vomit or have black, bloody or tarry stools

Low blood cell counts:

  • you have signs of infection such as fever, or severe chills
  • you have unexpected bleeding or bruising without having an injury

Your body may hold too much fluid (fluid retention):

  • you have difficulty breathing, chest pain, or a cough
  • you have swelling in your hands, ankles, or feet

Heart problems:

  • dizziness, palpitations or if you faint

Tell your doctor right away if you develop or have developed any of the above serious side effects.

The most common side effects of BOSULIF include:

  • Reduction in the number of platelets, red blood cells and/or neutrophils (type of white blood cells)
  • Diarrhea, vomiting, stomach pain, nausea
  • Fatigue, fever, swelling of hands, feet or face
  • Respiratory tract infection
  • Changes in liver blood test
  • Decrease of appetite
  • Joint pain
  • Headache
  • Shortness of breath
  • Skin rash, which may be itchy and/or generalized

Tell your doctor if you have any side effect that bothers you or that does not go away.

Serious Side Effects how Often They Happen and What to Do About Them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or pharmacist
Only if serveIn all
cases
Very
common
Reduction in the
number of
platelets, red
blood cells and
neutrophils (type
of white blood
cells)
Diarrhea,
vomiting,
stomach pain,
nausea
Fatigue
Changes in
blood test to
determine if
BOSULIF is
affecting your
liver
Skin rash which
may be itchy
and/or
generalized
CommonLow white blood
cells count
(leucopenia)
Fever associated
with a marked
decrease in the
number of
neutrophils (a
type of white
blood cells)
Fluid
accumulation in
the sac-like
covering the
heart
Stomach
irritation
(gastritis)
Fever
Swelling of
hands, feet or
face
Decreased
appetite
Joint pain
Headache
Shortness of
breath
Weakness, chest
pain, pain
Toxic damage to
the liver,
abnormal
hepatic function
including liver
disorder
Infection of the
lung
(pneumonia)
Changes in
blood tests to
determine if
BOSULIF is
affecting your
kidneys and.or
pancreas.
High level of
potassium in the
blood, low level
of phosphorous
in the blood,
excessive loss of
body fluid
(dehydration)
Back pain, pain
in the muscle
Feeling of
instability
(dizziness)
Alteration of the
sense of taste
(dysgeusia)
Fluid on the
lungs (pleural
effusion)
Itching, urticaria
(hives), acne
UncommonInflammation of
the sac-like
covering the
heart
(pericarditis)
Damage to liver
Influenza,
bronchitis,
nasopharyngitis
Loss of blood
from the
gastrointestinal
tract
Defect in cardiac
rhythm that
predisposes to
syncope,
dizziness and
palpitation
Kidney failure,
kidney
impairment
Respiratory
failure
Allergic
reaction,
potentially lifethreatening
(anaphylactic
shock)
Abnormally high
blood pressure in
the arteries of
the lungs
(pulmonary
hypertension)
Severe skin
disorder due to
an allergic
reaction
(erythema
multiforme),
exfoliative
(scaly, peeling)
rash, skin
eruption

This is not a complete list of side effects. For any unexpected effects while taking BOSULIF, contact your doctor or pharmacist.

How to Store It

Store at 25°C; excursions permitted to 15- 30°C.

Keep BOSULIF and all other medicines, out of the reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at: www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information)