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Bosutinib (Oral route)

Pronunciation:

boe-SUE-ti-nib

Brand Names:

  • Bosulif

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Bosutinib is used to treat chronic myeloid leukemia (CML) that is Philadelphia chromosome-positive (Ph+). Leukemia is a type of cancer where the body makes abnormal white blood cells.

Bosutinib is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by bosutinib, other side effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bosutinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bosutinib in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Colchicine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Afatinib
  • Amiodarone
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Azithromycin
  • Boceprevir
  • Bosentan
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Ceritinib
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabigatran Etexilate
  • Dabrafenib
  • Darunavir
  • Delavirdine
  • Dexamethasone
  • Dexlansoprazole
  • Diltiazem
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Efavirenz
  • Eliglustat
  • Erythromycin
  • Eslicarbazepine Acetate
  • Esomeprazole
  • Etravirine
  • Everolimus
  • Felodipine
  • Fluconazole
  • Fosamprenavir
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lansoprazole
  • Lapatinib
  • Lomitapide
  • Lopinavir
  • Mitotane
  • Modafinil
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Nevirapine
  • Nilotinib
  • Omeprazole
  • Oxcarbazepine
  • Pantoprazole
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Pixantrone
  • Pomalidomide
  • Posaconazole
  • Primidone
  • Quercetin
  • Rabeprazole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Romidepsin
  • Saquinavir
  • Siltuximab
  • Simeprevir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Ticagrelor
  • Tocophersolan
  • Tolvaptan
  • Topotecan
  • Trabectedin
  • Ulipristal
  • Verapamil
  • Vincristine
  • Vincristine Sulfate Liposome
  • Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia (low red blood cells) or
  • Blood or bone marrow problems or
  • Diarrhea or
  • Edema (fluid retention or swelling) or
  • Nausea or vomiting or
  • Neutropenia (low white blood cells) or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take this medicine with food. Swallow the tablet whole. Do not crush or break it and do not handle broken tablets.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher blood levels of bosutinib in the body. This could result in more side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For the treatment of leukemia:
      • Adults—500 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and more than 12 hours have passed, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 30 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Bosutinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have stomach pain, pale stools or dark urine, loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain, even after receiving medicines to prevent it. Ask your doctor or nurse about ways to control these side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Black, tarry stools
bleeding gums
blood in the urine or stools
chills
cough
difficult or labored breathing
fever
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
shortness of breath
sore throat
swelling of the hands, ankles, feet, or lower legs
tightness in the chest
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
wheezing
Less common
Abdominal or stomach pain or tenderness
agitation
chest pain or discomfort
clay-colored stools
cough with mucus
confusion
dark urine
decreased appetite
decreased urination
depression
diarrhea
dizziness
dry mouth
fainting
fast or irregular heartbeat
general feeling of discomfort or illness
headache
hives
hoarseness
hostility
increased sweating
increased thirst
irritation
itching
joint pain, stiffness or swelling
lightheadedness
loss of appetite
muscle aches, pains, or twitching
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
rapid breathing
rapid weight gain
redness of the skin
runny nose
seizures
shivering
skin rash
sneezing
sunken eyes
swelling of the eyelids, face, lips, hands, or feet
thirst
trouble sleeping
trouble swallowing
weakness or heaviness of the legs
wrinkled skin
Rare
Anxiety
blistering, peeling, loosening of the skin
bloating
blue lips, fingernails, or skin
chest pain, possibly moving to the left arm, neck, or shoulder
constipation
coughing that sometimes produces a pink frothy sputum
difficult, noisy breathing, sometimes with wheezing
indigestion
irregular, fast or slow, or shallow breathing
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
red, irritated eyes
vomiting of blood or material that looks like coffee grounds
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Back pain
difficulty with moving
lack or loss of strength
muscle stiffness
stuffy nose
Less common
Blemishes on the skin
burning feeling in the chest or stomach
change in taste
hearing loss
loss of taste
muscle cramping
pimples
ringing, buzzing, or other unexplained noise in the ears that continues
stomach upset
tenderness in the stomach area
Rare
Flaking and falling off of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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