Bosulif (bosutinib) is a tyrosine kinase inhibitor that's used to treat certain adults and children with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). This medication comes as tablets and capsules that are conveniently taken by mouth once a day. Bosulif (bosutinib) is one of the recommended options for CML in certain adults, but it can commonly cause bothersome side effects like diarrhea and other stomach issues.
Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
Bosulif (bosutinib) is a tyrosine kinase inhibitor (TKI). It blocks a certain protein in your body called BCR-ABL tyrosine kinase. This protein is only found on cancer cells like those of CML and typically causes the cancer cells to grow and multiply. By blocking BCR-ABL from working, Bosulif (bosutinib) stops the cancer from growing and spreading.
Source: DailyMed
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
difficult or labored breathing
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
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
Less common
Agitation
chest pain or discomfort
clay-colored stools
cough with mucus
confusion
dark urine
decreased appetite
decreased urination
dizziness
fainting
fast or irregular heartbeat
general feeling of discomfort or illness
headache
hoarseness
hostility
increased sweating
increased thirst
irritation
joint pain, stiffness or swelling
lightheadedness
loss of appetite
muscle aches, pains, or twitching
numbness or tingling in the hands, feet, or lips
rapid breathing
rapid weight gain
redness of the skin
seizures
shivering
stomach pain or tenderness
sunken eyes
swelling of the eyelids, face, lips, hands, or feet
thirst
trouble sleeping
trouble swallowing
vomiting
weakness or heaviness of the legs
wrinkled skin
Rare
Blistering, peeling, or loosening of the skin
blue lips, fingernails, or skin
chest pain, possibly moving to the left arm, neck, or shoulder
coughing that sometimes produces a pink frothy sputum
difficult, noisy breathing
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:
Less common
Blemishes on the skin
burning feeling in the chest or stomach
change in taste
hearing loss
loss of taste
muscle cramping
ringing, buzzing, or other unexplained noise in the ears that continues
stomach upset
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.
A pill that’s swallowed once a day
Recommended treatment option for CML in certain adults
More precise in treating CML than traditional chemotherapy because it specifically targets CML cancer cells
Can cause diarrhea, nausea, vomiting, and stomach pain
Requires regular blood tests so your provider can check for side effects
Might not be safe while pregnant or breastfeeding
Available as brand only
Take Bosulif (bosutinib) with food. Swallow the tablets or capsules whole; don’t cut, dissolve, or chew them.
If you can't swallow pills whole, you can open the Bosulif (bosutinib) capsule(s) for your dose and mix the contents with room-temperature applesauce or yogurt in a clean container. The amount of applesauce or yogurt to use depends on your dose. Take the entire mixture right away without chewing and have a full meal with your dose. Don't save the mixture for later. Don't take an extra dose if the whole thing wasn't swallowed; continue with your usual dosing schedule the next day.
If you miss a dose of Bosulif (bosutinib) by more than 12 hours, skip your missed dose. Take your next dose at your next regularly scheduled time. Don't take two doses at the same time.
Bosulif (bosutinib) can cause stomach troubles, such as diarrhea, nausea, vomiting, and stomach pain. This usually happens in the first few days of taking the medication and can last throughout treatment. Be sure to drink plenty of fluids to stay hydrated. Talk to your provider for suggestions on how to manage these issues if they’re bothersome.
Avoid grapefruit and grapefruit juice while you're taking Bosulif (bosutinib). It can raise the levels of the medication in your body and put you at risk for more side effects.
Tell your provider and pharmacist about all the medications you take, including supplements and over-the-counter medications. Before starting any new medications, be sure your provider knows that you're taking Bosulif (bosutinib). Some drug interactions can affect how safe your medications are for you or how well Bosulif (bosutinib) works to treat CML (like with proton pump inhibitors or PPIs). Your provider can suggest safer alternatives or how to best take your medications.
If you’re able to become pregnant, use reliable birth control while you're taking Bosulif (bosutinib) and for at least 2 weeks after your last dose. It’s possible that the medication can harm an unborn baby.
Ask your provider or pharmacist about the best way to safely handle and throw away Bosulif (bosutinib). Anticancer medications can be very harmful to people who handle or come into contact with them.
Bosulif (bosutinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Bosulif (bosutinib) can cause the levels of your red blood cells, white blood cells, and platelets to drop. When these cell counts are lower than normal, you can feel more tired. You can also have a higher risk of bleeding, bruising, and developing infections. Your provider will check your blood counts often while you’re taking Bosulif (bosutinib). Let your provider know right away if you experience fevers, chills, or bleeding and bruising that doesn’t stop or go away. You might need to stop this medication.
Bosulif (bosutinib) can cause liver injury. Signs of liver injury generally appeared within the first 3 months of taking the medication during clinical studies, but it can happen at any time during treatment. Your provider will regularly check your liver through blood work while you’re taking Bosulif (bosutinib). Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin. These can be signs of liver problems.
Risk factors: History of kidney problems | At risk for kidney problems
Bosulif (bosutinib) can damage your kidneys and affect how well they work, especially if you already have kidney problems. Your provider will regularly check your kidneys through lab work during treatment. Talk to your provider if you notice any changes in how often you urinate (more or less) or any blood in your urine. Your provider can check for kidney issues.
Risk factors: Older age | History of heart failure or other heart problems | Diabetes | Considered obese | High blood pressure
Bosulif (bosutinib) can cause new or worsening heart problems. These heart problems can happen when not enough oxygen reaches your heart or when your heart can’t pump blood well enough. Though rare, these problems can lead to serious complications, including heart attacks or heart failure.
Your provider might follow up with you more regularly while you’re taking Bosulif (bosutinib) if you currently have heart problems or have a higher risk for heart problems. Tell your provider right away or seek medical help if you have chest pain, arm or shoulder pain, sweating, dizziness, a racing heartbeat, shortness of breath, or swelling of your legs or feet.
Bosulif (bosutinib) can cause new or worsening swelling in the arms or legs (peripheral edema) or fluid buildup in the heart or lungs. Some symptoms of fluid buildup include shortness of breath during rest or exercise, weight gain, swelling of the legs or ankles, fatigue, and poor appetite. Let your provider know if you develop any of these symptoms during treatment. You might need to stop taking Bosulif (bosutinib) or have your dose changed.
Based on animal studies, Bosulif (bosutinib) can harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when it's taken during pregnancy. If you can get pregnant, you might need to take a pregnancy test before you start treatment. You should use birth control while you're taking Bosulif (bosutinib) and for at least 2 weeks after the last dose. Let your provider know right away if you become pregnant during this time.
Adults
Newly diagnosed with Ph+ CML: The typical dose is 400 mg by mouth once daily.
Previously treated with a similar medication: The typical dose of Bosulif (bosutinib) is 500 mg by mouth once daily.
Children aged 1 year and older
The dose is based on your child's body surface area or body size, which takes into account weight and height.
Newly diagnosed with Ph+ CML: The typical dose ranges from 150 mg to 400 mg by mouth once daily, depending on your child's body size.
Previously treated with a similar medication: The typical dose of Bosulif (bosutinib) ranges from 200 mg to 500 mg by mouth once daily, depending on your child's body size.
Your dose might differ if you have kidney or liver problems. Your provider will also adjust your dose if you have bothersome or severe side effects.
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.
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.
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