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.
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Note: Side effects were reported by adults. Side effects for children might differ.
Contact your healthcare provider immediately if you experience any of the following.
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.
Bosulif (bosutinib) isn't considered traditional chemotherapy. Traditional chemotherapy are medications that kill fast-growing cells in the body. These medications can kill cancer cells, but also other normal, healthy cells in the body that grow fast (causing side effects commonly linked to chemotherapy). Instead, Bosulif (bosutinib) is called targeted therapy. It only targets and affects cells in the body that have a specific protein called BCR-ABL. And this protein is only found on CML cancer cells. By blocking BCR-ABL on CML cancer cells, Bosulif (bosutinib) stops the cancer from growing and spreading.
In clinical studies, people who took Bosulif (bosutinib) didn't report hair loss. Speak with your provider if you notice hair thinning or hair loss while you're taking this medication. Your provider can examine you for other possible causes of hair loss and suggest ways to prevent more hair loss.
You should take Bosulif (bosutinib) once a day with food, so it might be helpful to pair when you take the medication with a meal that you consistently have. For example, you can take Bosulif (bosutinib) with lunch or with dinner. Be sure to stick to a routine and be consistent with when you take Bosulif (bosutinib) so that the medication works as best it can for you.
It's best to avoid drinking alcohol while you're taking Bosulif (bosutinib). In general, alcohol can raise the risk for certain other cancers besides CML. In addition, both alcohol and Bosulif (bosutinib) can cause liver injury. So drinking alcohol with the medication can put you at higher risk for liver damage. Speak with your provider about lowering how much you drink and stopping drinking if you need guidance doing so.
Take Bosulif (bosutinib) for as long as your provider instructed you to. In general, you'll continue taking the medication as long as it's working well to treat your CML and as long as any side effects you have are mild and tolerable. Your provider might decide to stop treatment if your lab work suggests that the medication isn't working well or if side effects, like diarrhea, nausea, low blood cell counts, and liver damage, become serious. Don’t stop taking Bosulif (bosutinib) without first talking with your provider.
You can take Bosulif (bosutinib) if you have liver or kidney problems, but you'll probably need to start the medication at a lower dose and follow up with your provider more often. Your liver and kidneys help break down Bosulif (bosutinib) in your body. Having liver or kidney problems can mean that your body might have a harder time getting rid of the medication. This can make the medication build up in your body, which can raise your risk for side effects from it. Tell your providers if you have problems with your liver or kidneys so they can adjust your treatment plan accordingly.
It isn’t recommended to take Bosulif (bosutinib) if you're pregnant because it's possible that the medication can cause harm to your unborn baby. If you can get pregnant, you should use reliable birth control while you're taking Bosulif (bosutinib) and for 2 weeks after the last dose. Tell your provider right away if you become pregnant while you're taking this medication.
Breastfeeding isn't recommend while you're taking Bosulif (bosutinib) and for 2 weeks after your last dose. We don’t know whether the medication can pass into human breast milk, but there’s a risk of serious harm to nursing infants if it does. Talk with your provider about other ways to feed your baby during treatment.
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.
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.
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.
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 50mg | 30 capsules | $5,345.53 | $178.18 |
| 100mg | 150 capsules | $26,703.73 | $178.02 |
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.
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.
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.