Bosutinib STADA
This medicine is used to treat a type of blood cancer called chronic myeloid leukemia (CML) in adults.
Form
tabletti, kalvopäällysteinen
Strength
400 mg
Active Ingredient
Bosutinib
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For newly diagnosed CML, the usual dose is 400 mg once daily. If other CML treatments haven't worked or aren't suitable, the usual dose is 500 mg once daily. Your doctor may adjust your dose if you have kidney problems.
Method
Take the tablet(s) whole with water, once daily, with food.
Important
The maximum daily dose is usually 400 mg or 500 mg, as prescribed by your doctor.
Possible Side Effects
COMMON
- •Low numbers of platelets, red blood cells, and/or certain white blood cells
- •Diarrhea, vomiting, stomach pain, nausea
- •Fever, swelling of hands, feet, or face, tiredness, weakness
- •Respiratory tract infection
- •Inflammation of the nose and throat (nasopharyngitis)
- •Changes in blood tests that check your liver, pancreas, or kidney function
- •Decreased appetite
- •Joint pain, back pain
- •Headache
- •Rash (can be itchy and widespread)
- •Cough
- •Shortness of breath
- •Dizziness, balance problems
- •Fluid in the lung sac (pleural effusion)
- •Itching
RARE
- •Low white blood cell count
- •Stomach irritation (gastritis), bleeding in the stomach or intestines
- •Chest pain, general pain
- •Toxic liver damage, abnormal liver function, liver disease, liver damage
- •Pneumonia, flu, bronchitis
- •Irregular heartbeats that can cause fainting, dizziness, or palpitations, high blood pressure
- •High potassium levels in blood, low phosphorus levels in blood, severe dehydration
- •Muscle pain
- •Taste changes
- •Acute kidney failure, kidney failure, worsening kidney function
- •Fluid around the heart (pericardial effusion), inflammation of the heart sac (pericarditis)
- •Ringing in ears (tinnitus)
- •Hives, acne
- •Sensitivity to light (photosensitivity reaction)
- •Allergic reaction
- •Abnormally high blood pressure in the lung arteries (pulmonary hypertension)
- •Acute inflammation of the pancreas (acute pancreatitis)
- •Respiratory failure
- •Fever with low white blood cell count (febrile neutropenia)
- •Severe decrease in certain white blood cells (granulocytes)
- •Fluid accumulation in lungs (acute pulmonary edema)
- •Severe skin disorders (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis)
- •Life-threatening allergic reaction (anaphylactic shock)
- •Nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and tiredness, linked to abnormal lab results from tumor lysis syndrome
- •Interstitial lung disease (a condition causing lung scarring) with symptoms like cough, difficulty breathing, and painful breathing
Important Warnings
- Do not take if you are allergic to bosutinib or any other ingredients in this medicine.
- Tell your doctor if you have or have had liver problems, or if your doctor says your liver is damaged or not working normally.
- Tell your doctor if you get diarrhea or vomiting, especially if it's severe or lasts a long time, or if you see blood. Certain anti-nausea medicines may increase heart risks with this medicine.
- Tell your doctor if you have unusual bleeding or bruising.
- Tell your doctor if you get signs of infection like fever, pain when peeing, cough, or sore throat.
Show 11 more warnings
- Tell your doctor if you notice swelling in your ankles, feet, or legs, difficulty breathing, chest pain, or a cough, which could be signs of fluid buildup.
- Tell your doctor if you have a heart condition, irregular heartbeat, or if you faint.
- Tell your doctor if you have kidney problems or notice changes in how often or how much you pee, or if you lose weight or have swelling in your body.
- Tell your doctor if you have ever had Hepatitis B, as this medicine can make the virus active again.
- Tell your doctor if you have or have had pancreas problems or get stomach pain.
- Tell your doctor right away if you get a severe skin rash with painful red or purple spots, blisters, or sores in your mouth or on your lips.
- Tell your doctor if you get side pain, blood in your urine, or pee less often, as these could be signs of Tumor Lysis Syndrome (a serious condition that can affect your kidneys).
- Your skin may become more sensitive to sun or UV light. Protect your skin by wearing clothes and using high SPF sunscreen.
- Do not eat grapefruit or drink grapefruit juice while taking this medicine, as it can increase the risk of side effects.
- This medicine should not be used during pregnancy as it can harm the baby. Use effective birth control during treatment and for at least 1 month after the last dose. Do not breastfeed.
- This medicine may cause dizziness, blurred vision, or unusual tiredness. Do not drive or operate machines until these effects have passed.