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Bosutinib STADA

Bosutinib Stada is a medicine used to treat adults with a type of blood cancer called chronic myeloid leukemia (CML), either when newly diagnosed or when other treatments haven't worked or are not suitable.

Form
tabletti, kalvopäällysteinen
Strength
500 mg
Active Ingredient
Bosutinib
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

The typical dose is 400 mg once daily for newly diagnosed CML. For CML that has not responded to other treatments, the typical dose is 500 mg once daily. Your doctor may adjust the dose based on your kidney function or how you respond to the treatment.

Method

Take the tablet(s) once a day with food. Swallow the tablets whole with water.

Important

The maximum daily dose is typically 500 mg, but your doctor may lower it if you have kidney problems.

Possible Side Effects

COMMON
  • •Reduced counts of blood cells (platelets, red blood cells, certain white blood cells).
  • •Diarrhea, vomiting, stomach pain, nausea.
  • •Fever, swelling (hands, feet, face), feeling tired, weakness.
  • •Common cold or respiratory infection.
  • •Inflammation of the nose and throat.
  • •Changes in blood tests for liver, pancreas, or kidney function.
  • •Loss of appetite.
  • •Joint pain, back pain.
  • •Headache.
  • •Rash, possibly itchy or widespread.
  • •Cough.
  • •Shortness of breath.
  • •Dizziness or balance problems.
  • •Fluid around the lungs (pleural effusion).
  • •Itching.
RARE
  • •Low white blood cell count (leukopenia).
  • •Stomach irritation (gastritis), bleeding in the stomach or intestines.
  • •Chest pain.
  • •Toxic liver damage, abnormal liver function.
  • •Pneumonia, flu, bronchitis.
  • •Irregular heartbeat (arrhythmia), leading to fainting, dizziness, or palpitations.
  • •High blood pressure.
  • •High potassium or low phosphate in the blood, severe dehydration.
  • •Muscle pain.
  • •Changes in taste (dysgeusia).
  • •Acute kidney failure, worsening kidney function.
  • •Fluid around the heart (pericardial effusion).
  • •Ringing in the ears (tinnitus).
  • •Hives, acne.
  • •Photosensitivity reaction (sensitivity to UV light from the sun or other sources).
  • •Allergic reaction.
  • •High blood pressure in lung arteries (pulmonary hypertension).
  • •Acute inflammation of the pancreas (pancreatitis).
  • •Respiratory failure.
  • •Fever with a low white blood cell count (febrile neutropenia).
  • •Life-threatening allergic reaction (anaphylactic shock).
  • •Fluid buildup in the lungs (acute pulmonary edema).
  • •Inflammation of the sac around the heart (pericarditis).
  • •Significant decrease in granulocytes (a type of white blood cell).
  • •Severe skin disease (erythema multiforme).
  • •Nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and tiredness with abnormal lab tests (high potassium, uric acid, phosphorus; low calcium) leading to kidney problems (tumor lysis syndrome).

Important Warnings

  • Do not take if you are allergic to bosutinib or any other ingredient in this medicine.
  • Do not take if your doctor has told you that you have liver damage and your liver is not working normally.
  • Tell your doctor if you have or have had liver problems, including hepatitis, or symptoms like itching, yellow skin or eyes, dark urine, or pain in the upper right side of your stomach.
  • If you have diarrhea or vomiting, especially with blood, black stools, or if you take anti-nausea medicine, tell your doctor as this could affect your heart rhythm.
  • Tell your doctor if you have bleeding problems, like unusual bleeding or bruising without injury.
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  • Tell your doctor if you have an infection, with symptoms like fever, painful urination, cough, or sore throat.
  • Tell your doctor if you notice fluid buildup, such as swelling in your ankles, feet, or legs, difficulty breathing, chest pain, or cough, as this could be fluid in your lungs.
  • Inform your doctor if you have heart problems like irregular heartbeat, a 'prolonged QT interval,' faint, or experience chest pain, especially if you also have ongoing diarrhea.
  • Tell your doctor if you have kidney problems or notice changes in your urination (more or less often, different color), or if you lose weight or have swelling in your feet, ankles, legs, hands, or face.
  • Tell your doctor if you have ever had or might have Hepatitis B, as this medicine can reactivate the virus, which can be life-threatening.
  • Tell your doctor if you have or have had pancreas problems, or experience stomach pain or discomfort.
  • Tell your doctor if you get a severe skin rash with painful red or purple patches that spread, blisters, or sores on your mouth or lips.
  • Tell your doctor if you have side pain, blood in your urine, or urinate less, as these could be signs of tumor lysis syndrome (TLS).
  • You may become sensitive to sun or UV light. Protect your skin by covering up and using high SPF sunscreen.
  • Do not take Bosutinib Stada with grapefruit or grapefruit juice, as this can increase side effects.
  • Do not use Bosutinib Stada if you are pregnant or might become pregnant, as it can harm the baby. Discuss with your doctor.
  • Do not breastfeed while taking Bosutinib Stada, as it can harm your baby.
  • Do not drive or operate machinery if you feel dizzy, have blurred vision, or are unusually tired, until these side effects pass.

Additional Information

ATC Code: L01EA04
→ View Professional Information (PDF)→ View Patient Leaflet (PDF)