Bozutinib inhibits the pathological kinase BCR-ABL (a protein responsible for oncogenic cell transformation), which causes the development of chronic myeloid leukemia (CML).

The drug Bozutinib-Promomed is indicated for use in adult patients aged 18 years and older with:

first diagnosed with chronic myeloid leukemia with positive Philadelphia chromosome (CML Ph+) in the chronic phase. Leukemia is a cancer of white blood cells. Usually, these white blood cells help the body fight infection. Chronic myeloid leukemia is a form of leukemia in which the uncontrolled growth of certain types of abnormal white blood cells (so-called myeloid cells) begins;
• chronic myeloid leukemia with positive Philadelphia chromosome (CML Ph+) in the chronic phase (the initial stage of CML, has no symptoms), acceleration phase (a more advanced stage of the disease development, in which various symptoms appear) or blast crisis (rapid progression of the disease) with intolerance or ineffectiveness of previous therapy with at least one of the tyrosine kinase inhibitors, including imatinib, nilotinib or dasatinib.

Like all medications, the drug Bosutinib-Promomed can cause undesirable reactions, but they do not occur in everyone.
Serious adverse reactions
Seek medical attention immediately if you experience any of the following serious adverse reactions - You may need urgent medical attention:

Loss of consciousness, cardiac arrhythmia, or cardiac activity disorders such as abnormal electrical signals called "QTc interval prolongation" may be signs of a cardiac disorder. This undesirable reaction occurs very often and can develop in more than 1 person out of 10; The presence of blood in the vomit, in the stool (during bowel movements), or black stools (black tar–like bowel movements) may be signs of gastrointestinal bleeding. This undesirable reaction occurs frequently and can develop in no more than 1 person out of 10; A decrease or absence of urine, swelling of the feet, ankles, legs, arms or face, weakness, sweating, high or low blood pressure may be signs of acute kidney injury. This undesirable reaction occurs frequently and can develop in no more than 1 person out of 10; itchy skin, yellowing of the whites of the eyes or skin, dark urine, pain or discomfort in the right upper abdomen, fever – these may be signs of liver inflammation (hepatitis). This undesirable reaction occurs frequently and can develop in no more than 1 person out of 10; nausea, vomiting, abdominal pain, blood in the urine or a decrease in the amount of urine, edema, seizures, cardiac arrhythmias – these may be signs of tumor lysis syndrome, which can lead to kidney failure and heart problems. This undesirable reaction occurs infrequently and can develop in no more than 1 person out of 100; shortness of breath, shortness of breath, chest pain, dry paroxysmal cough, increasing weakness – these may be signs of acute pulmonary edema. This undesirable reaction occurs infrequently and can develop in no more than 1 person out of 100; severe, persistent pain in the upper half of the abdomen, radiating to the back, nausea, vomiting with bile, bloating – these may be signs of inflammation of the pancreas (pancreatitis). This undesirable reaction occurs infrequently and can develop in no more than 1 person out of 100; A painful red or purple rash that spreads and causes blisters on the skin and/or mucous membranes (for example, in the mouth and lips) may be signs of severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). The frequency of these adverse reactions is unknown.

Do not take the drug Bosutinib-Promomed: if you are allergic to bosutinib or any other components of the drug (listed in section 6 of the leaflet).

Tell your doctor that you are taking, have recently taken, or may start taking any other medications. Some medications may affect the level of bosutinib in the body. If you are taking medications containing the following active ingredients, please inform your doctor.
The following medications may increase the risk of adverse reactions when taken together with the drug Bosutinib-Promomed:

• ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole are drugs used to treat fungal infections;
clarithromycin, telithromycin, erythromycin and ciprofloxacin are drugs used to treat bacterial infections;
• nefazodone is a drug used to treat depression;
• mibefradil, diltiazem and verapamil are drugs used to lower blood pressure in people with high blood pressure;
• konivaptan is a drug used to increase blood sodium levels;
• ritonavir, lopinavir/ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, amprenavir, fosamprenavir and darunavir/ritonavir are drugs used to treat human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS);
• boceprevir and telaprevir are drugs used to treat hepatitis C;
• aprepitant is a drug used to prevent and control nausea (feeling of nausea) and vomiting;
• imatinib is a drug used to treat a type of leukemia (blood cancer);
• crizotinib is a drug used to treat non–small cell lung cancer.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Keep the drug out of the reach of the child so that the child cannot see it. Store at temperatures below 25 °C. Store in the original packaging (pack). Do not dispose of the drug in the sewer

Do not give the drug to children aged 0 to 18 years due to the risk of inefficiency and possible insecurity.