Leukemia is a cancer of white blood cells (leukocytes). These cells usually help the body fight infection. In patients with CML, white cells called granulocytes begin to multiply uncontrollably. Dasatinib inhibits the growth of these leukemic cells.
In patients with ALL, white blood cells called lymphocytes multiply too fast and live too long. Dasatinib suppresses (inhibits) the growth of these leukemic cells.

The drug DASATINIB-PROMOMED is used to treat cancer in adults aged 18 and over:

• Newly diagnosed chronic myeloid leukemia with positive Philadelphia chromosome (CML Ph+ ) in the chronic phase;
• CML in the chronic phase, the phase of progression (acceleration), or the phase of myeloid or lymphoid very high content of tumor cells in the blood (blast crisis) with unresponsiveness (resistance) or intolerance to previous therapy, including imatinib;
• Acute lymphoblastic leukemia with positive Philadelphia chromosome (ALL Ph+) with resistance or intolerance to previous therapy.

• CML Ph+ in the chronic phase;
• ALL Ph+ was detected for the first time in combination with chemotherapy.

If you accidentally take too many pills, contact your doctor immediately. You may need medical attention.

Like all medications, DASATINIB-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
Serious adverse reactions
Tell your doctor immediately if you experience any of the following adverse reactions, you may need urgent medical attention.:
• 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 (no more than 1 person out of 10);
• infections, fever, decreased blood pressure, decreased urine output per day (diuresis), increased pulse and respiration (signs of febrile neutropenia and sepsis). These undesirable reactions occur frequently (no more than 1 person out of 10);
• severe chest pain, shortness of breath, dizziness, sudden sweating, impaired consciousness – these may be signs of acute coronary syndrome (narrowing of the coronary arteries and circulatory disorders of the myocardium), including cardiac arrest. This undesirable reaction occurs rarely (in no more than 1 person out of 1000);
• changes in mental state, impaired consciousness, severe headache, disorientation in space, time, personality, speech disorders, movement disorders − these may be signs of bleeding into the central nervous system (such as intracerebral hematoma (accumulation of blood), intracerebral hemorrhage, epidural hematoma, intracranial hemorrhage, hemorrhagic stroke, subarachnoid hemorrhage, subdural hematoma, subdural hemorrhage). Occur infrequently (no more than 1 person out of 100);
Nausea, vomiting, diarrhea, 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 (in no more than 1 person out of 100);
• respiratory disorders, severe shortness of breath, palpitations, rapid fatigue – these may be signs of fluid accumulation in the cavity around the lungs − pleural effusion (occurs very often, in more than 1 person out of 10) or in the cavity around the heart − pericardial effusion (may occur frequently, in no more than 1 person out of 10);
• difficulty breathing, shortness of breath, chest pain, dry paroxysmal cough, increasing weakness – these may be signs of acute pulmonary edema. This undesirable reaction occurs frequently (no more than 1 person out of 10);

Do not take the drug DASATINIB-PROMOMED: If you are allergic to dasatinib or any of the other components of the drug listed in section 6 of the leaflet.

You should not take the following medications while being treated with dasatinib:
• Antifungal drugs – ketoconazole, itraconazole;
• Antibiotics – clarithromycin, erythromycin, telithromycin;
• Antiviral drugs – ritonavir, atazanavir, indinavir, nelfinavir, saquinavir;
• Antiepileptic drugs – phenytoin, carbamazepine, phenobarbital;
• Synthetic glucocorticoid dexamethasone;
• Anti–tuberculosis drug - rifampicin;
• Drugs that reduce the acidity of gastric juice – famotidine, omeprazole;
• St. John's wort is an over–the-counter herbal preparation used to treat depression and other conditions (also known as St. John's Wort (Hypericum perforatum)); • Synthetic opioids – alfentanyl, fentanyl;
• H1-histamine receptor blocker – astemizole, terfenadine;
• A drug that increases motility in the upper gastrointestinal tract - cisapride;
• The antipsychotic drug pimozide;
• Antiarrhythmic drug – quinidine;
• Immunosuppressants − cyclosporine, sirolimus, tacrolimus;
• Ergot alkaloids (ergotamine, dihydroergotamine).
Do not take drugs that neutralize the acidity of gastric juice (antacids such as aluminum or magnesium hydrochloride) less than 2 hours before and 2 hours after taking dasatinib.
Tell your doctor if you are using medications to thin your blood or prevent blood clots.

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

Take DASATINIB PROMOMED daily until your doctor stops taking the drug. Make sure that you are taking DASATINIB PROMOMED for as long as it is prescribed.

DASATINIB-PROMOMED should not be used during pregnancy, except in cases of extreme necessity. If you are breastfeeding, tell your doctor. You should stop breastfeeding during treatment with dasatinib.

Store at temperatures below 25 °C. Store in the original packaging (pack).