The drug Nilotinib-Promomed contains the active substance nilotinib, which belongs to antitumor agents, protein kinase inhibitors, BCR-ABL tyrosine kinase inhibitors, that is, nilotinib blocks the action of enzymes involved in the process of tumor growth.

The drug Nilotinib-Promomed is indicated for use only in adults for treatment:

• For the first time, Philadelphia chromosome-positive (Ph+, the chromosomal mutation underlying the development of this disease) chronic myeloid leukemia (CML, an oncological disease with damage to bone marrow stem cells and subsequent proliferation (proliferation of body tissue through cell multiplication by division) of granulocytes (human blood cells) in the chronic phase with the possibility of discontinuation of therapy with stable deep molecular response (MO, used to evaluate ongoing therapy based on clinical blood analysis, standard cytogenetic examination and molecular genetic examination) against the background of nilotinib therapy for 3 years.
• Philadelphia chromosome positive (Ph+) CML in the chronic and acceleration phases (activation of the pathological process) in case of intolerance or resistance (immunity) to previous therapy, including imatinib, with the possibility of discontinuation of therapy with stable deep MO on the background of nilotinib therapy for 3 years after the change of imatinib treatment to nilotinib.

There have been isolated cases of drug overdose in which an unspecified number of capsules were taken simultaneously with alcohol and other medications. The development of neutropenia, vomiting and drowsiness was noted.
There were no ECG changes or signs of toxic liver damage. Recovery was noted in all cases.
Overdose treatment
In case of overdose with Nilotinib-Promomed, the doctor will provide the necessary supervision and apply appropriate symptomatic therapy.

Like all medications, Nilotinib-Promomed can cause undesirable reactions, but they do not occur in everyone.
It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, and prescribe additional therapy).
Some adverse reactions can be serious and life-threatening.
Tell your doctor immediately if you experience any of the following adverse reactions:
Very often – may occur in more than 1 person out of 10
• Frequent loose stools (diarrhea), vomiting, as they can cause dehydration of the body.
Often – may occur in no more than 1 person out of 10
• Febrile neutropenia is a life–threatening condition characterized by a sudden increase in body temperature, general weakness, chills, decreased blood pressure, increased heart rate, and a decrease in the number of neutrophils in the blood (determined by the results of a blood test).
• Cardiac arrhythmias (arrhythmias), including life-threatening conditions such as atrioventricular block, atrial flutter and ventricles, atrial fibrillation, as well as extrasystole (irregular heartbeat), tachycardia (increased heart rate above normal), bradycardia (decreased heart rate below normal).
• Prolongation of the QT interval on the ECG, as this increases the risk of life-threatening arrhythmias.
• Inflammation of the pancreas (pancreatitis), the possible symptoms of which may be severe pain in the hypochondrium, fever, nausea, vomiting, constipation or diarrhea, a feeling of dry mouth.

(For more information about all possible adverse reactions, see the instructions in the leaflet)

Do not take Nilotinib-Promomed in the following cases::

• if you are allergic to the active substance or any other components of the drug listed in section 6 of the leaflet;
• if you are pregnant or breastfeeding.

Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Nilotinib-Promomed, and possibly adjust the doses of the medications you are taking.
In particular, tell your doctor if you are taking any of the medications listed below.:

• Imatinib
• Blockers (inhibitors) of the CYP3A4 isoenzyme
• Inducers (drugs that stimulate activity) of the CYP3A4 isoenzyme
• Proton pump inhibitors
• Blockers of H2-histamine receptors
• Antacids
• Warfarin
• Midazolam
• HMG-CoA reductase inhibitors
• Drugs with which the CYP3A4 isoenzyme interacts, having a narrow therapeutic index
• Antiarrhythmic drugs
• Medications that cause prolongation of the QT interval
• Hematopoiesis stimulators
• Antitumor drugs

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. Do not take the drug after the expiration date (shelf life) indicated on the carton after "Good before". The expiration date is the last day of the given month. Store at temperatures below 30 ° C in the original packaging (pack).

Do not give the drug to children and adolescents under the age of 18, as the safety and efficacy of Nilotinib-Promomed in children and adolescents under the age of 18 have not been established.