The safety of nelarabine was assessed for the general population of patients enrolled in clinical trials. A general safety assessment was conducted for 103 adults and 84 children enrolled in controlled clinical trials. The most common adverse events: fatigue, gastrointestinal disorders, hemopoiesis disorders, respiratory system disorders and fever. Neurotoxicity is dose dependent. The adverse events presented below are listed in accordance with organ and organ damage and frequency of occurrence. Frequency of occurrence is defined as follows: highly often (≥1/10), often (≥1 / 100 and <1/10), notoften (≥1 / 1,000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), rarely (<1/10 LLC, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug.
Infections and invasions:
Highly often: infections, including sepsis, bacteremia, pneumonia, fungal infections. Haveseparate messages about development of fatal spurstunistic infections.
Registered one casedevelopment tea in an adult progressing multifocal leukoencephalopathy, confirmed by biopsy.
Neoplasms (benign and Malignant, including cysts and polyps) in adults
Often: tumor lysis syndrome.
From the side of metabolism
Highly often: hypokatemia (children). Often: hypokatiyemia (adults), hypocalcemia, hypomaghypoglycaemia (dety), anorexia (adults), increase in concentration creatinine in the blood.
From the side of the blood, the system is bleedingrhenia and lymphatic system:
Highly often: febrile neutropenia (adults), neutropenia, leukopenia (children), thrombosiscytopenia, anemia. Often: febrile neutropenia (children), leukopenia (adultsthirds).
From the side of the cardiovascular systemadult themes:
Often: reduction of arterial pressure.
From the respiratory, thoracic and mediastinal (adults):
Highly often: dyspnea, cough. Often: pleural effusion, whistlingrales.
From the gastrointestinal side tract
Often:
adults: diarrhea, nausea, vomiting, constipation.
Often: adults: stomatitis, abdominal pain; children: diarrhea, stomatitis, nausea, vomiting, constipation.
From the liver and biliary tract
Often: children: an increase in the activity of "liver" transaminases.
Often: hyperbilirubinemia, adultBare: increase in concentration aspartate-
aminotransferase.
From the musculoskeletal system and connective tissue
Often:
adults: myalgia.
Often: adults: muscular weakness, back pain, arthralgia, pain in the limbs;
children: arthralgia, pain in the extremities.
From the body as a whole Highly often. adults: edemas, peripheryedema, increased body temperature, pain, fatigue, asthenia.
Often: adults: breaking hikeki,
children: feverbody tours, pain, fatigueand asthenia.
From the side of the organs of vision in adults
Often: decreased visual acuity.
From the nervous system and the psyche
Highly often:
adults: dizziness, decreased sensitivity, paresthesia, drowsiness; peripheral neurologic disorders (motor and sensory), headache; children: peripheral neurological disorders (motor and sensory), headache.
Often: adults: confusionnania, amnesia, perversion taste, violation of control balance of the body, cloudedvision, convulsions (including convulsions, epipeptic status, large epileptic seizure), ataxia, tremor;
children: drowsiness, decrease sensitivity, paresthesia;
convulsions (including convulsions)these epileptic status, large epileptic attack), tremor, ataxia, confusion of consciousness.
Highly rarely: demyelination, ascendingperipheral neuropathy, similar in manifestations with Guillain-Barre syndrome (Guillain-Barre). Registration formOne case is fatalth epileptic status of patient of child age
Undesirable phenomena presented below were formed on the basis of postgistrational observation.
Disorders from the side of the skeletal- rhabdomyolysis (acute necrosis of skeletal muscles), an increase in the level of creatine phosphokinase in the blood.