In most patients, adverse events were transient, treatment with Spriceil was discontinued due to adverse reactions in 12% of patients with a newly diagnosed chronic phase of chronic myelogenous leukemia, and 15% of patients in the chronic phase of chronic myelogenous leukemia with resistance to imatinib or its intolerance, 16% in the phase of acceleration of chronic myelogenous leukemia, 15% in the phase of the myeloid blast crisis of chronic myelogenous leukemia and 8% in the phase of the lymphoid blast crisis of chronic myelogenous leukemia, as well as in 8% of the patient s with acute lymphoblastic leukemia with a positive Philadelphia chromosome.
The frequency of side effects is shown in accordance with the scale: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000).
Infections and infestations:
Often: infections (including bacterial, viral, fungal)
Often: pneumonia (including bacterial, viral and fungal), upper respiratory tract infections, herpetic infections, enterocolitis, sepsis (including infrequently - fatal)
From the hematopoietic system:
Often: febrile neutropenia, pancytopenia
Rarely: erythroblastopenia
From the immune system:
Infrequently: hypersensitivity reactions (including erythema nodosum)
Metabolic disorders:
Often: anorexia, anorexia, hyperuricemia
Infrequently: hypoalbuminemia
From the nervous system:
Often: headache
Often: insomnia, depression, neuropathy (including peripheral neuropathy), dizziness, taste perversion, drowsiness
Infrequently: anxiety, emotional lability, psychosis, decreased libido, hemorrhages (such as intracerebral hematoma, intracerebral haemorrhage, epidural hematoma,intracranial hemorrhage, hemorrhagic stroke, subarachnoid hemorrhage, subdural hematoma, subdural hemorrhage), tremor, fainting, amnesia
Rarely: convulsions, cerebrovascular accident (stroke), transient ischemic attack, inflammation of the optic nerve, paralysis of the VII pair of cranial nerves (facial nerve)
From the side of the organ of vision:
Often: visual disorders (indistinctness, vagueness, decreased visual acuity), dry eyes, bleeding in the sclera of the eye, conjunctival hemorrhages.
Infrequently: conjunctivitis,
Rarely: visual impairment
From the side of the organ of hearing and balance:
Often: noise in ears
Infrequently: vertigo
From the cardiovascular system:
Often: bleeding (such as nasal bleeding, gum bleeding, hematomas, petechiae, purpura)
Often: "tidal", increased blood pressure, pericardial effusion, arrhythmia (including tachycardia), cardiac dysfunction (including ventricular dysfunction, heart failure, congestive heart failure, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction reduction, ventricular failure), heart palpitations
Infrequently: interval lengthening Q-T on ECG, angina pectoris, cardiomegaly, lowering of arterial pressure, thrombophlebitis, pericarditis, ventricular arrhythmia (including ventricular tachycardia), myocardial infarction (including fatal)
Rarely: "pulmonary heart," myocarditis, acute coronary syndrome, "marbling of the skin"
From the respiratory system:
Often: pleural effusion, dyspnea, cough
Often: pulmonary infiltrates, pulmonary edema, pneumonitis, pulmonary hypertension
Infrequently: bronchial asthma, bronchospasm
Rarely: acute respiratory distress syndrome
From the digestive system:
Often: diarrhea, nausea, vomiting, abdominal pain
Often: inflammation of the mucous membranes (including mucositis / stomatitis), gastrointestinal bleeding, dyspepsia, bloating, constipation, gastritis, soft tissue damage to the oral cavity (including dry mouth, cheilitis, bubble rashes on the lips, dry lips, ulcers on the lips, erosion mucous membrane of the oral cavity), colitis (including neutropenic colitis)
Infrequently: dysphagia, ascites, anal fissures, ulceration of the upper gastrointestinal tract, pancreatitis, esophagitis
Rarely: gastrointestinal enteropathy with loss of protein, intestinal obstruction
From the liver and bile ducts:
Infrequently: Cholestasis, cholecystitis, hepatitis
From the skin and subcutaneous tissue:
Often: skin rash
Often: itching, acne, alopecia, dry skin, hyperhidrosis, urticaria, dermatitis (including eczema)
Infrequently: skin ulcers, bullous dermatosis, pigmentation disorders, nail lesions, photosensitization, acute febrile neutrophilic dermatosis, panniculitis, palmar-plantar erythrodysesthesia syndrome
From the side of the musculoskeletal system and connective tissue:
Often: musculoskeletal pain
Often: arthralgia, muscle weakness, myalgia, musculoskeletal stiffness, muscle spasms
Infrequently: an increase in the activity of creatine phosphokinase in the blood, rhabdomyolysis myositis, tendonitis
From the urinary system:
Infrequently: Renal failure, frequent urination, proteinuria, hematuria
On the part of the reproductive system:
Infrequently: gynecomastia, menstrual irregularities, vaginal bleeding, uterine bleeding
Other:
Often: fluid retention, localized swelling of subcutaneous tissue of various locations, edema of the tongue, edema of the lips, conjunctival edema, increased fatigue, fever
Often: generalized edema, asthenia, pain, chest pain, chills, decreased or increased body weight, confusion
Infrequently: malaise, intolerance of high and low temperatures, tumor lysis syndrome
In addition, when using the drug, information is received on the following phenomena, the frequency of which is not established, and / or their relationship with the use of the drug is not proved:
From the cardiovascular system:
atrial fibrillation / atrial flutter; thrombosis / embolism (including pulmonary embolism, deep vein thrombosis)
From the respiratory system: interstitial lung diseases, pulmonary arterial hypertension
From the digestive system: gastrointestinal bleeding with lethal outcome
Changes in laboratory indicators:
- Thrombocytopenia, anemia and neutropenia of grade 3 or 4, especially the patients with advanced phases of chronic myelogenous leukemia or acute lymphoblastic leukemia with a positive Philadelphia chromosome
- Hypokalemia, hypocalcemia; hypophosphatemia,
- Increased activity of hepatic transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)),
- Increased serum bilirubin and / or serum creatinine concentrations. The most common side effects of using Spriceil in patients with newly diagnosed chronic myelogenous leukemia in the chronic phase are fluid retention and diarrhea, and in patients with imatinib resistance or intolerance - fluid retention and diarrhea, headache, dyspnea, rash, fatigue, nausea, hemorrhages (such as gastrointestinal bleeding and others).