At the advanced stage of chronic myelogenous leukemia, patients can have multiple concomitant disorders that make it difficult to assess the side effects due to a number of symptoms associated with concomitant diseases, their progression and the intake of various medications. In patients with chronic myelogenous leukemia with prolonged daily intake
imatinib in general, was well tolerated. Most patients experienced mild to moderate side effects at a certain stage of treatment. Side effects are similar in almost all patients who received
imatinib for various indications.The most common adverse events associated with taking the drug are transient mild nausea, vomiting, diarrhea, myalgia, muscle cramps, rash. All these phenomena easily stop. The overall incidence of adverse events of various severity (except edema) and the incidence of serious adverse events are similar in patients receiving therapy with a dose of 400 mg / day and 800 mg / day.
There were undesirable phenomena listed below in the organs and systems with the frequency of their occurrence: very often (> 1/10), often (> 1/100 - <1/10), sometimes (> 1/1000 - <1/100) , rarely (> 1/10000 - <1/1000), very rarely (<1/10000), including individual messages:
From the hematopoiesis: very often - neutropenia, thrombocytopenia, anemia; often - febrile neutropenia, pancytopenia; sometimes - thrombocythemia, lymphopenia, inhibition of bone marrow hematopoiesis, eosinophilia, lymphadenopathy; rarely - hemolytic anemia.
From the nervous system: very often - headache, fatigue; often -bessonnitsa, dizziness, paraesthesia, taste disturbance, hypoesthesia; sometimes a migraine, drowsiness, syncope, peripheral neuropathy,depression, anxiety, decreased libido, memory impairment, sciatica, restless legs syndrome, tremor, hemorrhagic stroke; rarely, an increase in intracranial pressure, convulsions, optic neuritis, confusion.
From the digestive system: very often - nausea, vomiting, diarrhea, indigestion, abdominal pain; often - bloating, flatulence, constipation, dry mouth, gastritis, gastroesophageal reflux; sometimes - stomatitis, gastrointestinal bleeding, melena, ascites, ulceration of the oral mucosa, belching, esophagitis, gastric ulcer, vomiting of blood, cheilitis, dysphagia, pancreatitis; rarely - colitis, ileus, inflammation of the intestine. Metabolic and nutritional disorders: often-anorexia; sometimes - hypokalemia, increased appetite or decreased appetite, hypophosphatemia, dehydration, hyperuricemia, gout, hypercalcemia, hyperglycemia; hyponatremia; rarely hyperkalemia, hypomagnesemia.
From the liver and bile ducts: often - increased activity of liver transaminases; sometimes - jaundice, hepatitis, hyperbilirubinemia; rarely liver failure, necrosis of the liver.
From the sense organs: often - edema of the eyelids, conjunctival hemorrhages, conjunctivitis, increased lacrimation, dry eye syndrome, blurred vision; sometimes - eye irritation, eye pain, orbital edema, bleeding in the sclera of the eye, retinal hemorrhage, blepharitis, macular edema, vertigo, tinnitus, hearing loss; rarely - cataract, edema of the optic nerve, glaucoma.
From the cardiovascular system: sometimes - palpitations, congestive heart failure, pulmonary edema, tachycardia, "hot flashes", hemorrhages; rarely - arrhythmias, atrial fibrillation, sudden cardiac arrest; myocardial infarction, angina pectoris, pericardial effusion, pressure increase, hematomas, cold extremities, pressure decrease, Raynaud's syndrome.
From the respiratory system: often - nosebleeds, dyspnea, cough; sometimes - pleural effusion, pain in the pharynx or larynx, pharyngitis; rarely - pleural pain, pulmonary fibrosis, pulmonary hypertension, pulmonary hemorrhage.
From the skin: very often -periorbital edema, dermatitis, eczema, skin rash; often - puffiness of the face, itching, erythema, dry skin, alopecia, night sweats,photosensitivity reaction; sometimes a pustular rash, bruises, increased sweating, urticaria, ecchymosis, a tendency to hemorrhage, hypotrichosis, hyperpigmentation / hypopigmentation of the skin, exfoliative dermatitis, nail damage, folliculitis, petechiae, psoriasis, purpura, bullous rash; rarely acute febrile neutrophilic dermatosis (Sweet syndrome), discoloration of the nails, angioedema, erythema multiforme, leukoclastic vasculitis, Stevens-Johnson syndrome.
From the musculoskeletal system: very often - muscle spasms and cramps, myalgia, musculoskeletal pain, arthralgia, bone pain; often puffiness of the joints; sometimes stiffness of muscles and joints; rarely - muscle weakness, arthritis.
From the urinary system: sometimes - kidney pain, hematuria, acute renal failure, frequent urination.
On the part of the reproductive and endocrine system: sometimes - gynecomastia, erectile dysfunction, menorrhagia, menstrual irregularities, sexual dysfunction, pain in the nipples, enlargement of the mammary glands, swelling of the scrotum.
Infectious and parasitic diseases: sometimes - sepsis, pnevmoniya6, herpes simplex, herpes zoster, nasopharyngitis, sinusitis, cellulitis, influenza, urinary tract infection, gastroenteritis, upper respiratory tract infection; rarely - mycoses.
On the part of the body as a whole: very often - fluid retention and swelling, increased fatigue, weight gain; often - weakness, fever, anasarca, chills, trembling, weight loss; sometimes - chest pain, malaise, increasing the concentration of creatinine and the activity of alkaline phosphatase, creatine kinase, lactate dehydrogenase in the blood; rarely - increased activity of amylase in the blood plasma.
1It reported about individual cases of development of hepatic insufficiency and liver necrosis.
2 Unfavorable cardiac events, including congestive heart failure, were more common in patients with XML in the acceleration phase and with blast crises compared to patients with XMJ1 in the chronic phase (duration of follow-up was 1 year).
3Hemorrhages (hematomas, hemorrhages) were most often observed in patients with XML in the phase of acceleration and blast crisis. 4 Pleural effusion was more common in patients with XML in the acceleration phase and in blast crisis compared with patients with XML in the chronic phase (duration of follow-up was 1 year).
5 Musculo-skeletal pains, including myalgia, arthralgia, bone pain were often noted in patients with XML. Pneumonia was most often observed in patients with XML in the phase of acceleration and blast crisis.
When imatinib is used in clinical practice, as well as during additional clinical The following undesirable phenomena were noted, listed below for organs and systems with the frequency of their occurrence: very often (> 1/10), often (> 1/100 - <1/10), sometimes (> 1/1000 - <1/100), rarely (> 1/10000 - <1/1000), very rarely (<1/10000), including individual messages. The relationship between the use of imatinib and these adverse events has not been established (the size of the patient population is unknown).
From the nervous system: sometimes - edema of the brain.
From the sense organs: rarely - vitreous hemorrhage.
From the cardiovascular system: sometimes - thrombosis / embolism; rarely pericarditis; cardiac tamponade; very rarely anaphylactic shock.
From the respiratory system: sometimes - acute respiratory failure, interstitial pneumonia.
From the digestive system: sometimes - paralytic / obturation intestinal obstruction, gastrointestinal perforation; rarely - diverticulitis.
From the skin: rarely -hehenoid keratosis, red flat lichen; toxic epidermal necrolysis.
From the musculoskeletal system: rarely - avascular necrosis / necrosis of the head of the femur.
1 There are some reports of the development of severe acute respiratory failure with a fatal outcome in patients with severe infectious diseases, severe neutropenia and other serious concomitant diseases.
2It reported about individual cases of development of gastrointestinal perforations with a lethal outcome.