Undesirable reactions identified in clinical studies are listed in accordance with the defeat of organs and organ systems and frequency of occurrence (MedDRA).
Frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥1 / 100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥1 / 10,000 and <1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.
Infectious and parasitic diseases
Infrequently: influenza, nasopharyngitis, oral herpes, pneumonia, sinusitis, tonsillitis, upper respiratory tract infection.
Often: pharyngitis, urinary tract infection.
Benign, malignant and unspecified neoplasms (including cysts and polyps)
Infrequently: malignant neoplasms of the rectosigmoid part of the large intestine.
Violations of the blood and lymphatic system
Infrequent: anemia, anisocytosis, eosinophilia, hemolytic anemia, leukocytosis, myelocytosis, thrombocytopenia, an increase in hemoglobin concentration, an increase in the number of stab-like leukocytes, a decrease in the concentration hemoglobin, an increase in the number of platelets, a decrease in the number of leukocytes.
Immune system disorders
Infrequent: hypersensitivity.
Disorders from the metabolism and nutrition
Infrequent: anorexia, hypokalemia, decreased appetite, increased appetite, gout, hypocalcemia, increased concentration of uric acid in the blood.
Disorders of the psyche
Infrequent: sleep disturbance (insomnia), anxiety, depression, apathy, mood disturbance, tearfulness.
Disturbances from the nervous system
Often: paresthesia.
Infrequently: dysgeusia, hypoesthesia, somnolence, migraine, tremor, imbalance, dysesthesia, hemiparesis, migraine with aura, peripheral neuropathy, peripheral sensory neuropathy, speech impairment, toxic neuropathy, headache (including vascular type).
Disturbances on the part of the organ of sight
Often: dry eyes.
Infrequent vision, clouding of the lens, astigmatism, cortical cataract, conjunctival hemorrhages, pain in the eye, increased lacrimation, retinal hemorrhage, retinal pigment epitheliopathy, decreased visual acuity, visual impairment, abnormal results of visual acuity studies, blepharitis, dry keratoconjunctivitis.
Hearing disorders and labyrinthine disorders
Infrequent: earache, dizziness.
Heart Disease
Infrequently: tachycardia, acute myocardial infarction, cardiovascular,cardiovascular disorder, cyanosis, palpitations, sinus tachycardia, prolongation of the QT interval on an electrocardiogram.
Vascular disorders
Infrequent: deep vein thrombosis, hypertension, embolic complications, hot flushes, superficial thrombophlebitis, a feeling of "blood rush," a hematoma.
Disturbances from the respiratory system, chest and mediastinal organs
Very often: nausea, diarrhea.
Often: dryness of the oral mucosa, vomiting.
Infrequently: epistaxis, pulmonary embolism, pulmonary infarction, cough, nasal discomfort, blister rashes on the mucous membrane of the oropharynx, pain in the oropharynx, paranasal sinus disease, obstructive sleep apnea syndrome.
Disorders from the gastrointestinal tract
Infrequent: constipation, pain in the upper abdomen, abdominal discomfort, stomach fullness, dyspepsia, abdominal pain, gum bleeding, glossodynia, hemorrhoids, bleeding from the oral cavity, tenderness of the abdomen, discolored stool, bloating, food poisoning , frequent defecation, vomiting with blood, discomfort in the oral cavity.
Disturbances from the liver and bile ducts
Often: increased activity of aspartate aminotransferase (ACT), increased activity alanine aminotransferase (ALT), hyperbilirubinemia, deviation of liver function from normal values.
Infrequently: cholestasis, liver damage, liver damage, hepatitis.
Disturbances from the skin and subcutaneous tissues
Often: alopecia, rash.
Infrequent: itching, subcutaneous hemorrhage, hyperhidrosis, generalized itching, urticaria, dermatosis, petechiae, cold sweat, erythema, melanosis, night sweats, skin pigmentation disorder, skin discoloration, skin peeling, facial puffiness.
Disturbances from musculoskeletal and connective tissue
Often: back pain, chest pain of the musculoskeletal nature, musculoskeletal pain, myalgia, arthralgia, muscle spasm, bone pain, pain in the limbs, a feeling of heaviness.
Infrequently: muscle weakness.
Disorders from the kidneys and urinary tract
Infrequent: renal failure, leukocyturia, lupus nephritis, nocturia, proteinuria, an increase in urea concentration in the blood, an increase in the concentration of creatinine in the blood, an increased ratio of protein / creatinine in the urine.
General disorders and disorders at the site of administration
Infrequent: increased fatigue, peripheral edema, chest pain, sensation of heat, pain, bleeding at the site of vascular puncture, asthenia, a sense of anxiety,painful condition, inflammation of the wound, flu-like syndrome, malaise, mucositis, non-cardiac pain in the chest, fever, foreign body sensation.
Laboratory and instrumental data
Infrequent: increased albumin concentration in the blood, increased activity of alkaline phosphatase, increased total protein concentration, weight gain, decreased albumin concentration in the blood, increased urine pH.
Injury toxication and complications of manipulation
Infrequent: bruise, sunburn.
Undesirable reactions in patients with chronic viral hepatitis C
Infectious and parasitic diseases
Often: infection of the urinary tract, infection of the upper respiratory tract, bronchitis, nasopharyngitis, influenza, oral herpes, gastroenteritis, pharyngitis.
Benign. malignant and unspecified neoplasms (including cysts and polyps)
Often: malignant neoplasms of the liver.
Violations of the blood and lymphatic system
Very often: anemia.
Often: lymphopenia, hemolytic anemia.
Disorders from the metabolism and nutrition
Very often: decreased appetite.
Often: hyperglycemia, a pathological decrease in body weight.
Disorders of the psyche
Very often: insomnia.
Often: depression, anxiety, sleep disturbance, confusion, agitation.
Disturbances from the nervous system
Very often: headache.
Often: dizziness, impaired attention, dysgeusia, hepatic encephalopathy, lethargy, memory impairment, paresthesia.
Disturbances on the part of the organ of sight
Often: cataracts, exudates of the retina, dry eyes, icteric sclera, retinal hemorrhage.
Hearing disorders and labyrinthine disorders
Often: dizziness.
Heart Disease
Often: a feeling of palpitations.
Disturbances from the respiratory system, chest and mediastinal organs
Very often: cough.
Often: shortness of breath, pain in the oropharynx, dyspnea with physical exertion, productive cough.
Disorders from the gastrointestinal tract
Very often: nausea, diarrhea.
Often: vomiting, ascites, abdominal pain, upper abdominal pain, indigestion, dry mouth, constipation, bloating, toothache, stomatitis, gastroesophageal reflux disease, hemorrhoids, abdominal discomfort, gastritis, varicose veins of the esophagus, aphthous stomatitis, bleeding from varicose veins of the esophagus.
Disturbances from the liver and bile ducts
Often: hyperbilirubinemia, jaundice, portal vein thrombosis, hepatic insufficiency, drug damage to the liver.
Disturbances from the skin and subcutaneous tissues
Very often: itching, alopecia.
Often: rashes, dry skin, eczema, itchy skin rashes, erythema, hyperhidrosis, generalized itching, night sweats, skin lesions.
Disturbances from musculoskeletal and connective tissue
Very often: myalgia.
Often: arthralgia, muscle spasms, back pain, pain in the limbs, musculoskeletal pain, bone pain.
Disorders from the kidneys and urinary tract
Very often: dysuria.
General disorders and disorders at the site of administration
Very often: increased fatigue, hyperthermia, fever, asthenia, peripheral edema, flu-like illness, chills.
Often: irritability, pain, malaise, reaction at the injection site, non-cardiac pain in the chest, swelling, rash at the injection site, chest discomfort, itching at the injection site.
Laboratory and instrumental data
Often: an increase in the concentration of bilirubin in the blood, a decrease in body weight, leukopenia, a decrease in the concentration of hemoglobin, a decrease in the number of neutrophilic leukocytes, normalized ratio, increased activated partial thromboplastin time (APTT), hyperglycemia, a decrease in albumin concentration in the blood, prolongation of the QT interval on the electrocardiogram.
Undesirable reactions in patients with TAA
Disturbances from the nervous system
Very often: headache.
Disturbances from the respiratory system, chest and mediastinal organs
Very often: cough, shortness of breath, pain in the oropharynx, rhinorrhea.
Disorders from the gastrointestinal tract
Very often: abdominal pain, diarrhea, nausea.
Disturbances from the liver and bile ducts
Very often: increased activity of transaminases.
Disturbances from the skin and subcutaneous tissues
Very often: bruising.
Disturbances from musculoskeletal and connective tissue
Very often: arthralgia, muscle spasm, pain in the extremities.
General disorders and disorders at the site of administration
Very often: dizziness, fatigue, febrile neutropenia, hyperthermia.
In a non-comparative open TAA study, patients were diagnosed with cytogenetic abnormalities in bone marrow aspiration biopsies.In 7 patients, the newly discovered cytogenetic abnormalities were detected, of which 5 patients had changes in the 7th chromosome.
Post-marketing research
With the use of elethrombopag in the post-marketing period, the following undesirable reactions were recorded.
Information about them was obtained from spontaneous reports, and also were registered as serious adverse events in the registries, in studies sponsored by the researcher, clinical pharmacological studies and search studies when applied for unapproved indications.
Vascular disorders
Rarely: thrombotic microangiopathy with acute renal failure.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.